(119 days)
ESOTEST Probe is intended for continuous esophageal temperature monitoring. ESOTEST Monitor is intended for display continuous temperature measurement (℃) from 3 sensors temperature probe.
ESOTEST Esophageal Temperature Probe and Temperature Monitoring System consists of following main parts: Monitor, Interconnect Cable, Esophageal Probe. Monitor shows, on 3 separate led displays, the temperature detected by 3 thermocouple sensors placed in the esophageal probe. The incorporated alarm system allows the operator to set a threshold of adequate temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm. Esophageal probe is a Ø7Fr lead intended to continuous detection of esophageal temperature at three different points of esophagus. Temperature is get by 3 thermocouple sensors. Esophageal probe is connected to the monitor by interconnect cable.
Here's an analysis of the provided 510(k) summary regarding the ESOTEST Esophageal Temperature Probe and Temperature Monitoring System:
The document focuses on demonstrating substantial equivalence to a predicate device (S-Cath - Esophageal Temperature Probe and Temperature Monitoring System, K112376) through non-clinical performance testing. It does not describe a study involving human subjects or AI.
Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ESOTEST requirement) | Reported Device Performance |
|---|---|---|
| Accuracy of the device | ±0.3°C | ±0.3°C |
| Precision in condition of repeatability | 0.1°C | 0.1°C |
| Response Time | 1s (limit established: 1.6s) | Approximately 1s |
Study Details for the ESOTEST Esophageal Temperature Probe and Temperature Monitoring System
This summary does not contain information about studies involving human subjects, AI/algorithm performance, or extensive clinical trials. The "study" referenced is a set of non-clinical, bench-top performance tests.
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Sample size used for the test set and the data provenance:
- Accuracy Test: 3 ESOTEST Monitors with 3 Probes (meaning 9 independent thermometers were tested, as each monitor has 3 thermometers).
- Repeatability Test: 5 ESOTEST Monitors with Probes (meaning 15 independent thermometers were tested).
- Response Time Test: 6 ESOTEST Monitors and probes.
- Data Provenance: The tests were non-clinical, performed in a laboratory setting by FIAB SpA. The data is prospective, generated specifically for this 510(k) submission. No country of origin for patients or retrospective data is applicable as it's a bench test.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for these non-clinical tests was established by a reference thermometer (Pt100) and a reference thermometer, both calibrated, conforming to standards (ISO 80601-2-56:2009 and NIST Technical Note 1297: 1994 Edition). No human experts were involved in establishing the "ground truth" for the device's technical specifications in these bench tests.
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Adjudication method for the test set:
- Not applicable. This was not a human interpretation study. The "adjudication" was a direct comparison of the ESOTEST device's readings against a calibrated reference instrument.
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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:
- No MRMC comparative effectiveness study was done. This device is a temperature monitoring system and does not involve human readers interpreting images or data that AI would assist with.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of AI. The device itself is a standalone measurement system (without human-in-the-loop performance in terms of interpretation, though human intervention is required for placement and alarm setting). Its performance was tested as a standalone physical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Calibrated Reference Standard: The ground truth for all performance tests (accuracy, repeatability, response time) was established using highly accurate, calibrated reference thermometers and controlled laboratory conditions (thermostatic baths). This is a physical, objective standard.
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The sample size for the training set:
- Not applicable. This device is a hardware product with embedded firmware, not an AI model requiring a training set in the typical sense. Performance was evaluated through hardware testing.
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How the ground truth for the training set was established:
- Not applicable, as there is no AI 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.