(247 days)
The Lumiscope Model 2018 Thermometer has the same intended use as the predicate device. It is indicated for use in the measurement of oral and axillary temperature. It is not intended for rectal (rectum) temperature measurement. The device also provides a clock function when not in the temperature mode. The Lumiscope Model 2018 Thermometer is intended for use by adults and may be used by the infant or pediatric patient population for measurements of axillary body temperature or for measurements of oral body temperature if the child is able to hold the thermometer beneath the tongue while his mouth is closed.
The Lumiscope Model 2018 Thermometer is a thermometer of standard electrical transducer design, consisting of a flexible probe, connecting cord and display unit. The probe consists of a transducer and supporting plastic tube which houses the connection between the tube and cord. The display unit houses a 1.5V DC button battery, Liquid Crystal Display (LCD), slide switches for controlling the thermometer/clock mode and °F/°C mode, hour and minute set buttons, and temperature alert beeper.
Here's an analysis of the provided text regarding the Lumiscope Model 2018 Thermometer, focusing on acceptance criteria and study details.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ASTM E 1112-86) | Reported Device Performance |
|---|---|
| Accuracy (specific tolerances not detailed in document) | "Bench testing confirmed accuracy... measurements specified in the labeling." (Implies accuracy meets the ASTM standard, but quantitative values are not provided.) |
| Precision (specific tolerances not detailed in document) | "Bench testing confirmed... precision... measurements specified in the labeling." (Implies precision meets the ASTM standard, but quantitative values are not provided.) |
| Repeatability (specific tolerances not detailed in document) | "Bench testing confirmed... repeatability measurements specified in the labeling." (Implies repeatability meets the ASTM standard, but quantitative values are not provided.) |
| Other requirements of ASTM E 1112-86 (e.g., response time, stability, environmental conditions) | "The Lumiscope Model 2018 Thermometer meets the ASTM Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature (ASTM E 1112-86)." (This statement broadly indicates compliance with all aspects of the standard.) |
Note: The provided 510(k) summary only states that the device meets ASTM E 1112-86. It does not elaborate on the specific quantitative acceptance criteria within that standard or the exact numerical performance results of the Lumiscope Model 2018 against those criteria.
2. Sample size used for the test set and the data provenance
The document states "Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling." This indicates that the testing was performed in a lab setting, not on human subjects.
- Sample Size for Test Set: Not specified. The document only refers to "bench testing." For a thermometer, "sample size" would typically refer to the number of individual thermometers tested, or the number of measurements taken, or the number of simulated temperature points evaluated. None of these details are provided.
- Data Provenance (country of origin, retrospective/prospective): The data provenance is from "bench testing," meaning laboratory-generated data. The country of origin of the testing is not specified, nor is whether the data was retrospective or prospective (which is less relevant for bench testing than for clinical studies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to the described study. The ground truth for a digital thermometer's accuracy, precision, and repeatability in bench testing would typically be established against highly accurate calibration standards or reference thermometers, not by human experts.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are used when there are multiple human readers providing interpretations that need to be resolved. For bench testing of a thermometer, objective measurements against a standard are performed, not subjective interpretations.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI systems assisting human interpretation (e.g., in medical imaging). The Lumiscope Model 2018 is a standalone digital thermometer and does not involve AI or human readers for its operation or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, a standalone performance assessment was done. The "bench testing" described evaluates the device itself (the "algorithm only" in a broader sense of device function, though not an AI algorithm) against established standards (ASTM E 1112-86) without human-in-the-loop interpretation being part of its core function. The device's performance is independent of human interpretation for reading the temperature.
7. The type of ground truth used
The ground truth for the "accuracy, precision, and repeatability" testing was established by the ASTM Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature (ASTM E 1112-86). This standard outlines the methods and reference values/tolerances against which the thermometer's performance is measured. It relies on calibrated reference equipment and defined test procedures.
8. The sample size for the training set
This section is not applicable. The Lumiscope Model 2018 Thermometer is a traditional electronic device, not an AI/machine learning system that requires a "training set." Its functionality is based on predefined electronic circuits and physical principles, not learned from data.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 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.