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International Medsurg Connection's piston syringe is intended for the injection of fluids into, or withdraw of fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger. The intended use is the same as the intended use on IMC piston syringe sold by International Medsurg Connection, Reference K022159.

This submission includes piston syringe that will be sold both sterile and non-sterile syringes are to be sold to OEMs for EtO sterilization according to their validated process per ANSVAMMISO 11135. Sterile syringes are to be sold directly to users after EO sterilization validation per ANSVAMMI/ISO 11135

The device consists of a calibrated hollow barrel and a movable plunger with piston. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into or withdraw fluids from, the body.

The provided text describes a 510(k) submission for an IMC Piston Syringe and does not contain information about an AI/ML device. Therefore, it does not fit the typical structure of an acceptance criteria and study report for such a device. This document is a regulatory submission for a medical device (piston syringe) claiming substantial equivalence to a predicate device.

However, I can extract the relevant "performance data" and "acceptance criteria" presented in the context of this device's submission, along with other requested information where applicable.

Here's the information based on the provided text, adapted to your request format:

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

Note: For this traditional medical device, "acceptance criteria" means meeting the requirements of the specified ISO standards, and "reported device performance" indicates that the new device meets those requirements.

2. Sample sized used for the test set and the data provenance

The document does not specify the sample size used for testing the piston syringes. It also does not explicitly state the provenance (e.g., country of origin, retrospective/prospective) of the data. The tests are referenced by ISO standards, implying laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the device is a physical medical instrument (piston syringe), not an AI/ML device requiring expert ground truth for classification or diagnosis. Performance is evaluated against objective engineering standards (ISO 7886-1).

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert-dependent tasks, typically in AI/ML performance evaluation where human experts might disagree. The syringe's performance is determined by objective physical tests according to ISO standards.

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 section is not applicable. This is a submission for a physical medical device (piston syringe), not an AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this document.

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

This section is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by objective engineering standards and test methods defined in ISO 7886-1. The device is deemed to meet its performance criteria if it passes these standardized tests, indicating functional equivalence to the predicate device.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This section is not applicable for the same reasons as above.

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