(266 days)
Med-link Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitors of Philips Model Intelli Vue MP50, Mindray Model PM-9000, Datex-Ohmeda Model Cardiocap II, Drager Model Infinity Gamma XL.
These devices are used by qualified medical professional only.
The proposed devices are used for patient temperature measurement for multi-patient use. The temperature probes are reusable and consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement.
The Med-link Temperature Probes are intended for monitoring temperature for multi-patient use. They are reusable and designed for use with specific monitors (Philips Model IntelliVue MP50, Mindray Model PM-9000, Datex-Ohmeda Model Cardiocap II, Drager Model Infinity Gamma XL).
Here's an analysis of the acceptance criteria and supporting study information:
1. Acceptance Criteria and Reported Device Performance
The core performance acceptance criterion for the Med-link Temperature Probes appears to be accuracy.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy: ±0.1 °C | Accuracy: ±0.1 °C |
| Measurement Range: 25-45°C | Measurement Range: 25-45°C |
Other relevant criteria and performance:
- Type of Use: Prescription Use
- Operating Principle: Resistance of thermistor based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement.
- Measurement Site: Skin, Esophageal, and Rectal
- Component: Reusable
- Thermistor Resistance: 2.25K@25°C
- Sterilization: Non-sterile
- Electrical Safety: Comply with IEC 60601-1
- Performance Standard Compliance: ISO 80601-2-56
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the specific sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for any clinical studies.
The document mentions "performance bench testing in accordance with ISO 80601-2-56 for all models of the subject device with compatible monitors was conducted and the results met the requirements." This indicates that the testing was likely laboratory-based bench testing rather than clinical trials with human subjects.
3. Number of Experts and their Qualifications for Ground Truth
The document does not indicate the involvement of experts in establishing ground truth for a test set, as the testing described is primarily bench testing against recognized standards rather than clinical validation requiring expert interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable, as the document describes bench testing against technical standards, not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence based on technical standards and performance specifications, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study in the form of bench testing was conducted. The document states: "performance bench testing in accordance with ISO 80601-2-56 for all models of the subject device with compatible monitors was conducted and the results met the requirements." This testing evaluates the device's technical performance against a recognized standard without human interpretation in the measurement process.
7. Type of Ground Truth Used
The ground truth used was established by recognized international technical standards and specifications. Specifically, the device's performance was compared against the requirements 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.
- The stated accuracy of ±0.1°C and measurement range of 25-45°C are the "ground truth" against which the device's measured performance was assessed during bench testing.
8. Sample Size for the Training Set
The document does not describe any machine learning or AI components that would require a "training set." Therefore, this question is not applicable. The device is a traditional electronic thermometer.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for machine learning or AI.
§ 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.