(81 days)
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.
§ 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).