(140 days)
The gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Lubrication Gel (Sterile)". This type of document is for a medical device approval and typically does not contain information about software algorithms, AI performance, or clinical study details as requested in your prompt.
Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment can be found in this document.
This letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It's a regulatory approval, not a technical performance report for an AI/software device.
§ 880.6375 Patient lubricant.
(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.