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Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes
The provided text is a summary of safety and effectiveness for Uni-Patch TENS and Muscle Stimulation Electrodes, comparing them to previously cleared devices. It does not contain a detailed study with specific acceptance criteria and performance metrics in the format requested.
However, I can extract the relevant information and present it in the closest possible format based on the provided text.
Here's an attempt to structure the information as requested, acknowledging the limitations of the provided document:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The Uni-Patch Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes aim to be as safe and effective as the Axelgaard Manufacturing Company Pals® Plus Reusable Neurostimulation Electrode and the LMI Spec T.E.N.S. Repositionable Pin-Type TENS Electrode (K894042A). The primary safety concern addressed was skin irritation, and effectiveness was determined by comparing impedance levels.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Reference Standard | Uni-Patch Device Performance |
|---|---|---|
| Safety | Skin irritation (as specified in Tripartite Biocompatibility Guidance For Medical Devices) | The RG-60 Series gels used in Uni-Patch electrodes passed required skin sensitivity tests: Cytotoxicity, Dermal Sensitization Study (Buehler Patch Test), Repeat Insult Patch Test, and Primary Skin Irritation Test. Gels were already in use in other cutaneous electrodes by Uni-Patch and considered acceptable for short-term skin contact. |
| Effectiveness | Comparable impedance levels to predicate devices (Axelgaard Pals® Plus and LMI Spec T.E.N.S. K894042A) when measured at 1K-Hz. | Electrode impedance values were determined to be comparable to all tested electrodes (implied predicate devices). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document for the impedance testing or gel testing.
- Data Provenance: The document states that the RG-60 Series gels have passed specific biocompatibility tests and have been used in other cutaneous electrodes manufactured by Uni-Patch. The impedance testing was conducted by Uni-Patch. This suggests retrospective data for the gel's biocompatibility from prior uses/tests, and prospective internal testing for the impedance comparison. The country of origin for the data is not explicitly stated but likely internal to Uni-Patch (USA, given the address).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The biocompatibility testing likely involved certified labs and personnel, but no details are provided. For impedance testing, it was likely conducted by Uni-Patch's internal technical staff.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not described. This document reports the outcome of tests rather than an expert review process.
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
- MRMC Study: No, this is not an MRMC study. The device is an electrode, not an AI imaging or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This refers to the performance of a physical medical device (electrodes), not an algorithm or AI. The assessment of skin irritation and electrical impedance are inherent properties of the device components.
7. The type of ground truth used
- Ground Truth for Safety (Skin Irritation): Established by adherence to published criteria/standards (Tripartite Biocompatibility Guidance For Medical Devices) through various in vitro and in vivo (e.g., dermal sensitization) tests.
- Ground Truth for Effectiveness (Impedance): Established by direct comparison of the Uni-Patch electrode's measured impedance values against those of the identified predicate devices, based on a specific measurement method (1K-Hz drive).
8. The sample size for the training set
- Sample Size: Not applicable. The document describes a comparison test for a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable, as there is no training set for an AI model.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).