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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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The OBP Office-Spec Disposable Side Speculum is indicated for use on women undergoing a procedure requiring vaginal access and exposure (e.g., for a pelvic exam or Pap smear). The device uses opposing bi-valve plastic blades to separate the vaginal wall and is intended to expose the interior of the vagina and exterior of the cervix. It may be used with or without a removable light source.

The OBP Office-Spec Disposable Side Speculum is indicated for use on women undergoing a procedure requiring vaginal access and exposure (e.g., for a pelvic exam or Pap smear). The device uses opposing bi-valve plastic blades to separate the vaginal wall and is intended to expose the interior of the vagina and exterior of the cervix. It may be used with or without a removable light source.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to OBP Corporation regarding their "OBP Office-Spec Disposable Side Speculum."

It primarily communicates the FDA's determination of substantial equivalence for the device to legally marketed predicate devices and outlines the regulatory requirements the company must comply with. The "Indications for Use" section describes what the device is intended for, but it does not include performance metrics, study details, or acceptance criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study given the provided input.

Ask a specific question about this device