(102 days)
The Philips Self-Adhesive Electrodes are intended for use with the PulseRelief device for applying Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS)
The Philips Self-Adhesive Electrodes is used as a transcutaneous electrical nerve stimulation electrode in conjunction with the Philips PulseRelief device which is an electrical stimulator for TENS or EMS. Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device. It is composed of: 1. Metal target, 2. Rivet, 3. Textile adhesive layer, 4. Carbon layer, 5. Hydrogel layer, 6. Backing sheet. Proper current distribution is delivered via use of a printed silver pattern.
The provided text describes the acceptance criteria and performance data for the Philips Self-Adhesive Electrodes in the context of demonstrating substantial equivalence to a predicate device for FDA 510(k) clearance. This is not a study proving a device meets acceptance criteria for an AI/ML algorithm or a new medical device that requires clinical performance studies based on efficacy or accuracy.
The "acceptance criteria" here refers to the parameters assessed for substantial equivalence with a legally marketed predicate device (Axelgaard ValuTrode® Neurostimulation Electrodes K130987). The "study" refers to the performance data gathered to support this claim, primarily focusing on physical and electrical characteristics as well as biocompatibility, rather than clinical efficacy studies often associated with AI/ML devices.
Therefore, for most of the requested information points (especially those related to AI/MRMC studies, ground truth, experts, and data provenance related to clinical performance), the document does not provide the relevant data because this is a 510(k) submission for a simple medical device (electrodes), not an AI/ML diagnostic tool.
I will populate the table and answer the questions based only on the information available in the provided document, acknowledging where the information is not applicable or not present for this type of device submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate or general standards for electrodes) | Reported Device Performance (Philips Self-Adhesive Electrodes) |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity test | Tested in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| - Sensitization test | Tested in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| - Irritation test | Tested in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| Electrical Performance: | |
| - Current distribution (equal) | Tested to assure the current is equally distributed. |
| - Impedance (proper electrical connection) | Tested for Impedance to assure proper electrical connection to the skin. |
| - Average power density (max 0.25 W/cm²) | Calculated average power density: 0.0026 W/cm². This is below the maximum value of 0.25 W/cm². |
| (Calculation: Max current 60mA, Max voltage 60V, Surface area 25cm² (50x50mm). Worst case r.m.s. current in program 1: (2*90µs/10ms)*60mA = 1.08mA. Current density = 1.08mA/25cm² = 43µA r.m.s. Power = 43µA * 60V = 0.0026 W/cm².) | |
| Mechanical Performance: | |
| - Initial adhesion force | Tested. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| - Adhesion force after multiple uses | Tested. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| - Connector/Magnetic clamping reliability (multiple use) | Tested to assure multiple use and to assure the TENS PulseRelief stays fixed to the Philips Self-Adhesive Electrode during use. (Results implicitly positive, as the conclusion states the device is safe and effective). |
| Packaging/Storage: | |
| - Storage conditions (41°F to 80.6°F / +5°C to +27°C) | Tested for storage conditions. (Results imply compliance with specified range). |
| - Accelerated aging (function as expected within expiration date) | Tested for accelerated aging in worst storage condition to assure function within the expiration date. (Results implicitly positive, as the conclusion states the device is safe and effective). |
2. Sample size used for the test set and the data provenance
The document does not specify the explicit sample sizes for the various performance tests (e.g., number of electrodes tested for electrical properties, adhesion, accelerated aging).
The data provenance is from tests conducted on the Philips Self-Adhesive Electrodes, which are manufactured by Axelgaard (the same manufacturer as the predicate device). The nature of the testing described (biocompatibility, electrical, mechanical, packaging) suggests it is prospective testing specifically for this device's submission. No geographical origin of the testing data is specified beyond the parent company being Philips Consumer Lifestyle, located in Stamford, Connecticut, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device submission. The tests performed are engineering, material, and safety tests, not clinical evaluations requiring expert interpretation or ground truth establishment in a diagnostic sense.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or multi-reader scenarios, not for the direct physical/electrical testing described for this electrode.
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, an MRMC comparative effectiveness study was not done. This device is an electrode, not an AI-assisted diagnostic tool. Therefore, this section is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests outlined here is derived from engineering and material standards, electrical measurement principles, and established biocompatibility testing protocols (e.g., ISO 10993-1). It's based on objective quantifiable results against predefined acceptance limits, not expert consensus or direct clinical outcomes in the diagnostic sense.
8. The sample size for the training set
This information is not applicable. This device is not an AI/ML algorithm and therefore does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this device.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).