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The PharmaJet® Stratis Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet® Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self-inject, or to have other individuals administer injections of prescribed medication.

The PharmaJet® Stratis 0.5 mL Needle-free Injection System is a compact, spring-loaded needle-free hypodermic injection system. The PharmaJet® System consists of an injector, a reset station, a single use, sterile disposable filling adapter, and a single use, sterile, disposable needle-free syringe. The components of the system may be sold separately for replacements as they are used. The components of the PharmaJet® System are unique and cannot be used with any other needle-free system.

The provided document describes a Special 510(k) Premarket Notification for the PharmaJet® Stratis 0.5 mL Needle-free Injection System. This submission focuses on demonstrating substantial equivalence to a predicate device (PharmaJet® 0.5 mL Needle-free Injection System, K081532) rather than establishing novel safety and effectiveness criteria through extensive clinical trials. Therefore, the information typically available for AI/ML device studies (such as MRMC studies, detailed expertise of adjudicators, specific ground truth methods beyond bench and animal testing, and large training/test sets for algorithm performance) is not directly applicable or available in this type of submission.

The "acceptance criteria" here largely refer to meeting the requirements of the Product and Engineering Specifications, essential requirements of ISO21649:2006, and demonstrating substantial equivalence to the predicate device through various non-clinical and animal studies.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document emphasizes substantial equivalence to a predicate device. Acceptance criteria are primarily regulatory and standard-based, rather than performance metrics of an AI model. "Reported Device Performance" for this submission focuses on demonstrating these equivalences and compliance.

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

• Bench Tests: No specific sample sizes (n-numbers) are provided for each individual bench test (e.g., how many devices were tested for dose accuracy or life cycle). The document states "The following tests have been successfully completed" without quantification of samples per test.
• Animal Test: The document states "Animal testing was performed... in an animal (pig) model." No specific number of animals (sample size) or injections is specified.
• Data Provenance:
  • Bench tests are assumed to be conducted in-house or by a contract lab.
  • Animal test data is from an "animal (pig) model," implying a laboratory setting.
  • The document does not mention country of origin for the data, but the applicant (PharmaJet®, Inc.) is based in Golden, CO, USA.
  • All data described appears to be prospective testing specifically conducted for this submission.

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

• Not Applicable (N/A) for this type of submission. This submission is for a physical medical device (needle-free injection system), not an AI/ML diagnostic or prognostic device that relies on expert interpretation of medical images or data for ground truth. Ground truth for this device is based on objective measurements from bench tests, animal studies, and compliance with recognized standards.

4. Adjudication Method for the Test Set

• Not Applicable (N/A) for this type of submission. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in radiological reads). This device relies on objective physical measurements and functional performance, not subjective expert judgment that requires adjudication.

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 (N/A) for this type of submission. MRMC studies are specific to evaluating the clinical performance of AI/ML algorithms, particularly in diagnostic imaging, by comparing human readers' performance with and without AI assistance. This document describes a physical medical device and its equivalence to a predicate, not an AI system.

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

• Not Applicable (N/A) for this type of submission. This question pertains to AI/ML software performance. The PharmaJet® Stratis Needle-free Injection System is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance and safety is established through:

• Objective Measurements: Results from bench tests such as dose accuracy, life cycle, temperature, free-fall, vibration, shock, performance profile, and noise testing, using calibrated equipment and defined protocols based on ISO 21649:2006.
• Animal Study Observations: Data from the pig model for intramuscular and subcutaneous penetration depth. This serves as a proxy for in-vivo performance compared to the predicate.
• Material Science & Biocompatibility Testing: Compliance with ISO 10993 for material safety.
• Compliance with Standards: Meeting the requirements of ISO 21649:2006.

8. The Sample Size for the Training Set

• Not Applicable (N/A) for this type of submission. The concept of a "training set" applies to machine learning algorithms. This document describes the development and testing of a physical medical device, not an AI model.

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

• Not Applicable (N/A) for this type of submission. As there is no AI training set, there is no ground truth established for it.

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The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines intradermally by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine into the dermis. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may also be used by patients authorized by their physicians to self-inject, or have other individuals administer injections of prescribed medication.

The PharmaJet 0.1 ml Needle-free Iniection System (PharmaJet Svstem) is a compact, spring-loaded needle-free hypodermic injection system. The PharmaJet System consists of an injector; a reset station; a single use, sterile disposable filling adapter; and, a single use, sterile, disposable needle-free syringe. The components of the system may be sold separately for replacements as they are used. The components of the PharmaJet System are unique and cannot be used with any other needle-free system.

An injector is placed in the reset station and the lid is depressed to reset the spring in the injector. A health care worker puts a filling adapter into a vial of liquid medicine or vaccine. A Needle-free syringe is placed into the filling adapter, the liquid is drawn into the Needle-free syringe and is slightly over filled. The filled Needle-free syringe is removed from the adapter and the plunger is broken off and discarded. The Needle-free syringe is placed into the injector with a ¼ turn to the right, which positions the plunger so that a 0.1ml dose is ready for use. The Needle-free syringe is placed against the injection site; gentle pressure is applied until the inner housing stops. This action allows the trigger to be released. By depressing the trigger the spring is released and the plunger moves forward into the needle-free syringe barrel discharging the contents. Once the injection has been performed, the Needle-free syringe is properly disposed of and a new syringe may be filled, injector reset, and the system again prepped for use.

Acceptance Criteria and Study for PharmaJet 0.1 ml Needle-free Injector System

The PharmaJet 0.1 ml Needle-free Injector System underwent non-clinical testing to establish its performance and substantial equivalence to existing devices. The primary focus was on meeting the requirements of the PharmaJet 0.1ml Product and Engineering Specifications, as well as the essential requirements of ISO21649:2006 Needle-free injectors for medical use - Requirements and test methods.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for most of the non-clinical bench tests (temperature, free-fall, vibration, shock, dose accuracy, life cycle, performance profile, emitted noise, irradiated dose test, microbial ingress, functional testing after disinfection, biological testing). These tests are typically performed on a statistically significant number of units to ensure reliability, but the exact numbers are not provided.

For the animal testing (comparative effectiveness study), the sample size is also not explicitly stated. The data provenance regarding the country of origin and whether it was retrospective or prospective is not mentioned for any of the tests. Given it's animal testing, it was inherently prospective for the purpose of this submission.

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

This information is not provided in the document. The tests performed are primarily engineering and biological studies, where "ground truth" is established by direct measurement against defined standards and technical specifications, rather than expert interpretation of data like in medical imaging.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. As mentioned above, the tests are objective measurements against established technical standards (e.g., ISO21649:2006 benchmarks, physical measurements, biological assays), rather than subjective assessments requiring adjudication.

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

There was no MRMC comparative effectiveness study involving human readers with and without AI assistance mentioned. The comparative study was an animal study comparing the device against a predicate device (Terumo 1cc Allergy Syringe) to demonstrate substantial equivalence in intradermal injection characteristics. Therefore, there is no effect size given for human reader improvement with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance

This device is a physical medical device (a needle-free injector system), not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only) performance" does not apply to this submission. The tests performed demonstrate the physical and functional performance of the device itself.

7. Type of Ground Truth Used

For the various bench tests, the ground truth was established by engineering specifications, international standards (ISO21649:2006), and direct physical/chemical measurements.

For the animal study demonstrating substantial equivalence, the ground truth was based on quantifiable biological endpoints (bleb diameter, depth of penetration based on dermal height, dye dermal contact area, skin volume occupied by dye) directly measured from the animal subjects after injection.

8. Sample Size for the Training Set

The document does not mention a "training set" as this is not an AI/machine learning device. The tests described are for the validation and verification of a hardware medical device.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

Ask a specific question about this device

The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.

The PharmaJet, Inc. PharmaJet Needle-free Injector System (PharmaJet System) is a compact, spring-loaded needle-free hypodermic injector system. The PharmaJet System consists of two (2) injectors (One is the light injector suitable for infants up to two years old, geriatric adults or locations with thin skin and minimal adipose tissue and one is the heavy injector suitable for adults and children two years and older, or locations with thicker skin and more adipose tissue.), a cocking device, a single use, sterile, disposable filling adapter, and a single use, sterile, disposable needle-free syringe.

The PharmaJet Needle-free Injection System was evaluated through pre-clinical animal testing and bench testing to demonstrate its performance and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Preclinical Animal Testing: The specific number of animals (pigs and lambs) used for each test is not explicitly stated.
  • Pigs: Used as predictive models for healthy adults and children two years and older, or locations with thicker skin and more adipose tissue (for deltoid, lateral thigh, or buttocks injections).
  • Lambs: Used as predictive models for infants up to two years old, geriatric adults, or locations with thin skin and minimal adipose tissue.
  • Provenance: Retrospective, as these are established animal models for such studies.
• Bench Testing: The sample sizes for each specific bench test (e.g., free-fall, vibration, shock, dose accuracy) are not explicitly stated in the provided text, but the tests were performed to establish that the system meets the essential requirements of ISO21649:2006.

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

Not applicable. The reported studies are focused on objective device performance criteria (e.g., depth of penetration, dose accuracy, durability) and material resistance, rather than diagnostic interpretation requiring human expert ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The studies involved objective measurements of device performance rather than subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the device itself and its equivalence to predicate devices, not on human readers improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance evaluation of the device was done. All tests described (preclinical animal testing and bench testing) assessed the device's functional and material performance independently.

7. The Type of Ground Truth Used:

• Preclinical Animal Testing: The ground truth for depth of penetration in animal models was established through direct measurement in the animal tissues. This is a form of direct biophysical measurement.
• Bench Testing: The ground truth for various performance criteria (e.g., dose accuracy, life cycle, temperature resistance, sterilization effectiveness) was based on established engineering and medical device standards (specifically ISO21649:2006) and physical measurements.

8. The Sample Size for the Training Set:

Not applicable. This device is a mechanical medical injector, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model.

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

Not applicable, as there is no training set for a mechanical device.

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