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The function of the ENTHERMICS TRU-5000™ Thermal Recovery Radiant Heating Unit is to provide a safe yet effective means of patient rewarming in the recovery of adult hypothermic human subjects. The use of the TRU-5000 is a physician prescribed therapy for surgically- or trauma-induced hypothermia, with the ultimate responsibility of the patients overall recovery falling on the physician.

The TRU-5000 consists of (1) an aesthetically pleasing fiberglass exterior encasing the semicylindrical heating chamber, (2) a modified heat resistant stretcher with a unique lock and key design, (3) a stand-alone, dual-probe, skin temperature audible-alarm system and (4) standard hospital sheets used as insulating drapes. An easy to operate control panel provides quick and easy control of all rewarming operations. The control system includes an LED readout of chamber control temperature, two independent skin temperatures and control setpoint with an audible alarm which sounds whenever the skin temperature setpoint is exceeded. The heating surface temperature controller of the TRU-5000 is factory preset at 70 °C to minimize operator error and provide optimum patient warming. The system requires no additional power demands and includes self diagnostic features to ensure operational accuracy. Quick and easy access to the heating chamber is devised in case of medical intervention.

The provided text is a 510(k) Summary of Safety and Effectiveness for the ENTHERMICS TRU-5000™ Thermal Recovery Radiant Heating Unit. This document states that the device is "identical in function" to two predicate devices (Augustine Medical Bair Hugger™ Convective Warming System (K873745) and Marquest Temp Marq™ Convective Warming System (K904690)).

The summary focuses on demonstrating substantial equivalence to these predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance data for the TRU-5000 itself. It leverages the historical safety and effectiveness of the existing devices. Therefore, the information required for the requested table and study details cannot be fully extracted from the provided text.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Limitations: The text does not provide quantitative acceptance criteria (e.g., target temperature ranges, maximum allowable temperature deviations, or specific thresholds for thermal injury prevention). Performance is described qualitatively and by referencing the predicate devices.

Regarding a specific study for the ENTHERMICS TRU-5000:

The document clearly states: "The ENTHERMICS TRU-5000 Thermal Recovery Radiant Heating Unit is identical in function to the Augustine Medical Bair Hugger™ Convective Warming System (K873745) and the Marquest Temp Marq™ Convective Warming System (K904690)..." This is a claim of substantial equivalence, not a description of a separate clinical study conducted explicitly for the TRU-5000 to define its acceptance criteria and prove performance independently.

Therefore, the following information is not present in the provided text:

• 2. Sample size used for the test set and data provenance: No test set is described. The device's safety and effectiveness are inferred from predicate devices.
• 3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no explicit 'test set' or 'ground truth' establishment is described for the TRU-5000.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned. The document is comparing a new device to existing predicate devices, but not in an MRMC format for human reader performance.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.
• 7. The type of ground truth used: Not explicitly stated, as no independent detailed study for the TRU-5000 is presented. The "ground truth" seems to be the established safety and efficacy profiles of the predicate devices.
• 8. The sample size for the training set: Not applicable; there is no AI/algorithm training set.
• 9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary relies on the "Substantial Equivalence" pathway to demonstrate safety and effectiveness. It asserts that the ENTHERMICS TRU-5000 is functionally identical to predicate devices and will meet or exceed their established safety and effectiveness standards due to its design features. It does not detail a separate, comprehensive study with explicit acceptance criteria and performance data for the TRU-5000 in the way one might for an AI/ML-based device or a novel therapeutic with clinical trials. The "study" here is the comparison to existing, cleared devices.

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