(56 days)
The NEBL CAP-AID (Improved) is designed to effectively occlude the male meatus thereby preventing urinary leakage.
The product prevents urinary leakage in men with urinary incontinence.
The CAP-AID (Improved) is exactly similar in indications, design and features to the original CAP-AID device. Only the materials are different. The material changes requested in the "Improved" version allow additional comfort and ease of use for the patient.
This looks like a 510(k) submission for a penile clamp device, not an AI/ML powered device. As such, the typical acceptance criteria and study design elements requested in your prompt (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.
The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through material changes for improved comfort and ease of use, rather than a performance study as would be seen for an AI algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, ground truth establishment, or expert involvement.
- Information on MRMC studies or standalone algorithm performance.
The provided text simply states that "The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical."
§ 876.5160 Urological clamp.
(a)
Identification. A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.(b)
Classification. Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.