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The Affinity Medical Patient Cable Systems are intended to transmit data in the form of electrocardiographic signals from patient ECG electrode pads to ECG monitors.

The Affinity Cable and Leadwire System includes ECG cables, individual leadwires, and accessories. The Affinity Cable and Leadwire System is based upon proven designs to assure secure connections for patient safety and operator ease of use. The Affinity Cable and Leadwire System is reusable and is designed and tested to conform to the following standards: ANSI/AAMI EC53-1995 and 21 CFR Part 898.

The Affinity Cable and Leadwire System is manufactured of materials with a proven history of use for ECG cables. The Affinity Cable and Leadwire System contains no latex or latex products which are external and exposed to the patient.

The Affinity Cable and Leadwire System is provided non-sterile.

The Affinity Cable and Leadwire System is designed to minimize the potential for incorrect attachments. Leadwires are color coded for positive identification. Leadwire connectors include recessed sockets to preclude attachment to power cables or outlets.

The provided text describes the regulatory clearance for the "Affinity Medical Patient Cable Systems" (K980806) and states that it is substantially equivalent to a predicate device, the "Tronomate™ Patient Cable and Leadwire System" (K952659).

However, the documentation provided does not contain information about specific acceptance criteria or a dedicated study that proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the submission relies on the concept of substantial equivalence to a predicate device and adherence to recognized standards.

Here's a breakdown of the requested information based on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document does not describe a clinical or performance study with a 'test set' in the conventional sense of evaluating a diagnostic algorithm. The testing mentioned appears to be related to engineering design verification and validation against standards, not patient data analysis.
• Data Provenance: Not applicable, as no clinical data test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. The document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is an ECG cable system, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is an ECG cable system, which is a passive device for signal transmission. It does not involve algorithms or human-in-the-loop performance that would require such a study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable in the context of a performance study evaluating diagnostic accuracy. The "ground truth" here is adherence to engineering standards (ANSI/AAMI EC53-1995, 21 CFR Part 898) and functional equivalence to the predicate device.

8. The sample size for the training set

• Not applicable. There is no AI model or training set involved.

9. How the ground truth for the training set was established

• Not applicable. There is no AI model or training set involved.

Summary of Device Acceptance:

The Affinity Medical Patient Cable Systems were accepted for market clearance based on substantial equivalence (SE) to a legally marketed predicate device (Tronomate™ Patient Cable and Leadwire System, K952659) and through demonstrating conformity to applicable performance standards (ANSI/AAMI EC53-1995 and 21 CFR Part 898). The submission focuses on design, material composition, and adherence to safety and performance standards for medical cables, rather than clinical performance metrics from a typical diagnostic algorithm study. The device's function is to reliably transmit ECG signals, and its acceptance criteria are primarily related to its physical and electrical properties ensuring that function, patient safety, and compatibility with monitors, as dictated by the predicate device and relevant standards.

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