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The SetPoint® Endovascular Temperature Probe is indicated for use with the SetPoint Endovascular Temperature Management System to measure core body temperature.

The SetPoint Endovascular Temperature Probe consists of a sheath containing two 400-series equivalent thermistors on separate and independent circuits. This Probe is intended for endovascular placement similar to other venous catheters with temperature measurement capability, including the Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404). The outer sheath is Pebax and has a soft, straight Pebax tip. The Endovascular Probe is heparin-coated for hemocompatibility. It is compatible with a 4 Fr. introducer with Touhy-Borst hemostasis valve. The intended use is to measure a patient's core body temperature via venous blood temperature. The Endovascular Probe is for single use only. It is provided sterile and packaged in a polyethylene/Tyvek pouch. Sterilization is by gamma irradiation.

Here's a breakdown of the acceptance criteria and study information for the Radiant Medical SetPoint Endovascular Temperature Probe based on the provided document:

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical outcome studies. Therefore, the information regarding in-depth clinical studies, expert-based ground truth, and specific acceptance criteria as might be seen for AI/ML devices, is limited.

Acceptance Criteria and Device Performance

Note: The document states the device "performs with similar safety and effectiveness" to predicate devices, but it does not define explicit numerical acceptance criteria or provide specific numerical results for the probe's temperature measurement accuracy, precision, or other performance characteristics.

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

• Sample Size: Not explicitly stated for specific performance tests. The document mentions tests for functionality and biocompatibility, but not the number of probes or samples used in these tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). These were likely bench and lab tests, not human subject clinical trials with specific patient data provenance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This type of information is not applicable to the regulatory submission for this device. The tests mentioned (functionality, biocompatibility, electrical safety) are typically engineering and laboratory-based assessments, not dependent on expert consensus or clinical interpretation for ground truth.

3. Adjudication method for the test set

• Not applicable. As the tests described are engineering and laboratory tests, an adjudication method as would be applied to subjective clinical assessments is not relevant.

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

• No. This is not an AI/ML device, and no MRMC comparative effectiveness study was performed or described. This type of study is specifically for evaluating the impact of AI on human interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a hardware device (temperature probe), not an algorithm. Standalone performance as defined for AI algorithms is not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for functionality would have been established by reference standards or highly accurate calibrated measurement devices (e.g., a known temperature bath for temperature accuracy, or standard test blocks for mechanical properties).
• For biocompatibility, the ground truth is established by adherence to ISO 10993 standards and their specified chemical/biological assays, rather than expert consensus on clinical images or pathology.

7. The sample size for the training set

• Not applicable. This is a traditional medical device (temperature probe) and does not involve AI/ML algorithms or a "training set" in the context of machine learning.

8. How the ground truth for the training set was established

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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