(14 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (ISO 80601-2-56:2009 requirement for clinical thermometers) | The accuracy within the rated output range in normal use is not greater than 0.3°C. (Meets the predicate device's accuracy of not greater than 0.3°C and the ISO 80601-2-56:2009 requirement). |
| Precision and Repeatability | 0.1°C. (The predicate device did not specify precision and repeatability, so the subject device meets or exceeds this aspect compared to the predicate). |
| Time Response (Heating transient) | Approximately 7 seconds. (The predicate device had a heating transient response time of approximately 29 seconds, indicating the subject device has a faster response time). |
| Time Response (Cooling transient) | Approximately 4.5 seconds. (The predicate device had a cooling transient response time of approximately 18 seconds, indicating the subject device has a faster response time). |
| Biocompatibility (ISO 10993-1) | Evaluated to ISO 10993-1 and meets biocompatibility requirements. |
| Electrical Safety (IEC 60601-1) | Fully complies with IEC 60601-1:1988 + A1:1991 + A2:1995. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Fully complies with IEC 60601-1-2:2007. |
| Programmable Electrical Medical Systems (IEC 60601-1-4) | Complies with IEC 60601-1-4 / 2000 Consol. Ed 1.1. |
| Risk Management (ISO 14971) | Complies with ISO 14971 / 2007. |
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.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.