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Smart Conversation Topics (SCT) – Instructions for Use and Product Label

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Written by Becca

Smart Conversation Topics (SCT) – Instructions for Use

Instructions for use version: 1.0

Date of issue: 19/10/2026

Device Identification

Device name: Smart Conversation Topics (SCT)

Manufacturer: Accurx Ltd

Manufacturer address: 7 Curtain Road, Shoreditch, London, EC2A 3LT, United Kingdom

Manufacturer email: support@accurx.com

Intended Purpose

The Smart Conversation Topics (SCT) device is intended for use in primary care, as part of the patient triage pathway. The software generates short summaries of patient medical requests for healthcare staff, which they may use to prioritise the order in which they review the full patient requests.

Intended Users

The device is intended to be used by trained healthcare professionals in primary care settings.

Intended Patient Population

The intended patient population are patients in primary care settings.

Indications

The device is indicated for use in primary care settings.

Contraindications

The device is contraindicated for use by patients requiring urgent medical assistance.

Expected Clinical Benefits

Smart Conversation Topics provides the following intended clinical benefit:

  • To generate short summaries of patient medical requests for healthcare staff, which they may use to prioritise the order in which they review the full patient requests

Summary of Safety and Performance Characteristics

Key safety and performance results from the pre-market Clinical Performance Evaluation:

Clinical Safety

Result

Inappropriate de-prioritisation – SCT could reasonably result in HCP inappropriately de-prioritising when to review a patient request.

0%

Hallucinations:

– SCTs that introduce hallucinated information.

– Hallucinations that could reasonably result in patient harm.

2.7%

0%

Clinical Performance

Result

Supporting Prioritisation

97.5%

Readability and Language

86.7%

Residual Risks

All residual risks related to the device have been reduced as far as reasonably possible and to acceptable levels through implemented risk control measures.

The device does not replace professional clinical judgement.

⚠️ Warnings

The device uses generative AI, which may result in errors or inappropriate summaries.

Precautions

  • This software summarises patient triage requests to support prioritising the order in which to review full patient requests. It does not replace the clinical judgement of the triaging healthcare professional.

  • Do not base diagnostic or management decisions on the SCT.

  • Do not use the device for urgent medical queries.

System Requirements

The following are required to access the STQs device:

Healthcare staff:

Serious Incident Reporting

Users should report any serious incident that has occurred in relation to the device to the manufacturer and to the UK competent authority.

  • Manufacturer: Contact support@accurx.com or use the in-product Report feedback tool.

  • United Kingdom competent authority: the Medicines and Healthcare products Regulatory Agency (MHRA), via the Yellow Card scheme (yellowcard.mhra.gov.uk).

Operating Instructions

Healthcare staff instructions:

  1. Access outputs: the healthcare professional may view the device output within the conversation list and within the patient header when a conversation is open for medical requests only.

  2. Triage: use the smart conversation topics to help prioritise the order in which you review the full patient medical triage requests. Do not make triage, diagnostic or management decisions on the sole basis of smart conversation topics.

  3. Review: Review the patient's full medical request before acting upon them using professional clinical judgement.

  4. Record keeping: Conversation topics are not intended to be saved to the medical record or prescriptions. Verify all content before it is copied or transferred into medical records or prescriptions; do not copy or transfer unverified content.

Paper Copy

Email Accurx Support at support@accurx.com if you require a paper copy of the Instructions for Use.


Smart Conversation Topics (SCT) – Product Label

Product label version: 1.1
Date of issue: 20/10/2026

Device Identification

Device name: Smart Conversation Topics (SCT)

Type: Class I - UK MDR 2002

UDI: 01050569305000168012v4.1.0-df1dcd04

Date of software version: 07/10/2026

Manufacturer Information

Manufacturer: Accurx Ltd

Manufacturer address: 7 Curtain Road, Shoreditch, London, EC2A 3LT, United Kingdom

Manufacturer email: support@accurx.com

Intended Purpose

The Smart Conversation Topics (SCT) device is intended for use in primary care, as part of the patient triage pathway. The software generates short summaries of patient medical requests for healthcare staff, which they may use to prioritise the order in which they review the full patient requests.

⚠️ Warnings

The device uses generative AI, which may result in errors or inappropriate summaries.

Precautions

  • This software summarises patient triage requests to support prioritising the order in which to review full patient requests. It does not replace the clinical judgement of the triaging healthcare professional.

  • Do not base diagnostic or management decisions on the SCT.

  • Do not use the device for urgent medical queries.

Instructions For Use

Available electronically above. Please email Accurx Support at support@accurx.com if you require a paper copy of the Instructions for Use.

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