(67 days)
The Disposable Snap Electrodes are intended to be used with compatible 1.5mm touchproof button snap cables for transferring surface biopotential signals to use during sleep studies, EEG, EMG, and recording evoked potential signals from a cutaneous location. For use on Adults.
The Disposable Snap Electrode is a cutaneous applied electrode supporting interface of biopotential signals to user equipment. The Snap Electrode has a 4 mm snap contact that can connect with commercially available snap electrode lead wires.
The provided text describes a 510(k) premarket notification for a medical device called the "Disposable Snap Electrode." This notification focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving a new device's efficacy through extensive clinical studies involving AI. Therefore, much of the requested information regarding AI-specific studies, MRMC studies, ground truth establishment for training data, and expert adjudication cannot be directly extracted from this document.
However, I can extract the acceptance criteria and performance data for the device itself (the electrode), as well as details about the testing methodology for its substantial equivalence.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Summary of Requirement) | Reported Device Performance |
|---|---|---|
| Performance requirements | Essential performance for: AC Impedance, DC offset, Combined offset instability, Combined offset instability test and Bias current | Pass |
| Adhesion | Retains adhesion to cutaneous location for minimum of 10 hours. | Pass |
| Dimensions | 1.9 inches +/- 10% | Pass |
| Lead wire compatibility | Compatible with snap electrode lead wires. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance tests (e.g., how many electrodes were tested for adhesion, impedance, etc.). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these performance tests. This level of detail is typically not included in a 510(k) summary, which focuses on regulatory substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is a simple cutaneous electrode, not an AI-driven diagnostic or image-based device requiring expert interpretation of complex data for ground truth establishment. The performance tests are largely engineering and material science evaluations.
4. Adjudication Method for the Test Set
Not applicable for the type of device and tests described. Adjudication methods like 2+1 or 3+1 are used for evaluating human or AI interpretations of medical images or complex diagnostic scenarios, not for evaluating physical device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This type of study is specifically designed to assess the impact of an AI system on human reader performance for tasks such as diagnosis or lesion detection. This document describes a physical medical device (an electrode), not an AI algorithm.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical electrode, not a standalone algorithm.
7. Type of Ground Truth Used
For the performance tests, the "ground truth" is defined by the engineering specifications and functional requirements of a cutaneous electrode. For example:
- For "Performance requirements": The ground truth is compliance with established electrical performance standards for electrodes (e.g., AC impedance, DC offset).
- For "Adhesion": The ground truth is the physical ability to retain adhesion for a specified duration (10 hours).
- For "Dimensions": The ground truth is the measured dimensions falling within the specified tolerance.
- For "Lead wire compatibility": The ground truth is successful physical and electrical connection with standard snap electrode lead wires.
8. Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI model that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is an electrode, not an AI model requiring a training set and corresponding ground truth.
Summary of what the document does prove:
The document serves as a 510(k) notification, aiming to prove that the "Disposable Snap Electrode" is substantially equivalent to legally marketed predicate devices. This is achieved by:
- Comparing technological characteristics (Table 1) to two predicate devices (K021537 and K142159). Key comparisons include intended use, indications for use, environment of use, single patient use/disposability, duration of use, patient applied location, diameter, pre-gelled status, electrode contact material, patient contact material, sterility, pre-attached lead wires, snap lead wire compatibility, and shelf life.
- Demonstrating compliance with performance requirements relevant to an electrode, as outlined in the "Performance Tests" table. These are standard engineering/functional tests for electrodes.
- Confirming biocompatibility based on supplier-provided test results for cytotoxicity, sensitization, and irritation of the materials.
- Concluding that "The Disposable Snap Electrode meets performance requirements. The intended use and technology of the Disposable Snap Electrode are the same as the predicate devices. The Disposable Snap Electrode is substantially equivalent to the predicate devices."
§ 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).