(304 days)
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.
| Parameter | Acceptance Criteria (ESOTEST requirement) | Reported Device Performance |
|---|---|---|
| Accuracy of the device | ±0.3°C in the rated range +10 to +45°C | Met (implied by "In all testing, the pre-determined acceptance criteria were met.") |
| Precision in condition of repeatability | 0.1°C | Met (implied by "In all testing, the pre-determined acceptance criteria were met.") |
| Response Time | 1 s (temperature step +27 to +43 °C) | Met (implied by "In all testing, the pre-determined acceptance criteria were met.") |
| Alarm Threshold | Auditory and visual alarm is triggered when outside threshold | Validated through performance testing and software verification/validation. Met (implied by "In all testing, the pre-determined acceptance criteria were met.") |
| Electrical Safety | Compliance with IEC 60601-1:2005 | Verified by testing, criteria met. |
| EMC | Compliance with IEC 60601-1-2:2014 | Verified by testing, criteria met. |
| Sterilization Process | Validation according to ISO 11135-1:2007 (EO gas) | Validated and routinely controlled, criteria met. |
| Biocompatibility | Compliance with ISO 10993-1:2009 | Tested for cytotoxicity, sensitization, and intracutaneous reactivity (ISO 10993-5:2009, ISO 10993-10:2010), criteria met. |
| Risk Analysis | Compliance with ISO 14971:2007 | Conducted, criteria met. |
Study Details
The studies performed are non-clinical bench and lab tests, not clinical studies involving human subjects or AI/ML algorithm evaluation.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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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.
§ 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.