(301 days)
Intended for use in defibrillation procedures. This device also allows for ECG monitoring. There are no population restrictions for the device except as noted in the directions for use.
A pre-gelled conductive electrode consisting of a means of attaching the electrode to the cable, an insulating layer of vinyl, a layer of metal foil, a conductive adhesive hydrogel, a pressure sensitive adhesive ring and a release liner. Device is packaged in pairs in a heat sealed pouch, 10 pouches are packaged into one shelf-box/shipper.
The provided 510(k) summary describes a medical device, the Medi-Trace® 1110L Combination Defibrillation and ECG Electrode, but it does not contain information related to an AI/ML-driven device or study evaluating such a device. The document focuses on performance testing of a physical electrode against established industry standards.
Therefore, many of the requested categories for AI/ML device evaluation (like sample size for test/training sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, adjudication methods) are not applicable to this document.
However, I can extract the relevant acceptance criteria and performance information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Electrical Performance: ANSI/AAMI DF39-1993, part 3.3.19 | "Test results indicated that this device meets or exceeds ANSI/AAMI specifications for electrical testing as established in DF39-1993, part 3.3.19" |
| Labeling Requirements: ANSI/AAMI DF39-1993, part 3.1.2 | "Test results indicated that this device meets or exceeds... labeling requirements as established in part 3.1.2 for self adhesive electrodes for monitoring and defibrillation." |
| Biocompatibility: ISO-10993 (FDA May 1, 1995 memo) | "The device was found to be non-irritating, noncytotoxic and non-sensitizing." |
| Shelf Life: Subst substantiate claimed shelf life (Accelerated Shelf Life Studies) | "Data obtained in accelerated shelf life studies was reviewed and found to substantiate our claimed shelf life." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "The device was subjected to AAMI electrical tests" and "The device was subjected to biocompatibility testing," implying tests were performed on a sample of the electrodes, but the specific number of electrodes tested for each criterion is not provided.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are laboratory and accelerated aging studies on the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device requiring expert-established ground truth for its performance evaluation. The "ground truth" here is compliance with engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Performance is measured against objective standards, not through human interpretation or adjudication.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI/ML device. The "standalone" performance here refers to the device itself meeting physical and electrical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is adherence to established industry engineering standards (ANSI/AAMI DF39-1993 for electrical and labeling, and ISO-10993 for biocompatibility).
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device that requires a training set.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.