(308 days)
- Relieves minor muscle aches and pains .
- Relieve muscle spasm
- Temporary Improvement in local circulation
- Temporarily reduces the appearance of cellulite .
The TriActive system utilizes pulsatile vacuum action to achieve massaging results.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, there are no specific acceptance criteria listed, nor is there any reported device performance data from a clinical study. The summary explicitly states:
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Nonclinical Performance Data | Not specified | "none" |
| Clinical Performance Data | Not specified | "none" |
2. Sample Size Used for the Test Set and Data Provenance
Since no clinical or nonclinical performance data was submitted, there is no test set, sample size, or data provenance mentioned in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
As no performance data was provided, there was no ground truth established for a test set, no experts involved, and therefore no qualifications specified.
4. Adjudication Method for the Test Set
With no test set or expert evaluation, there was no adjudication method employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The summary explicitly states "Clinical Performance Data: none."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device, the Cynosure TriActive Therapeutic Massage System, is a physical therapeutic massager, not an AI or algorithm-based device. Therefore, a standalone (algorithm-only) study is not applicable and was not performed.
7. Type of Ground Truth Used
No ground truth was used as no performance data was submitted.
8. Sample Size for the Training Set
Since this is a physical device and no AI/algorithm is involved, there is no training set mentioned or applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, the establishment of ground truth for a training set is not applicable.
Summary of Device Clearance Rationale:
The Cynosure TriActive Therapeutic Massage System received 510(k) clearance based on its substantial equivalence to a legally marketed predicate device (LPG Therapeutic Massager and Vibrator). The FDA concluded that the device is "another safe and effective device for the indications" primarily because it has the "same indications as the predicate device" and utilizes a similar mechanism of action (pulsatile vacuum). The clearance was granted without the submission of new clinical or nonclinical performance data for the TriActive system itself. The assumption is that the safety and effectiveness of the type of device and its intended use had already been established through the predicate device.
§ 890.5660 Therapeutic massager.
(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.