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The WarmTouch™ Surgical Access Blanket is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia. The warming system is for use only in a hospital or clinical environment, and only by trained and licensed caregivers.

The WarmTouch™ Torso Blanket is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia. The warming system is for use only in a hospital or clinical environment, and only by trained and licensed caregivers.

The WarmTouch Surgical Access Blanket is a sterile full body blanket with a rectangular opening that allows access to the abdominal or lower back. This blanket stays in place via medial tape.

The WarmTouch Torso Blanket is a non-sterile blanket that is intended to cover the patient from the shoulders to the waist/hips. This blanket has flaps on either side that are tucked underneath the patient and medical tape at the distal end.

These blankets are intended to be used with the WarmTouch convective warming units.

The document describes a 510(k) premarket notification for the "WarmTouch Surgical Access & Torso Blankets," demonstrating substantial equivalence to a predicate device. This submission focuses on non-clinical performance and does not involve AI or algorithms, and therefore does not include information typically found in studies for AI/ML devices.

Here's the information based on the provided text, with clarifications where the requested information is not applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for each specific test (e.g., number of blankets tested for Contact Surface Temperature or Useful Life). It refers to "verification and validation testing."

• Data Provenance: Not specified, but generally, such non-clinical testing would be conducted in a laboratory or simulated environment by the manufacturer (Covidien, USA). The data is retrospective in the sense that the testing was completed before the submission to demonstrate compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable to this submission. "Ground truth" in the context of expert review is typically relevant for diagnostic AI devices where human experts label data. For this device, the "ground truth" is established by engineering specifications, regulatory standards, and objective physical measurements to determine if a "Pass" or "Fail" outcome is met.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies with human assessors, particularly for subjective assessments or when there's disagreement among experts. Here, the tests are primarily objective measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a medical device (surgical blankets) and not an AI/ML diagnostic or treatment assistance device. Therefore, no MRMC study or AI-related performance improvement metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device. The device's performance is standalone in the sense that it functions physically as intended without algorithmic intervention.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, established industry standards, and regulatory requirements for the safety and effectiveness of thermal regulating systems. For example, "Contact Surface Temperature" would have a defined acceptable range, and if the blanket's temperature falls within that range, it "Passes."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set." The engineering and design processes involve iterative development and prototyping, but not in the context of machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML model. The design and performance criteria for the blankets are established through engineering design principles, risk analysis, and compliance with medical device standards.

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