(102 days)
Skintact® Radioiransparent Multifunction Electrodes are for use on adults and children over eight years old or weighing more than 25 kg for external defibrillation, pacing, monitoring and cardioversion. The device is non - sterile and single use only.
All Skintact Multifunction Electrodes are self-adhesive, non-sterile, single use disposable electrodes. Multifunction electrodes can be used for defibrillation, pacing, cardioversion and monitoring. These multifunction electrodes have the additional feature "radiotransparent" which allows these electrodes to stay on the patient when moving through different departments.
This document is a 510(k) summary for a medical device called "Skintact Radiotransparent Multifunction Electrodes." It is not a study report or clinical trial. Therefore, it does not contain the detailed information necessary to answer all the questions about acceptance criteria, device performance, and study methodology as typically found in a clinical study report for AI/ML-based devices.
However, I can extract the information that is present and explain why certain details are missing.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of "acceptance criteria" for an AI/ML device or detailed "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity, accuracy).
Instead, it states that the device's performance met specifications established in existing standards:
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ANSI/AAMI DF80:2003 | Met specifications |
| IEC/EN 60601-2-4:2003 | Met specifications |
| ISO 10993 (intact skin) | Passed |
These standards relate to the electrical safety and performance of defibrillation electrodes and biocompatibility, not to the diagnostic performance of an AI/ML algorithm.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes performance testing against established standards for medical devices, which typically involves laboratory testing or bench testing, not clinical studies with "test sets" in the context of AI/ML evaluation.
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)
This information is not provided as the device is a piece of hardware (multifunction electrodes) and not an AI/ML diagnostic tool requiring expert-established ground truth for performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided for the same reason as above.
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
This information is not applicable and therefore not provided. The device is an electrode, not an AI system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and therefore not provided. The device is a physical electrode, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically discussed for AI/ML devices is not applicable here. The "ground truth" for this device's performance would be objective measurements against the technical specifications outlined in the mentioned standards (ANSI/AAMI DF80:2003, IEC/EN 60601-2-4:2003, ISO 10993).
8. The sample size for the training set
This information is not applicable and therefore not provided. This device is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. There is no training set for this device.
Summary of Device and Evaluation:
The document describes the submission of "Skintact Radiotransparent Multifunction Electrodes" for 510(k) clearance. The purpose of the submission is for an additional feature: "radiotransparent," allowing the electrodes to remain on a patient during imaging.
The basis for equivalence (and thus, acceptance) to predicate devices is primarily focused on:
- Biocompatibility testing: Passed ISO 10993 for intact skin.
- Performance data: Met specifications as established in ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003. These standards relate to the electrical and functional performance of defibrillation electrodes.
The crucial point is that this document is for a traditional medical device (electrodes), not an AI/ML-driven diagnostic or treatment device. Therefore, the questions related to AI/ML specific evaluation metrics, ground truth, expert adjudication, and training/test sets are not relevant to this submission. The "study" mentioned refers to performance testing against established safety and efficacy standards for the hardware itself.
§ 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.