(74 days)
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.
| Performance Metric (from Predicate Device Studies) | Acceptance Criteria (Inferred from Bioequivalence Standard) | Reported Device Performance (from Predicate Device Studies) |
|---|---|---|
| Bioequivalence (Needle-free vs. Needle delivery of Saizen®) | Demonstrates comparable pharmacokinetic and pharmacodynamic profiles. | Demonstrated bioequivalence between needle and cool.click® needle-free delivery of growth hormone. |
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.
§ 880.5430 Nonelectrically powered fluid injector.
(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).