(301 days)
Intended for use in defibrillation procedures, cardioversion and pacing. This device is intended for use on adults. Not for use on children or infants.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from AAMI DF-39) | Reported Device Performance (Medi-Trace® 1210H) |
|---|---|
| Electrical Tests | Met specifications established in DF-39 for self-adhesive electrodes for monitoring, defibrillation, and pacing. |
| DF-39, 3.3.19 (specific electrical test requirements) | Met specifications. |
| Energy Throughput Testing | Met specifications established in DF-39 for self-adhesive electrodes for monitoring, defibrillation, and pacing. |
| Simulated Use Testing (Multiple Defibrillation Shocks & Max Current Pacing) | Met specifications established in DF-39 for self-adhesive electrodes for monitoring, defibrillation, and pacing. |
| Biocompatibility (Non-irritating) | Found to be non-irritating. |
| Biocompatibility (Non-cytotoxic) | Found to be non-cytotoxic. |
| Biocompatibility (Non-sensitizing) | Found to be non-sensitizing. |
| Shelf Life | Data from accelerated shelf-life studies substantiated the claimed shelf life. (Specific duration of shelf life not provided in the text). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for specific tests. The text indicates "The device and the predicate were subjected to AAMI electrical tests" and "In addition, the device was subjected to simulated used testing." This implies at least one device, but the number of units tested for each criterion is not specified.
- Data Provenance: Not explicitly stated. The studies were conducted by the manufacturer, Graphic Controls Corporation, located in Buffalo, NY, USA. The text does not indicate the country of origin of patient data (as no patient data was used in these technical/lab tests) or whether the studies were retrospective or prospective. Given the nature of the tests (electrical, simulated use, biocompatibility), they are almost certainly prospective lab-based studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The "ground truth" for these tests is established by objective, quantifiable performance specifications outlined in the AAMI DF-39 standard and ISO-10993 for biocompatibility. These are technical and performance benchmarks, not subjective assessments requiring expert consensus on clinical findings.
4. Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" is based on objective standards, there is no need for expert adjudication. The results are either "met specifications" or "did not meet specifications."
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 electrocardiograph electrode, not an AI-powered diagnostic tool requiring human interpretation of images or signals. Therefore, no MRMC study or AI assistance evaluation was performed or relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a passive medical device (electrode), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- Established Technical Standards and Specifications: The ground truth for this device's performance is based on:
- AAMI DF-39 Standard: For electrical performance, energy throughput, and simulated use.
- ISO-10993 (Part 1): For biocompatibility (specifically non-irritating, non-cytotoxic, non-sensitizing properties).
- Manufacturer-defined specifications for shelf life, substantiated by accelerated aging data.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 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.