(71 days)
The Welch Allyn SureTemp® Plus thermometer enables the health care professional to make an accurate prediction of a febrile or hypothermic patient's oral temperature in approximately 4-6 seconds (in Normal mode). Pediatric Axillary (age 17 and younger) temperatures can be obtained in approximately 10-13 seconds. Adult Axillary temperatures (in Normal mode) can be obtained in approximately 12-15 seconds. Rectal temperatures (in Normal mode) can be obtained in approximately 10-13 seconds. Normal (predictive) mode is available for oral, rectal, and axillary use.
In the Monitor mode, the instrument provides the capability of accurate, long-term monitoring of actual oral, rectal or axillary temperature, and of following the temperature whether constant, increasing, or decreasing.
The SureTemp is a clinical grade thermometer intended for use by healthcare practitioners only; typically in a hospital, clinic, long- term care, or mobile health care environment. It is not intended for home use.
The Welch Allyn SureTemp Plus thermometer is intended to be used by healthcave professionals, to provide an accurate prediction of patient temperature using the oval, axillary or reastal booky sives in 4 to 15 seconds , or to provide an actual temperature reading in the continuous monitor mode about 3 minutes . 11 =
The SureTemp® Plus clinical electronic thermometer consists of an elongated metal heat-conductive probe connected to the thermometer's main body through a coiled cord. The probe contains a thermistor that conveys temperature information to the main body for calculation of patient temperature.
Prior to use, a plastic probe cover must cover the probe. This cover must not be a significant barrier to the transfer of heat from the patient to the probe body (and thermistor). In addition, the disposable nature of the probe cover prevents microbiological cross-contamination among patients which might occur with a reuseable probe. Calculation of patient temperature may (in the normal or predictive mode) utilize algorithms that enable accurate temperature prediction within 4 to 15 seconds of probe placement (times vary based on the temperature mode selected).
There are two model designations for the SureTemp® Plus and they are the Model 692 and 690. The Model 690 is the lower cost version of the Model 692 and does not include the backlit display and security features or pulse timer.
This document does not contain the detailed information necessary to complete all sections of your request. The provided text is a 510(k) summary for a medical device (SureTemp® Plus thermometer) and focuses on regulatory aspects like substantial equivalence, indications for use, and device description, rather than a detailed study report of an AI algorithm's performance.
However, I can extract the following based on the provided text:
Acceptance Criteria and Reported Device Performance
| Metric / Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Oral Temperature Prediction | Accurate prediction of febrile or hypothermic patient's oral temperature | Approximately 4-6 seconds (in Normal mode) |
| Pediatric Axillary Temperature Prediction | Accurate prediction of axillary temperature (age 17 and younger) | Approximately 10-13 seconds |
| Adult Axillary Temperature Prediction | Accurate prediction of axillary temperature (adults) | Approximately 12-15 seconds |
| Rectal Temperature Prediction | Accurate prediction of rectal temperature | Approximately 10-13 seconds |
| Continuous Monitor Mode | Accurate, long-term monitoring of actual temperature (oral, rectal, or axillary) | Approximately 3 minutes for actual reading (implied for initial reading in monitor mode) |
(Note: The "acceptance criteria" are inferred from the "Intended Use" section describing the device's capabilities and expected performance. No explicit numerical acceptance criteria for accuracy (e.g., within +/- 0.1°C) are provided in this document.)
Information Not Available in the Provided Text:
The document does not provide information about the following, as it is a regulatory submission summary and not a detailed study report for an AI/algorithm:
- Sample size used for the test set and the data provenance: There is no mention of a specific test set, its size, or where the data came from (country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a thermometer which takes physical measurements.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this device is a thermometer, not an AI-assisted diagnostic tool for "human readers."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device uses algorithms for predictive temperature, but it's an integrated system, not a standalone algorithm being tested separately from the hardware. The performance described is of the device as a whole.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a thermometer, the "ground truth" would typically be a highly accurate reference thermometer measurement. This specific detail is not present.
- The sample size for the training set: Not applicable, as there's no mention of a "training set" in the context of an AI algorithm for this device. The predictive algorithms would have been developed and validated, but the specifics of that process (like a "training set" in the machine learning sense) are not detailed here.
- How the ground truth for the training set was established: Not applicable.
§ 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.