(90 days)
The EC-3890LI, Video Colonoscope is intended to provide optical visualization (via a video monitor) of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes but is not restricted to the organs, tissues and subsystems: Large Bowel and Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
The EC-3890L, Video Colonoscope must be used with a Video Processor (software controlled device). The endoscope has a flexible insertion tube, a control body and umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices or other devices may be introduced. The Video Processor, EPK-I, contains a 300 watt short Arc Xenon lamp which provides white light is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collect image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
The provided text is a 510(k) summary for the PENTAX EC-3890LI, Video Colonoscope. It describes the device, its intended use, and comparison to predicate devices, but does not contain information about acceptance criteria or specific studies proving the device meets those criteria.
Generally, 510(k) submissions for devices like colonoscopes focus on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance testing and comparison of technical specifications, rather than clinical efficacy studies with predefined acceptance criteria in the way a pharmaceutical trial or a software AI device would.
Therefore, many of the requested details cannot be extracted from this document as they are not typically included in this type of submission for such a device.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance:
- Cannot be answered from the provided text. The document states: "The submission for substantial equivalence is not based on an assessment of clinical performance data." It mentions "system performance testing" was included in the submission, but does not detail the acceptance criteria or results of that testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be answered from the provided text. Since clinical performance data was not the basis of the submission, there is no mention of a "test set" in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be answered from the provided text. No such information is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be answered from the provided text. No such information is provided.
5. 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:
- Cannot be answered from the provided text. This device is a video colonoscope, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be answered from the provided text. This device is a colonoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be answered from the provided text. Ground truth is not a concept applied to this type of device where substantial equivalence is demonstrated through technical and functional comparisons.
8. The sample size for the training set:
- Cannot be answered from the provided text. This device is a colonoscope, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Cannot be answered from the provided text. This device is a colonoscope, not an AI model, and therefore no ground truth for a training set is relevant.
Summary of what the document does provide regarding "studies":
The document states: "The submission for substantial equivalence included literature describing the system including; specifications, the identification of standard set components and optional accessories, tables to summarize the comparisons to the predicated device(s), and system performance testing. The submission for substantial equivalence is not based on an assessment of clinical performance data."
This indicates that the "study" for this device involved comparing its specifications and performance characteristics against a predicate device (EC-3800L, Video Colonoscope) and demonstrating that it is substantially equivalent, thereby not requiring new significant clinical studies. The "system performance testing" would likely refer to engineering and functional tests to ensure the device meets its design specifications (e.g., image quality, angulation range, water/air delivery, suction, channel patency, biocompatibility, electrical safety), but the specific acceptance criteria and results are not detailed in this summary.
§ 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.