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The LectraJet Needle-Free Injection System is intended to deliver subcutaneous (SQ) or intramuscular (IM) injections of vaccines and other injectable medications.

The LectraJet Needle-Free Injection System may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections.

The LectraJet Needle-Free Injection System may also be used by patients to self inject or to have other individuals administer injections of prescribed medications.

The components of the LectraJet® Needle-Free Injection System include the needle-free single-use syringes with disposable vial adapter and cap with plunger rod attached and the injector handpiece with manual reset mechanism.

The LectraJet® handpiece and reset mechanism are sold as a complete injection system contained within a carrying case. The carrying case is an accessory of convenience that provides for portability, organization, and ease of use for the practitioner.

The LectraJet® syringes are packaged sterile and designed to be filled by the end user at the time of use. The polycarbonate syringes have a molded orifice at the front end. The syringe orifice is available in sizes 0.006", 0.008", 0.010" and 0.012" diameter, which allows the user to choose the syringe appropriate for the desired depth of penetration (IM/SQ) and patient selection (child/adult).

The syringes have a flange at the back end that is held by the injector handpiece when delivering the injection. Syringes are designed to be used immediately upon filling, similar to a traditional needle and syringe, and identical to the Biojector 2000® and Medi-Jector Vision® syringe filling philosophy. After the syringes are filled, they are inserted directly into the LectraJet® handpiece.

The LectraJet® handpiece contains a spring drive system that, when compressed, provides the energy to deliver the injection. To compress the spring, the handpiece is placed in a manual reset mechanism and hand pressure is applied to the reset mechanism lever. In the Medi-Jector Vision®, the manual power source used to compress the spring is a hand-twist knob. In the Biojector 2000®, the power source is either a gas cartridge or a gas cylinder.

When the LectraJet® handpiece is actuated, the spring drive system is released, and the handpiece ram contacts the syringe piston to drive the injectate out through the syringe orifice, creating a jet stream with enough energy to penetrate the tissue. This is identical in principle to the Biojector 2000® and the spring powered Medi-Jector Vision®.

After the injection, the used syringe is released into an appropriate trash container.

Little maintenance is required for the LectraJet® handpiece. There are no o-rings or seals to change. No sterilization of the handpiece is required.

All of the above features are similar to the Biojector 2000® and the Medi-Jector Vision®, predicate devices and accessories.

The LectraJet® Needle-Free Injection System demonstrates substantial equivalence to predicate devices (Biojector 2000® and Medi-Jector Vision®) based on a non-clinical study evaluating injection force profile, injection duration, and depth/dispersion into a homogeneous substrate.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly define "acceptance criteria" in a quantitative sense with specific thresholds. Instead, the study's conclusion is that the LectraJet® is substantially equivalent to the predicate devices based on the test results. The device performance is reported in a comparative manner against these predicates.

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

• Sample Size: The document does not specify the exact sample size for the test set (number of injections performed or devices tested).
• Data Provenance: The study is reported within a 510(k) submission to the FDA, suggesting it was likely conducted by or for D'Antonio Consultants International, Inc. (DCI, Inc.) at their facility or a contracted lab. The country of origin of the data is not explicitly stated but can be inferred as the USA, given the submitter's location (East Syracuse, NY) and the FDA submission context. The study is non-clinical (bench testing), not referring to patient data, therefore the terms retrospective or prospective do not apply in the typical sense.

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

This section is not applicable as the study described is a non-clinical bench test comparing physical characteristics of the device against predicate devices. There is no "ground truth" established by experts in the context of clinical outcomes or imaging interpretation. The ground truth for the comparison is the measured performance of the predicate devices themselves.

4. Adjudication Method for the Test Set

This section is not applicable. As a non-clinical bench test, there is no need for adjudication by experts in the way clinical studies or image interpretation studies would. The measurements of force, duration, depth, and dispersion are objective physical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The described study is a non-clinical performance evaluation of the device itself, not a comparative study of human readers' performance with and without AI assistance.

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

This section is not applicable. The LectraJet® is a physical medical device (a needle-free injection system), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant. The study evaluates the standalone performance of the physical device.

7. The Type of Ground Truth Used

The ground truth for this non-clinical study is the measured physical performance of the predicate devices (Biojector 2000® and Medi-Jector Vision®) for the parameters of injection force profile, injection duration, and depth/dispersion into a homogeneous substrate. The LectraJet®'s performance was then compared to these established predicate device measurements to determine substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" for this type of non-clinical device performance study. The LectraJet® is a mechanical device, not an AI model that requires training data.

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

This section is not applicable as there is no training set for a mechanical device.

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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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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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