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The Biojector® 2000 is indicated for delivery of subcutaneous (SC), intramuscular (IM) or intradermal (ID) injections of vaccines and other pharmaceutical injectables. The Biojector® 2000 may be used by healthcare providers who routinely administer injections. The Biojector® 2000 may also be used by patients authorized by their healthcare practitioner to self inject, or have other individuals administer injections of prescribed medication.

The addition of the intradermal indication is facilitated by using the new Intradermal Spacer with a No. 2 Syringe. Intradermal injections of vaccines and other pharmaceuticals are performed on the same patient populations that are now being treated with the Biojector® 2000 for the previously cleared indications.

The Bioject® 2000 Needle-Free Injection Management System is designed to deliver vaccines and other pharmaceutical injectables by producing a high pressure injectate stream that penetrates the dermis. The system is composed of three major components: (1) the injector -Biojector® 2000; (2) sterile single use disposables - syringes in multiple orifice sizes, safety cap, filling adapter and intradermal spacer (packaged for use with a No. 2 syringe only); and (3) power source - carbon dioxide (CO2) cartridge or tank.

The depth of injectate penetration is dependant upon the svringe orifice diameter. In general. the larger the diameter of the syringe orifice, the deeper into the tissue the fluid will be deposited. Disposable syringes with a variable volume from 0.1 ml to 1 ml are numbered 2, 3, 4, 5 and 7, and have increasing syringe orifice diameters, 0.04", 0.08", 0.10" and 0.14" respectively. Intradermal injections (ID) are only performed using a No. 2 syringe (the smallest diameter) and an ID Spacer. As the distance from the syringe orifice to the skin is increased, the energy density of the fluid stream is decreased. The ID Spacer utilizes this principle to provide the optimum distance from the syringe to the skin to provide enough energy for the injectate to penetrate the epidermis, but not enough energy to transverse the underlying dermal tissue Subcutaneous (SC) injections are performed using a No. 2 syringe that is in direct contact with the skin, no spacer is utilized. Intramuscular (IM) injections are performed using syringes in contact with the skin and with larger orifice diameters.

The disposable syringe assemblies are provided sterile in a Tyvek blister peel pouch. The ID Spacer is manufactured from a high density polyethylene that meets the same environmental, biocompatibility and sterility requirements as the disposable syringes. The ID Spacer is packaged as a component with Biojector® No. 2 syringe assemblies.

This looks like a 510(k) premarket notification for a medical device, not an AI/ML medical device. The information requested (such as expert consensus, MRMC studies, or training set data) is typically relevant for evaluating AI/ML device performance and isn't provided in traditional medical device submissions like this.

However, I can extract the closest equivalent information from the given text based on how a traditional medical device's performance is demonstrated to meet its acceptance criteria.

Here's the analysis of the provided text in the context of your questions:

The submission K121270 is for the Biojector® 2000 Needle-Free Injection Management System to add a new Indication for Use for administering intradermal injections using an ID Spacer. The primary method of demonstrating acceptance is through non-clinical performance testing and a comparative animal study against predicates.

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

The acceptance criteria are primarily derived from the international standard ISO 21649:2006 for Needle-free injectors and biocompatibility/sterilization standards. For the intradermal indication, the performance is also evaluated against a needle and syringe and a predicate needle-free injector concerning specific injection characteristics.

2. Sample size used for the test set and the data provenance

• Non-Clinical Performance Testing (ISO 21649:2006, Biocompatibility, Sterilization): The document does not specify the exact sample sizes for these tests (e.g., how many devices were tested for dose accuracy, how many samples for biocompatibility). These are typically standard tests with defined sample sizes per the respective ISO standards. The data provenance is from non-clinical laboratory testing presumably conducted by or for Bioject, Inc. (manufacturer).
• Animal Studies: The text states, "Testing in an accepted porcine model was conducted." The exact number of animals or injections performed is not specified. The provenance is prospective animal (porcine) study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in this type of submission. Ground truth for device performance in this context is established through objective measurements (e.g., instrument readings for dose accuracy, histological analysis in animal studies) rather than expert human interpretation.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical image interpretation or clinical outcomes, which is not relevant to the non-clinical and animal studies described here.

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 is not applicable. This is a submission for a mechanical medical device, not an AI device, so MRMC studies involving human readers with/without AI assistance are not relevant.

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

This is not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

• For Non-Clinical Performance (e.g., Dose Accuracy, ISO 21649:2006): The ground truth is based on objective measurement standards and engineering specifications.
• For Biocompatibility and Sterilization: The ground truth is based on defined biological responses or chemical analyses as per the ISO standards.
• For Intradermal Injection Equivalence (Animal Study): The ground truth was established by direct observation and measurement within the porcine model for "wheal size, depth of penetration, and dye dermal contact area." This would likely involve histological analysis or other direct measurement techniques after injection.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device, and therefore does not have a "training set" in that context. The device's design and engineering would have involved iterative development and testing, but not in the sense of an AI training set.

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

This is not applicable for the same reason as above.

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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.

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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 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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The cool.click 2™ Needle-free Growth Hormone Delivery System is indicated for the administration of Serono's growth hormone drug products and is intended for home use by patients authorized by their physicians to self-inject.

cool.click 2™ is a needle-free delivery device for Serono growth hormone products. The device delivers the drug product by firing a jet of liquid directly through the skin to the subcutaneous region. The jet is created via a powerful spring acting on a piston inside the nozzle and the liquid is forced out through a small aperture at high speed, creating a very fine, high pressure stream of drug that penetrates the skin. The key difference of the cool.click 2™ Needle-Free Growth Hormone Delivery System is it has a digital display to provide more clear and accurate information to users.

The provided text is a 510(k) summary for the cool.click 2™ Needle-free Growth Hormone Delivery System, a medical device. It does not describe a study involving an algorithm, AI, or human readers, nor does it provide detailed acceptance criteria and performance data in the way a clinical study report for an AI-powered device would.

Therefore, many of the requested items, such as multi-reader multi-case studies, standalone algorithm performance, number of experts, and training set details, cannot be extracted from this document, as they are not relevant to a traditional medical device submission like a needle-free injector.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:
"Extensive design verification, functional and performance testing have been conducted. The information provided in this premarket notification demonstrates that the cool.click 2™ Needle-Free Growth Hormone Delivery System is safe and effective for the intended use and is substantially equivalent to the legally marketed predicate devices."

This statement serves as the general acceptance criteria and performance summary. However, specific numerical acceptance criteria (e.g., "must achieve X% accuracy") and their corresponding reported values are not detailed in this summary. Instead, the focus is on demonstrating substantial equivalence to predicate devices, implying that if it performs comparably to already approved devices, it meets the required safety and effectiveness standards.

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing would have been conducted as part of the device's design verification and validation, likely under controlled conditions by the manufacturer, Medical House Products Limited (United Kingdom).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. For a simple mechanical device like a needle-free injector, "ground truth" established by human experts in the context of diagnostic interpretation is not relevant. The testing would involve engineering and functional performance evaluations.

4. Adjudication method for the test set:

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations, which is not relevant for this type of device testing.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or systems where human interpretation is involved. The cool.click 2™ is a mechanical drug delivery device.

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

• No, a standalone algorithm performance evaluation was not done. This device does not feature an algorithm or AI component.

7. The type of ground truth used:

• Not applicable in the context of an AI device. For this mechanical device, "ground truth" would relate to engineering specifications, performance against established standards (e.g., injection force, volume accuracy, sterility, durability), and safety parameters as defined during the design and testing phases. The document does not specify the exact nature of these "truths" but confirms "Extensive design verification, functional and performance testing have been conducted."

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

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

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The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patient authorized by their physicians to self inject at home.

The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body.

This submission (K051985) is for a "label-only" modification to an already marketed device, the BioValve Mini-Ject Needlefree Injection System. As such, the submission explicitly states that no performance data was required or provided to demonstrate the device meets acceptance criteria because the technological characteristics and the device itself remained unchanged.

Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable to this specific 510(k) submission.

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

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

• Not applicable. This submission focuses on updating the Instructions for Use (labeling) for an already marketed device. The text explicitly states: "No change was made to the Mini-Ject device and therefore no physical testing was required to confirm the injectors meet their specifications." This indicates that previous acceptance criteria were met by the device itself, but those criteria and performance data are not part of this submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No new performance testing was conducted for this label-only modification.

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. No new performance testing was conducted for this label-only modification, so no ground truth establishment for a test set was required.

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

• Not applicable. No new performance testing was conducted for this label-only modification.

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 device is a needle-free injection system, not an AI-assisted diagnostic or therapeutic device that would typically involve human readers or MRMC studies.

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

• Not applicable. This device is a mechanical injection system, not an algorithm.

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

• Not applicable. No new performance testing was conducted for this label-only modification.

8. The sample size for the training set

• Not applicable. This device is a mechanical injection system, not a machine learning model that requires a training set.

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

• Not applicable. This device is a mechanical injection system, not a machine learning model.

Summary of the 510(k) Submission (K051985):

This 510(k) submission sought to update the Instructions for Use (IFU) for the BioValve Mini-Ject Needlefree Injection System. The device itself (including its technological characteristics) remained unchanged from the previously cleared version (K021969). Therefore, the manufacturer stated, and the FDA determined, that no new performance data or testing was required to demonstrate substantial equivalence for this specific submission, as it was solely a labeling modification. The substantial equivalence was based on the device being identical to the legally marketed predicate device, with only the instructions for use being updated to clarify and simplify warnings, precautions, and contraindications.

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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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The GMTI PharmaJet System is intended to deliver various predetermined medicines and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet which penetrates the surface of the skin and delivers the medicine or vaccine to the body.

The Genesis Medical Technologies, Inc. (GMTI) PharmaJet Needle-free Injector System (PharmaJet System) is a compact, spring-loaded needle-free hypodermic injector system. The PharmaJet System consists of an injector, a cocking station and single-use, sterile, disposable vials.

The provided document, a 510(k) Premarket Notification for the Genesis Medical Technologies, Inc. PharmaJet Needle-free Injector System, is a summary of safety and effectiveness, and the FDA's acceptance letter. It does not contain the detailed study information required to answer many of the questions regarding acceptance criteria and device performance. The document only states that the device was validated through "rigorous testing according to international standards and internal protocols to ensure biocompatibility, sterility assurance, functionality, and general device safety." However, it does not provide the specifics of these tests, their acceptance criteria, or the reported performance data.

Therefore, the following answers are based only on the information available in the provided text and indicate where information is not present.

1. Table of acceptance criteria and the reported device performance

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 provided in the document.
• Data provenance: Not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided. The document describes a medical device, not an AI or diagnostic tool where expert ground truth would typically be established for a test set. The validation seems to be based on engineering and functional performance testing rather than human expert interpretation data.

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

• Not applicable/Not provided. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the nature of the device validation described.

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 is not an AI or diagnostic device. It's a needle-free injector system.

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

• The device is a physical medical device, not an algorithm. Performance testing would inherently be "standalone" in the sense that the device performs its function independently, but this question is generally applied to AI algorithms.

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

• The document implies ground truth was established through adherence to "international standards and internal protocols" for metrics like biocompatibility, sterility assurance, functionality, and general device safety. The specific "types" of ground truth (e.g., specific chemical analyses for biocompatibility, sterility testing methodology, physical measurements for functionality) are not detailed in this summary.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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