(140 days)
The US Endoscopy Endoscopic Retrieval Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for "The US Endoscopy Endoscopic Retrieval Device." This letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This type of FDA clearance does not typically involve the rigorous multi-reader multi-case (MRMC) comparative effectiveness studies, standalone algorithm performance studies, or detailed statistical evaluations of acceptance criteria that would be conducted for novel AI/ML medical devices.
Instead, substantial equivalence is determined by demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this type of regulatory document.
Here's why and what can be inferred:
Reasons for Absence of Requested Information:
- Device Type: This is for an "Endoscopic Retrieval Device," which is a physical instrument (likely a forceps or snare) used to grasp and retrieve objects during endoscopy. It is not an AI/ML diagnostic or prognostic device.
- Regulatory Pathway (510(k)): The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device. This typically involves bench testing, biocompatibility testing, and sometimes limited clinical testing, but not the extensive multi-reader performance studies or detailed statistical analyses of acceptance criteria for diagnostic accuracy characteristic of AI/ML devices.
- Focus of the Document: The provided text is an FDA clearance letter and an "Indications for Use" statement. These documents confirm clearance and define intended use, but do not contain detailed study reports.
Information that CAN be inferred or stated based on the document:
- Acceptance Criteria and Reported Device Performance: This information is not provided in a quantified manner. The letter establishes "substantial equivalence" as the primary acceptance criterion, meaning the device performs similarly to existing predicate devices.
- Sample Size for Test Set and Data Provenance: Not applicable for this type of device and regulatory submission as detailed in the document. Performance would typically be assessed through bench testing (e.g., strength, durability, material compatibility) rather than a clinical "test set" in the context of diagnostic accuracy.
- Number of Experts and Qualifications for Ground Truth: Not applicable. For physical medical devices, "ground truth" might relate to physical properties or performance in a simulated environment, not expert consensus on diagnostic images.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is typically for evaluating the impact of AI on human diagnostic performance, which is not relevant for a physical endoscopic retrieval device.
- Standalone (algorithm-only) Performance: No. This is not an algorithm.
- Type of Ground Truth Used: Not applicable in the context of diagnostic accuracy. "Ground truth" for this device would relate to its mechanical function and safety (e.g., ability to grasp, material integrity, biocompatibility).
- Sample Size for Training Set: Not applicable. This device is not an AI/ML model that undergoes "training."
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document is for a physical medical device cleared via the 510(k) pathway based on substantial equivalence. It does not contain the information requested, which is typically associated with the evaluation and clearance of AI/ML diagnostic or prognostic devices.
§ 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.