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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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Pharmacokinetic Equivalence (Adults)
AUC (Area Under the Curve) 90% Confidence Interval (CI) for Test/Reference Ratio	(0.95, 1.12), falling within the (80%, 125%) required interval.
Cmax (Maximum Concentration) 90% Confidence Interval (CI) for Test/Reference Ratio	(0.81, 1.20), falling within the (80%, 125%) required interval.
tmax (Time to Maximum Concentration)	Not statistically different between needle and needle-free.
t1/2 (Half-life)	Assessed for assumptions, no significant difference.
Pharmacodynamic Equivalence (Adults)
Serum IGF-1 levels (24 hours)	Very similar to needle injection.
User Experience (Adults)
Pain	Trend toward less pain with jet-injector (p = 0.093).
Ease of Use	Highly significant preference for jet-injector (p = 0.017).
Convenience	Highly significant preference for jet-injector (p = 0.004).
Pleasantness	Highly significant preference for jet-injector (p = 0.011).
Less Apprehension	Highly significant preference for jet-injector (p = 0.0110).
Overall Preference	Highly significant preference for jet-injector (p = 0.053).
User Experience (Children)
Pain	Highly significant difference favoring needle-free (p < 0.01).
Unpleasantness	Highly significant difference favoring needle-free (p < 0.01).
Convenience	No significant difference.
Ease of Use	No significant difference.
Nervousness with first injection	Significantly more nervous than with familiar needle injection.
Drug Integrity (Shear Stress Testing)
Saizen® structure after injection	Results within assay variability for HPLC, physical tests, and pH, indicating no physical alteration.
Chemical Compatibility (Clear View Nozzle & Stem Tip)
Interaction with Saizen®	Results within assay variability for HPLC, physical tests, and pH, indicating suitability for use.
Chemical Compatibility (Vial Connector)
Particulates	No particulates observed at 7 and 14 days.
pH and Purity (SE-HPLC)	Results demonstrated within-assay variability for HPLC, physical tests, and pH, indicating suitability for use.
Microorganism Growth (Bioburden Study)
Microorganism growth in injected liquid	No microorganism growth in any sample.
Microorganism growth on nozzle surface	Growth in only one sample (non-pathogenic Staphylococcus species).
Microorganism growth on Stem Tip	Growth in two samples (mold (Aspergillus glaucus) and non-pathogenic bacteria (Bacillus lichenformis)). No growth on more concentrated filtration samples.
Microorganism growth in vial contents	Growth on only one sample (non-pathogenic mold (Aspergillus versicolor)).
Microorganism growth on vial adapter surface	Multiple occurrences of skin contaminants (non-pathogenic Staphylococcus species).
Absence of pathogenic microorganisms	All recovered isolates determined not to be Escherichia coli, Pseudomonas aeruginosa, Salmonella, or Staphylococcus aureus.
Clinically significant microorganisms	No clinically significant microorganisms found within the nozzle or vial over 14 days.

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

Clinical Efficacy (Adults) - Pharmacokinetic/Pharmacodynamic Study:
- Sample Size: 21 subjects (healthy adults aged 18-40 years).
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective. Likely conducted in a single country, but not specified.
Clinical Efficacy (Children) - Acceptability Study:
- Sample Size: 29 children (adolescents aged 12-18 years) with Type I diabetes mellitus.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective. Likely conducted in a single country, but not specified.
Laboratory Studies (Shear Stress, Chemical Compatibility, Bioburden):
- Specific numbers of drug lots and jet-injectors are mentioned for some tests (e.g., 2 lots of 5.0mg Saizen, 1 lot of 8.8mg Saizen for shear stress; 12 jet-injectors for bioburden), but a single overall "test set" sample size isn't applicable in the same way as clinical studies. These are laboratory-based, prospective tests.

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

Not Applicable. For this device (a drug delivery system), the "ground truth" is established through quantifiable physiological responses (e.g., GH and IGF-1 levels, documented bioequivalence), objective measurements (e.g., HPLC, pH, physical tests for drug integrity), and patient-reported outcomes (e.g., pain, preference). There isn't a subjective "ground truth" established by experts in the typical sense of diagnostic imaging or clinical assessment. The "experts" involved would be the clinical researchers, statisticians, and laboratory technicians conducting the studies.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, ground truth is based on quantitative data, not subjective expert consensus requiring adjudication. Statistical bioequivalence analysis (e.g., 90% confidence intervals) and p-values for statistical significance are the methods used for evaluating the results against the acceptance criteria.

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 device for drug delivery, not a diagnostic imaging or AI-assisted interpretation tool. Therefore, MRMC studies are not relevant.

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

Not Applicable. This device does not involve an algorithm or AI. It is a mechanical medical device.

7. The Type of Ground Truth Used

Clinical Ground Truth:
- For pharmacokinetic/pharmacodynamic studies: Measured serum concentrations of Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1), analyzed statistically for bioequivalence.
- For patient experience: Patient-reported outcomes via questionnaires (e.g., pain, ease of use, preference).
Laboratory Ground Truth:
- For drug integrity: High-Pressure Liquid Chromatography (HPLC) analysis, physical tests, and pH measurements to assess the structural integrity and purity of Saizen®.
- For chemical compatibility: Same as drug integrity (HPLC, physical tests, pH), plus visual inspection for particulates.
- For microbiological safety: Culture-based methods to identify and quantify microorganisms, screened for specific pathogens.

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" in that context. The studies described are validation studies for a physical medical device and drug delivery system.

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

Not Applicable. See point 8.

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