(228 days)
The model MT series digital thermometers (MT-201, 301, 402 and 403) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. The devices are reusable for clinical or home use on people of all ages.
The device model MT-405 is intended to measure oral temperature only. It is reusable for clinical or home use for children under the age of four.
Digital Thermometer Model MT series (MT-201, MT-301, MT-402, MT-403 and MT-405) enable fast and reliable measurements. These thermometers provide very high clinical accuracy, and have been designed to provide maximum userfriendliness.
The basic principle of these thermometers is that a change of thermistor resistance, caused by changes of temperature, is converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of the oscillator.
For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
This document describes the Sejoy Electronics & Instruments Co., LTD Digital Thermometer Model MT Series. The provided text, however, is a 510(k) summary for regulatory clearance and does not contain the detailed acceptance criteria or the specific study results in the format requested. While it mentions clinical studies were conducted, it does not provide the quantitative data needed to complete the table or answer all of your specific questions.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated, but implied by regulatory compliance) | Reported Device Performance (Implied by regulatory clearance and substantial equivalence) |
|---|---|
| Compliance with ASTM E 1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) | Implicitly met, as stated in "Discussion of Non-Clinical Tests Performed" |
| Compliance with IEC60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Implicitly met, as stated in "Discussion of Non-Clinical Tests Performed" |
| Compliance with IEC60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests) | Implicitly met, as stated in "Discussion of Non-Clinical Tests Performed" |
| Clinical accuracy (bias, uncertainty, repeatability) | Evaluated using a "Sejoy Clinical Test Protocol outline" (Specific quantitative results not provided) |
| Substantial equivalence to predicate devices in intended use and technological characteristics | Determined by FDA, as evidenced by 510(k) clearance |
Detailed Study Information (Based on the provided text, much of this is not available):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states "Controlled human clinical studies were conducted using the digital thermometer model MI series."
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The specific method for establishing "ground truth" (e.g., how the reference temperature was obtained in the clinical studies) is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- Not applicable. This device is a digital thermometer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or "AI assistance" is not relevant to its performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the typical sense for an AI algorithm. The device is the "standalone" measurement tool. The "performance" being evaluated is the accuracy of the thermometer itself, not an algorithm's interpretation of data for human review.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For clinical thermometers, the ground truth is typically established by extremely accurate reference thermometers or highly controlled temperature environments calibrated against international standards. The document mentions "clinical bias, clinical uncertainty and clinical repeatability," which implies comparison against a reference standard, but the specific type of ground truth (e.g., calibrated reference thermometer readings) is not explicitly detailed.
8. The sample size for the training set
- Not applicable in the context of machine learning model training. This device is a hardware-based digital thermometer, not an AI model that undergoes training.
9. How the ground truth for the training set was established
- Not applicable as there is no "training set" in the context of an AI model for this device. The device's calibration and accuracy are established through engineering design, manufacturing processes, and testing against known temperature standards.
§ 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.