(68 days)
The Signal Amplifier for BOTOX® is intended to aid in the guidance of injections into the muscles.
Not Found
I am sorry, but the provided text from the FDA 510(k) letter for "Signal Amplifier for BOTOX®" (K051852) does not contain the information necessary to answer your request regarding acceptance criteria and the study proving the device meets those criteria.
The 510(k) letter is a premarket notification that determines substantial equivalence to a predicate device. It indicates that the device can be legally marketed, subject to general controls. It does not typically detail the specific performance studies, acceptance criteria, or ground truth methodologies that would be part of a robust clinical trial report.
Here's what the provided text does contain:
- Trade/Device Name: Signal Amplifier for BOTOX®
- Regulation Number/Name: 21 CFR 882.1835, Physiological signal amplifier
- Regulatory Class: II
- Product Code: GWL
- Indications for Use: "The Signal Amplifier for BOTOX® is intended to aid in the guidance of injections into the muscles."
To answer your questions, I would need access to the actual 510(k) submission document, any associated clinical study reports, or other performance data presented to the FDA for review, which are not included in the provided text.
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).