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The Safety Blood Collection Sets for Single Use and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury.

The Safety Blood Collection Sets for Single Use are used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately the following venipuncture to aid in the protection against accidental needlestick injury. The Safety Blood Collect Sets is compatible for use with a tube and syringe. The product is to be used by appropriately trained healthcare professionals, only following the product instructions. The Blood Collection needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect to the needle holder, which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber cap and a needle holder. The opposite end of the needle is 3/4" long for withdrawing blood and is fitted with a needle sheath. The needle holder and needle sheath protect the needle. The safety feature is operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. This mechanism is substantially equivalent to the predicate device. The proposed devices are packaged as sterile, single-use, and single patient use only. The proposed device consists of ten components: 1. needle holder 2. rubber sleeve 3. puncture needle 4. needle hub (male luer lock connector) 5. connect base (female luer lock connector) 6. flexing tube 7. safety shield 8. wings 9. patient-end tube needle 10. needle sheath

The provided text is a 510(k) summary for a medical device (Safety Blood Collection Sets for Single Use). It details the device's characteristics, comparison to a predicate device, and various performance, biocompatibility, and sterility tests conducted. However, it does NOT describe a study that proves the device meets specific acceptance criteria in terms of AI or algorithm performance, nor does it involve human readers, expert consensus for ground truth, or an MRMC study.

The document discusses "acceptance criteria" only in the context of the physical and biological testing of the blood collection set (e.g., sterilization, biocompatibility, mechanical performance). It explicitly states: "No clinical study is included in this submission." This type of 510(k) submission generally relies on demonstrable substantial equivalence to a legally marketed predicate device through non-clinical testing, rather than novel clinical performance studies involving human subjects or AI algorithms.

Therefore, many of the requested bullet points, particularly those related to AI/algorithm performance, human readers, sample sizes for test/training sets for AI, ground truth establishment for AI, and MRMC studies, are not applicable to the content of this document.

I will address the applicable parts based on the provided text, and explicitly state when information is not present or not relevant to the document's content.

Description of Acceptance Criteria and Proving Device Meets Them

The document describes the acceptance criteria in the context of various performance, biocompatibility, and sterility tests for a physical medical device (blood collection set). It does not pertain to the performance of an AI/algorithm-based device.

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

The document states that "All of the pre-determined acceptance criteria were met" for various tests, but it does not provide a specific table with the acceptance criteria values alongside numerical performance results for the device. It generally states compliance with relevant ISO and ASTM standards.

Here's a summary of the stated compliance:

2. Sample sizes used for the test set and the data provenance:

• Sample Sizes: The document does not specify the exact sample sizes used for each of the non-clinical performance, biocompatibility, or sterility tests. It confirms that the tests were conducted.
• Data Provenance: The manufacturer is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. in Anhui Province, China. The testing would have been conducted by or for this manufacturer. The data relates to the physical device's characteristics and performance, not patient data. These were laboratory tests, not retrospective or prospective clinical studies involving patients.

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 the testing of a physical medical device (blood collection set) and not an AI or algorithm-based device that would require expert-established ground truth from images or other data.

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

• This question is not applicable for the same reasons as point 3.

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 submission explicitly states, "No clinical study is included in this submission," and the device is a physical blood collection set, not an AI-assisted diagnostic tool.

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

• This question is not applicable. The device is not an algorithm.

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

• This question is not applicable in the context of AI/algorithm ground truth. For the physical device, the "ground truth" or "acceptance criteria" are defined by compliance with established international standards (ISO, ASTM) for material properties, mechanical strength, sterility, biocompatibility, and safety features.

8. The sample size for the training set:

• This question is not applicable as there is no training set for an AI/algorithm described.

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

• This question is not applicable as there is no training set for an AI/algorithm described.

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