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Disposable Blood Collection Needles is designed for use in the daily blood collection routine when delegated by a qualified practitioner.

Blood collection needle is a sterile and disposable medical device. It is consist of a puncturing needle which is punctured into vein, a bottle needle which is insert to the blood collection bottle to collect blood, a needle holder which connects the puncturing needle and bottle needle, two needle caps which protect puncturing needle and bottle needle and a latex cover to protect bottle needle.

The provided document is a 510(k) summary for a Disposable Blood Collection Needle and does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would typically be described for software or AI-driven medical devices.

Instead, this document describes a traditional medical device (a needle) and its substantial equivalence to a predicate device. The "testing" section refers to adherence to international standards and biological evaluation, not performance against specific acceptance criteria for characteristics like sensitivity, specificity, or accuracy, which are common in AI/software device evaluations.

Therefore, many of the requested categories are not applicable to the information contained in this 510(k) submission. I will fill in what information is available and indicate where the information is not present.

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

• Similar indications for use
• Similar design features
• Similar functional features
• Same safety compliance | "substantially equivalent (SE) to the predicate devices." |
  | Material Properties (Stainless Steel) | Conformance to ISO 9626:1991 (Stainless steel needle tubing for the manufacture of medical devices/Amendment:2001) | Implied by "designed, tested and will be manufactured in accordance with" |
  | Sterility & Single Use | Conformance to ISO 7864:1993 (Sterile hypodermic needles for single use) | Implied by "designed, tested and will be manufactured in accordance with" |
  | Biocompatibility/Biological Safety | Conformance to ISO 10993 series:
• ISO 10993-1 (Guidance on selection of tests)
• ISO 10993-4 (Interactions with Blood)
• ISO 10993-5 (In vitro cytotoxicity)
• ISO 10993-10 (Irritation and delayed-type hypersensitivity)
• ISO 10993-11 (Systemic toxicity)
• ISO 10993-12 (Sample preparation and reference materials) | Implied by "designed, tested and will be manufactured in accordance with" and "Laboratory testing was conducted to validate and verify... that the proposed device... met all design specifications" |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "Laboratory testing" and "Biological Evaluation," but does not specify sample sizes for these tests, nor the origin or type of data (retrospective/prospective, country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. This is a physical medical device (a needle), not an AI/software device requiring expert interpretation for ground truth establishment.

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

This information is not applicable and not provided. As above, this type of adjudication is typically for image or data interpretation, not for a physical device like a blood collection needle.

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 information is not applicable and not provided. An MRMC study is for evaluating diagnostic performance, often for AI-assisted image interpretation. This document is about a physical blood collection needle.

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

This information is not applicable and not provided. This concept relates to AI algorithm performance, which is not relevant to this device. The device itself is a standalone physical product.

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

This information is not applicable and not provided in the context of an AI-driven ground truth. The "ground truth" for this device's performance would be its adherence to the specified ISO standards for materials, sterility, and biocompatibility, as confirmed by laboratory testing.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable and not provided. There is no "training set" or corresponding ground truth establishment methodology in the context of this device.

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