(210 days)
Disposable Pre-gelled Ag/AgCl Surface Electrodes are intended for recording/stimulation and monitoring of the Electromygraphy (EMG), Electroencephalograph(EEG) and Evoked Potential(EP) signals.
Friendship's Pre-gelled Ag/AgCl Surface Electrodes are disposable (for "single Use Only"). Used to detect electrophysiological signals or provide electrical stimulation subcutaneously. The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The surface electrodes is comprised of top woven layer, carbon layer, Ag/AgCl layer and hydrogel layer on one end electrically connected to lead wire and a touch-proof connector on the other end.
The provided document describes the "Friendship Pre-gelled Ag/AgCl Surface Electrodes," a disposable device for detecting electrophysiological signals or providing electrical stimulation subcutaneously.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Predicate Devices) | Reported Device Performance (Friendship Pre-gelled Ag/AgCl Surface Electrodes) |
|---|---|---|
| Biocompatibility | Known biocompatibility (Katecho hydrogel) for Cytotoxicity, Skin Irritation, and Skin Sensitization (ISO 10993-5, 10993-10) | Katecho hydrogel is of known biocompatibility, and materials were tested for safety and biocompatibility by Katecho Inc. (Cytotoxicity, Skin Irritation, Skin Sensitization). |
| Electrical Performance | Meet voluntary standard requirements under ANSI/AAMI EC12/2000 in compliance with IEC60601-1 | Tested and meets voluntary standard requirements under ANSI/AAMI EC12/2000 in compliance with IEC60601-1. |
| Device Description/Functionality | Similar materials, design, and function to predicate devices. | Similar materials, design, and function to predicate devices. |
| Simulated Use | Found acceptable for intended use by healthcare professionals. | Evaluated by healthcare professionals during a simulated use test and found acceptable for its intended use. |
| Substantial Equivalence | Comparable to predicate devices (Sunspot Pre-gelled Surface Electrodes K062198, Rhythmlink International Cutaneous Pad Electrodes K052188) | Determined to be substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions a "simulated use test" but does not quantify the number of electrodes or participants involved.
- Data Provenance: The document does not specify the country of origin for the "simulated use test." It is implied to be related to the manufacturer's location in Xi'an, Shaanxi, China, but this is not explicitly stated as the origin of the test data. The biocompatibility data is from Katecho Inc. and refers to international ISO standards.
- Retrospective or Prospective: The "simulated use test" sounds like a prospective test, but without more details, it's difficult to confirm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The document states the device "was evaluated by health care professionals during a simulated use test."
- Number of Experts: Not specified.
- Qualifications of Experts: It collectively refers to "health care professionals," but no specific qualifications (e.g., years of experience, specialty) are provided.
4. Adjudication Method for the Test Set
- No specific adjudication method is mentioned for the "simulated use test." The evaluation by healthcare professionals seems to have led to a conclusion of "acceptable for its intended use" without detailing a multi-reader review process or conflict resolution.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 a pre-gelled surface electrode, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) performance study was not done. This device is a physical electrode, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance relies primarily on adherence to established voluntary standards (ANSI/AAMI EC12/2000 and IEC60601-1 for electrical performance) and biocompatibility testing against ISO standards, along with subjective evaluation by healthcare professionals during a simulated use test for overall acceptability.
- There is no mention of pathology, outcomes data, or expert consensus in the typical sense for a diagnostic device. The "ground truth" for substantial equivalence is based on direct comparison to already cleared predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device (electrode), not an algorithm or AI model 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 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).