(437 days)
This device is intended for cosmetic use.
The InterX 1000/Derma 200 Stimulator for Cosmetic Use is a hand-held, battery operated device consisting of a main operating unit (InterX 1000) and an external electrode (Derma 200).
The provided text does not contain detailed acceptance criteria or a study that specifically proves the InterX 1000/Derma 200 Stimulator for Cosmetic Use meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or reader improvement.
However, based on the available information, here's what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Compliance with Performance Standards | Device complies with performance standard requirements (21 CFR 898.12) relating to patient lead wires and electrodes. |
| Equivalence for Cosmetic Use (Comparison to Predicate Devices) | Equivalent in technology to InterX 5000 (K042912). Indications for cosmetic use are equivalent to devices cleared under K040871 (Facemaster) and K011935 (Rejuvenique Salton Facemaster). |
| Intended Use | Intended for cosmetic use. |
Study Information (Based on interpretation of "Performance Testing" mentioned):
The document broadly mentions "Bench and clinical testing were conducted to demonstrate performance for the device's intended use." However, it does not provide any specific details about these tests in terms of methodology, results, or quantitative metrics.
Therefore, for the following points, the information is not available in the provided text.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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: Not provided. This device is an electrical stimulator for cosmetic use, not an AI-powered diagnostic tool, so an MRMC study with human readers assisting AI or vice-versa is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (electrical stimulator) rather than an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided. Given its intended "cosmetic use," ground truth might relate to aesthetic improvements, but no details are given.
8. The sample size for the training set: Not applicable and not provided. This device is not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable and not provided.
§ 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).