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The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA S-CATH M Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA S-CATH M Probe.

The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe.

The monitor displays 12 temperature probe sensor readings (°C), the minimum and maximum temperature of all sensors, and contains an alarm system with userselected levels. The measured temperatures can be stored in the internal memory of the device and examined at a later time on an external personal computer (after exporting the corresponding data file to an USB flash drive).

The S-CATH M Esophageal Temperature Probe provides continuous temperature measurement (℃) and operates in direct mode (operating mode of a clinical thermometer where the output temperature is an unadjusted temperature that represents the temperature of the measuring site to which the probe is coupled). The probe contains 12 thermistor sensors located along an s-curve. The sensors measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the CIRCA Scientific monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus.

The Probe is also equipped with 4 electrode sensors. By connecting the S-CATH M Probe to a 3D cardiac mapping system through the optional component Mapping Interconnect Cable, the probe can be visualized inside a 3D model of the patient's body for optimal placement.

The provided text describes a 510(k) premarket notification for the CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System. This is a medical device, and the submission aims to demonstrate its substantial equivalence to a legally marketed predicate device, not to showcase an AI algorithm.

Therefore, the requested information regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, standalone algorithm performance, training sets, and ground truth establishment for training sets, is not present in the provided document. This document focuses on the equivalence of a physical medical device and its performance against established medical device standards.

However, I can extract information related to the device's functional performance testing and acceptance criteria as described for a physical medical device:

Device Performance and Acceptance Criteria (as described for a physical medical device)

The document outlines various non-clinical performance data for the CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System to demonstrate its compliance with recognized standards and its substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

In addition, a key "acceptance criterion" for this type of submission is substantial equivalence to the predicate device. The comparison table (pages 5-6) and the "Substantial Equivalence Discussion" (pages 8-9) highlight this:

• Accuracy: The acceptance criterion for accuracy is ± 0.3°C within rated output range, as per ISO 80601-2-56 requirements. The device reported meeting this requirement.
• Response Time: The predicate device had a response time of approximately 1 second. The subject device's response time was deemed to show "substantial equivalence" despite being "an average of only 2 seconds faster" in heating and cooling transients when tested with the same methodology as the predicate.
• Temperature Measurement Range: Subject device: 0-45°C. Predicate device: 0-75°C. The subject device's range is lower but meets the consensus standard ISO 80601-2-56 requirement (34.0°C to 43.0°C).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state sample sizes for each non-clinical test. The tests are primarily laboratory-based and conducted on the device components or system. Data provenance is not specified beyond "non-clinical testing" and a "performance test in vivo (animal) setting." There is no mention of country of origin or whether the data is retrospective or prospective, as these are typically considerations for human clinical trials.

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

Not applicable. This filing describes the performance of a physical medical device against engineering standards (e.g., ISO, IEC) and internal testing protocols, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for human interpretation or AI-assisted studies where inter-reader variability or differences in opinion need to be resolved. This document details physical device performance.

5. 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 is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the measurement standards and specifications of the relevant international and national standards (e.g., ISO 10993-1 for biocompatibility, ANSI/AAMI/ISO 11135 for sterility, IEC 62304 for software, IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC, ISO 80601-2-56 for accuracy and response time, ANSI/AAMI EC53:2013 for mapping cable). The in-vivo animal study likely used direct measurements (e.g., fluoroscopy) as the ground truth for assessing mapping system accuracy.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. As above, this is not an AI device.

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Esophageal Temperature Probe: The Esophageal Temperature Probe is intended for continuous temperature monitoring. The radiopaque probe is designed for placement in the esophagus. Temperature Monitor: Display continuous temperature measurement (°C) from 12-sensor temperature probe.

The CIRCA Scientific Temperature Monitoring System consists of: touch-screen monitor, interconnect cable, and temperature probe. The monitor displays 12 temperature probe sensor readings (°C), the maximum temperature of all sensors, and contains an alarm system with user-selected levels. The S-Cath™ Esophageal Temperature Probe provides continuous temperature measurement (°C) and operates in direct mode. The probe contains 12 thermistor sensors located along an scurve. The sensors measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus.

The information provided focuses on the non-clinical performance data for the CIRCA Scientific Temperature Monitoring System, specifically the S-Cath™ Esophageal Temperature Probe and Temperature Monitoring System.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes non-clinical performance testing. It does not provide specific sample sizes (e.g., number of probes tested) for the accuracy, precision, repeatability, and time response tests. It states these tests were performed per Standard ISO 80601-2-56 / First Edition 2009-10-01. The data provenance (country of origin, retrospective/prospective) is not specified for these tests, but they are typically laboratory-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The studies described are non-clinical performance tests for a temperature monitoring device, not studies requiring expert interpretation or ground truth establishment in a diagnostic context. Ground truth for temperature measurement would be established by reference standards in a controlled laboratory environment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the type of non-clinical performance tests described. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple readers.

5. 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

This information is not applicable. The submission is for a temperature monitoring device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

This information is not applicable. The device is a physical temperature probe and monitor, not an algorithm, and its performance is inherently "standalone" in terms of its physical measurement capabilities. Its "performance" is its ability to accurately, precisely, and quickly measure temperature.

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

For the non-clinical performance tests (accuracy, precision, repeatability, time response), the ground truth would be established by reference temperature standards in a controlled laboratory environment, conforming to the requirements of ISO 80601-2-56. This standard outlines methods for testing clinical thermometers, ensuring traceability to national or international temperature standards.

8. The sample size for the training set

This information is not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for an AI/ML algorithm.

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