(42 days)
This instrument has been designed to be used with the Olympus Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical Unit, Endo-therapy accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, and sigmoid colon, colon, and ileocecal valve).
The subject devices, EVIS EXERA Colonovideoscope XCF-Q160W1L/I are identical to the predicate device, CF-Q160AL/I, in intended use. These instrument have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories such as biopsy forceps and ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). As for the device specifications, they are basically identical to the predicate devices, the CF-Q160AL/I, with the exception that the subject devices have wider field of views compared to the CF-Q160AL/I/. With this field of view, the XCF-Q160W1L/I may improve the detection of lesions in the colon and has been shown to reduce overall procedure time.
I am sorry, but based on the provided text, there is no study described that proves the device meets specific acceptance criteria.
The document is a 510(k) summary for the EVIS EXERA Colonovideoscope XCF-Q160W1L/I. The core assertion within this 510(k) is that the device is substantially equivalent to a predicate device (EVIS EXERA Colonovideoscope CF-Q160AL/I). This means that instead of conducting new clinical trials to prove safety and effectiveness against specific acceptance criteria, the manufacturer is arguing that the new device is so similar to an already approved device that it can be presumed safe and effective.
Here's a breakdown of why the requested information cannot be provided from this text:
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No Acceptance Criteria or Reported Performance: The document does not list any specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, or procedure time reduction targets) for the new colonovideoscope. Consequently, it also doesn't report any performance metrics against such criteria. The "Comparison of Technological Characteristics" table only compares physical specifications (Field of View, Diameter).
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No Study Described: The document explicitly states: "Therefore, clinical data is not necessary for its evaluation of safety and efficacy." This indicates that a study demonstrating performance against acceptance criteria was not conducted or submitted for this 510(k) pathway. The basis for approval here is substantial equivalence.
Therefore, for your specific questions:
- Table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not applicable, as no such study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a hardware device, not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The closest thing to a "performance claim" is the statement that "the XCF-Q160W1L/I may improve the detection of lesions in the colon and has been shown to reduce overall procedure time" due to its wider field of view. However, this is presented as a potential benefit and an observation, not as a result of a formal study demonstrating it meets predefined acceptance criteria for these outcomes.
§ 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.