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The Medi-Therm is intended for use in supplying warm or cold water at controlled temperatures via water circulating blankets or body wraps for the application of regulating patient temperature in situations where a physician determines that temperature therapy is necessary and desirable.

Indications for use for the Medi-Therm thermal regulating system include:
a. To maintain pre-set body temperature as determined by the physician
b. To maintain normal body temperature during surgical procedures
c. For use in all hospital areas including invasive and coronary care units, in operating, recovery and emergency rooms, in burn units and on medical/surgical floors
d. This system can be used with adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients

The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket/s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system.

The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.

The provided document is a 510(k) summary for the Gaymar Medi-Therm Hyper/Hypothermia System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the technological characteristics, intended use, and general safety and effectiveness.

Based on the provided text, there is no information available regarding a study that assesses device performance against specific acceptance criteria in the format you requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, or reader improvement with AI).

The document mentions "Bench testing was conducted to confirm the MTA6900 and MTA7900 and their disposable accessories operate as described in this submission and therefore are as safe and effective as the predicate devices to which it claims substantial equivalence." The types of bench testing listed are:

• Temperature Control Performance
• Temperature Stability and Flow
• Biocompatibility (ISO 10993-5; ISO10993-10; 16 CFR 1500)
• Ship Testing (ISTA 1A)

However, the document does not provide:

• Specific acceptance criteria for these tests (e.g., "temperature control performance must maintain patient temperature within +/- 0.5°C").
• Reported device performance against such criteria in a quantitative table.
• Details about sample sizes, data provenance, ground truth establishment, expert involvement, or MRMC studies. The context of this device (a thermal regulating system) does not typically involve the kinds of diagnostic accuracy studies (MRMC, standalone, human-in-the-loop) that would require such detailed information on ground truth, expert consensus, and reader performance.

Therefore, I cannot populate the table or answer most of your specific questions as the necessary information is not present in the provided 510(k) summary. The document focuses on demonstrating that the device meets safety and performance standards generally expected for its product classification and is substantially equivalent to existing devices through engineering and functional comparisons, not clinical performance metrics in the way a diagnostic AI device would be evaluated.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Study Information (Based on the document):

1. Sample size used for the test set and the data provenance: Not applicable/not provided. The document refers to "Bench testing," which implies laboratory-based tests rather than patient data test sets.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth establishment with experts is typically for diagnostic devices assessing images or other complex data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not mentioned and is not typically relevant for a thermal regulating system.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This refers to diagnostic algorithm performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided. For bench testing, the "ground truth" would be the expected physical or electrical output/behavior based on design specifications or industry standards.
7. The sample size for the training set: Not applicable/not provided. This device is not described as involving machine learning or algorithms that require a "training set" in the context of data analysis. Its "microprocessor control" refers to conventional programming.
8. How the ground truth for the training set was established: Not applicable/not provided.

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