(221 days)
The Physiometrix PSArray² EEG Electrode is applied directly to the patient's skin to enable recording of electrophysiologic signals (such as EEG).
The Physiometrix Model 4310, PSArray² EEG Electrode, is a single-use, disposable, pre-gelled electrode array. The PSArray² is comprised of six (6) electrodes located at F7, Fp1, FpZ', FpZ, Fp2 and F8. The electrode is packaged with 1 electrode per pouch, 25 pouches per box and 4 boxes per case. The electrodes are mounted in a polyethylene foam coated with a pressure sensitive adhesive. The electrode pad is an area of silver/silver chloride ink that is connected to cable connector by a silver ink trace. An electrolyte gel is held in place over the electrode pad by a open-cell polyurethane sponge located in wells created by the foam basepad. The electrolyte gel was selected for its low impedance properties. No pre-application prepping is required to achieve adequate impedance levels for operation of the PSA4000. The PSArray² EEG Electrode is connected to the PSA4000 System via a patient cable that attaches to the substrate connector. The PSArray² is designed for use with the PSA4000 System.
The provided text is a 510(k) summary for the Physiometrix Model 4310 PSArray² EEG Electrode. This submission focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in the way a new, high-risk device might. The "acceptance criteria" here are largely met by demonstrating compliance with recognized standards and similarity to the predicate.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Electrical Testing (AAMI/ANSI EC-12 (1991) for Disposable ECG Electrodes) | The PSArray² device exceeded requirements indicated in the standard. |
| Biocompatibility Testing (ISO-10993, Biological Evaluation of Medical Devices Part I & FDA Guidance "Protocol for Dermal Toxicity Testing") | The skin contact materials were determined to be safe for contact with skin. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the electrical or biocompatibility testing. The nature of these tests (e.g., electrical impedance, irritation assays) typically involves a sample of the manufactured device.
Data provenance is not specified (e.g., country of origin). The studies appear to be laboratory-based tests conducted by the manufacturer, rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is generally not applicable to the tests performed for this device. Electrical and biocompatibility testing rely on objective measurements against established standard thresholds, not expert consensus on interpreting complex medical data.
4. Adjudication Method for the Test Set:
Not applicable. The tests are designed to provide objective, quantitative results against a standard, not subjective interpretations 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 EEG electrode, a hardware component for signal acquisition. It does not involve AI or human interpretation of complex medical images, and therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is a passive electrode, not an algorithm.
7. The Type of Ground Truth Used:
- Electrical Testing: The "ground truth" is defined by the objective performance requirements outlined in the AAMI/ANSI EC-12 (1991) standard for disposable ECG electrodes. The device performance (e.g., impedance, offset voltage) is measured against these numerical targets.
- Biocompatibility Testing: The "ground truth" is established by the accepted scientific methodologies and criteria defined in ISO-10993 Part I and FDA Guidance documents for evaluating the biological safety of materials in contact with skin (e.g., absence of cytotoxicity, irritation, sensitization).
8. The Sample Size for the Training Set:
Not applicable. This device is a hardware component and does not utilize a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
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).