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 =

Device Description

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.

AI/ML Overview

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.

Summary

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510(k) Summary Section 11:

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR § 807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

Submitted By

MAY 0 6 2003

Debra L. Jackson, RAC Senior Manager, Quality Assurance & Regulatory Affairs Welch Allyn, San Diego 7420 Carroll Road San Diego, California 92121

Telephone: (315) 685-4133 Contact: Dave Klementowski Date Prepared: February 21, 2003

Device Name

Common or usual name: Thermometer, Electronic Thermometer, Predictive Thermometer

Classification Class: Il Panel: 80 Procode: FLL - clinical electronic thermometer

Predicate Devices

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 amonq 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).

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Device Description

Intended Use

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 6 2003

Ms. Debra L. Jackson Senior Manager, QA/RA Welch Allyn, Incorporated 7420 Carroll Road San Diego, California 92121

Re: K030580

Trade/Device Name: SureTemp® Plus Regulation Number: 880.2910 Regulation Name: Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 21, 2002 Received: February 24, 2003

Dear Ms. Jackson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Jackson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Punoe

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) NUMBER (IF KNOWN): K030580

DEVICE NAME: SureTemp® Plus

INDICATIONS FOR 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 =

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use
(Optional Format i-2-96)

Patricia Cuccente

(Division Sign-Off) Division of Anesthesiology, General I Infection Control, Dental Device

510(k) Number: K030580

Regulation Number and Section

§ 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.