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The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adaper and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

This document describes the premarket notification (510(k)) for the Promisemed Safety Winged Blood Collection Set. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (K170276). It does not involve AI or algorithms, but rather a physical medical device. Therefore, many of the requested elements regarding AI/algorithm performance are not applicable.

Here's an analysis based on the provided document:

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

The acceptance criteria are demonstrated through adherence to various international and national standards, showing the device's conformance to established safety and performance benchmarks. The reported device performance is indicated by "passing results" for all tests.

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

The document does not specify exact sample sizes for each test listed, but it indicates "Non-Clinical bench testing" was performed. The data provenance is implied to be from the manufacturer's internal testing in China (Promisemed Hangzhou Meditech Co., Ltd., Hangzhou City, Zhejiang, China). The tests are retrospective, as they are part of the device development and verification process before submission.

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

Not applicable. This is a physical medical device. Ground truth is established through adherence to international standards and validated laboratory testing procedures for physical, chemical, and biological properties, not through expert consensus on images or interpretations.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reading images) where disagreement might occur. For physical device testing, the results are typically quantitative or pass/fail based on established standards.

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 product is a physical blood collection device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and human reader improvement are irrelevant.

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

Not applicable. This product is a physical blood collection device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by the specified international and national consensus standards (e.g., ISO, USP, ASTM) for medical devices, which define acceptable physical, chemical, and biological properties. This includes:

• Physical performance metrics: Bond strength, needle dimensions, patency, kink stability, puncture force, safety mechanism activation.
• Chemical properties: Absence of harmful residues or leaching.
• Biological properties: Biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, bacterial endotoxin) and sterility.
• Outcomes: The device is designed to prevent needlestick injuries, and its safety mechanism is tested to meet this outcome requirement.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model. There is no "training set" in the context of this 510(k) submission.

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

Not applicable. As there is no training set, this question is not relevant.

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