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The Equator® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Equator® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.

The Snuggle Warm® Convective Warming Blanket is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warming blanket can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Snuggle Warm® Convective Warming Blanket can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.

The Equator® Convective Warmer (convective warmer) draws ambient- temperature air through a 0.2 micron particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the convective warming blanket) through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the convective warming blanket gently disperse the warmed air over and around the patient.

The convective warmer has three outlet temperature settings, which provide flexibility in patient treatment: 36°C, 40°C, and 44°C. These temperature settings are servo-controlled by a thermistor placed at the end of hose where the hose connects to the blanket. A fourth temperature setting delivers ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the blanket at the end of the hose. A control thermistor in the convective warmer adjusts the power applied to the heater to maintain the selected temperature. This enables the system to maintain the selected temperature under variations in ambient temperature.

A safety thermistor provides a signal to a separate high-temperature analog circuit. The safety thermistor activates and causes an alarm if the temperature exceeds the set point. The analog safety circuit provides an independent means of shutoff, which discontinues power to the heater and motor. This prevents patient exposure to excessive temperatures. Patient contact is not applicable to convective warmers, warmer accessories, or warmer spare parts, as there is no direct patient exposure.

Snuggle Warm® Convective Warming Blankets: a single-use disposable blanket consisting of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket. The distribution of air is designed to minimize temperature differences throughout the blanket. The convective warming blankets are not sterilized with the exception of the Sterile Cardiac Convective Warming Blanket (SWU-2008).

Snuggle Warm® Sterile Cardiac Convective Warming Blanket: identical in material and construction to the convective warming blankets listed in the preceding section. The only difference is that it is sterilized using a routine Ethylene Oxide (EO) sterilization cycle developed to deliver a sterility assurance level of 10-6 and meets ISO standards for EO residuals prior to release for distribution.

Adapters: available from Smiths Medical ASD, Inc. are made from natural acetyl copolymer material and are designed to fit compatible warmer hose ends using the adapters (SWU-9001, SWU-9002, SWU-9003, SWU-9004). To ensure proper securement, a Level 1 elbow nozzle, included with each adapter, must be used to connect the convective warming blanket to the warmer. Adapters are designed to connect the Level 1 elbow nozzle to a compatible warming unit's hose.

The provided text describes the acceptance criteria and a summary of studies for the Equator Convective Warmer and Snuggle Warm Convective Warming Blanket. However, it does not contain information about a study proving the device meets the acceptance criteria in the format requested, particularly for AI-related performance metrics. This document is a 510(k) premarket notification for a medical device (convective warmer and blankets), primarily focusing on demonstrating substantial equivalence to predicate devices rather than the detailed performance evaluation of an AI-powered system.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides tables (Table 3.6.1, 3.6.2, 3.6.3, and 3.6.4) comparing the proposed devices to predicate devices. The "Acceptance Criteria" for the proposed devices are implicitly that they "Pass" the safety and performance specifications, or are "Identical" to predicate devices, which themselves were accepted. The reported device performance is indicated as "Pass" or "Identical".

For Snuggle Warm® Convective Warming Blankets (Various models):

For Equator® Convective Warmer (models EQ-5000, EQ-5000HF):

2. Sample size used for the test set and the data provenance:
The document states: "Performance tests and results for the Snuggle Warm® Convective Warming Blankets and the Equator® Convective Warmer are documented by Smiths Medical engineering test reports and independent test house reports."
However, specific sample sizes for testing and data provenance (e.g., country of origin, retrospective/prospective) are not provided in this summary. The testing appears to be primarily engineering verification and validation, likely conducted in-house or by a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The device is a convective warming system, not an AI diagnostic device requiring expert consensus for ground truth. Technical specifications and safety parameters are evaluated against engineering standards and design requirements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. As mentioned above, this is not an AI diagnostic device.

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 versus without AI assistance:
No MRMC study was done, and this information is not applicable. This document pertains to a physical medical device (convective warmer), not an AI-assisted diagnostic tool. No AI component is described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance was done, and this information is not applicable. The device described is a physical warming system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device would be established through engineering specifications, international standards (e.g., IEC, ISO for safety and performance), and established physical principles of heat transfer and materials science. For example, temperature measurements are verified against calibrated instrumentation, and material conformity is checked against regulatory standards (e.g., 16CFR1610 for flammability).

8. The sample size for the training set:
This information is not applicable. There is no AI or machine learning component described that would require a training set.

9. How the ground truth for the training set was established:
This information is not applicable. There is no AI or machine learning component described that would require a training set.

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