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This device is used for endoscopic injection into gastrointestinal mucosa. The intended population is adult use only.

The Gastrointestinal Injection Needles (subject devices) are sterile, single use devices that consist of a needle on an inner catheter fitted inside an outer catheter sheath featuring a luer slip/adjustment wheel handle with either a plastic or metal hub used as an injection port at the proximal end of the device. The devices are compatible with endoscopes with a minimum accessory channel of 2.0 mm or 2.8 mm. The Gastrointestinal Injection Needles have catheters which ranges in length from 195 to 315 cm, outer diameters of 5.4 FR and 6.9 FR, and needle gauges of 21, 23 and 25. Some configurations of the Gastrointestinal Injection Needles include ink marks at the distal end of the device to aid endoscopic visualization.

The provided text describes the regulatory clearance for "Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)" and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It does not contain information about an AI/ML device or its acceptance criteria and a study proving it.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states that "non-clinical bench testing demonstrates that the Gastrointestinal Injection Needles meet the performance requirements to fulfill the intended use of the device" and lists the following tests:

• Functional Testing
• Tensile Strength Testing
• Needle Verification and Validation Testing
• Shelf Life Testing
• Packaging Validation
• Biocompatibility testing (in accordance with ISO 10993-1)

However, it does not provide specific acceptance criteria or detailed results from these tests. It only concludes that the testing "confirmed that the subject device performs as intended" and that modifications "do not raise any new questions of safety or effectiveness."

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