(152 days)
The Reaction™ system is intended for the treatment of the following medical conditions, using the B-contour and F-contour applicators for delivering non thermal RF combined with massage: - relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and - temporary reduction in the appearance of cellulite.
Using the ST applicator for delivering RF, the Reaction™ system is intended for the treatment of relief of minor musele aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
The Reaction™ system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The Reaction™ treatment is indicated for the treatment of selected medical conditions such as relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite
The Reaction™ system provides the treatments using 3 specially-designed applicators that treat various areas of the body, including large and small areas.
The system includes five core modules: the Console, the hand piece, and 3 treatment applicators: B-Contour, F-Contour and ST.
The Reaction™ console houses the following components:
- Power supply
- Hand piece
- Vacuum pump
- RF Generator
- Main CPU
- Display unit
The hand piece allows the operator to adjust the treatment parameters of the RF power and intensity of mechanical vacuum massage.
The applicators incorporate operator panels and are used to adjust the treatment parameters of the RF power and mechanical vacuum manipulation.
The provided text is a 510(k) summary for the Reaction™ System, which focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than on detailed clinical study results and acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly stated in this document.
However, I can extract the following based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or detailed performance metrics. The claim of "substantial equivalence" implies that the Reaction™ System's performance characteristics are comparable to those of the predicate devices for the stated indications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated and not a clinical study. The device is seeking clearance based on substantial equivalence to predicate devices for its intended use and performance characteristics. | The Reaction™ System has "the same intended use and the same performance characteristics as the following predicate devices" for each respective application. |
2. Sample Size Used for the Test Set and Data Provenance:
No clinical test set or study data is described that would involve a "sample size" in the context of efficacy or performance evaluation for this 510(k) summary. The submission is based on comparison to predicate devices, not on a new clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
4. Adjudication Method:
Not applicable, as no new clinical study data requiring ground truth establishment or expert adjudication is described in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. This 510(k) summary focuses on demonstrating equivalence to existing devices, not on comparing AI-assisted vs. non-AI-assisted human reader performance.
6. Standalone Performance:
Not applicable. The Reaction™ System is a physical device (combining RF technology with mechanical vacuum massage) and does not involve an "algorithm only" or "human-in-the-loop" AI performance as implied by this question. Its performance is inherent to its physical operation.
7. Type of Ground Truth Used:
Not applicable, as no new clinical study requiring ground truth is described. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate devices.
8. Sample Size for the Training Set:
9. How the Ground Truth for the Training Set Was Established:
Not applicable. The Reaction™ System is not an AI/machine learning device that would involve a training set.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.