(90 days)
Video Image Processor ENDO VIP 5588 is a video contrast enhancer and is used in connection with a video system. It enhances the detail definition of medical video images. It is used as an accessory during diagnostic and therapeutic interventions in video endoscopy and video microscopy.
The Video Image Processor ENDO VIP 5588 enhances the detail definition of medical video images. It is connected between video camera and video monitor. The enhancement level is manual controlled in 3 steps.
This 510(k) summary for the ENDO VIP 5588 Video Image Processor does not contain the detailed information requested regarding acceptance criteria, specific device performance, study design, or ground truth establishment. This is because the device described is a video contrast enhancer, not a diagnostic AI device requiring such clinical validation.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in terms of clinical performance metrics (e.g., sensitivity, specificity, AUC). The document mentions testing against "specified standards IEC601-1, IEC601-1-2 and UL2601-1," which are likely electrical safety and electromagnetic compatibility standards, not clinical performance standards.
- Reported Device Performance: The document states "enhances the detail definition of medical video images" and "improve detail visibility in video images." This is a general claim rather than a quantifiable performance metric (e.g., a percentage improvement in specific feature detection).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document explicitly states: "No clinical tests performed." Therefore, there was no test set of clinical data, no sample size, and no data provenance.
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)
- Not Applicable. As no clinical tests were performed, there was no test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical tests were performed, so no adjudication method was used for a test set.
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
- No. The document explicitly states: "No clinical tests performed." This device is a video enhancer, not an AI-assisted diagnostic tool in the sense of providing algorithmic interpretations for comparison with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable for a diagnostic AI sense. The device is a video processor that applies a "fixed algorithm with user-variable parameters to improve detail visibility." While it has an algorithm, it's not performing diagnostic interpretation standalone. Its "performance" would be assessed by how well it enhances images, not by its diagnostic accuracy. The provided text does not contain any standalone performance metrics relevant to an AI diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No clinical ground truth was established as no clinical tests were performed. For a video enhancer, "ground truth" might relate to image quality metrics, but these are not described as being used in a clinical test setting.
8. The sample size for the training set
- Not Applicable. This device uses a "fixed algorithm." It is not described as a machine learning model that requires a training set in the typical sense of AI for diagnostic image analysis. Therefore, there is no mention of a training set or its size.
9. How the ground truth for the training set was established
- Not Applicable. As there's no mention of an AI model requiring a training set, there's no ground truth establishment for such a set.
Summary based on the provided text:
The ENDO VIP 5588 is a video image processor that enhances detail definition in medical video images. Its acceptance criteria appear to be based on compliance with electrical safety and compatibility standards (IEC601-1, IEC601-1-2, UL2601-1). The document explicitly states that no clinical tests were performed to demonstrate safety and effectiveness. Therefore, the detailed information requested about clinical study design, sample sizes, expert involvement, and ground truth establishment is not available in this 510(k) summary. The device's "performance" is generally described as improving detail visibility without specific quantifiable metrics or clinical accuracy claims.
§ 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.