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TK Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspirations injection.

The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip / lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas and is labeled Non-Pyrogenic. The device is intended for single use only.

The provided text is a 510(k) summary for a medical device called "TK Sterile Piston Syringe without Needle." It outlines the device's characteristics and compares them to a legally marketed predicate device (U&U Sterile Piston Syringe without Needle) to establish substantial equivalence.

However, the provided document DOES NOT contain information about a study that uses an AI/ML algorithm or requires ground truth established by experts. It describes a conventional medical device (syringe) and its testing against established international standards for physical, chemical, and biological properties. Therefore, I cannot generate the requested table and study details related to acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies in the context of an AI/ML study.

The document focuses on demonstrating that the new syringe complies with performance standards through non-clinical performance testing (e.g., liquid leakage, air leakage, conical fitting integrity), sterility testing, and biocompatibility testing.

Here's what I can extract and present based on the provided text, reinterpreting "acceptance criteria" in the context of a non-AI/ML medical device's performance testing:

Acceptance Criteria and Device Performance (for a non-AI/ML device)

The device, "TK Sterile Piston Syringe without Needle," is a conventional medical device. Its acceptance criteria are based on compliance with established international standards for syringes, rather than AI/ML performance metrics. The study described focuses on demonstrating equivalence to these standards and to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML specific questions:

2. Sample sizes used for the test set and the data provenance: Not applicable. This document is for a physical medical device, not an AI/ML algorithm. Testing involves physical samples of syringes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a syringe's performance is established by objective physical, chemical, and biological measurements against established standards, not expert consensus on an AI's output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like those listed are used for human reader studies with AI, not for physical device testing.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" for performance is defined by the objective pass/fail criteria of the various ISO and USP standards referenced (e.g., specific thresholds for fluid leakage, absence of microbial growth, acceptable levels for extractable metals, absence of adverse biological reactions).
8. The sample size for the training set: Not applicable. This applies to AI/ML devices.
9. How the ground truth for the training set was established: Not applicable. This applies to AI/ML devices.

Conclusion stated by the submitter:

"The TK Sterile Piston Syringe without Needle is substantially equivalent to the U&U Sterile Piston Syringe without Needle. The materials, performance, and operational features of both the subject device and the predicate device are substantially equivalent."

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