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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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The Injex 30 Injector System is designed to deliver various medicines and vaccines by means of a narrow, high velocity jet of fluid which penetrates the surface of the skin and delivers the medicine or vaccine to the body.

Equidyne Systems Injex 30 Injector System is a means of administering subcutaneous medications without the use of needles. The needle free injector utilizes a high velocity focused jet of liquid to penetrate the skin and deposit the medication in the subcutaneous tissue. The process takes place in a fraction of a second. Needle free injection is useful in a wide range of drug therapy including immunization vaccines, hormones and local anesthetics, as well as the administration of insulin to the diabetic population, where individuals may need a number of injections per day.

The Injex 30 Injector system consists of four main components;

1. Injector A small re-usable hand held Injector,
2. Reset Box A compact re-usable Reset Box used to reset and store the Injex 30 Injector,
3. Ampule A disposable, sterile 0.3 ml Ampule that functions like a needle syringe to draw the medication from the medicine bottle or vial using a hand draw with a plunger. Once the Ampule is loaded into the Iniex 30 Iniector, the dose is injected into the individual by releasing the Safety and pressing the trigger.
4. Vial Adapter A disposable, sterile Vial Adapter facilitates the transfer of the medication from the medicine bottle or vial to the Ampule.

The Injex 30 Injector can deliver variable doses of fluid medication from 0.05 ml to 0.30 ml.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Injex 30 Needle Free Injection System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative manner for the Injex 30's primary function of medication delivery compared to a predicate. Instead, it describes a comparative study aiming for "substantial equivalence." The "acceptance criteria" are implied by the conclusion of this equivalency testing.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: The "equivalency tests" involved injecting colored water into chicken breasts. The term "chicken breast" was used as a human subcutaneous tissue model.
• Sample Size: The document does not specify the number of chicken breasts used, or how many injections were performed at each volume.
• Data Provenance: The study was conducted by Equidyne Systems Inc. It is a prospective study, specifically designed to demonstrate equivalence for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• No external experts are mentioned for establishing ground truth regarding the injection performance.
• The comparison was performed internally by Equidyne Systems Inc., with "The injection sites were then dissected and the flow and dispersion of the colored water was examined and compared" to the predicate device. The qualifications of the individuals performing this comparison are not stated.

4. Adjudication Method for the Test Set

• None described. The comparison appears to have been a direct observation and qualitative assessment by the company, not involving a formal adjudication process or multiple independent reviewers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This study solely focused on the physical characteristics of the injection performed by the device, not on human reader interpretation or clinical outcomes with and without AI assistance. The device is a physical delivery system, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

• Yes, a standalone study was done. The "equivalency tests" were conducted on the device itself (Injex 30 Injector System) in a model (chicken breast) to assess its performance in delivering fluid compared to a predicate device, independent of human interaction beyond the operation of the device during the test. There is no AI involved, so the concept of "human-in-the-loop" is not applicable here.

7. Type of Ground Truth Used

• For Biocompatibility: Laboratory test results (non-toxic, non-irritating) are the ground truth.
• For Equivalency (Injection Performance): The "ground truth" was a direct comparison to the predicate device's performance in the same chicken breast model. The predicate's fluid flow and dispersion characteristics served as the benchmark for "substantial equivalence." This is a comparative engineering/performance assessment, not a clinical ground truth like pathology or patient outcomes.

8. Sample Size for the Training Set

• Not applicable. The Injex 30 is a mechanical device, not an AI/machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an AI model, this question is irrelevant to the Injex 30.

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