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The ESOTEST MULTI Temperature Monitoring System is composed of ESOTEST MULTI Monitor and ESOTEST MULTI 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 ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI 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 ESOTEST MULTI system in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

The device is composed of the following cleared (K180047) system components:

• Monitor ESOTEST MULTI MONITOR
• Esophageal probe ESOTEST MULTI PROBE
• Patient cable ESOTEST MULTI PATIENT CABLE

The Adapter cable ESOTEST MULTI ADAPTER CABLE has been added to the system.

The ESOTEST MULTI MONITOR is a device for measuring the esophageal temperature through a sterile, single-use probe. This component, called ESOTEST MULTI PROBE, contains up to seven independent thermal sensors, each one consisting in T-type thermocouple soldered to a spherical steel electrode. The ESOTEST MULTI PATIENT CABLE connects the main unit of the monitor to the temperature probe and continuously converts to digital signals the analog voltages generated by the thermocouples. ESOTEST MULTI MONITOR is able to keep track of the esophageal temperature during clinical procedures which involve heating or cooling processes, with an accuracy of 0.3°C and a response time of 1s. The detected temperatures are visualized as numerical values, colored bars and scrolling plots. An integrated alarm system allows the operator to set 2 independent alarm thresholds, called "upper alarm threshold" and "lower alarm threshold". If any of the measured temperatures gets hotter than the upper threshold or colder than the lower threshold, ESOTEST MULTI MONITOR immediately emits sound and visual effects aimed at getting the attention of the operator. The measured temperatures and the alarm conditions can be stored in the internal memory of the device and examined at a later time on the monitor itself or on an external personal computer (after exporting the corresponding data to an USB mass storage device). By connecting the ESOTEST MULTI to a mapping system through the optional component ESOTEST MULTI ADAPTER CABLE, the probe sensors can be visualized inside a 3D model of the patient's body for optimal placement.

The provided text describes the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System with Visualization (subject device) and its substantial equivalence to a predicate device (K180047 – ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and performance specifications. The "acceptance criteria" can be inferred from the predicate device's established performance and relevant standards. The reported device performance is presented as being "Same" or compliant with the standards listed.

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

The document does not explicitly state specific sample sizes for test sets used in each non-clinical test. The testing is described generally as "non-clinical testing" or "several clinical procedures" for the adapter cable validation.

The data provenance is industrial/laboratory testing to verify compliance with various international standards (e.g., ISO, IEC, EN, ANSI/AAMI, USP). It is not specified as country-of-origin, but given it's for FDA clearance, it's assumed to be conducted in a manner acceptable to the FDA. The tests are retrospective in the sense that they are conducted on the manufactured device to demonstrate its performance against predefined standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not mention the use of experts to establish ground truth for the test set in the traditional sense of clinical/diagnostic accuracy studies. The "ground truth" for the performance tests (e.g., accuracy, response time) is established by the specified international standards (e.g., ISO 80601-2-56:2009). For biocompatibility and sterilization, the ground truth refers to the limits and methodologies defined by the relevant ISO, ANSI/AAMI, and USP standards.

The phrase "verified during several clinical procedures" for the adapter cable to mapping systems does not specify the number or qualifications of clinicians involved, nor how "ground truth" (e.g., correct visualization) was formally established or assessed by experts.

4. Adjudication Method for the Test Set:

Not applicable in the context of the described technical and performance bench testing against standards. Such tests typically involve direct measurement and comparison to predefined thresholds or specifications, not expert adjudication of subjective interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical compliance and performance testing, not on comparing reader performance with or without AI assistance. The device is a monitor and probe system, not an AI diagnostic tool.

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

No, this is not applicable. The device is an esophageal temperature monitoring system, which requires human interaction for placement and interpretation of displayed temperature values. It does not contain an AI algorithm for standalone diagnostic performance.

7. The Type of Ground Truth Used:

The ground truth used for these tests is based on:

• Established International Standards and Benchmarks: For accuracy, response time, electrical safety, EMC, software compliance, biocompatibility, and sterility, the ground truth is defined by the requirements and test methodologies outlined in standards such as ISO 80601-2-56:2009, IEC 60601-1, IEC 60601-1-2, EN 62304, ISO 10993 series, ANSI/AAMI ST72:2011, USP <151>, ISO 11607, and ANSI/AAMI EC53:1995.
• Direct Measurement and Comparison: The performance parameters (e.g., temperature values, response times, residual levels) are directly measured and compared against the specified limits and benchmarks derived from these standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a measurement and monitoring system, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as no training set is used for this device.

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The ESOTEST MULTI Temperature Monitoring System is composed of ESOTEST MULTI Monitor and ESOTEST MULTI 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 ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI Probe.

The ESOTEST MULTI Temperature Monitoring System is composed of the following device components:

• Monitor ESOTEST MULTI MONITOR
• Esophageal probe ESOTEST MULTI PROBE
• Patient cable ESOTEST MULTI PATIENT CABLE

The LCD display of ESOTEST MULTI monitor shows the temperatures detected by the thermocouple sensors located in the probe, which is measuring the temperature of the patient's esophagus. Temperatures are displayed as numeric values and as scrolling plots. The user is able to set the value of an upper alarm threshold and that of a lower alarm threshold. If any measured temperature exceeds the upper alarm threshold or falls below the lower alarm threshold, ESOTEST MULTI monitor immediately emits visual and audible alarm signals.

The ESOTEST MULTI esophageal probe has a 7 French body equipped with 11 French sensors and is intended for the detection of esophageal temperature at multiple locations. The probe is connected to the monitor by ESOTEST MULTI patient cable.

The provided text describes the regulatory clearance of a medical device, the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System, and details the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. This is not an AI/ML powered device, therefore the information requested about the number of experts used to establish ground truth, the adjudication method, MRMC studies, or training set details are not applicable as these pertain to performance studies of AI/ML algorithms.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ESOTEST MULTI system are based on established international standards for clinical thermometers and medical device safety/performance.

Study Details

The studies performed are non-clinical bench and lab tests, not clinical studies involving human subjects or AI/ML algorithm evaluation.

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

   • The document does not specify exact sample sizes for each non-clinical test (e.g., how many probes were tested for accuracy, or how many sterilization cycles were validated).
   • The data provenance is from non-clinical laboratory testing performed by the manufacturer, Fiab SpA, in Italy. The tests are retrospective in the sense that they were completed prior to the 510(k) submission.

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

   • This question is not applicable as the device is a direct measurement medical thermometer, not an AI/ML algorithm requiring expert interpretation of complex data for ground truth establishment. Ground truth for the device's accuracy and performance parameters (e.g., temperature values, alarm functionality) is established by calibration against known standards and physical measurements.

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

   • This question is not applicable as it pertains to the resolution of discrepancies in expert interpretations, typically for AI/ML performance studies, which is not relevant for this device.

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:

   • This is not applicable. The device is an esophageal temperature monitoring system, not an imaging device or an AI-assisted diagnostic tool where human readers would be involved in interpreting data with or without AI assistance.

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

   • This is not applicable as there is no AI/ML algorithm in this device. The device performs direct physical measurements.

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

   • For temperature accuracy, the ground truth is established by calibrated reference standards (e.g., precision temperature baths and reference thermometers) that meet the requirements of relevant international standards (e.g., ISO 80601-2-56).
   • For other aspects like electrical safety, EMC, sterilization, and biocompatibility, the "ground truth" is compliance with the specific requirements and test methods outlined in the cited international standards (e.g., IEC 60601-1, ISO 11135-1, ISO 10993-1).

7. The sample size for the training set:

   • This is not applicable as there is no AI/ML algorithm requiring a training set for this device.

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

   • This is not applicable as there is no AI/ML algorithm requiring a training set for this device.

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