(327 days)
Short-term (
Pregelled electrodes are of Aq/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.
The provided text describes a 510(k) submission for ECG electrodes, which are hardware devices, not AI/ML software. Therefore, many of the requested categories in the prompt are not applicable. The core of the submission is to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a study with the detailed elements requested for AI/ML.
Here's an attempt to address the prompt based on the available information, noting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
The submission demonstrates substantial equivalence to predicate devices rather than meeting specific quantifiable performance metrics. The implicit "acceptance criteria" for a 510(k) are that the device is as safe and effective as a legally marketed predicate. The "reported device performance" is that it is identical in composition, function, and design, and has comparable biocompatibility.
| Acceptance Criteria (Implied for 510(k) SE) | Reported Device Performance (as stated) |
|---|---|
| Safe for intended use | Biocompatibility established in standard safety tests. |
| Effective for intended use | Identical in composition, function, and design to predicate devices. Performs "at least as well as other disposable ECG monitoring electrodes." |
| Substantially equivalent to predicate device | Stated to be "identical in composition, function and design" and has the "same intended use" as legally marketed disposable ECG monitoring electrodes. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study assessing AI/ML software performance. The submission relies on demonstrating substantial equivalence through comparison of technological characteristics and biocompatibility testing, not clinical "test sets" in the AI/ML context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment for a test set is not relevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication for a test set is not relevant for this type of device submission.
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 is a passive ECG electrode, not an AI/ML system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (ECG electrode), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Ground truth is not a concept applied in this context for ECG electrodes. What is relevant is the established safety and efficacy of the predicate device, against which these electrodes are being compared for substantial equivalence.
8. The sample size for the training set
Not applicable. There is no AI/ML model to train for this device.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model to train 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.