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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 text describes a 510(k) summary for a "Blood Collection Needle" and largely focuses on its substantial equivalence to a predicate device. This type of submission does not typically involve the detailed performance studies, particularly those related to AI algorithms or diagnostic accuracy, that your request for "acceptance criteria and reported device performance" (especially with specifics like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) implies.

Blood collection needles are low-risk devices where performance demonstration usually revolves around adherence to established international standards for physical characteristics, sterility, and biocompatibility, rather than diagnostic accuracy metrics.

Therefore, many of the specific questions in your prompt cannot be directly answered from the provided document because they are not relevant to the type of device (a hypodermic needle) or the nature of its 510(k) submission.

Here's an attempt to answer as much as possible, interpreting "acceptance criteria and reported device performance" as compliance with relevant standards and basic physical properties mentioned:

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information and understanding of 510(k) for this device type)

1. Sample size used for the test set and the data provenance: Not explicitly stated. For compliance with ISO standards for physical characteristics and biocompatibility, samples would be drawn from production batches and subjected to laboratory testing. The data provenance would be laboratory test reports, likely conducted in China given the manufacturing location. This is not "data" in the sense of patient imaging or clinical records.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For these types of devices, "ground truth" refers to objective measurements against ISO standards (e.g., needle diameter, tensile strength, sterility testing results, cytotoxicity assays), not expert interpretation of medical images or conditions.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations, not objective performance testing against standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. MRMC studies are used for diagnostic imaging devices to assess human reader performance, often with and without AI assistance. This is a physical medical device (a needle), not a diagnostic tool where human interpretation is involved.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve algorithms or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Objective measurements against predefined ISO standard specifications and validated laboratory test methodologies for physical properties, sterility, and biocompatibility.

7. The sample size for the training set: Not applicable. This device does not use machine learning or AI models, so there is no "training set."

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary of what the document implies about "studies":

The "studies" for this device are laboratory-based performance tests and biocompatibility assessments conducted to demonstrate compliance with recognized international standards (ISO 7864, ISO 9626, ISO 10993). The conclusion of the submission is that "The applicant device is Substantially Equivalent (SE) to the predicate device," based on having the "same classification information, same indications and intended use, similar product design, same performance effectiveness, performance safety." This reliance on substantial equivalence, supported by standard compliance, is typical for 510(k) submissions of low-to-moderate risk medical devices without complex diagnostic or algorithmic components.

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