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Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

The Single Use Injection Needles are sterile, single-use devices. The Single Use Injection Needles can is expected to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract. The Single Use Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1800mm, 2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.

The provided document is a 510(k) Summary for a Single Use Injection Needle, which is a medical device, not an AI/ML software. Therefore, the questions related to AI/ML software performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "training set," and "ground truth for the training set" are not applicable to this submission.

The document describes the non-clinical performance testing conducted to demonstrate the essential performance of the proposed device and confirm it works as intended and is substantially equivalent to a predicate device.

Here's the information extracted from the document regarding the acceptance criteria and study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" side-by-side with "reported device performance" in the format typically seen for AI/ML models (e.g., sensitivity, specificity thresholds). Instead, it lists the types of performance tests conducted and concludes that the results demonstrated substantial equivalence. The predicate device's characteristics serve as the de-facto acceptance criteria for equivalence.

Here's a summary of the non-clinical performance tests and the conclusion of equivalence:

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of units tested) for each non-clinical bench test. It states that "Performance testing was conducted to demonstrate the essential performance of the proposed device." For shelf-life testing, it mentions "Three-year aging will be performed." These tests are typically conducted on a representative sample of manufactured devices.

• Data Provenance: The tests were conducted by the manufacturer, Anrei Medical (Hangzhou) Co., Ltd., which is located in Hangzhou, China. The data would be originating from their testing facilities. These are prospective tests performed on the manufactured device models to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. For a medical device like an injection needle, "ground truth" as understood in AI/ML (e.g., expert annotations of images) is not established. Device performance is determined through objective physical, chemical, and biological tests according to established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used for establishing ground truth from multiple human reviewers, especially in diagnostic imaging AI/ML studies. This is a physical device subject to engineering and biological testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device. No MRMC study was performed or required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm. The device's performance is inherently "standalone" in the sense that its physical and material properties are tested directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this medical device, "ground truth" is established through:

• Physical/Mechanical Testing: Adherence to design specifications and functional performance in simulated use (e.g., smooth puncturing, patency of lumen).
• Biocompatibility Testing: Compliance with ISO 10993 standards for biological safety (e.g., absence of cytotoxicity, irritation).
• Sterilization Validation: Achievement of a specified Sterility Assurance Level (SAL) through methods conforming to ISO 11135.
• Shelf-Life Testing: Stability and integrity over time, conforming to ASTM F1980-16.
• Comparison to Predicate Device: The performance and characteristics are compared to those of a legally marketed predicate device (K150434) to establish substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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