(57 days)
The Skintact® Multifunction Electrodes are for use on adults and children over eight years old for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single-use only.
Skintact Multifunction Electrodes are self-adhesive, non-sterile, single use disposable clectrodes. Skintact® Multifunction Electrodes consist of a foam backing, a laminated metallic substrate and conductive adhesive gel DH 02. Several shapes and sizes are offered, in accordance with standards. Skintact® Multifunction Electrodes are packaged in pairs with color-coded cabling within watervapor-proof, heat-sealed, non-transparent, aluminized pouches.
The provided text is a 510(k) summary for the Skintact® Multifunction Electrodes. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on comparison and testing. However, it does not contain the detailed study information needed to fill out all aspects of your request regarding acceptance criteria and performance studies for an AI/CAD device.
The document discusses performance testing but in a general sense related to electrical safety, biocompatibility, and meeting international standards for defibrillation electrodes, not in the context of an AI/CAD diagnostic or detection system. Therefore, I cannot provide information on acceptance criteria and study details as they would apply to an AI-driven device.
Here's what I can extract and infer based only on the provided text, heavily indicating what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: No risk from hydrogel. | Biocompatibility tests in accordance with ISO 10993 performed on hydrogel; confirms gel is biocompatible and does not introduce any risks. |
| Performance with Defibrillators: Meets specifications for monophasic and biphasic defibrillators. | Testing in accordance with internationally recognized standards demonstrated that performance meets specifications and are suitable for use with monophasic and biphasic defibrillators. |
| Shelf-Life: 24 months. | Demonstrated 24-month shelf-life (based on prior products with same packaging); accelerated aging confirmed 24-month shelf-life for DH02 gel and materials. |
| Adult Defibrillation Area: Minimum active (gel) area of 82 cm²; total area of two electrodes at least 164 cm². | Skintact Multifunction Electrodes for adult defibrillation (and children over 8 years) and pacing have a minimum active (gel) area of 82 cm² and the total area of the two electrodes is at least 164 cm², thus meeting standard requirements. |
Missing Information/Not Applicable (for AI/CAD specific criteria):
- No specific quantitative criteria like sensitivity, specificity, AUC for a diagnostic task.
- No details on how performance was measured (e.g., number of tests, specific outcomes).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the performance tests. The document refers to "biocompatibility tests," "testing to evaluate the performance," and "accelerated aging" without providing numbers of units tested or duration of tests beyond the 24-month shelf-life claim.
- Data Provenance: Not specified.
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 as this is not a diagnostic AI/CAD device. The ground truth for performance relates to physical and electrical properties, not clinical diagnoses requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not a diagnostic AI/CAD device.
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, a MRMC study was not done. This device is a medical electrode, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm. Performance tests would be for the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility: Ground truth established by adherence to ISO 10993 standards and presumably laboratory test results (e.g., cytotoxicity, irritation tests).
- For electrical performance: Ground truth established by adherence to "internationally recognized standards" for defibrillation electrodes, likely involving electrical measurement tests.
- For shelf-life: Ground truth established through accelerated aging tests and potentially real-time aging data from existing products.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for these electrodes would be their design, manufacturing processes, and materials selection.
9. How the ground truth for the training set was established
- Not applicable. As above, this is a physical medical device, not an AI algorithm requiring a training set with established ground truth in the AI/ML sense.
§ 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.