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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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The IRTS Probe is intended for continuous esophageal temperature monitoring.

The IRTS Patient Monitoring Unit Patient Interface Unit (PIU) is intended to display continuous temperature measurements (C°) from the IRTS Thermal Imaging Probe.

The Securus InfraRed Thermographic System (IRTS) is an esophageal temperature probe and monitoring system intended for continuous temperature monitoring of the patient's esophagus. The Probe includes a thermocouple sensor for temperature monitoring and a thermographic sensor for thermal imaging. Data from both sensors are displayed on a monitor for the user.

The InfraRed Thermographic System (IRTS) consists of three components:

• A. Thermal Imaging Probe (TIP or Probe)
• B. Patient Interface Unit (PIU)
• C. Patient Monitoring Unit (PMU)

The Probe provides esophageal temperature monitoring through the use of a standard thermocouple mounted in a flexible 9 French catheter. In addition, the IRTS incorporates a thermographic sensor and fiber optic assembly to passively collect the infrared radiation that is self-emanating from the surrounding esophageal tissue surface. The thermal data is presented on the Patient Monitoring Unit as a two-dimensional color map with peak temperature over the mapped area. The thermal image and peak temperature are offered as additional temperature monitoring features.

Here's an analysis of the acceptance criteria and study information for the InfraRed Thermographic System (IRTS), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

The document does not specify the sample size used for the performance tests (accuracy, response time, mechanical testing). It states "Finished devices were tested" and "Probes were tested."

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. However, the nature of the tests (biocompatibility, electrical safety, EMC, software V&V, performance testing, mechanical testing) suggests these were prospective, laboratory-based tests conducted on manufactured devices or components.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not provided in the document. The performance tests described are primarily objective, quantitative measurements against international standards (e.g., ISO, IEC). There's no indication that human experts were used to establish a "ground truth" in the traditional sense for these technical performance metrics.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts are interpreting data and their disagreements need resolution to establish a consensus ground truth. The tests described here are technical and objective (e.g., measuring temperature accuracy against a known standard, confirming compliance with electrical safety).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The document focuses on the technical performance and safety of the device itself, not on its comparative effectiveness with or without AI assistance for human readers/clinicians, nor on the impact of its thermal imaging feature on clinical outcomes.

6. Standalone (Algorithm Only) Performance

Partially applicable/implicitly yes. The core performance tests (accuracy, response time) for the thermocouple sensor are standalone performance metrics of the device's ability to measure temperature. The document explicitly states the "InfraRed Thermographic System (IRTS) was tested in accordance with the requirements of ISO 80601-2-56... Testing included accuracy and response time. All performance testing data shows that the IRTS system meets the requirements of ISO 80601-2-56." This describes the standalone performance of the temperature sensing component.

For the thermographic sensor (the "AI-like" component that displays a 2D color map), the document states: "The thermal data of the IRTS is not classified under the Clinical Thermometer designation of ISO 80601-2-56." It also mentions "The thermal image and peak temperature are offered as additional temperature monitoring features." While it describes the function of this feature, it does not provide standalone performance metrics (e.g., accuracy, sensitivity, specificity) specifically for the thermal imaging capability itself, nor does it specify a study proving its individual performance against a ground truth. It states "The performance testing supports substantial equivalence of the IRTS to the predicate," but the predicate did not have this feature.

7. Type of Ground Truth Used

For the thermocouple sensor's performance (i.e., temperature measurement):
The ground truth used for accuracy and response time testing was based on known, standardized reference values or conditions as dictated by ISO 80601-2-56. For example, temperature accuracy is typically measured against a highly accurate reference thermometer in a controlled bath with known temperatures.

For the thermal imaging feature:
The document does not specify a ground truth method or study for the thermal imaging feature's performance in terms of its ability to accurately represent esophageal temperature distribution. It only states its output as "additional temperature monitoring features" and the data "is not classified under the Clinical Thermometer designation."

8. Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI. The product description and performance data focus on the physical and electrical characteristics of a medical device (thermometer), not an AI algorithm that would typically require a training set. The "thermal imaging" component is described as passively collecting infrared radiation and presenting it as a map, which sounds more like signal processing and display rather than a machine learning model requiring training.

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

As no training set is mentioned or implied for a machine learning model, this question is not applicable.

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