(83 days)
The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces.
The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces. Each unit is labeled with instructions for use as well as specific warning statements. Our product consists of an inner plastic pouch containing a green-colored water and an outer pouch containing ammonium nitrate. To activate the product, simply rupture the inner pouch by using an external force, such as a fist. Then, as the two ingredients mix, a chemical reaction results by producing temperatures below 40°F for a minimum of 15 minutes. These are single use devices.
This 510(k) summary describes a basic medical device (an instant cold compress), and therefore, most of the requested information regarding AI/algorithm performance and clinical study details (like sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable. The device is a simple chemical cold pack, not a diagnostic or prognostic AI algorithm.
However, I can extract the relevant "acceptance criteria" based on the provided text, and show how the description "proves" it meets those criteria.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Produces temperatures below 40°F | Produces temperatures below 40°F |
| For a minimum of 15 minutes | For a minimum of 15 minutes |
| Single use device | These are single use devices. |
| Contains green-colored water | Contains a green-colored water |
| Contains ammonium nitrate | An outer pouch containing ammonium ammonium nitrate |
| Activates by rupturing inner pouch and mixing ingredients | To activate the product, simply rupture the inner pouch by using an external force, such as a fist. Then, as the two ingredients mix, a chemical reaction results. |
1. A table of acceptance criteria and the reported device performance:
See table above. The acceptance criteria are derived directly from the functional description and requirements stated in the 510(k) summary. The reported device performance is the affirmation that the device does meet these functional aspects.
2. Sample size used for the test set and the data provenance: Not applicable. This device is a physical product, not an AI algorithm evaluated on a data set. The "performance" claims are based on fundamental chemical properties and manufacturing specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review of images or data is involved for this type of device. Its "truth" is its physical functionality (i.e., does it get cold for 15 minutes).
4. Adjudication method: Not applicable.
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 not an AI-assisted diagnostic or prognostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This product does not involve an algorithm.
7. The type of ground truth used: The "ground truth" for this device is its physical and chemical properties and performance as tested internally by the manufacturer (implied by the statement "a chemical reaction results by producing temperatures below 40°F for a minimum of 15 minutes"). This would typically be verified through laboratory testing and quality control processes during manufacturing.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.