(88 days)
To be utilized by a trained physician through a flexible endoscope for the collection of duodenal or jejunal fluids for diagnostic analysis.
The Hobbs Medical Aspiration Catheter is a sheath within a sheath design. The inner sheath is actuated using a proximal handle. The inner sheath is protected by an elastomeric membrane that has a slit at the distal end to allow for the inner sheath to advance. The inner sheath has three side holes at the distal tip for collection of aspirate. Once the sample is collected the inner sheath is retracted to protect the sample from contamination as it is withdrawn from the endoscope.
The provided text describes a 510(k) premarket notification for an Aspiration Catheter, which is a medical device for collecting duodenal or jejunal fluids. However, the document does not contain information about a study involving an AI/Machine Learning component, nor does it provide the detailed specifics required to answer your questions about acceptance criteria, study design, ground truth, or expert involvement in the context of an AI-based device.
The document primarily focuses on demonstrating the substantial equivalence of the new Aspiration Catheter to a legally marketed predicate device (Hobbs Medical/Jayco Aspiration Catheter K844550) through physical performance testing, rather than a clinical study evaluating an AI algorithm's performance.
Therefore, I cannot provide the requested information based on the provided text, as it does not pertain to the development or validation of an AI/ML medical device.
Here's a breakdown of why I cannot answer each question based on the provided text:
- A table of acceptance criteria and the reported device performance: The document mentions "Joint integrity testing," "Deployment force testing," "Endoscope compatibility testing," "Design verification and validation," "Protection of sample from contamination," and "Shelf life testing." However, specific numerical acceptance criteria (e.g., "deployment force must be less than X N") and the quantitative results for these tests are not provided. These are engineering/device performance tests, not AI performance metrics.
- Sample sized used for the test set and the data provenance: No information on sample sizes for clinical or AI-specific testing is available. The provenance of any data (country of origin, retrospective/prospective) is also not mentioned, as it's not a data-driven AI study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert annotation or ground truth establishment for an AI algorithm.
- Adjudication method: Not applicable. There's no AI algorithm requiring adjudication.
- MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted human reader study.
- Standalone (algorithm only without human-in-the loop performance) study: Not applicable. This device is not an algorithm.
- The type of ground truth used: Not applicable. The "ground truth" for this device would relate to its physical performance meeting specifications, not clinical diagnoses or classifications.
- The sample size for the training set: Not applicable. No AI training was conducted.
- How the ground truth for the training set was established: Not applicable. No AI training was conducted.
§ 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.