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The Zetajet is indicated for delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs into standard injection sites. The Zetajet may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Zetajet may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.

The Zetajet Needle-free Injection Therapy System is a compact, spring-powered, needlefree delivery system. It is intended to deliver vaccines and injectable medications either subcutaneously or intramuscularly. The Zetajet system consists of the injector body and the single-use, sterile syringe assembly with a pre-inserted piston in the syringe. The Zetajet uses jet force to propel a finely dispersed stream of the injectable medication into the subcutaneous or intramuscular tissue.

The disposable assembly consists of a single-use, sterile, disposable syringe designed to contain a volume between 0.05 and 0.5 ml and a plunger to discharge the medicine or vaccine through a syringe orifice size based on the type of injection to be given (either subcutaneous or intramuscular).

The provided text is a 510(k) summary for the Zetajet Needle-Free Injection Therapy System. This document focuses on demonstrating substantial equivalence to a predicate device (Biojector® 2000), rather than detailing original acceptance criteria and a study to prove meeting those criteria.

Therefore, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, and specific study types (like MRMC or standalone performance) is not present in the provided text.

The closest relevant information is about the intended use and comparison to the predicate device as part of demonstrating substantial equivalence.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

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

This information is not provided in the 510(k) summary. The document asserts that the Zetajet "has the same intended use and operational performance as the predicate device" and that "The Zetajet is as safe and effective as the legally marketed predicate device." However, specific numerical acceptance criteria or performance metrics for either device are not detailed.

2. Sample sized 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 510(k) summary. The document relies on demonstrating substantial equivalence to a predicate device, not on presenting a de novo performance study with a specific test set.

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 provided in the 510(k) summary. As no specific ground truth establishment for a test set is mentioned, expert involvement is not detailed.

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

This information is not provided in the 510(k) summary.

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 improvise with AI vs without AI assistance

This information is not provided and is not applicable. The device is a "Needle-free Fluid Jet Injector" for administering medications, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not provided and is not applicable as the device is not an algorithm, but a physical injection system.

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

This information is not provided in the 510(k) summary. The document focuses on showing equivalence to an existing device rather than establishing ground truth for a new performance claim.

8. The sample size for the training set

This information is not provided in the 510(k) summary. The device does not involve a "training set" in the context of machine learning.

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

This information is not provided in the 510(k) summary, as it's not relevant to this type of device and submission.

Summary of Available Information:

The provided document is a 510(k) summary, the purpose of which is to demonstrate substantial equivalence to an already legally marketed device (the Biojector® 2000). The core argument is that the Zetajet is as safe and effective as the predicate device because:

• It has the same intended use: "delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs into standard injection sites."
• It has the same operational performance (asserted, but not quantified with specific metrics in this document).
• It has similar technological characteristics (e.g., use of different syringe orifice sizes to control penetration depth).
• The key technological difference (spring power vs. compressed CO2 gas) "does not raise new questions of safety or effectiveness."

To reiterate, this document does not contain details about specific acceptance criteria, a novel performance study (including sample sizes, expert qualifications, or ground truth methods), or a multi-reader comparative effectiveness study, as it is a substantial equivalence submission for a physical medical device.

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