(267 days)
Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
These devices are used by qualified medical professional only.
The subject devices are used for patient temperature measurement. The probes are reusable or disposable depending on models. These probes 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 subject devices are designed to be used in healthcare facilities like hospital and compatible with a monitor of Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The NTC of the six models are identical. Reusable models T1306, T2306, T3306, T4306 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models T5106 and T6106 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.
Model: T1306, Description: Skin contact Temperature Probe, adult, reusable
Model: T2306, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult, reusable
Model: T3306, Description: Skin contact Temperature Probe, pediatric, reusable
Model: T4306, Description: Body cavity Temperature Probe, Esophageal/Rectal, pediatric, reusable
Model: T5106, Description: Skin contact Temperature Probe, adult/ pediatric, disposable
Model: T6106, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult/ pediatric, disposable
The provided FDA 510(k) clearance letter describes a medical device, the Reusable and Disposable Temperature Probes, but does not include information about AI/ML performance. Therefore, I will respond to the prompt by extracting the acceptance criteria and study information pertinent to this medical device, which focuses on traditional medical device performance rather than AI/ML.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Supporting Performance |
|---|---|---|
| Accuracy | ±0.1℃ | Bench Testing (ISO 80601-2-56) |
| Measurement Range | 25-45℃ | Bench Testing (ISO 80601-2-56) |
| Electrical Safety | Complies with IEC 60601-1 | Bench Testing (IEC 60601-1) |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 | Bench Testing (IEC 60601-1-2) |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 | Biocompatibility testing |
| Operating Environment | +5 to +40°C, ≤80% humidity (non-condensing), 86kPa~106kPa | Bench Testing (IEC 60601-1 and ISO 80601-2-56) |
| Storage Environment | -20℃ to 55℃, ≤93% humidity, 86kPa~106kPa | Bench Testing (IEC 60601-1 and ISO 80601-2-56) |
| Compatibility with Monitors | Verifies compatibility with Mindray Model PM-8000 and other YSI 400 series compatible monitors | Bench Testing |
Note: The document presents "Accuracy" and "Measurement Range" as inherent characteristics of the device and states that bench testing was conducted to verify that design specifications were met, which implies these values are the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the test sets (e.g., number of units tested, number of temperature measurements, or specific test configurations) for the bench testing or biocompatibility testing.
The document also does not provide information about the provenance of data in terms of country of origin or whether studies were retrospective or prospective. The testing described appears to be laboratory-based verification and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The device is a clinical electronic thermometer, and its performance is assessed against technical specifications and international standards, not against human expert interpretation of medical images or data. Ground truth for temperature measurement is typically established by reference standards or calibrated equipment.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., image interpretation by multiple readers), which is not relevant for the objective performance testing of a temperature probe.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not conducted as this is a medical device for objective temperature measurement, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation. The document does not mention any AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is an electronic temperature probe, not an algorithm or software. Its performance is inherent to its physical and electrical properties, evaluated through bench testing against established standards.
7. Type of Ground Truth Used
The ground truth for the performance evaluations (accuracy, measurement range, electrical safety, etc.) would be established by:
- Reference Standards/Calibrated Equipment: For accuracy and measurement range, the device's readings would be compared against highly accurate and calibrated reference thermometers in controlled temperature environments.
- International Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and thermometer-specific performance (ISO 80601-2-56) serves as the ground truth for safety and performance.
- Laboratory Analysis: For biocompatibility, laboratory tests (cytotoxicity, sensitization, irritation) are conducted to assess the biological response to the device materials according to ISO 10993 standards.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is a hardware medical device with no mention of machine learning or algorithms that would require 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 involved, no ground truth was established for a training set.
§ 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.