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

The Safety Blood Collection Device for Single Use is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The Safety Blood Collection/Infusion Set is individually wrapped, sterile, non-pyrogenic and is designed for collection of blood specimens or short-term intravenous administration of fluid (up to 2 hours under direct clinical supervision). When it's equipped with male luer adapter and/ or tube holder, it can be used for taking samples from the patients through vacuum tubes. It is also indicated for short-term intravenous fluids (up to 2 hours under direct clinical supervision) after attaching to an IV set, a transfusion set or to other compatible/appropriate device.

Three models were included in this submission, which are JT-HSQ, JT-HSQ-B, and JT-HSQ-Z.

The provided text is a 510(k) Summary for a medical device called "Safety Blood Collection Device for Single Use." This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than presenting a clinical study with acceptance criteria and comparative human reader performance as one might find for an AI/ML medical device.

Therefore, many of the requested details, such as sample size for test sets (in the context of clinical studies), data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or not provided in this document. The document describes bench testing of physical and chemical properties and biocompatibility, not clinical performance for diagnostic accuracy or human-in-the-loop performance.

Here's an analysis based on the provided text, addressing what can be inferred and highlighting what is absent:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

The acceptance criteria are implicitly defined by the successful adherence to recognized international standards and FDA guidance documents for medical devices of this type. The reported device performance is that it met the requirements of these standards and guidance documents.

Since this premarket notification is for a conventional medical device (safety blood collection device) and not an AI/ML-based diagnostic or imaging device, the following points are largely not applicable or not detailed in the submission.

1. Sample size used for the test set and the data provenance:

   • The document mentions "test devices" for performance testing and "samples" for biocompatibility but does not specify the number of units or lot sizes tested for each standard.
   • Data provenance (e.g., country of origin, retrospective/prospective) is not applicable given this is hardware testing against engineering standards, not patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance and biocompatibility is established by adherence to international engineering and biological safety standards, not expert consensus on clinical data.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical bench testing.

4. 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 device is not an AI/ML diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

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

   • For biocompatibility: Ground truth is established by the results of standardized biological tests (e.g., cell cultures, animal irritability tests) that comply with ISO 10993 series.
   • For performance: Ground truth is established by meeting the quantified specifications and thresholds defined within various ISO engineering standards (e.g., tensile strength, flow rate, dimensions).

7. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

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