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The AnoSPEC Disposable Anoscope with light is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

AnoSPEC Disposable Anoscope with light

The provided document is a 510(k) clearance letter from the FDA for the "AnoSPEC Disposable Anoscope with light." This letter indicates that the device has been found substantially equivalent to a predicate device already on the market.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or details about the training set.

The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive performance studies with specific acceptance criteria that would typically be detailed in a separate clinical or non-clinical performance report.

In summary, none of the requested information can be extracted from the provided text. The document only provides the following:

• Device Name: AnoSPEC Disposable Anoscope with light
• Regulation Number: 21 CFR § 876.1500
• Regulatory Class: II
• Product Code: FER
• Indications for Use: The AnoSPEC Disposable Anoscope with light is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

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