(156 days)
The device is intended to be used with ECG. The lead wire 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 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 lead wire connector plugs into one end of the trunk cable which are plug into an ECG monitor. The proposed devices are available in disposable and reusable two types.
The provided text is a 510(k) summary for Patient Cables and Leadwires, Disposable ECG Leadwires. It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and does not include a study proving that the device meets specific performance acceptance criteria in the context of a clinical or standalone effectiveness study.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable based on the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit performance acceptance criteria in the format typically used for studies evaluating a device's diagnostic or monitoring accuracy against a specific metric. Instead, it refers to compliance with safety and performance standards for non-clinical aspects.
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | ISO10993-1, ISO10993-5 (In Vitro Cytotoxicity), ISO10993-10 (Irritation and Skin Sensitization) | No irritation, No sensitization, No cytotoxicity |
| Electrical 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 with IEC 60601-1 and EC53 |
| Functional Performance | ANSI/AAMI EC53:2013 (ECG Trunk Cables and Patient Leadwires) | Comply with EC53 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical tests (biocompatibility, electrical safety, functional performance) on the device itself or its materials, not studies with a "test set" of patient data.
3. 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. There is no test set or ground truth established by medical experts for evaluating clinical performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is mentioned.
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
Not applicable. This device is an ECG leadwire, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an ECG leadwire, which facilitates signal transmission, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests, the "ground truth" is defined by the requirements of the standards (e.g., cytotoxicity assays, electrical safety measurements, material property tests).
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm-based device requiring a training set.
Summary of the Study (as described in the document):
The "study" described in this 510(k) summary consists of non-clinical tests performed to verify that the proposed device (Patient Cables and Leadwires, Disposable ECG Leadwires) meets design specifications and is substantially equivalent to a predicate device (K120010).
- Type of Study: Non-clinical bench testing.
- Purpose: To demonstrate compliance with recognized industry standards for biocompatibility (ISO 10993 series), electrical safety (IEC 60601-1), and functional performance of ECG leadwires (ANSI/AAMI EC53).
- Conclusion: "The test results demonstrated that the proposed device complies with the following standards." and "No clinical study is included in this submission."
- General conclusion: Based on these non-clinical tests, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
§ 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).