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510(k) Data Aggregation
(231 days)
MEDI-TRACE 200, MEDI-TRACE 200-30
Intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician.
A conductive wet gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated ABS cyelet, nickel plated brass stud, an adhesive foam substrate, vinyl label and polystyrene release liner. Electrodes are packaged either as 100 per pouch (Medi-Trace® 200) or 30 per pouch (Medi-Trace® 200-30); pouches are heat sealed. Unit of sale for each packaging is a case of either 600 or 1000 electrodes.
This document describes a 510(k) summary for ECG electrodes, which are hardware devices and do not involve AI or algorithms. Therefore, much of the requested information (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) is not applicable.
However, I can extract the acceptance criteria and performance summary related to the physical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| AAMI EC12-1991 (Electrical Performance) | Meets or exceeds performance specifications |
| AAMI EC12-1991 (Labeling) | Meets AAMI standard |
| AAMI EC12-1991 (Shelf Life) | Meets AAMI standard |
| AAMI EC12-1991 (Packaging) | Meets AAMI standard |
| AAMI EC12-1991 (Safety) | Meets AAMI standard |
| Graphic Controls' Internal Specifications (Trace Performance) | Meets internal specifications |
| ISO 10993 Part 1 (Biocompatibility - Irritation) | Non-irritating |
| ISO 10993 Part 1 (Biocompatibility - Cytotoxicity) | Non-cytotoxic |
| ISO 10993 Part 1 (Biocompatibility - Sensitization) | Non-sensitizing |
| Real-time shelf life studies | Substantiates claimed shelf life |
2. Sample size used for the test set and the data provenance:
- This information is not explicitly provided in the document. The tests performed are for device performance as per AAMI standards.
- Data provenance is not specified, but the testing would have been conducted by or for Graphic Controls Corporation.
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 a hardware device. Device performance is measured against established industry standards (AAMI EC12-1991) and internal specifications, not expert-established ground truth in a diagnostic sense.
4. Adjudication method for the test set:
- Not applicable. Performance is measured against objective standards, not through expert 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:
- Not applicable, as this is a hardware device (ECG electrode), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a hardware device (ECG electrode), not an AI algorithm.
7. The type of ground truth used:
- The "ground truth" here is the set of specifications and performance requirements outlined in the AAMI EC12-1991 standard for Disposable ECG Electrodes, as well as Graphic Controls' internal specifications and the biocompatibility standards of ISO 10993.
8. The sample size for the training set:
- Not applicable, as this is a hardware device (ECG electrode), not an AI algorithm.
9. How the ground truth for the training set was established:
- Not applicable, as this is a hardware device (ECG electrode), not an AI algorithm.
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