(27 days)
Multi-Link Cable and Lead Wire Systems are electrode cable systems used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctors offices, emergency vehicles, as well as in home use.
Multi-Link Cable and Lead Wire Systems are a reusable electrode cable systems used to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. This type of device is common to both the industry and to most medical establishments.
The provided K980582 submission describes a medical device, the "Multi-Link Cable and Lead Wire Systems," which are reusable electrode cable systems used to transmit ECG signals. The study described is a comparison to a predicate device, not a standalone AI device study. Therefore, many of the requested categories are not applicable.
Here's the analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 21CFR Part 898: Performance Standard for Electrode Lead Wire and Patient Cables (effective May 11, 1998) | Meets 21CFR Part 898: Performance Standard for Electrode Lead Wire and Patient Cables |
| AAMI ECGC-5/83 (Electrical and Mechanical Testing) | Meets equivalent electrical and mechanical testing to AAMI ECGC-5/83 |
| Substantial Equivalence to ConMed 3. Corp. ECG Patient Cables and Leadwires (K933649) | Demonstrated substantial equivalence to the predicate device |
Since this is a submission for an ECG lead wire and cable system, and not an AI-powered diagnostic device, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The study involved a "comparison of the predicate device's production and both electrical and mechanical testing to AAMI ECGC-5/83 was made to the equivalent production, electrical and mechanical testing of the Multi-Link Cable and Lead Wire Systems." This suggests product testing rather than a clinical dataset in the traditional sense for an AI device.
- Data Provenance: Not applicable in the context of clinical data for AI. The testing would have been performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert-established clinical ground truth for diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of diagnostic findings.
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, an MRMC comparative effectiveness study was not done. This device is an ECG cable system, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For electrical and mechanical testing, the "ground truth" would be the specifications and requirements of the AAMI ECGC-5/83 standard and 21CFR Part 898. For substantial equivalence, it would be a direct comparison of the device's characteristics and performance to the predicate device.
8. The sample size for the training set:
- Not applicable. This device does not involve a training set as it's not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).