(523 days)
Control pain associated with injections, venipuncture, IV starts, cosmetic injections and the temporary relief of minor injuries (muscle or tendon aches, splinters and bee stings). Also intended to treat myofascial pain caused by trigger points, restricted motion and muscle tension
Not Found
The document provided is an FDA 510(k) clearance letter for the device "Buzzy®". This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria, study details, or performance metrics of the device.
The letter confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" for the Buzzy® device, but it does not present any data from studies proving that the device meets those indications with specific performance metrics.
To address your specific questions:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided FDA letter.
- Sample size used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
- Adjudication method for the test set: Not available in this document.
- 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 available in this document. This device is a therapeutic vibrator, not an AI-assisted diagnostic tool, so an MRMC study with AI assistance would not be relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in this document. As it is not an algorithm-based device, this is not relevant.
- The type of ground truth used: Not available in this document.
- The sample size for the training set: Not available in this document.
- How the ground truth for the training set was established: Not available in this document.
In summary, the provided FDA 510(k) clearance letter is a regulatory document affirming substantial equivalence, not a clinical study report that would detail the performance metrics or the underlying studies used for validation.
§ 890.5975 Therapeutic vibrator.
(a)
Identification. A therapeutic vibrator is an electrically powered device intended for medical purposes that incorporates various kinds of pads and that is held in the hand or attached to the hand or to a table. It is intended for various uses, such as relaxing muscles and relieving minor 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.