(269 days)
Used for introduction of irrigation fluid into the gastrointestinal tract through the endoscope working channel.
The Accessory Irrigation Adapter is a non-sterile device that is compatible with endoscopes with a maximum working channel of 2.2 mm. The Accessory Irrigation Adapter is approximately 2 inches long.
This document is a 510(k) premarket notification for an "Accessory Irrigation Adapter." It describes the device and claims substantial equivalence to a predicate device. This type of regulatory submission historically focuses on bench testing to demonstrate performance, rather than clinical studies to evaluate diagnostic or therapeutic effectiveness.
Therefore, the input doesn't provide information about an AI/ML powered device, and the specifics requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth are typically not part of a 510(k) submission for a non-diagnostic, non-therapeutic accessory like an irrigation adapter.
Based on the provided document, here's what can be extracted and what cannot:
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Functional user requirements met after accelerated aging. Such as:
- Able to insert through biopsy cap
- Able to irrigate through adapter
- Able to remove the adapter from working channel | Met. Non-clinical bench testing demonstrated that the Accessory Irrigation Adapter met the performance requirements to fulfill the intended use of the device after accelerated aging. |
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. The document refers to "performance testing consisting of non-clinical bench testing," but doesn't quantify the number of devices or tests performed.
- Data Provenance: Not specified. This was non-clinical bench testing, not human data.
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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. Ground truth as typically defined for AI/ML diagnostic devices (e.g., expert consensus on images, clinical outcomes) is not relevant for this type of device's performance testing. The "ground truth" here is whether the device physically performs its function.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for expert review of cases in diagnostic studies. For bench testing, success/failure is determined by whether the device meets pre-defined engineering and functional specifications.
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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, an MRMC study was not done. This device is an irrigation adapter, not an AI-powered diagnostic or therapeutic tool for which an MRMC study would be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical accessory and does not involve algorithms or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of diagnostic/AI ground truth. For this device, the "ground truth" is its functional performance determined by engineering specifications and bench tests (e.g., the ability to insert, irrigate, and remove).
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device, so there is no training set or its associated ground truth establishment.
§ 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.