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510(k) Data Aggregation
(16 days)
The M5T is non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.
The M5T is a compact predictive clinical thermometer designed to measure human body temperature by detecting heat from three different body sites: axilla, rectum and mouth, by using the heat conduction principle and prediction.
The M5T is designed to calculate the maximum temperature of a probe in contact with the body site. The temperature reading range is from 35.0℃ to 42.0℃ (95.5°F to 107.6°F) and the time of measurement varies between 8 to 10 seconds.
The LCD, push button, battery, microprocessor and the PCB are located in one housing, which includes upper cover, lower cover and the battery cover. The entire device is compact, lightweight, small in size, easy to use and portable,
Here's an analysis of the provided text regarding the M5T Instant Fever Thermometer, focusing on acceptance criteria and study details:
The provided document is a 510(k) summary, which largely focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a comprehensive study report with specific performance metrics and statistical analyses. Therefore, much of the requested information regarding detailed acceptance criteria, specific performance numbers, multi-reader studies, and training set details is not present in this document.
Acceptance Criteria and Reported Device Performance
The document states: "A clinical study was performed in order to evaluate the safety and performance of the M5T following the heater removal. The study results demonstrated that the M5T is safe and effective without raising new safety and/or effectiveness issues."
This is a very high-level statement and does not provide specific quantitative acceptance criteria or detailed performance metrics. The implicit acceptance criterion is that the device is "safe and effective" and comparable to the predicate device. Without further details, we cannot create a table with specific numerical acceptance criteria and reported performance values.
However, based on the general context of clinical thermometers, typical acceptance criteria would involve accuracy (e.g., within a certain deviation from a reference standard) and precision. The document doesn't provide these specific values for the M5T or its predicate.
Study Details
Given the limited information in a 510(k) summary, much of the requested detail is not available.
| Category | Information from Document |
|---|---|
| 1. Acceptance Criteria & Performance | Acceptance Criteria: Implicitly, "safe and effective without raising new safety and/or effectiveness issues" when compared to the predicate device (Up-Grade and Up-Grade Pro Thermometer). |
| Reported Performance: "The study results demonstrated that the M5T is safe and effective without raising new safety and/or effectiveness issues." (No specific quantitative performance metrics provided). | |
| 2. Sample size (test set) & Data Provenance | Sample Size: Not specified. |
| Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). A "clinical study was performed," suggesting prospective data, but "where" is not mentioned. | |
| 3. Number of Experts & Qualifications (Ground Truth) | Not specified. |
| 4. Adjudication Method (Test Set) | Not specified. |
| 5. MRMC Comparative Effectiveness Study | No. This is a medical device (thermometer) and not an AI or imaging diagnostic device where MRMC studies are typically performed. The study likely focused on direct measurement accuracy and safety. |
| 6. Standalone Performance Study | Yes (implicitly). The "clinical study" evaluated the M5T's performance as a standalone device. There is no mention of a human-in-the-loop component. |
| 7. Type of Ground Truth | Not explicitly stated, but for a clinical thermometer, the ground truth would typically be established using a highly accurate reference thermometer (e.g., a calibrated mercury thermometer or a high-precision electronic standard) for temperature measurement. |
| 8. Sample Size (Training Set) | Not applicable/not specified. The M5T is a hardware device with a simple predictive algorithm, not a machine learning model that would require a "training set" in the conventional sense. The "prediction" aspect likely refers to a pre-defined algorithm rather than a learned model. |
| 9. How Ground Truth for Training Set was Established | Not applicable/not specified (refer to point 8). |
Additional Notes:
- Device Type: The M5T is an electronic clinical thermometer. The "prediction" mentioned ("using the heat conduction principle and prediction") likely refers to an internal algorithm that extrapolates the final stable temperature from a short measurement period, rather than a complex AI model requiring extensive training with labeled data.
- 510(k) Context: This document is a 510(k) premarket notification. Its primary goal is to show "substantial equivalence" to a currently marketed device, not to provide an exhaustive clinical trial report with all statistical details and raw data. The level of detail often found in publications for novel AI algorithms is typically not present in these regulatory submissions for established device types.
- Missing Information: The lack of specific numerical data for clinical performance (e.g., accuracy, bias, precision against a reference standard in degrees Celsius/Fahrenheit) means we cannot fully assess the device's adherence to typical thermometer performance expectations. A more detailed clinical study report would contain such data.
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