(80 days)
The Paired Hydrogel Electrode is used for evoked electrophysiological monitoring in soft tissue surgeries were motor nerves are at risk.
The Paired Hydrogel Electrodes are a modification of the M203KEN electrode currently distributed as the Singlet and Triplet Hydrogel Electrodes by Neurovision Medical Products. The Paired Hydrogel Electrode is created by attaching two Singlet M203KEN electrodes by their lead wires to the same DIN plug (shorting the electrodes). The Paired version is designed to provide a single pole of electrophysiological monitoring across a surface too wide to be covered by a single electrode.
Here's an analysis of the provided text regarding the Neurovision Medical Paired Hydrogel Electrode, focusing on acceptance criteria and supporting studies:
This submission is a Special 510(k), indicating a modification to an already cleared device. The focus of the performance testing is typically to demonstrate that the modified device (Paired Hydrogel Electrode) is substantially equivalent to the predicate devices and that the modification does not introduce new questions of safety oreffectiveness, or alter the fundamental scientific technology.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Performed Test/Reported Performance |
|---|---|---|
| Material Biocompatibility | Freedom from sensitization | Tested free of Sensitization (ISO 10993: Part 10) |
| Freedom from cytotoxicity | Tested free of Cytotoxicity (Agarose Overlay Method) | |
| Freedom from irritation | Tested free of Irritation (ISO 10993: Part 10) | |
| Physical Performance | Electrode adhesion | Demonstrated equivalence to predicate singlet |
| Impedance | Demonstrated equivalence to predicate singlet | |
| Electrophysiological Properties | Electrophysiological properties | Demonstrated equivalence to predicate singlet |
| Shelf-Life | Shelf-life duration | Demonstrated a 3-year shelf life (ANSI/AAMI EC12:2000) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for performance tests (adhesion, impedance, electrophysiological properties).
- For biocompatibility, it states "Animal testing demonstrated the Biocompatibility," implying animal subjects, but the number is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal or contracted by the manufacturer. The studies are prospective as they were conducted to support the 510(k) submission for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This type of device (hydrogel electrode) does not typically involve human-read interpretations or ground truth established by experts in the context of clinical imagery. The performance criteria are technical and measurable (e.g., adhesion strength, electrical impedance, biological reactions).
4. Adjudication Method for the Test Set
Not applicable, as the performance testing involves measurable technical parameters, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not the type of device or study for which an MRMC comparative effectiveness study would be performed. The device is a surface electrode for physiological monitoring, not an imaging or diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device itself is hardware (an electrode) that facilitates electrophysiological monitoring, which then requires an EMG unit (compatible device) and human interpretation of the signals. There is no "algorithm only" performance for an electrode.
7. Type of Ground Truth Used
- Biocompatibility: In-vitro (cytotoxicity via Agarose Overlay) and in-vivo (irritation and sensitization via animal testing according to ISO 10993).
- Physical and Electrophysiological Properties: Measured technical specifications of the device compared against the known performance of the predicate device (Singlet Hydrogel Electrode). The "ground truth" here is the established performance characteristics of the predicate device.
- Shelf-Life: Time-dependent measurements demonstrating stability over the claimed 3-year period, adhering to ANSI/AAMI EC12:2000 standards.
8. Sample Size for the Training Set
Not applicable. This is a hardware device (electrode), not a software/AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this hardware device.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.