(323 days)
It is intended for use in measuring temperature in the human body (Armpit or Oral).
The body temperature is converted into electronic signal by the temperature sensor, and then the electronic signal is converted into LCD digital display. The Electronic Thermometers TF3100, TF3101 and TF3102 have the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.
The provided PDF outlines the acceptance criteria and a study demonstrating that the Electronic Thermometer (Models TF3100, TF3101, TF3102) meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The primary performance characteristics addressed in the submission are accuracy and response time. The acceptance criteria are based on recognized international and national standards for clinical electronic thermometers.
| Acceptance Criteria (Standard) | Reported Device Performance (Electronic Thermometer TF3100, TF3101, TF3102) |
|---|---|
| Accuracy (ASTM E1112-00) | |
| $0.05°C$ for temperatures between $35.30°C$ and $39.00°C$ | $0.05°C$ (for $35.30°C ~ 39.00°C$) |
| $0.1°C$ for temperatures below $35.30°C$ or above $39.00°C$ | $0.1°C$ (for $ 39.00°C$) |
| Response Time (Not explicitly stated as an acceptance criterion but matched) | 5 minutes |
| Precision and Repeatability | 4 numerical digits, display in 0.01 degree increments |
| Other Standards Compliance: | Compliance demonstrated for: |
| Electrical Safety (IEC 60601-1) | Yes |
| Home-used medical equipment requirements and Environmental test (IEC 60601-1-11) | Yes |
| Electromagnetic Compatibility Requirements (EN 60601-1-2) | Yes |
| Biocompatibility Evaluation (ISO 10993-5, ISO 10993-10) | Yes (for parts contacted to patient) |
| Temperature Range | $32.00°C ~ 42.00°C$ |
| Ambient Temperature Environment | $+5°C~+40°C$ |
| Water-proof | IP22 |
2. Sample size used for the test set and the data provenance:
The document states that "Clinical evaluation of Electronic Thermometers has been conducted by SHENZHEN PUMP MEDICAL SYSTEM CO., LTD." However, the specific sample size used for the test set and the data provenance (e.g., country of origin, retrospective or prospective) for this clinical evaluation are not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a clinical thermometer, the ground truth would typically be established by highly accurate reference thermometers and not by "experts" in the sense of medical professionals adjudicating images or cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and therefore not provided in the context of evaluating a clinical electronic thermometer. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of medical images or diagnoses, not for the direct measurement of physical parameters like temperature.
5. 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 information is not applicable and therefore not provided. The device is an electronic thermometer, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone electronic thermometer, designed to provide direct temperature readings. The "clinical evaluation" conducted would have assessed the device's accuracy in measuring human body temperature without human subjective interpretation. The document, however, does not explicitly describe the methodology or results of this standalone performance assessment beyond stating that "clinical evaluation... has been conducted."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a clinical electronic thermometer, the ground truth would most likely be established by a highly accurate reference thermometer (e.g., a laboratory-grade mercury-in-glass thermometer or a highly calibrated electronic reference thermometer) under controlled conditions. The document does not explicitly state the type of ground truth used for the clinical evaluation, but it is inferable given the nature of the device.
8. The sample size for the training set:
This information is not applicable as the device is not an AI/ML product that would require a "training set." The submission describes a traditional electronic thermometer.
9. How the ground truth for the training set was established:
This information is not applicable as the device is not an AI/ML product that would require 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.