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The Disposable Safety Self-destructive is used to inject fluids into, or withdraw fluids from the body. In addition, it is designed to aid in the prevention of needle stick injuries.

The JIANGSU YILE MEDICAL ARTICAL C0., LTD Disposable Safety Self-destructive Syringes, 5MLs are single lumen hypodermic needles with a safety mechanism to prevent needle stick after the usage. The Disposable Safety Self-destructive Syringe is used to inject fluids into, or withdraw fluids from the body. In addition, it is designed to aid in the prevention of needle stick injuries.

The syringes are made of a protector, needle, up connector, 0-ring seal, down connector, barrel, piston and plunger. The syringe and body are constructed of Polypropylene (PP). The piston and 0-ring seal are made of natural rubber. Lumens are constructed of 304 Stainless Steel.

The provided document is a 510(k) summary for a medical device (Disposable Safety Self-destructive Syringes, 5ML) seeking substantial equivalence to a predicate device. It focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The document does not describe an acceptance criteria table with reported device performance in the context of an AI/ML study, nor does it involve a “study that proves the device meets the acceptance criteria” in the typical sense of showing AI model performance against a clinical ground truth.

Instead, the acceptance criteria and study described here pertain to bench testing and material biocompatibility to demonstrate substantial equivalence of a physical medical device (a syringe) to a predicate device. Therefore, many of the requested points related to AI/ML studies (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or discernible from this document.

However, I can extract the information that is present about the non-clinical and performance tests for the physical device.

Here's an interpretation based on the provided document, addressing the relevant points and noting where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests and standards that the device was subjected to. The acceptance criteria for these tests are generally implied to be conformance with the referenced standards. The "reported device performance" is summarized as "All test results were satisfactory," indicating that the device met the requirements of these standards.

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

• Sample Size: The document does not specify the exact number of units tested for each non-clinical and performance test. Medical device testing typically involves statistically significant sample sizes to ensure reliability, but specific numbers are not provided here.
• Data Provenance: Not explicitly stated, but these tests would have been performed by the manufacturer (Jiangsu Yile Medical Article Co., Ltd) or a qualified testing laboratory on their behalf. The country of origin of the device is China. The tests are prospective in the sense that they are conducted on fabricated devices to demonstrate compliance for regulatory 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 as the document describes bench and performance testing of a physical medical device (syringe) against established engineering and biocompatibility standards, not an AI/ML system requiring expert-established ground truth from clinical images or data. The "ground truth" here is the pass/fail criteria defined by the cited international and national standards.

4. Adjudication method for the test set

• This question is not applicable for the same reasons as #3. There are no clinical "case" assessments requiring adjudication.

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

• This question is not applicable. The document describes testing of a physical medical device, not an AI model, and therefore no MRMC studies or human reader improvement with AI assistance are relevant.

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

• This question is not applicable. The device is a physical syringe, not an algorithm.

7. The type of ground truth used

• For the performance and biocompatibility tests, the "ground truth" is defined by adherence to the specific international and national standards (e.g., ISO, ASTM, USP) and FDA guidance documents cited. For instance, for sterility, the ground truth is "sterile" as determined by ISO 11737-2. For sharps injury protection, the ground truth is that the mechanism effectively prevents needlesticks as per ISO 23908 and FDA guidance.

8. The sample size for the training set

• This question is not applicable. There is no AI/ML model described that would require a training set.

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

• This question is not applicable for the same reasons as #8.

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