The Timex AccuCurve ™ Talking 30 Second Thermometer is an electronic thermometer to measure patient body temperature orally. Timex AccuCurve ™ Talking 30 Second Thermometer is intended for professional and over-the-counter use.

Device Description

Electronic Thermometer

AI/ML Overview

The provided text is a 510(k) summary for the Timex AccuCurve™ Talking 30 Second Thermometer. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or the study data that would demonstrate the device explicitly meets those criteria.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Temperature range	90.0°F to 108.0°F
Measurement accuracy	±0.2°F
Display graduation	0.1°F intervals
Measurement time	Approx. 30 seconds
Ambient temperature environment	60°-94°F (95% Relative Humidity)
Voice announcement	Yes
Nightlight display	Yes (Indiglo™)
Curved probe	Yes

Missing Information: The document states these are "Performance Characteristics" but does not explicitly label them as "acceptance criteria" nor does it provide a study report detailing how the device's performance was measured against these characteristics. It only lists what the device is designed to do.

2. Sample size used for the test set and the data provenance

Sample size: Not mentioned.
Data provenance: Not mentioned. The document only references substantial equivalence to another device and lists performance characteristics, not actual test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The device is a thermometer, and its accuracy would typically be verified against known temperature standards or highly accurate reference thermometers, not expert opinions.

4. Adjudication method for the test set

Not applicable and not provided, as ground truth is not established by expert consensus for this type of device.

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 an electronic thermometer, not an AI-assisted diagnostic tool that requires human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not explicitly stated, but the "Performance Characteristics" section describes the device's inherent capabilities, which implies standalone performance. However, there is no detailed study report provided.

7. The type of ground truth used

The document implies that the ground truth for evaluating temperature accuracy would be a known temperature standard or a highly accurate reference thermometer. This is inferred from the nature of the device (a thermometer) and the specified accuracy (±0.2°F). However, the document does not explicitly state the methodology for establishing ground truth during testing.

8. The sample size for the training set

Not applicable. This device is a traditional electronic thermometer, not a machine learning or AI-based device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Overall Conclusion based on the provided text:

The 510(k) summary provided describes the device's intended performance characteristics and asserts its substantial equivalence to a predicate device. However, it does not include the detailed study reports or data that would explicitly demonstrate how these characteristics were tested and met in a formal study. The FDA's letter simply acknowledges the 510(k) submission and determines substantial equivalence based on the information provided by the applicant, but it does not reproduce the full study details within this summary document. For a complete understanding of how these performance criteria were met, one would typically need to review the full 510(k) submission, which contains the detailed testing information.

Summary

{0}------------------------------------------------

023538

510k Submission MedPort, Inc., The Ocean Group

Timex AccuCurve ™ Talking 30 Second Thermometer

510 (K) SUMMARY

Date of Summary

October 16, 2002

1 2002 NOV

Product Name:

Timex AccuCurve ™ Talking 30 Second Thermometer

Manufacturer:

Global Treasures Industrial Ltd. Nan Fung Ind. Cit 18 Tin Hau Road Tuen Mun N.T. . HK

Sponsor

MedPort, Inc. The Ocean Group, Inc. 23 Acorn Street Providence, RI 02903

Correspondent:

Fran White MDC Associates 163 Cabot Street Beverly, MA 01915

Substantially Equivalent Device:

Product: GT010706 Digital Thermometer (K021052) Manufactured by: Global Treasures Industrial, Inc.

Product Description:

Electronic Thermometer

Intended Use:

The Timex AccuCurve ™ Talking 30 Second Thermometer is an electronic thermometers to measure patient body temperature orally.

Timex AccuCurve ™ Talking 30 Second Thermometer is intended for professional and over-thecounter use.

Performance Characteristics:

The Timex AccuCurve ™ Talking 30 Second Thermometer measures patient body temperature in approx. 30 seconds. The thermometer is programmed to announce the current body temperature. Current body temperature is digitally displayed. The Thermometer is equipped with an Indiglo™ "nightlight" display to be easier reading. The thermometer is designed with a curved probe to more easily measure body temperature from the "hot spot" under the tongue. The temperature detected is graduated on 0.1°F intervals, reading a range of 90.0°F to 108.0°F, ±0.2°F. The ambient temperature environment in which the device is intended for use is 60°-94°F (95% Relative Humidity).

Conclusion:

Timex AccuCurve ™ Talking 30 Second Thermometer is substantially equivalent to the electronic thermometer manufactured by Global Treasures, GT010706 Digital Thermometer (K021052).

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered on the image. The font is a simple sans-serif font. The text is likely part of a document or presentation.

od and Drug Administra 9200 Corporate Boulevard Rockville MD 20850

1 2002 NOV

MedPort, Incorporated The Ocean Group, Incorporated C/O Ms. Fran White - - - - - -MDC Associates 163 Cabot Street Beverly, Massachusetts 01915

Re: K023538

Trade/Device Name: Timex AccuCurve™ Talking 30 Seconds Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: 80 FLL Dated: October 16, 2002 Received: October 21, 2002

Dear Ms. White:

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.

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.

{2}------------------------------------------------

Page 2 - Ms. White

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510k Submission MedPort, Inc., The Ocean Group

Timex AccuCurve ™ Talking 30 Second Thermometer

510(k) Number:

Timex AccuCurve ™ Talking 30 Second Thermometer Device Name:

Indication for Use:

The Timex AccuCurve ™ Talking 30 Second Thermometer is an electronic thermometer to measure catient temperature orally. Targeted users include professional and over-the-counter users. The Thermometer is programmed to announce the current body temperature in a clear pleasant voice.

(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 1-2-96)

Patricia Cricht

on of Anesthesiology, General Hospital, ion Control, Dental Devices

510(k) Number. N023538

MedPort 510F Page 8 of 65 Submission

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.