(266 days)
The Luer-Split MAJ-2092 has been designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of EndoTherapy accessories.
The Luer-Split MAJ-2092 ("Luer-Split") has been designed to be attached to the instrument channel port of endoscopes to allow both irrigation and the use of endoscopy accessories. The Luer-Split is a reusable device after appropriate cleaning and disinfection/ reprocessing as stated in the instruction manual accompanied with device. The Luer-Split is provided as a single model (MAJ-2092) and packed as a single unit. The Luer-Split is mounted on the instrument channel port of endoscope and the sealing accessory (i.e., single use biopsy valve) is attached on the proximal end of the Luer-Split. The side arm/T-Pipe of the Luer-Split, also referred to as the irrigation port, is connected to the irrigation tube and irrigation equipment. EndoTherapy devices are inserted via attached sealing accessory to perform procedures.
It appears you've provided the text of an FDA 510(k) clearance letter for the "Luer-Split MAJ-2092." However, the content of this document does not describe acceptance criteria for a device's performance nor does it detail a study proving the device meets those criteria in the context of an AI/software as a medical device (SaMD) product.
This 510(k) is for an endoscope accessory (a physical device), not a software or AI product. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section mentions "Performance Testing - Bench" (Flow Rate, Composite Durability), "Human Factors Validation," and "Reprocessing Validation," along with "Biocompatibility Evaluation." It explicitly states "Clinical testing is not applicable."
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to AI/software performance.
- Sample size and data provenance for a test set in an AI/software study.
- Number of experts and their qualifications for ground truth establishment for AI/software.
- Adjudication method for an AI/software test set.
- MRMC comparative effectiveness study for human readers with/without AI assistance.
- Standalone AI algorithm performance.
- Type of ground truth for AI/software.
- Sample size and ground truth establishment for an AI/software training set.
The provided document simply isn't about an AI/SaMD product. It's a clearance letter for a mechanical accessory for endoscopes.
§ 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.