(159 days)
The Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes are indicated for use with transcutaneous electrical stimulation devices as non-sterile. Latex free, reusable device for single patient use only. The electrodes provide the conductive interface between the stimulation device and the patient's skin. The starburst gradient pattern provides optimal current distribution.
The proposed electrode composes of a top cover, a reinforcement film, a conductive member with printed Silver, conductive hydrogel which contains Aloe Vera and green pigment, a release liner which protects the conductive hydrogel before use and during storage, and a wire secured in between reinforcement film and conductive member. The wire connects the electrode to the transcutaneous electrical stimulation devices. Four finished electrodes are placed into a protective pouch. The pouches are sealed and boxed for shipping.
The provided document is a 510(k) Premarket Notification for a medical device: "Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or a specific level of standalone performance with detailed acceptance criteria and studies as one might find for a novel AI or diagnostic device.
Therefore, the requested information, particularly regarding specific acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, or detailed ground truth methodologies, is not present in the provided text. The document indicates a simpler approach to demonstrating equivalence.
Here's a breakdown of what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in detail for the proposed device in the same way one would see for an AI algorithm. The document states: "Performance data for the proposed electrodes are compared to that of the predicate device. Results from biocompatibility study, physical and functional performance evaluation demonstrate that the proposed device is substantially equivalent to the legally marketed device."
This implies that the "acceptance criteria" were likely a demonstration of comparable physical and functional characteristics to the predicate device, but specific quantitative thresholds are not listed.
2. Sample Sizes Used for the Test Set and Data Provenance
Not provided. The document refers to "biocompatibility study, physical and functional performance evaluation" but does not give sample sizes, countries of origin, or whether the studies were retrospective or prospective. Given the nature of TENS electrodes, these studies likely involved bench testing and possibly limited human subject testing for biocompatibility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/Not provided. For a TENS electrode, the "ground truth" is typically defined by standard engineering and biocompatibility testing protocols, not by expert medical interpretation of data.
4. Adjudication Method for the Test Set
Not applicable/Not provided. See above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. It is not relevant for a TENS electrode.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. The device is a physical electrode, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device would be established by:
- Biocompatibility testing standards: Ensuring the materials are safe for skin contact (e.g., ISO 10993).
- Physical and electrical performance standards: Measuring impedance, adhesion, current distribution, reusability, etc., and comparing these to the predicate device and relevant industry standards.
The document states: "The starburst gradient pattern provides optimal current distribution," indicating current distribution was a performance characteristic evaluated.
8. The Sample Size for the Training Set
Not Applicable. The device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
Summary based on the provided text:
This 510(k) submission primarily relies on demonstrating "substantial equivalence" of the proposed electrode to a previously marketed predicate device. The performance data mentioned (biocompatibility, physical, and functional) were used to show this equivalence rather than to meet specific acceptance criteria for a novel device or AI algorithm. Details typically requested for AI/diagnostic devices are not relevant or provided for this type of product submission.
§ 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).