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The ATS Thermal Imaging Probe is intended for continuous esophageal temperature monitoring.

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

The Securus Aurora Thermographic System (ATS) 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 the Patient Interface Unit.

Aurora Thermographic System (ATS) consists of two components:

• A. ATS Thermal Imaging Probe
• B. ATS Patient Interface Unit

The ATS Thermal Imaging Probe provides esophageal temperature monitoring through the use of a standard thermocouple mounted in a flexible 9 French catheter. This design is standard for esophageal temperature probes commonly used in the industry. In addition, the ATS Thermal Imaging Probe 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 ATS Patient Interface Unit displays temperature measurements (°C) from the ATS Thermal Imaging Probe. The ATS Patient Interface Unit has a Digital Video (DVI) port for streaming thermal image data to an auxiliary monitor (not offered with the system).

The ATS Thermal Imaging Probe and ATS Patient Interface Unit is a medical device intended for continuous esophageal temperature monitoring and displaying these temperature measurements. The product is a modification of the previously cleared InfraRed Thermographic System (IRTS). The modifications include combining two connectors into one handle, modifying the distal tip to include BaSO4 filler, changing the housing and circuit boards of the patient interface unit, and modifying the software.

Here's an analysis of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for "all samples tested" or the number of units tested for each criterion. It mentions "All samples tested" for thermocouple accuracy, IR accuracy, and mechanical connections.

Data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission, the testing would typically be prospective and conducted in a controlled lab environment as part of the device development and validation process.

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

This information is not applicable and not provided. The testing described is performance testing against established engineering and medical device standards (e.g., ISO 80601-2-56), not a diagnostic study relying on expert interpretation of results to establish ground truth. The "ground truth" for these tests comes from objective measurements and calibrated reference standards.

4. Adjudication Method for the Test Set

Not applicable. The tests are for objective device performance measurements against predefined technical specifications and standards, not for subjective interpretation requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. The device is a continuous esophageal temperature monitoring system, not an AI-assisted diagnostic imaging device that involves human readers interpreting data.

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

Yes, the testing described is primarily focused on the standalone performance of the device's hardware and software against objective technical standards. The thermocouple and infrared sensors' accuracy, response time, and the software's functional requirements are evaluated directly, independent of a human operator's interpretation, to ensure the device performs as intended.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on objective measurements against established and calibrated reference standards as defined by recognized consensus standards, specifically ISO 80601-2-56 for clinical thermometers and relevant electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2). For example:

• Accuracy: Measurements against a known, precise temperature in a controlled bath.
• Response Time: Time taken to reach a stable reading after a known temperature differential, again in a controlled environment.
• Mechanical Strength: Application of a precisely measured force (3.37 lbs) and observation of joint integrity.
• Biocompatibility: Results from standardized biological tests as per ISO 10993-1:2009.
• Software Functionality: Verification against predefined software requirement specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a medical instrument for direct measurement, not an AI/machine learning algorithm that requires a training set. The software mentioned in the document refers to control software for the device's operation, not a learning algorithm that processes data for diagnostic purposes.

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

Not applicable, as no training set was used.

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