U-RIGHT TD-1240 Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.

Device Description

U-RIGHT TD-1240 Thermometer is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.

AI/ML Overview

The provided text is a 510(k) summary for the U-RIGHT TD-1240 Thermometer. It describes the device and claims substantial equivalence to a predicate device. However, it does not contain a detailed study report with acceptance criteria or performance data for the U-RIGHT TD-1240 Thermometer itself. Instead, it relies on the assertion of "substantial equivalence" to a predicate device, the FORA ComfortScan Ear Thermometer (model TD-1261, K081445).

Therefore, I cannot directly extract the specific information requested in your prompt regarding the acceptance criteria and a study proving the device meets those criteria for the U-RIGHT TD-1240. The document states: "U-RIGHT TD-1240 Thermometer has the same performance characteristics as the predicate device. A comparison of system accuracy performance demonstrated that U-RIGHT TD-1240 Thermometer and Fora ComfortScan Ear Thermometer (cleared under K081445) are substantially equivalent."

This means that the performance characteristics are assumed to be met because they are the same as the predicate device, which would have undergone its own studies.

If you are looking for the original performance data, you would need to access the K081445 submission for the FORA ComfortScan Ear Thermometer.

Based on the provided text, here's what can be answered, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot provide. The document does not specify unique acceptance criteria or detailed performance data for the U-RIGHT TD-1240. It claims "same performance characteristics" as the predicate device.

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

Cannot provide. No specific test set sample size or data provenance is mentioned for the U-RIGHT TD-1240.

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

Cannot provide. No information on ground truth establishment or experts is given for the U-RIGHT TD-1240.

4. Adjudication method for the test set

Cannot provide. No information on adjudication is given.

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 thermometer, not an AI-assisted diagnostic tool involving human readers or cases.

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

Partially applicable, but no data provided. The device is a "standalone" thermometer in that its measurement is direct. However, the document doesn't provide specific performance metrics for this standalone operation beyond stating it has "same performance characteristics" as the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot provide. No information on ground truth type is available in this document for the U-RIGHT TD-1240. For a thermometer, ground truth typically involves comparison to a highly accurate reference thermometer measurement.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses a "training set" in the conventional sense.

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

Not applicable. See point 8.

Summary of what the document does state about performance equivalence (not direct performance):

The document asserts that the U-RIGHT TD-1240 Thermometer is substantially equivalent to the predicate device, FORA ComfortScan Ear Thermometer (model TD-1261, K081445).

"U-RIGHT TD-1240 Thermometer has the same performance characteristics as the predicate device."
"A comparison of system accuracy performance demonstrated that U-RIGHT TD-1240 Thermometer and Fora ComfortScan Ear Thermometer (cleared under K081445) are substantially equivalent."
"Software verification and validation, performance and safety tests confirmed that the performance, safety and effectiveness of the U-RIGHT TD-1240 Thermometer are equivalent to the predicate device."

To understand the actual acceptance criteria and performance data, one would need to refer to the 510(k) submission for the predicate device, K081445.

Summary

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K113159

JAN - 6 2012

Section 11. 510(k) Summary

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is:

l. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan
Correspondence: Linda Ko Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1158 Fax: +886-2-6625-0288 Email: kolinda@taidoc.com.tw

Date of submission: October 20, 2011

1. Device name:
  Proprietary name: U-RIGHT TD-1240 Thermometer

Regulatory information:

Regulation section: 21 CFR 880.2910 A.
Classification: Class II B.
C. Product Code: FLL, Clinical electronic thermometer
D. Panel: General Hospital (80)

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3. Intended Use:

. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

4. Device Description:

Substantial Equivalence Information:

A. Predicate device name:

FORA ComfortScan Ear Thermometer, model TD-1261

Predicate K number: K081445 B.

Comparison with predicate: C.

The modified U-RIGHT TD-1240 Thermometer has the following similarities to the predicate device:

same operating principle,
B same fundamental scientific technology,
. incorporate the same basic circuit design,
I incorporate the same materials,
l same shelf life
packaged using the same materials, and
. manufactured by the same process.

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The modifications encompass:

B modification in the physical appearance
a modification in the user interface
1 increased memory storage capacity
이 removed the data transmission function
. labeling change due to the modifications
1. Test Principle:

The thermometer measures temperature by reading infrared radiation emitting from the skin and converts it into a temperature value.

1. Performance Characteristics:
  U-RIGHT TD-1240 Thermometer has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that U-RIGHT TD-1240 Thermometer and Fora ComfortScan Ear Thermometer (cleared under K081445) are substantially equivalent.

Software verification and validation, performance and safety tests confirmed that the performance, safety and effectiveness of the U-RIGHT TD-1240 Thermometer are equivalent to the predicate device.

1. Conclusion:
  Based on the information provided in this submission, the U-RIGHT 1240 Thermometer is substantially equivalent to the predicate Fora ComfortScan Ear Thermometer, model TD-1261.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

JAN - 6 2012

Ms. Linda Ko Regulatory Affairs Specialist TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Road Wugu District New Taipei City CHINA 24888

Re: K113159

Trade/Device Name: U-RIGHT TD-1240 Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 20, 2011 Received: December 21, 2011

Dear Ms. Ko:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Ko

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. 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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Section 8. Indications for Use

Indications for Use

510(k) Number:

Device Name: U-RIGHT TD-1240 Thermometer

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off Office of Device Evaluation (ODE) 510(k)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Ald C. Chypman 1/3/2012
(Division Sign-Uff)

Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K113159

A/P 1-5-12

8-1 of 1

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.