(221 days)
Endoscopic Video Image Processor: This device is used in conjunction with the video endoscopes produced by our company to process the images collected by the video endoscopes and send them to the display, and provide power for the endoscope.
Single-Use Video Gastroscope: This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of upper digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use in adults.
Single-Use Video Colonoscope: This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of lower digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use in adults.
The proposed device, Digestive Endoscopy System, which includes a Single-Use Video Gastroscope and Single-Use Video Colonoscope, and Endoscopic Video Image Processor is intended for observation, diagnosis, photography and treatment of the upper and lower gastrointestinal tract.
The Single-Use Video Gastroscope is available in two models with different length of image processor connection section, RP-Gl-G02A, RP-Gl-G02B. The Single-Use Video Colonoscope is available in two models with different length of image processor connection section and different diameters, RP-GI-C02B. The Endoscopic Video Image Processor is available in four models with disk space, RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D.
The Single-Use Video Gastrocope and Single-Use Video Colonoscope are sterile and single-patient-use device. The Endoscopic Video lmage Processor is non-sterile and multi-patient-use device, and it will be cleaned and disinfected before first use.
The provided text is a 510(k) summary for an Endoscopic Video Image Processor, Single-Use Video Gastroscope, and Single-Use Video Colonoscope. It does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/human performance study. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and comparison testing.
Therefore, for aspects like acceptance criteria for AI algorithms, sample size for test sets (in an AI context), expert details, adjudication methods, MRMC studies, standalone AI performance, and AI training set details, the information is not available in the provided text.
Based on the provided document, here's what can be extracted regarding performance testing, which is primarily focused on the device's functionality and image quality as an endoscopy system, rather than an AI component:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance values for an AI component. Instead, it describes various performance tests conducted. The implicit acceptance criterion for these tests is that the proposed device performs comparably to or meets the standards of the predicate device or relevant ISO standards.
| Acceptance Criteria Category | Reported Device Performance (Summary from text) |
|---|---|
| Optical Performance | Demonstrated through ISO 8600 tests, intensity uniformity, depth of field, signal-to-noise ratio, color reducibility, geometric distortion, and dynamic range tests. The device was found to be "proved to be predicate device" in terms of optical properties and "similar to that of the predicate device" in image quality evaluation. |
| Mechanical Performance | Evaluated for surface & edge, general size, water supply system, suction/instrument channel system, bending section control system, fatigue test of bending knob, vertical pressure test of bending section, tensile strength of insertion portion, tensile resistance strength between image processor connection section and endoscopic video image processor, and connecting force test of suction connector, auxiliary water supply connector, water supply connector, and accessories. No specific results are provided, but the implication is that it met internal specifications or predicate performance. |
| Interoperability with Accessories | Performed successfully. The device was found to be "proved to be predicate device" in terms of interoperability. |
| Image Quality Simulation Test | Image quality of the proposed device was "similar to that of the predicate device." |
| Image Frame Frequency and System Delay | Testing was conducted, but specific results or acceptance criteria are not detailed. |
| Backflow Prevention | Testing was conducted, but specific results or acceptance criteria are not detailed. |
2. Sample Size used for the test set and the data provenance
This information is not available in the provided text. The "test set" in the context of this document refers to the physical devices (Endoscopic Video Image Processor, Single-Use Video Gastroscope, Single-Use Video Colonoscope) subjected to performance tests, not a dataset for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text. The studies described are non-clinical engineering and performance tests, not clinical studies requiring expert ground truth for interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. Adjudication methods are typically employed in clinical image interpretation studies, which this document does not describe.
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
This information is not available in the provided text. The device described is an endoscope system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided text. There is no mention of an algorithm or AI functionality in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided text. The "ground truth" for the non-clinical performance tests would be established by engineering specifications, calibration standards, and comparison with the predicate device.
8. The sample size for the training set
This information is not available in the provided text. The document does not describe an AI training set.
9. How the ground truth for the training set was established
This information is not available in the provided text. The document does not describe an AI training set.
§ 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.