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The Snuggle Warm 4000 Convective Warming System is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.

The Snuggle Warm consists of a disposable single use warming blanket that is placed in contact with the patient and a warming unit with a hose end temperature control connected to the blanket. The warming unit generates warm air that is distributed throughout the warming blanket to warm the patient during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.

The provided text is a 510(k) Premarket Notification for the Snuggle Warm® 4000 Convective Warming System. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel technology.

Therefore, the information required to populate the requested table regarding acceptance criteria and device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for the Snuggle Warm® 4000 Convective Warming System is not present within the provided text.

The document explicitly states: "There are no significant changes in technological characteristics or intended use that impact the safety or effectiveness of these warming devices." This indicates that the submission relies on the established safety and effectiveness of the predicate device (Temp Marq™/ Snuggle Warm Convective Warming System, K904690) rather than new performance studies for the modifications made to the Snuggle Warm® 4000.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

• Not provided. The document focuses on demonstrating "substantial equivalence" to a predicate device, implying that the performance is expected to be similar, but it does not specify new acceptance criteria or report specific performance metrics for the modified device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. No new test data is presented for the Snuggle Warm® 4000.

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):

• Not applicable / Not provided. Since no new test set is described, there's no mention of experts or ground truth establishment for such a test.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable / Not provided.

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 device is a convective warming system, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• Not applicable. This device is hardware, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable / Not provided.

8. The sample size for the training set:

• Not applicable / Not provided. This document is for a hardware device, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable / Not provided.

In summary, the provided 510(k) notification focuses on the regulatory process of demonstrating substantial equivalence to a predicate device rather than presenting new performance data or detailed studies as would be expected for a novel device or AI algorithm.

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