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The GMTI PharmaJet System is intended to deliver various predetermined medicines and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet which penetrates the surface of the skin and delivers the medicine or vaccine to the body.

The Genesis Medical Technologies, Inc. (GMTI) PharmaJet Needle-free Injector System (PharmaJet System) is a compact, spring-loaded needle-free hypodermic injector system. The PharmaJet System consists of an injector, a cocking station and single-use, sterile, disposable vials.

The provided document, a 510(k) Premarket Notification for the Genesis Medical Technologies, Inc. PharmaJet Needle-free Injector System, is a summary of safety and effectiveness, and the FDA's acceptance letter. It does not contain the detailed study information required to answer many of the questions regarding acceptance criteria and device performance. The document only states that the device was validated through "rigorous testing according to international standards and internal protocols to ensure biocompatibility, sterility assurance, functionality, and general device safety." However, it does not provide the specifics of these tests, their acceptance criteria, or the reported performance data.

Therefore, the following answers are based only on the information available in the provided text and indicate where information is not present.

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not provided in the document.
• Data provenance: Not provided in the document.

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

• Not applicable/Not provided. The document describes a medical device, not an AI or diagnostic tool where expert ground truth would typically be established for a test set. The validation seems to be based on engineering and functional performance testing rather than human expert interpretation data.

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

• Not applicable/Not provided. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the nature of the device validation described.

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

• No. This is not an AI or diagnostic device. It's a needle-free injector system.

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

• The device is a physical medical device, not an algorithm. Performance testing would inherently be "standalone" in the sense that the device performs its function independently, but this question is generally applied to AI algorithms.

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

• The document implies ground truth was established through adherence to "international standards and internal protocols" for metrics like biocompatibility, sterility assurance, functionality, and general device safety. The specific "types" of ground truth (e.g., specific chemical analyses for biocompatibility, sterility testing methodology, physical measurements for functionality) are not detailed in this summary.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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