(82 days)
The family of "THD disposable Anoscope/Proctoscope" is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The family of "THD disposable Anoscope/Proctoscope" are designed for examination and treatment of the anal (Anoscope) and recture (Proctoscope) examination and consists of transparent plastic disposable anoscopes and proctoscopes in sterile and non sterile conditions, for diagnostic or therapeutic use. The family of THD disposable Anoscopes and Proctoscopes is made by 2 categories of devices: Diagnostic Anoscopes and Proctoscopes, Surgical Proctoscopes. Illumination is provided by a PenLight or by the "Shining Light" illuminator both supplied and manufactured by THD Spa. A PenLight is a battery powered illuminator while the "Shining Light" is AC powered. Both of these accessories are light sources employed to optimize the use of the anoscopes and proctoscopes.
The provided text is a 510(k) summary for a medical device, the "THD disposable Anoscope/Proctoscope." This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove device performance against specific acceptance criteria through a clinical study or direct performance testing.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, number of experts for ground truth, or adjudication methods for performance evaluation.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of AI assistance.
- Details on standalone algorithm performance.
- The type of ground truth used for performance evaluation.
- Sample size for a training set or how ground truth for a training set was established, as this is not an AI/ML device.
Instead, the document focuses on:
- Substantial Equivalence: The core of this 510(k) is to demonstrate that the "THD disposable Anoscope/Proctoscope" is substantially equivalent to existing predicate devices (Sapimed Self Light Disposable Anoscope K070913 and Sapimed Disposable Sigmoidoscope/Proctoscope K070915). This is a regulatory pathway that relies on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as the predicate device.
- Device Description: It describes the device's components, variations (diagnostic vs. surgical), and illumination methods.
- Indications for Use: Clearly states the intended purpose for examining the anal sphincter, anus, rectum, and for diagnostic/therapeutic procedures.
- Supporting evidence for safety and identity:
- Shelf Life: Accelerated aging testing was performed to substantiate a 5-year expiration date. (This is a form of performance testing, but not directly related to accuracy or clinical effectiveness in the way an AI would be evaluated).
- Biocompatibility: The devices are compliant with ISO10993 standards. (This is safety testing, not performance criteria for a diagnostic/therapeutic outcome).
In summary, the provided text is a regulatory submission demonstrating substantial equivalence based on device characteristics, intended use, and safety standards, not a performance study as you've outlined for an AI/ML or diagnostic device.
§ 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.