(132 days)
Skintact® Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. These electrodes have been qualified for use with defibrillators delivering a maximum of 100 joules such as: Zoll M and E series and PD1200, 1400, 1600 & 1700 defibrillators; Medtronic LifePak 9, 10, 12 and 20 defibrillators; Philips Heartstart MRx and XL defibrillators; Welch Allyn PIC 30, PIC 40 and PIC 50 defibrillators; Philips Codemaster XE, XL, XL+ and 100 defibrillators.
All Skintact® Multifunction Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® Pediatric Multifunction Electrodes with DH03 Gel are composed of the same materials as the predicate device K073322 by Leonhard Lang except the modified DH03 Gel (made by Leonhard Lang).
The provided text describes a 510(k) submission for the "Skintact® Pediatric Multifunction Electrodes with DH03 Gel". The submission aims to demonstrate substantial equivalence to predicate devices, rather than proving that the device meets specific acceptance criteria through a standalone study with detailed performance metrics.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this type of regulatory document.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical targets. Instead, it states that the device "met specifications as established in ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003". This implies that the acceptance criteria are defined by these international standards for defibrillation electrodes. The "reported device performance" is the statement that the device met these specifications.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI DF80:2003 (Defibrillation Electrodes) | Met specifications |
| IEC/EN 60601-2-4:2003 (Medical Electrical Equipment - Defibrillators) | Met specifications |
| ISO 10993 (Biocompatibility for intact skin) | Conducted and passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the performance testing or the provenance of the data (country of origin, retrospective/prospective). This level of detail is typically not included in a 510(k) summary but would be part of the full test reports.
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 is not applicable as the performance testing involved meeting engineering and biocompatibility standards, not clinical diagnosis or interpretation by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the evaluation was against technical standards and not subjective interpretation requiring 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
Not applicable. This device is an electrode, not an AI-powered diagnostic tool, and no MRMC study was conducted or is relevant to its substantial equivalence claim.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done in the sense that the electrodes themselves were tested against the specified standards (biocompatibility, electrical performance). This is an "algorithm only" equivalent for a physical device, where the "algorithm" is the device's design and materials performing its intended function. The testing did not involve human-in-the-loop performance studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device is defined by the technical specifications and testing methodologies outlined in the referenced standards (ANSI/AAMI DF80:2003, IEC/EN 60601-2-4:2003, and ISO 10993). These standards define acceptable performance parameters for biocompatibility and electrical characteristics of defibrillation electrodes.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
§ 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.