(166 days)
The ECG Cable/Leadwires is intended to be used with ECG. The ECG Cable/Leadwires is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
The ECG Cable/Leadwires is comprised of Plug, cable/leadwires and connector. The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The leadwires connector plugs into one end of the external trunk cable which is plug into an ECG monitor.
This is a 510(k) premarket notification for an ECG Cable/Leadwires device. The document states that no clinical tests were performed, which means no studies were done to establish the acceptance criteria for device performance or to prove the device meets those criteria in a clinical setting.
The provided information focuses on demonstrating substantial equivalence to a predicate device (K120010) through nonclinical testing.
Here's a breakdown of the requested information based on the provided document:
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A table of acceptance criteria and the reported device performance
Acceptance Criterion (Standard) Reported Device Performance Electrical Performance and Safety: IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 (Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance) Comply AAMI/ANSI EC53:2013 (ECG Trunk Cables and Patient Leadwires) Comply Biocompatibility: ISO 10993-1:2009 (Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process) No cytotoxicity, No irritation, No sensitization (Implied) Note: The document states that the device "Comply with" these standards for electrical performance and safety, and lists biocompatibility results for "No cytotoxicity, No irritation, No sensitization," implying these are the acceptance criteria met through testing following ISO 10993-1.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for non-clinical tests.
- Data Provenance: Not specified, but generally, bench testing (non-clinical) is conducted by the manufacturer or a contracted lab. The manufacturer is Shenzhen Coreray Technology Co., Ltd. in P.R China. The testing would be prospective in nature for device validation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is a medical device (ECG Cable/Leadwires) undergoing non-clinical bench testing for electrical safety, performance, and biocompatibility, not an AI/diagnostic software that requires expert ground truth for interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for non-clinical bench testing. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies.
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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. A MRMC comparative effectiveness study was not done. This device is an ECG cable/leadwire, which is a hardware component for signal transmission, not an AI-powered diagnostic tool for interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is an ECG cable/leadwire, a hardware component for signal transmission. It is not an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international and national standards (IEC 60601-1, AAMI/ANSI EC53, ISO 10993-1). Compliance with these standards indicates the device adequately performs its intended function and is safe.
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The sample size for the training set
- Not applicable. This is a hardware medical device; there is no "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).