ThermoFlash™ is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contacting to human body. It can be used by consumers in household environment and doctor in clinic as reference.

Device Description

ThermoFlash™, including LX-26, LX-261, LX-260 and LX-260T, are handheld electronic thermometer that measures the body temperature based on the infrared sensor technology. All objects emit energy by radiation. The intensity of this energy depends on the temperature of the object. ThermoFlash™ is, therefore, able to measure the temperature of a person by the energy the person emits. Infrared sensor can sense the infrared emissions from the human body (forehead) and environment; then the electronic signal will be transferred by AD module to the digital signal and displayed on the LCD screen.

A LX-26 is a thermometer with basic temperature measurement functions.
A LX-260 is an advanced model to LX-26, which provides three additional keys which allow user to select the measurement directly;
ア LX-261 is an advanced model to LX-260, which provides a rechargeable station base and inner Li rechargeable battery which can be recharged;
LX-260T is an advanced model, which provides voice indicating of measured temperature.

AI/ML Overview

The provided text is for a 510(k) submission for an infrared thermometer, not an AI/ML powered device. As such, it does not include information typically associated with AI/ML device testing, such as:

Acceptance criteria directly related to AI/ML performance metrics (e.g., sensitivity, specificity, AUC for a diagnostic algorithm)
Study design for AI/ML performance evaluation
Sample sizes for test sets in an AI/ML context
Data provenance for AI/ML training/testing
Expert adjudication methods or qualifications
Multi-reader multi-case (MRMC) studies
Standalone algorithm performance
Detailed ground truth descriptions for AI/ML validation
Training set sample size or ground truth establishment for AI/ML

Therefore, I cannot directly answer your request based on the provided text using the categories you've specified for an AI/ML device.

However, I can extract the acceptance criteria and study information that is present in the document for this non-AI medical device:

Acceptance Criteria and Study for ThermoFlash™ Infrared Thermometer (K112929)

The device, ThermoFlash™ Infrared Thermometer (Models: LX-26, LX-261, LX-260, LX-260T), is intended for body surface and forehead temperature measurement for infants and adults without contacting the human body.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standards Met)	Reported Device Performance (Compliance)
IEC 60601-1 (General Safety)	Device complies with the standard
IEC 60601-1-2 (EMC Requirements)	Device complies with the standard
ASTM E1965-98 (R2009) (Infrared Thermometers for Intermittent Determination of Patient Temperature)	Device complies with the standard

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

Sample Size: Not explicitly stated in the provided text. The document mentions "Bench tests were conducted."
Data Provenance: Not explicitly stated. Bench tests generally imply controlled laboratory settings.

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

Not applicable/Not stated. This is a non-AI/ML device where performance is typically validated against established measurement standards and reference devices, not human expert interpretation of outputs.

4. Adjudication method for the test set:

Not applicable/Not stated. Performance is assessed by direct comparison to standard measurements, not expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This type of study is not relevant for this device.

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

Yes, effectively. The "Bench tests" would represent the standalone performance of the device against a reference standard without human interpretation influencing the measurement itself, beyond proper operation.

7. The type of ground truth used:

The ground truth would be established by reference standards and calibrated equipment as per the requirements of the listed ASTM and IEC standards for medical thermometers. This would involve comparing the device's readings against highly accurate and traceable temperature measurements.

8. The sample size for the training set:

Not applicable/Not stated. This device is not an AI/ML product developed through a training set.

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

Not applicable. This device is not an AI/ML product developed through a training set.

Summary of Study:

The primary study mentioned is non-clinical bench testing. These tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to its predicate device (Remote Infrared Thermometer, RC002, K090361). The documented results demonstrated compliance with:

IEC 60601-1 (General Requirements for Safety)
IEC 60601-1-2 (Electromagnetic Compatibility)
ASTM E1965-98 (R2009) (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature).

The key conclusion was that the differences between the proposed device and the predicate (additional features like voice indicator, rechargeable battery, and different power supply specifications) were determined "not to affect the performance and effectiveness." This conclusion supports the finding of Substantial Equivalence.

Summary

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Premarket Notification 510(k) Submission

K112929

Section III 510(k) Summary

OCT 1 8 2011

III-I

Section III 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: _

Date of Submission: July 26, 2011
Sponsor

Visiomed Group SA 21, avenue Victor Huge, 75116, Paris, France

Establishment Registration Number: Not yet registered

Contact Person: Mr. Eric Sebban Position: President TEL: +33 1 40 67 06 50 FAX: +33 1 44 17 93 10 Email: eric@visiomed-lab.com

3. Proposed Device Identification

Proposed Device Name: ThermoFlash™ Infrared Thermometer Proposed Device Model: LX-26, LX-261, LX-260 and LX-260T

Classification: Class II Product Code: FLL Regulation Number: 21 CFR 880.2910 Review Panel: General Hospital

Intended Use Statement:

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4. Predicate Device Identification

510(k) Number: K090361 Product Name: Remote Infrared Thermometer, RC002 Manufacturer: Rycom Electron Technology Limited

1. Device Description
  ThermoFlash™, including LX-26, LX-261, LX-260 and LX-260T, are handheld electronic thermometer that measures the body temperature based on the infrared sensor technology.

All objects emit energy by radiation. The intensity of this energy depends on the temperature of the object. ThermoFlash™ is, therefore, able to measure the temperature of a person by the energy the person emits. Infrared sensor can sense the infrared emissions from the human body (forehead) and environment; then the electronic signal will be transferred by AD module to the digital signal and displayed on the LCD screen.

A LX-26 is a thermometer with basic temperature measurement functions.
A LX-260 is an advanced model to LX-26, which provides three additional keys which allow user to select the measurement directly;
ア LX-261 is an advanced model to LX-260, which provides a rechargeable station base and inner Li rechargeable battery which can be recharged;
LX-260T is an advanced model, which provides voice indicating of measured temperature. A
1. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ア IEC 60601-1, Mcdical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General);
A IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests +Amendment 1: 2004;
ASTM E1965-98 (R2009): Standard Specification for Infrared Thermometers for Intermittent A Determination of Patient Temperature. (General Plastic Surgery/General Hospital).

III-2

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7. Substantially Equivalent Conclusion

Compared with the predicate device, ThermoFlash™ Infrared Thermometers have some additional features of voice indicator and rechargeable battery, and different specifications of power supply. Based the on the comparison and analysis in Section 7 Substantially Discussion, these differences were determined not to affect the performance and effectiveness.

The proposed device, ThermoFlash™ Infrared Thermometer, is determined to be Substantially Equivalent (SE) to the predicate device, Remote Infrared Thermometer, RC002, K090361 in respect of safety and effectiveness.

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. . .

III-3

Concern Comments

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OCT 1 8 2011

Visiomed Group SA C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607

Re: K112929

Trade/Device Name: ThermoFlash™ Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 21, 2011 Received: October 3, 2011

" Dear Mr. Mouser:

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 - Mr. Mouser

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony O. n

Unthony D. Watson, B.S., M.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

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Section II Indications for Use

510(k) Number:

Device Name: ThermoFlash™ Infrared Thermometer Models: LX-26, LX-261, LX-260 and LX-260T

Indications for Use:

[ ]PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

& OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

FDA CDRH DMC

OCT 3 2011

Received

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Rld C. Ch

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112929

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.