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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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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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