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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.

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