(461 days)
The values are used in conventional gastrointestinal endoscope to control the functions of water/gas injection and suction during the endoscopic operation.
Disposable Endoscope Valves Kit consists of Water/gas button, Attraction button, Biopsy cap and Water injection adapter. Disposable Endoscope Valves Kit connect the endoscope operating handle matched with the model, and install the water gas button into the water gas port of the operating handle; Align the positioning boss of the suction button with the card slot of the operating handle and install it into the suction port; Install the biopsy cap into the clamp opening of the operating handle.
The provided text describes the acceptance criteria and a study demonstrating the substantial equivalence of the "Disposable Endoscope Valves Kit" to a predicate device. However, it does not include information typically found in studies proving an AI/ML device meets acceptance criteria, such as specific performance metrics like sensitivity, specificity, or AUC, detailed sample sizes for test sets, expert qualifications, or adjudication methods for ground truth.
This document is a 510(k) summary for a medical device that does not appear to be an AI/ML device. It seems to be a physical medical accessory. Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI vs without AI, standalone algorithm performance, training set details) are not applicable to this submission.
The study described is a non-clinical performance data study, not a clinical study involving AI/ML.
Here's an attempt to answer the relevant questions based on the provided text, while noting the limitations due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document frames "acceptance criteria" as meeting regulatory standards and demonstrating substantial equivalence to a predicate device through non-clinical testing. It doesn't list quantitative performance metrics for the proposed device in the way one would for an AI/ML diagnostic tool (e.g., sensitivity, specificity).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biological Evaluation | Meets ISO 10993 requirements |
| Sterilization | Meets ISO 11135-1 and ISO 10993-7 requirements (EO Sterilization) |
| Appearance | Passing |
| Physical Properties | Passing |
| Substantial Equivalence | Established through comparison to predicate device K220210 |
2. Sample size used for the test set and the data provenance
The document mentions "bench tests" were performed. For these non-clinical performance tests (Appearance, Physical properties), the specific sample size is not explicitly stated, nor is the data provenance. These would typically involve testing a certain number of manufactured units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical accessory and the evaluation is based on engineering and material standards, not diagnostic interpretation requiring expert ground truth in the AI/ML context.
4. Adjudication method for the test set
This question is not applicable for the same reasons as above. The evaluation of appearance and physical properties would follow established testing protocols and standards, not a clinical adjudication process.
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 such study was conducted or reported. This type of study is relevant for AI/ML diagnostic devices, which this device is not. The document explicitly states: "No Clinical Study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical endoscope accessory, not an algorithm.
7. The type of ground truth used
For the non-clinical tests (biological evaluation, sterilization, appearance, physical properties), the "ground truth" would be compliance with established international standards (ISO series) and predefined specifications for the physical characteristics of the device. This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI/ML diagnostic validation.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
§ 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.