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Use of the Talley TableGard Pressure Relieving Patient Warming Mattress is indicated for use for patients that may be benefited by the application of heat during surgical procedures to help maintain normothermia. It is intended for use in the operating rooms, recovery rooms, intensive care departments, emergency rooms in hospitals and outpatient clinics to assist patients to maintain normal body temperature. The TableGard mattress also includes alternating air support to relieve pressure against soft tissues during prolonged periods of immobilization.

The TableGard Pressure Relieving Patient Warming Mattress system consists of an alternating air mattress (patient support surface) with air pump, and a connectable and thermally regulated warm air blower unit. The air mattress is enclosed in a vinyl and polyurethane cover, which is in turn fitted with air inlet and outlet ports to receive and recirculate warmed air within the air mattress cover under the patient. The patient is warmed by conduction of heat (regulated between 34° and 40° C) thru the polyurethane cover. The air pump and air blower unit operate on 110V, but there is no electrical contact between the control devices and the patient support mattress. The air pump alternately cycles pressures between sections of the mattress to relieve interface pressure against the patient's soft tissues.

The provided text describes the TableGard Pressure Relieving Patient Warming Mattress (K080763). It focuses on the device's functional and safety testing to support its substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria in a human population.

Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC study details, training set information, and specific effect sizes) is not applicable or not available in the provided 510(k) summary.

However, I can extract the acceptance criteria related to the device's functional performance and how it was tested.

Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on functional and safety testing, establishing that the device's performance is acceptable and does not introduce new safety or effectiveness concerns compared to predicate devices. The "acceptance criteria" here are implicitly related to the prevention of thermal injury and effective pressure relief, ensuring the device operates within safe and intended parameters.

Study Details (Based on available information):

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified. The testing described is "functional and safety testing" and "simulated skin temperatures," implying laboratory or engineering tests, not a clinical study with a patient cohort.
   • Data Provenance: Not explicitly stated, but the nature of the tests suggests they were internal laboratory tests conducted by the manufacturer, Talley Medical/Jaxports. These are not human subject data (retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the functional tests would be the physical measurements taken by instruments according to engineering specifications and safety standards, not expert consensus on clinical outcomes.

3. Adjudication method for the test set: Not applicable. This concept is for clinical studies involving human interpretation or outcomes, not functional device testing.

4. 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 vs without AI assistance: Not applicable. This device is a patient warming mattress, not an imaging or diagnostic AI device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm. The device's performance (temperature regulation, pressure relief) is "standalone" in the sense that it operates according to its design parameters.

6. The type of ground truth used: For temperature testing, the "ground truth" was established by measurements of "simulated skin temperatures" against predetermined safety limits (likely based on established thresholds for thermal injury). For pressure relief, the "ground truth" was the physical measurement of "interface pressure" by instruments, demonstrating cyclical and consistent relief according to the device's design.

7. The sample size for the training set: Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable. See point 7.

Summary of the study:

The study described is a series of functional and safety tests performed on the TableGard Pressure Relieving Patient Warming Mattress system. These were engineering/laboratory tests, not clinical studies involving human subjects.

• The tests evaluated:
  • Thermal Regulation: Achieved surface temperatures were measured under normal operating conditions and in conditions of possible single-fault failures. The goal was to confirm that the warming system would not cause thermal injury.
  • Pressure Relief: Interface pressure between the patient support surface and the patient was measured to confirm that it was fully relieved on a cyclical and consistent basis.

The conclusion drawn from these tests was that the device met its functional and safety requirements, demonstrating substantial equivalence to predicate devices and not introducing new safety or effectiveness issues.

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