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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:

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.

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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:

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.

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Ask a specific question about this device