(162 days)
Intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on neonatal and pediatric patients.
A neonatal ECG monitoring electrode consisting of a conductive adhesive gel, a silver/silver chloride plated eyelet, a foam substrate and vinyl label and a 24 inch lead wire terminating in a 0.059" DIN standard safety socket.
Here's a breakdown of the acceptance criteria and the study details for the Graphic Controls Corporation Medi-Trace® 4103 Neonatal ECG Electrode with Preattached Lead Wire, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| AAMI electrical tests (ANSI/AAMI DF-12, 1991) | Met specifications established in DF-12-1991 |
| ECG trace quality | Found comparable to the predicate device |
| Biocompatibility (ISO-10993 Part 1) | Non-irritating, non-cytotoxic, and non-sensitizing |
| Shelf life | Data substantiated claimed shelf life |
Note: The document states that the modified device was found "comparable" to the predicate for ECG trace quality. Specific quantitative metrics for ECG trace quality or a detailed comparison are not provided.
Study Details
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the test set used in the performance summary. It broadly states that "the device and the predicate were subjected to AAMI electrical tests" and implies a comparison.
- The data provenance is not explicitly mentioned (e.g., country of origin). The testing seems to have been conducted by the manufacturer, Graphic Controls Corporation.
- The nature of the data (retrospective or prospective) is not indicated, but given the context of device testing for a premarket notification, it would typically be prospective testing conducted by the manufacturer.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The performance tests appear to be objective electrical and biocompatibility assessments against standards rather than expert-derived ground truth. For "ECG trace quality," it's mentioned as comparable to the predicate, but the methodology for this comparison (e.g., expert review vs. automated measurement) is not detailed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- There is no mention of an adjudication method. The reported performance is based on meeting voluntary standards for electrical characteristics and biocompatibility testing.
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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 electrode, not an AI-powered diagnostic tool, so such a study would not be applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (an electrode) and does not involve an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the electrical tests and biocompatibility was defined by the specifications of the ANSI/AAMI DF-12, 1991 voluntary standard and the recommendations in the ISO-10993 Biological Evaluation of Medical Devices Part 1. For "ECG trace quality," the ground truth was the performance of the legally marketed predicate device.
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The sample size for the training set:
- Not applicable. This device is a physical electrode and does not utilize a training set in the context of machine learning or algorithms.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.