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The Barrier EasyWarm Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

The Barrier EasyWarm Active Self-Warming Blanket is a non-sterile, single use blanket that is intended to prevent hypothermia by providing warmth to the patient during the period. The blanket contains warming pads (or heating elements) that are contained within sealed pouches that are advantageously positioned and sewn into the blanket's fabric for appropriate distribution of heat. The warming pads contain iron, active coal, water, salt, clay with a sodium polyacrylate cover. The device is supplied in a vacuum sealed packaging. Once the blanket is removed from its packaging, the blanket produces heat via an exothermic chemical reaction that takes place within the warming pads upon exposure to air. The chemical reaction results from the oxidation of iron.

This document does not contain information about an AI/ML device, nor does it provide the specific details required to complete your request about acceptance criteria and study data for an AI/ML device.

The document is a 510(k) summary for a Barrier EasyWarm Active Self-Warming Blanket, a medical device intended to prevent hypothermia by providing warmth to patients. It discusses modifications to a previously cleared device (K132048).

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance related to an AI/ML device.
2. Sample sizes, data provenance, or details about test and training sets for an AI/ML device.
3. Information on experts or adjudication for ground truth for an AI/ML device.
4. MRMC studies or effect sizes for AI assistance.
5. Standalone performance for an AI algorithm.
6. Types of ground truth for AI.

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The BARRIER® EasyWarm® Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

The BARRIER® EasyWarm® Active Self-Warming Blanket is a disposable blanket 152 x 92 cm in size. The blanket contains warming pads (or heating elements) that are contained within sealed pouches that are advantageously positioned and sewn into the blanket's fabric for appropriate distribution of heat. The device is supplied in a vacuum sealed packaging. Once the blanket is removed from its' packaging, the blanket produces heat via an exothermic chemical reaction that takes place within the warming pads upon exposure to air.

Here's the analysis of the BARRIER® EasyWarm® Active Self-Warming Blanket based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for BARRIER® EasyWarm® Active Self-Warming Blanket

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, side-by-side format. However, based on the Evaluation of Device Performance section, the implicit acceptance criteria and the device's reported performance can be inferred.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Clinical Study:

  • Sample Size: Not explicitly stated for the test set. It mentions "Subjects in the BARRIER® EasyWarm® treatment arm" and "subjects in the control treatment arm," indicating a patient population, but the specific number is not provided.
  • Data Provenance: The clinical study was described as a "prospective multi-center randomized controlled clinical study." This indicates that data was collected specifically for this study with a forward-looking design, and from multiple locations (centers). The country of origin is not specified.

• Independent Non-Interventional Evaluation:

  • Sample Size: Not explicitly stated.
  • Data Provenance: Not explicitly stated, but it's a separate evaluation.

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

• The document does not mention the use of experts to establish a ground truth for the clinical study's primary outcomes (core body temperature, incidence of hypothermia, adverse events). These outcomes are typically measured directly or observed by medical staff involved in the study rather than being adjudicated by external experts in the way that, for example, imaging studies might require.
• The independent non-interventional evaluation involved determining average and maximum skin temperatures, which would likely be measured by instruments. There is no mention of experts establishing ground truth for this.

4. Adjudication Method for the Test Set

• No specific adjudication method (e.g., 2+1, 3+1) is mentioned. Given the nature of the primary endpoints (core body temperature, incidence of hypothermia, adverse events), these are typically direct measurements or clinician observations, rather than requiring expert adjudication of complex interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly done. The clinical study performed was a randomized controlled clinical study comparing the device (treatment arm) to a control arm to assess effectiveness in maintaining core body temperature and reducing hypothermia. This is a common and appropriate study design for medical devices that directly impact physiological parameters.
• The concept of "human readers improving with AI vs. without AI assistance" is not applicable to this device, as it is a physical warming blanket, not an AI-assisted diagnostic or interpretative tool.

6. Standalone (Algorithm Only) Performance

• Not applicable. This device is a physical active self-warming blanket. It does not employ an algorithm or AI that would have a "standalone" performance. Its performance is directly tied to its physical interaction with the patient.

7. Type of Ground Truth Used

• For the clinical study, the ground truth was based on direct physiological measurements and clinical observations:
  • Core body temperature: Measured directly.
  • Incidence of hypothermia: Defined and observed based on measured core body temperatures.
  • Adverse events: Clinically observed and reported.
• For the independent non-interventional evaluation, the ground truth for skin temperature was based on direct temperature measurements.

8. Sample Size for the Training Set

• Not applicable. This device is a physical product and does not involve AI/machine learning algorithms that require a "training set" in the conventional sense. The "training" for such a device would be its design, manufacturing, and testing to meet performance specifications.

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

• Not applicable. As mentioned above, there is no "training set" for this type of device. The extensive "bench testing" conducted (temperature characteristics, rise time, duration) characterizes the device's physical performance, similar to how a product's specifications are verified, but it's not a "training set" for an algorithm.

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