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The Airgent™ System is a needle-free injection system designed for the administration of various medicines and vaccines to the body by means of a high velocity jet of fluid that penetrates the skin. The Airgent™ includes a disposable delivery kit intended for multiple injections on a single patient. The Airgent™ System is indicated for professional use only.

The Airgent" System is an automated, multi-use, needless injector system, intended to deliver medications and vaccines to the body by a highly accelerated pneumatically powered jet of fluid via a very small entry point in the surface of the skin The system is comprised of a console and single-use sterile injector kit The user may control the dosage (150ul/200ul) and system pressure for the injection via the graphical user interface on the front panel of the console The entire injector kit is replaced between patients and may be used for multiple injections per patient

The provided text describes the 510(k) summary for PerfAction's Airgent™ needle-free injection system. It details the device's intended use, description, and performance data used to demonstrate substantial equivalence to predicate devices. However, the document does not contain explicit "acceptance criteria" for specific performance metrics from a study or the "reported device performance" against those criteria in the typical format of a clinical or performance study with quantified outcomes. Instead, it focuses on demonstrating equivalence through comparison testing and adherence to standards.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

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

The document does not specify quantitative acceptance criteria or reported device performance in a table format. The performance data section broadly states:

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 explicitly stated. The document mentions "ex-vivo testing" was conducted, but does not provide details on the number of samples or tests performed.
• Data Provenance: The document does not specify the country of origin for the ex-vivo testing data or whether it was retrospective or prospective.

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)

Not applicable. The study involved ex-vivo mechanical testing, not a human reader study requiring expert ground truth for interpretation.

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

Not applicable. This was ex-vivo performance testing, not a human reader study.

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 document describes a medical device (a needle-free injection system), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

Yes, in a sense. The "Performance Data" section describes "Comparison Testing" as "ex-vivo testing... to confirm the performance of Argent." This testing would be considered standalone performance of the device without human intervention beyond operating the device for the test.

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

The ground truth for the ex-vivo testing would likely be based on established engineering and performance specifications for needle-free injection systems (e.g., penetration depth, injection force, dosage accuracy, leakage) as outlined in ISO 21649. The document states the testing demonstrated the Airgent performs "as safe and effective as its predicate devices," implying the predicate devices' established performance acts as a comparative benchmark for "ground truth".

8. The sample size for the training set

Not applicable. The Airgent is a physical medical device, not an AI model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The INJEX ™- and ROJEX ™ needle- free Injection System Extra is exclusively designed to deliver medicines that can be administrated subcutaneously by jet injection propelling a jet of liquid medicine through the skin into subcutaneous tissue under high pressure.

This medical device is intended for the application of prescription drugs and to sale by or on the order of a physician.

Target Population: Patients who have to be injected with liquid pharmaceuticals.

The INJEX™ and ROJEX™ Systems Extra are medical devices to apply liquid medicine needle-free through the skin into the subcutaneous tissue. The process is based on the generation of a defined high velocity jet of fluid to penetrate the skin and to transport the medicine to the subcutaneous tissue. The energy source to accelerate the fluid within the ampoule is an internal spring.

The INJEX™ Injector is designed for multi- use. To tense the spring within the small hand- held injector for injection the reset box is used. For patient's safety the injector is equipped with two safety mechanisms. The automatic mechanism will be deactivated by mounting the ampoule onto the injector, and before injecting

The ROJEX™ Injector is a disposable medical device for single- use. For patient's safety the injector is equipped with a manual safety mechanism, the safety ring. Before injecting the dose of medicine to the individual the safety ring needs to be shifted into the safe- off position.

To transfer the medicine from its different repositories into the ampoule several adapters are designed. In case, medicines in cartridges are used an aid is available: the transporter.

The INJEX™ Systems Extra consist of two main components which are re- usable:

• . INJEX™ Injector
• . Reset Box

The ROJEX™ Systems Extra represent the disposable medical device:

• · ROJEX™ Injector, pre- tensed

The three accessories for INJEX™ needle- free Injection systems Extra are:

• Transporter, re- usable .
• Adapter, sterile, usable for one medicine repository .
• Ampoule, sterile, for single- use .

The provided text describes a 510(k) premarket notification for the INJEX™/ROJEX™ Needle-free Injection System Extra. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the given information:

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

• This information is not available in the provided text. The submission focuses on substantial equivalence rather than presenting specific performance acceptance criteria and corresponding test results.

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

• This information is not available in the provided text. The document mentions non-clinical tests but does not specify a test set sample size or data provenance in the context of device performance.

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

• This information is not available in the provided text. The submission does not describe a study involving expert-established ground truth for performance evaluation.

4. Adjudication method for the test set:

• This information is not available in the provided text.

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 information is not available in the provided text. The device is a needle-free injection system, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.

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

• This information is not available in the provided text. The device is a physical medical device, not an algorithm.

7. The type of ground truth used:

• This information is not available in the provided text in the context of device performance. The submission discusses "biological effects as cytotoxicity, tissue irritation, systemic toxicity, and sensitisation" as part of non-clinical tests, which could be considered a form of ground truth for safety, but not for broader device performance as typically understood in the context of acceptance criteria.

8. The sample size for the training set:

• This information is not available in the provided text. The device does not involve a "training set" in the context of machine learning or algorithms.

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

• This information is not available in the provided text. As above, this concept is not applicable to the device described.

Summary of available information regarding compliance/testing:

The submission states:

• "In addition to the supplier's raw material testing reqarding the ampoule, biological effects as cytotoxicity, tissue irritation, systemic toxicity, and sensitisation were analysed."
• "The body contact of the ampoule is classified as short term (

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