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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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