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The Radiant Medical Reprieve® Endovascular Temperature Therapy System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care.

The Reprieve System consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an integrated temperature probe; and an external controller. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via the Cassette and extension lines. The catheter is designed for placement in the inferior vena cava via the femoral vein using a 12 Fr hemostatic introducer sheath.

The provided document is a 510(k) summary for the Reprieve® Endovascular Temperature Therapy System. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way your request outlines (e.g., sensitivity, specificity, or performance against a set of statistical targets for a diagnostic device).

This document focuses on establishing substantial equivalence based on technological characteristics and the successful completion of general performance and safety tests, rather than a clinical trial demonstrating specific performance outcomes against a predefined set of acceptance criteria for diagnostic accuracy.

Here's a breakdown based on the information available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided 510(k) summary. The document states:
"The Reprieve Endovascular Temperature Therapy System has been tested for system performance." and "Based upon the successful completion of performance verification tests and the comparison to the predicate devices, the Radiant Medical Reprieve Endovascular Temperature Therapy System performs with safety and effectiveness equivalent to the predicate device."

This indicates that some performance tests were conducted to demonstrate safety and effectiveness, but the specific acceptance criteria (e.g., target temperature range, heating/cooling rates, or a numerical accuracy metric) and the quantitative results against those criteria are not detailed in this summary. Instead, it relies on demonstrating equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

This information is not present. The 510(k) summary refers to "performance verification tests" but does not specify the sample size, type (e.g., in-vitro, ex-vivo, clinical), or data provenance (country, retrospective/prospective) of any test sets used.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/not present. The device is a thermal regulating system, not a diagnostic device that requires expert interpretation to establish a "ground truth" for a test set in the way a diagnostic AI would. The performance tests would likely focus on objective measurements of temperature regulation, safety, and functionality according to engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable/not present for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is being evaluated. The Reprieve® System is a thermal regulating therapy device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this type of "standalone" evaluation aligns with the "Performance Test" section. The document states: "The Reprieve System has been tested for system performance." and details various tests for the catheter (BS EN ISO 10555), biocompatibility (ISO 10993), sterility (ISO 11137), and electrical safety of the controller (IEC 60601). These are all standalone engineering and safety tests of the device itself. The clinical performance related to achieving normothermia would also be considered a standalone function of the device's ability to heat/cool the patient.

7. The Type of Ground Truth Used

For a thermal regulating system, the "ground truth" for performance tests would involve objective, measurable physical parameters, such as:

• Temperature measurements: Verifying the device can achieve and maintain target temperatures within specified tolerances using calibrated thermometers.
• Flow rates and pressure measurements: Ensuring fluid circulation within the system meets specifications.
• Safety parameters: Confirming the device operates without adverse events (e.g., overheating, electrical hazards).
• Biocompatibility: Testing materials for biological safety rather than clinical outcomes directly.

The document refers to adherence to international standards (e.g., ISO 10555, ISO 10993, IEC 60601), which inherently define the "ground truth" or acceptable performance against which the device is tested.

8. The Sample Size for the Training Set

This information is not applicable/not present. The Reprieve® System is a hardware medical device with embedded control logic, not an AI/ML algorithm that undergoes a training phase with a distinct training dataset in the sense of modern deep learning models. Its design and performance are based on established engineering principles and validation testing, not statistical learning from a clinical dataset (training set).

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

This information is not applicable/not present for the same reasons as #8.

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