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The disposable insulin syringe is intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of insulin into parts of the body below the surface skin.

The proposed device is a syringe with fixed needle tube which is intended for injection the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The insulin is injected to subcutaneous tissue by pushing force generated through pushing plunger rod of the insulin syringe. The proposed devices are provided sterile, single use.

The proposed device is available in 0.3ml, 0.5ml and 1ml volumes.

This document describes the premarket notification (510(k)) for the Disposable Insulin Syringe (K162180) by Berpu Medical Technology Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K072739).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with various international standards for medical devices and specific tests. The table below summarizes these, acting as both acceptance criteria and reported performance (as the tests were performed to verify compliance).

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

The document does not specify the exact sample sizes for each of the physical, mechanical, chemical, packaging, sterilization, or biocompatibility tests. It broadly states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is implied to be from internal testing conducted by Berpu Medical Technology Co., Ltd in China, as they are the sponsor. The studies are prospective in the sense that they are conducted on the device being submitted for approval.

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

This information is not provided. The ground truth for these types of device performance tests is typically established by compliance with international standards and validated testing methodologies, rather than expert consensus on individual cases.

4. Adjudication method for the test set

This information is not provided, as the studies are device performance tests against pre-defined standards, not typically involving adjudication of subjective outcomes by experts.

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

A MRMC comparative effectiveness study was not done. This device is a disposable insulin syringe, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable to a disposable insulin syringe, which is a physical medical device and not an algorithm. Therefore, no standalone algorithm performance study was conducted.

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

The ground truth for the performance of the Disposable Insulin Syringe is largely based on compliance with established international and national standards (ISO 9626, ISO 7864, ISO 8537, ISO 11135, ISO 10993-7, ISO 10993-11, USP 38-NF 33 <85>, ASTM F88/F88-09, ASTM F1140/F1140M-13, ASTM F1929-12). These standards define acceptable ranges, limits, and methodologies for evaluating the physical, mechanical, chemical, and sterility properties of such devices.

8. The sample size for the training set

This is not applicable. The device is a physical medical instrument, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

This is not applicable, as there is no training set for this device.

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