COCET Digital Thermometer measures body temperature. This digital thermometer is used in the armpit (axillary) to take temperature measuring results. The device is for adult use.

Device Description

COCET Digital Thermometer (Models: KFT-01/KFT-02/KFT-03/KFT-04/ KFT-05/KFT-06/ KFT-07/KFT-08/ KFT-09/KFT-10) is a hand-held electronic thermometer, it comprised of an electronic thermo resistor (thermistor) sensor connected to printed circuit board(PCB) with liquid crystal display(LCD) user readout. The outer material of thermometer is made of ABS and the measuring tip is stainless steel. The thermometer using a temperature sensor to output an electrical signal, and then converting the current signal into a liquid crystal digital display temperature. The thermometers are powered by LR41 battery. The battery can be replaced.

AI/ML Overview

The provided text describes the 510(k) summary for the COCET Digital Thermometer. It outlines a comparison to a predicate device and details non-clinical tests performed. However, it does not contain the specific information required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop study.

The document is for a digital thermometer, which is a fairly straightforward medical device. The "study" described is primarily bench testing to demonstrate performance according to recognized standards, rather than a clinical trial involving a large number of human subjects and complex ground truth establishment as would be seen for an AI diagnostic device.

Here's what can be extracted and what is missing based on the provided text:

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

Acceptance Criteria (from text, implied by standards adherence)	Reported Device Performance (from text)
Accuracy: +/- 0.1 °C (±0.2°F) from 35.5 °C to 42 °C (95.9°F-107.6°F)	+/- 0.1 °C (±0.2°F) from 35.5 °C to 42 °C (95.9°F-107.6°F)
Accuracy: +/- 0.2 °C (± 0.4 °F) in the rest measuring range	+/- 0.2 °C (± 0.4 °F) in the rest measuring range
Biocompatibility: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10	Device passed cytotoxicity, skin irritation, and sensitization testing.
Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2	Performed in accordance with IEC 60601-1:2005 and IEC 60601-1-2:2014.
Clinical Electronic Thermometer Standards: Compliance with specific standards	Complies with ISO 80601-2-56:2017.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for specific tests. The tests performed are primarily bench testing (e.g., testing multiple physical units of the thermometer for accuracy, biocompatibility, and electrical safety). It's typically a small number of physical samples (e.g., n=3 or n=5) from a production lot for regulatory testing, not a "data set" in the AI sense.
Data Provenance: Not applicable in the sense of patient data. The tests are laboratory bench tests.
Retrospective or Prospective: Not applicable as it's not a clinical study on patients. These were tests conducted on the physical device itself.

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

Not Applicable. For a digital thermometer, "ground truth" for temperature is established using calibrated reference thermometers and controlled environments (e.g., water baths). There are no human experts "adjudicating" temperature readings in the way a diagnostic image might be.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

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

No. This device is a standalone digital thermometer, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant or performed for this type of device.

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

Yes, in essence. The performance data presented (accuracy, biocompatibility, safety) are inherent properties of the device itself, functioning independently of human interpretation in a diagnostic context. However, it's not an "algorithm" in the typical software sense, but the physical device's performance.

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

The ground truth for temperature accuracy is established against calibrated reference standards, typically highly accurate laboratory thermometers traceable to national/international standards.
For biocompatibility, the ground truth is the absence of adverse biological reactions in established in-vitro and in-vivo tests according to ISO standards.
For safety and EMC, the ground truth is compliance with the specified electrical and electromagnetic compatibility limits/requirements defined in the IEC standards.

8. The sample size for the training set

Not Applicable. This is a physical digital thermometer, not an AI model that requires a "training set."

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

Not Applicable. See point 8.

In summary: The provided document is for a general medical device (digital thermometer) and describes its compliance with established performance, safety, and biocompatibility standards through bench testing. It does not describe an AI/ML-driven device or a clinical study that would involve expert readers, complex ground truth establishment, or MRMC studies. The "study" proving acceptance criteria is a series of non-clinical, laboratory-based tests comparing the device's performance to recognized international standards and its predicate device.

Summary

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November 20, 2018

Kangfu Medical Equipment Factory Mr. Zelong Cao Quality Manager No. 380 Ningkang East Road Yueqing City, Zhejiang 325600 CHINA

Re: K182652

Trade/Device Name: COCET Digital Thermometer (Models: KFT-01/KFT-02/KFT-04/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 24, 2018 Received: September 24, 2018

Dear Mr. Zelong Cao:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, >Tina Kiang - S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182652

Device Name

COCET Digital Thermometer (Models: KFT-01/KFT-02/KFT-03/KFT-07/KFT-07/KFT-07/KFT-08/KFT-09/KFT-09/KFT-10)

Indications for Use (Describe)

COCET Digital Thermometer measures body temperature. This digital thermometer is used in the armpit (axillary) to take temperature measuring results. The device is for adult use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

[Refer to 21 CFR §807.92]

K182652

1.	Submitted by:	Kangfu Medical Equipment FactoryNo.380 Ningkang East Road, Yueqing City 325600 Zhejiang ProvinceChinaPhone: 086-577-55775583E-mail: zelong_858@126.comContact Person: Zelong CaoDate Prepared: November 16, 2018
2.	Trade Name:	COCET Digital Thermometer (Models: KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/ KFT-07/ KFT-08/ KFT-09/KFT-10 )Common Name: Clinical electronic thermometerRegulation Number: 21 CFR 880.2910Regulation Name: Clinical electronic thermometerClassification: Class IIProduct Code: FLL
3.	Predicate Device:	K120004, DIGITAL THERMOMETER (Models: YT301/ YT302/ YT303)Manufacturer: CHINA (Shenyang) Med-land Imp/Exp Corp., Ltd.
4.	Device Description:	COCET Digital Thermometer (Models: KFT-01/KFT-02/KFT-03/KFT-04/ KFT-05/KFT-06/ KFT-07/KFT-08/ KFT-09/KFT-10) is a hand-heldelectronic thermometer, it comprised of an electronic thermo resistor(thermistor) sensor connected to printed circuit board(PCB) with liquidcrystal display(LCD) user readout. The outer material of thermometer ismade of ABS and the measuring tip is stainless steel. The thermometerusing a temperature sensor to output an electrical signal, and thenconverting the current signal into a liquid crystal digital displaytemperature. The thermometers are powered by LR41 battery. Thebattery can be replaced.
5.	Indications for Use:	COCET Digital Thermometer measures body temperature. This digitalthermometer is used in the armpit (axillary) to take temperaturemeasuring results. The device is for adult use.

Predicate Device Comparison 6.

Table 1 Predicate Product Comparisons - COCET Digital Thermometer Models: KFT-01/ KFT-02/ KFT-03/ KFT-04/ KFT-05/ KFT-06/ KFT-07/ KFT-08/ KFT-09/ KFT-10

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Feature	Kangfu Medical EquipmentFactory Models: KFT-01/ KFT-02/ KFT-03/ KFT-04/ KFT-05/KFT-06/ KFT-07/ KFT-08/ KFT-09/ KFT-10	CHINA (Shenyang) Med-land Imp/Exp Corp.,LtdYT301/ YT302/ YT303	Discussion
510(k) Number	K182652	K120004	Different
Indications for Use	COCET Digital Thermometermeasures body temperature.This digital thermometer isused in the armpit (axillary) totake temperature measuringresults. The device is for adultuse.	The Digital Thermometer isused for the measurementand monitoring of humanbody temperature. Bodytemperature can bemeasured with the DigitalThermometer by oral,axillary (under the arm) andrectal methods. The deviceis for adult and pediatricuse.	Different
thermometer type	under arm	oral, axillary (under thearm) and rectal.	Different
components	Electronic thermoresistor(thermistor) sensorPrinted circuit board(PCB)Liquid crystal display(LCD)OuterTip	Electronic thermoresistor(thermistor) sensorPrinted circuit board(PCB)Liquid crystal display(LCD)OuterTip	Same
principal of operation	Using a temperature sensor tooutput an electrical signal, andthen converting the currentsignal into a liquid crystaldigital display temperature	Using a temperature sensorto output an electricalsignal, and then convertingthe current signal into aliquid crystal digital displaytemperature	Same
Temperature MeasurementTechnology	NTC Thermistor ResistanceTechnique	NTC Thermistor ResistanceTechnique	Same
Key TemperatureSensor	NTC Thermistor	NTC Thermistor	Same
Power requirements	1xLR41 batteryStandard voltage 1.5V,termination voltage 0.9V.Discharge with 1K dischargeresistor, sustainable dischargefor 670 hours. Working	1xLR41 battery	Same
capacity 28mAh, weight 0.61g.Load resistance 22K
Materials	ABS plastic cabinet (White and blue), Stainless steel	ABS plastic cabinet (White), Stainless steel	Different
Temperature range	32.0 °C ~ 42.9 °C (90°F-109.2 °F)	32.0 °C ~ 42.9 °C (90°F - 109.2 °F)	Same
Accuracy	+/- 0.1 °C(±0.2°F) from 35.5 °C to 42 °C(95.9°F-107.6°F)+/- 0.2 °C(± 0.4 °F) in the rest measuring range	+/- 0.1 °C( ± 0.2 °F) from 35.5 °C to 42 °C(95.9°F-107.6 °F)+/- 0.2 °C(±0.4°F) in the rest measuring range	Same
Biocompatibility	Comply with ISO 10993-1ISO10993-5ISO 10993-10	Comply with ISO 10993-1ISO10993-5ISO 10993-10	Same
Voluntary standards for Clinical Electronic Thermometers	Comply with ISO 80601-2-56	Comply with ASTME1112-00	Different
Medical Electrical Safety and EMC	IEC 60601-1, IEC 60601-1-2	IEC 60601-1, IEC 60601-1-2	Same

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Discussion:

Indications for Use is different from the description of the contrasting devices are measuring human body temperature, the predicate device is used orally, axillary (under the arm) and rectal for adult and pediatric, our COCET Digital Thermometer is only used under arm for adult, the difference does not raise performance questions.
Thermometer type: Our product COCET Digital Thermometer is only used in the armpit, the predicated device can be used orally , axillary (under the arm) and rectal, the difference does not raise performance questions.
Materials: The ABS plastic cabinet of predicate device only has white color, COCET Digital Thermometer has two color white and blue. However, it is conformed with ISO 10993 series standard. It can be proved in the biocompatibility testing report. The difference does not raise performance questions.
Voluntary standards for Clinical Electronic Thermometers: Electronic Thermometer comply with ASTME1112-00 and COCET Digital Thermometer comply with The ISO 80601-2-56, the two standards were meets FDA guidelines. The difference does not raise performance questions.

Name	Model	principal of operation	Dimension	Materials
COCET DIGITALTHERMOMETER	KFT-01	This digital thermometer is used inthe armpit (axillary) and using atemperature sensor to output anelectrical signal, and then convertingthe current signal into a liquid crystaldigital display temperature	124.5mm ×18mm×9mm	ABS plasticcabinet(Whitecode:WH),Stainlesssteel
COCET DIGITALTHERMOME	KFT-02	same	120mm ×16mm ×9.5mm	ABS plasticcabinet(Whitecode:WHBluecode:BU),Stainlesssteel
COCET DIGITALTHERMOME	KFT-03	same	127mm×19mm ×11.5mm	ABS plasticcabinet(Whitecode:WHBluecode:BU),Stainlesssteel
COCET DIGITALTHERMOME	KFT-04	same	127.5mm ×19mm ×11.5mm	ABS plasticcabinet(Whitecode:WHBluecode:BU),Stainlesssteel
COCET DIGITALTHERMOME	KFT-05	same	133mm ×27.5mm ×10mm	ABS plasticcabinet(Whitecode:WHBluecode:BU),Stainlesssteel
COCET DIGITALTHERMOME	KFT-06	same	132mm ×20mm ×7.5mm	ABS plasticcabinet(Whitecode:WHBluecode:BU),

COCET DIGITALTHERMOME	KFT-07	same	127mm×19mm ×11.5mm	StainlesssteelABS plasticcabinet(Whitecode:WHBluecode:BU)
COCET DIGITALTHERMOME	KFT-08	same	127.5mm ×19mm ×11.5mm	ABS plasticcabinet(Whitecode:WHBluecode:BU),Stainlesssteel
COCET DIGITALTHERMOME	KFT-09	same	127mm ×19mm ×11.5mm	ABS plasticcabinet(Whitecode:WHBluecode:BU),Stainlesssteel
COCET DIGITALTHERMOME	KFT-10	same	127.5mm ×19mm ×11.5mm	ABS plasticcabinet(Whitecode:WHBluecode:BU),Stainlesssteel

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7. Non-clinical Tests

Safety and EMC:

Safety and EMC test was performed in according to the

IEC 60601-1:2005+CORR.1:2006+CORR.2.2007+a1:2012 . Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 :2014 -

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential

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performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests Biocompatibility:

Biocompatibility testing was performed to evaluate the biocompatibility of the contact materials in accordance with ISO 10993-1:2009, the device passed each biocompatibility test identified below:

। Cytotoxicity testing in according to ISO 10993-5:2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
Skin irritation testing in according to ISO 10993-10:2010 Biological evaluation of medical devices--Part 5: Tests for in vitro cytotoxicity
Sensitization testing in according to ISO 10993-10:2010 Biological evaluation of medical devices- । Part 5: Tests for in vitro cytotoxicity

Performance Data:

The following bench testing was conducted in order to support substantial equivalence:

। ISO 80601-2-56:2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.

8. Conclusion

Based on performance testing and compliance with voluntary standards demonstrate that the proposed device is substantially equivalent to the predicate device.

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.