(71 days)
The Nanma Vacuum Pumps are external penile rigidity devices designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pumps are used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)
Nanma Vacuum Pump, Model 2M1333
I am sorry, but after carefully reviewing the provided document, I cannot identify any information regarding acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) premarket notification letter from the FDA to Nanma Manufacturing Co. concerning their Nanma Vacuum Pump. It declares the device substantially equivalent to legally marketed predicate devices and permits its marketing.
The document does not include:
- A table of acceptance criteria or reported device performance.
- Information about sample sizes for test sets, data provenance, or the number of experts used for ground truth.
- Details on adjudication methods, MRMC studies, or standalone algorithm performance.
- The type of ground truth used, training set sample size, or how ground truth for the training set was established.
Therefore, I cannot fulfill your request based on the provided text.
§ 876.5020 External penile rigidity devices.
(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.