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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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This product is indicated for Needle-Free Self Injection of Saizen® [somatotropin (rDNA origin) for the replacement of endogenous growth hormone in adults with growth hormone deficiency.

Needle-Free Self Injection Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection]. Needle-Free Injector, Jet Injector

The provided document is a 510(k) Summary for a medical device (cool.click® Needle-Free Jet Injector) and primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device. It is not a study report that details acceptance criteria and the performance of an AI/ML device in a clinical or technical study.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth for training sets cannot be extracted from this document in the context of an AI/ML device assessment.

The document explicitly states:

• "No new nonclinical or clinical tests were conducted as part of this submission."
• It refers to previously submitted nonclinical and clinical studies for the predicate device (K994384) which demonstrated bioequivalence between needle and cool.click® needle-free delivery of growth hormone (Saizen®).

The core of this submission is a labeling change to expand the indications for use of an existing device to include adults, aligning with updated indications for the drug Saizen®.

However, based on the limited information that is present in the document about the predicate device's studies, I can infer some aspects related to bioequivalence, which was the performance measure used in those predicate studies.

Here's an attempt to answer the questions based on the available information, noting where information is absent or inferred:

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

Since this is a 510(k) for a labeling change based on a predicate device, explicit "acceptance criteria" for this specific submission in terms of device performance are not stated in the provided text. The key performance aspect mentioned relates to the predicate device's demonstrated bioequivalence.

Note: The specific statistical thresholds (e.g., 90% confidence interval for AUC, Cmax ratios within 80-125%) typically associated with bioequivalence are not provided in this summary but would have been part of the original predicate device's studies.

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 (Test Set): Not specified in this document. This information would have been part of the studies conducted for the predicate device (K994384).
• Data Provenance: Not specified. The studies were "conducted for the predicate cool.click submission K994384." Whether they were prospective or retrospective, and the country of origin, is not mentioned here.

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 is not applicable to this type of device (needle-free jet injector). The "ground truth" in bioequivalence studies is typically the pharmacokinetic and pharmacodynamic data derived from blood samples and clinical observations. It doesn't involve expert interpretation in the way AI/ML diagnostics do.

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

Not applicable. Bioequivalence studies typically involve statistical analysis of quantitative data, not human adjudication of interpretations.

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

Not applicable. This is a medical device for drug delivery, not an AI/ML diagnostic or assistive technology involving human "readers."

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

Not applicable. This is not an algorithm-based device.

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

For the predicate device studies, the ground truth was based on pharmacokinetic (PK) and pharmacodynamic (PD) data (e.g., drug concentration in blood, biological response) collected from study participants following administration of Saizen® using both needle and needle-free methods. This would qualify as outcomes data (physiological measurements).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a training set.

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

Not applicable. This is not an AI/ML device.

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This product is indicated for use with Saizen® [somatropin (rDNAorigin) for injection] for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.

Clicker™ Needle-Free Self-Injection Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection]. This submission changes the labeling of the Vitajet 3, (Innova) (K962625) to allow the device to be used for needle-free subcutaneous administration of Saizen® [somatropin (rDNAorigin) for injection]. There are no other significant changes to the Vitajet 3 (Innova) in device design or function.

Here's a summary of the acceptance criteria and study details for the Bioject Clicker™ Needle-Free Self-Injection Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Biojector® 2000 is indicated for delivery of subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs. The Biojector® 2000 may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Biojector@ 2000 may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.

The Biojector® 2000 is a needle free injection management system designed to deliver drugs both subcutaneously (SC) and intramuscularly (IM). It is a non-electrically powered device which is intended to administer an injection by means of a high velocity jet of fluid that penetrates the surface of the skin and delivers drug to the bodv. The system is comprised of three major components: The single use sterile medication syringe (medication container), the Biojector® (injector), and the Carbon Dioxide (CO2) cartridge (power source). The device is also capable of being powered with a CO2 tank with a specialized adapter.

The syringe holds a variable volume of drug up to a maximum of one cubic centimeter (cc) or milliliter (ml.). Volume increments are marked at 0.10, 0.20, 0.25, 0.30, 0.40, 0.50, 0.60, 0.75, 0.80, 0.90, and 1.0 cc or ml. The syringe is filled using either a fill needle, or a plastic fluid transfer device. Once the syringe is filled, it is loaded in the Biojector®. Syringes are available in five sizes which are numbered 2, 3, 4, 5 and 7. The syringe sizes have the following orifice diameters: 0.004, 0.008, 0.010 & 0.014 inches, respectively. The number 2 syringe is used for all subcutaneous injections. The remaining syringes, numbered 3, 4, 5, and 7, are used for intramuscular injections. Depth of penetration of the drug varies with the orifice diameter selected. The larger the orifice diameter, the deeper the penetration of the drug.

Activation of the Biojector® is initiated when the actuator is depressed. CO2 gas is released. through the action of a series of valves within the injector. This causes the plunger to push the drug out of the sterile syringe, through the syringe orifice at a high velocity, allowing it to penetrate the skin and be deposited in the tissue. Exhaust CO2 is expelled, through the exhaust and bleed valves, in the rear section of the Biojector®, as well as into the cartridge compartment. The CO2 does not come in contact with the drug.

This 510(k) summary describes modifications to the Biojector 2000 device, asserting its substantial equivalence to a previously cleared predicate device (K920631). As such, the document focuses on demonstrating that the modified device is as safe and effective as the predicate without introducing new safety or efficacy issues.

Here's an analysis of the provided information relevant to acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not specify a sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are referred to as "Product qualification testing and biocompatibility data," which are general categories and not detailed clinical studies with specific test sets in the traditional sense. It's likely that "test set" here refers to a set of devices or components undergoing engineering and biocompatibility evaluations, not human subjects.

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

This information is not provided in the document. Given that the focus is on device modification and functional equivalence to a predicate, "ground truth" would likely relate to engineering specifications and performance metrics rather than clinical diagnoses.

4. Adjudication Method for the Test Set

This information is not provided. Since the studies appear to be primarily engineering and biocompatibility assessments, a traditional adjudication method for human subject data is not applicable here.

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 explicitly mentioned or indicated in this document. The submission focuses on substantial equivalence based on material and design modifications, not on improved human reader performance with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. The Biojector 2000 is a physical medical device for drug delivery, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context would implicitly be defined by:

• Engineering Specifications: Performance parameters (e.g., injection pressure, drug delivery volume accuracy, CO2 efficiency, depth of penetration for different syringe sizes) set during the design and manufacturing of the device.
• Predicate Device Performance Data: The known and accepted performance characteristics of the legally marketed predicate device (Biojector® 2000 Jet Injection System, K920631).
• Biocompatibility Standards: Established standards for materials that come into contact with the patient.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this particular submission, as it's a modification of an existing device seeking substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable and not provided. As noted, this is not an AI/algorithm-based device that would require a "training set."

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

This information is not applicable and not provided for the same reasons mentioned in point 8.

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The intended use of the Bioject Needle-Free Vial Adapter is to allow single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, and reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physicians to administer injections of prescribed medication.

The Bioject Needle-Free Vial Adapter is a device which provides single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter is a one piece, polycarbonate adapter with a standard female luer lock fitting compatible with standard luer taper syringes and a shielded spike designed to fit 13 mm outside diameter vial stopper overseals. The spike is designed to direct fluid along the drug vial walls in order to minimize foaming when used to reconstitute medications. The Bioject Needle-Free Vial Adapters are sterile, nonpyrogenic, and intended for single-use only. The adapters are individually packaged in a sterile, single-use Tyvek blister pack.

This K963012 document describes a Bioject Needle-Free Vial Adapter. It is a medical device and not an AI/ML-based diagnostic or prognostic tool. Therefore, the questions regarding acceptance criteria and studies demonstrating performance in the context of AI/ML are not applicable here.

The document focuses on demonstrating substantial equivalence to existing predicate devices (Baxter Needle*Less™ Drug Vial Adapter and Abbott LifeShield™ Vial Adapter) to gain FDA clearance. This involves showing that the new device has the same intended use, materials, design, and operational principles, and does not raise new questions of safety or effectiveness.

Here's why the provided questions cannot be answered from this document:

• No AI/ML Component: The device is a physical adapter for drug vials; it does not involve any algorithms, image analysis, or decision support based on data.
• No Diagnostic/Prognostic Claim: The device facilitates medication transfer, not diagnosis or prognosis, so performance metrics like sensitivity, specificity, AUC, or reader improvement are irrelevant.
• No "Study Proving Device Meets Acceptance Criteria" in an AI/ML Sense: The "proof" here is the demonstration of substantial equivalence to legally marketed devices, not a clinical trial evaluating AI performance against ground truth.

If this was an AI/ML device submission, the requested information would be crucial. However, for a traditional medical device like a vial adapter, the document instead focuses on:

• Device Description: What it is, what it's made of (polycarbonate), how it works.
• Intended Use/Indications For Use: Its purpose (accessing drug vials without needles for medication transfer, reconstitution).
• Predicate Devices: Identifying similar devices already on the market.
• Substantial Equivalence Argument: Directly comparing key features (intended use, materials, design, operational principles, sterility, single-use) to the predicates to demonstrate it's as safe and effective.

Therefore, I cannot populate the table or answer the specific questions because they pertain to a type of device and evaluation methodology not present in the provided text.

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