(99 days)
The V-Touch is intended for dermatological procedures.
The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.
Viora's V-Touch system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The V-Touch system provides the treatments using the following speciallydesigned applicator:
The ST applicator, which was cleared for Viora's Reaction system under K090221, utilizes RF bipolar energy, through 2 electrodes. It is used for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.
The provided text is a 510(k) summary for the V-Touch device and a letter from the FDA determining its substantial equivalence. This type of regulatory document primarily focuses on demonstrating equivalence to a predicate device based on similar technology, intended use, and safety/performance standards, rather than presenting a detailed clinical study with acceptance criteria and results.
Therefore, the document does not contain the specific information required to complete all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.
However, I can extract the following information available in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or specific quantifiable metrics for the V-Touch's dermatological procedures or the ST applicator's indications. Instead, it relies on substantial equivalence to a predicate device and compliance with general safety and performance standards.
The document states:
- "V-Touch successfully passed validation and verification testing, including testing for RF power accuracy."
- "Bench testing demonstrated that the V-Touch is as safe and effective as the cleared predicate device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing focuses on bench testing and substantial equivalence, not a clinical trial with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document, as no clinical test set with expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as no clinical test set requiring adjudication is described.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned in the document. The device described is a physical medical device (RF energy system), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. For the bench testing, the "ground truth" would likely refer to engineering specifications and performance benchmarks, not clinical outcomes or expert consensus.
8. The sample size for the training set
This information is not provided in the document. The device is not an AI/machine learning model, so there is no "training set" in that sense.
9. How the ground truth for the training set was established
This information is not provided in the document, as there is no training set mentioned in the context of AI/machine learning.
Summary regarding information gaps:
The provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (V-Touch) based on shared technology, intended use, and compliance with general safety standards and bench testing. It explicitly states: "Predicate comparison of the handpiece was unnecessary, since the predicate device uses the same handpiece. Bench testing demonstrated that the V-Touch is as safe and effective as the cleared predicate device."
This type of submission typically does not include detailed clinical study designs with acceptance criteria, patient sample sizes, expert ground truth, or MRMC studies, especially if relying on the substantial equivalence of a previously cleared component (the ST applicator).
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.