(366 days)
The Applied Medical Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.
The Applied Medical Anoscope consists of a one-piece polycarbonate half round channel with a tapered closed tip. The device retracts the anal sphincter and provides access to the anorectal anatomy during transanal procedures.
The provided document is an FDA 510(k) clearance letter for the Applied Medical Anoscope. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance beyond general biocompatibility and functional performance tests.
The 510(k) summary (page 4) states: "The anoscope is a simple one-piece device that provides a passage into the anal canal. There are no recognized performance standards for access devices of this kind. Therefore, Applied Medical devised criteria by which to assess safety and efficacy, including a computer-aided simulation and a compression test."
This indicates that while some criteria and tests were performed, their details (specific quantitative acceptance criteria, the results of these tests, sample sizes, ground truth establishment, expert involvement, etc.) are not included in this publicly available 510(k) clearance document.
Therefore, I cannot fulfill your request for the following information based solely on the provided text:
- A table of acceptance criteria and the reported device performance: Not detailed in the document.
- Sample sizes used for the test set and the data provenance: Not detailed for the described "computer-aided simulation and a compression test."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the testing described is physical, not interpretive, and not detailed in the document.
- Adjudication method for the test set: Not applicable based on the described tests.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical anoscope, not an AI or imaging device with human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical anoscope.
- The type of ground truth used: Not applicable for the described physical tests.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of technological characteristics (page 4), noting minor differences like the pre-existence of a dedicated light source channel in the predicate vs. the subject's larger lumen and use of external light sources.
- Biocompatibility testing (page 4) against ISO 10993-1 endpoints (cytotoxicity, intracutaneous irritation, sensitization), which the device passed.
- Functional performance testing (page 4), which involved a "computer-aided simulation and a compression test." The details of these tests and their results are not provided.
In summary, this document is a regulatory clearance letter, not a detailed scientific study report. It states that the manufacturer "devised criteria" and conducted "computer-aided simulation and a compression test" to assess safety and efficacy, but it does not provide the specific quantitative acceptance criteria or the results of those tests.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.