DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or consumers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided non-sterile. The device is for people of all ages.

Device Description

DT100 digital thermometer is a fast, highly accurate, and easy to use clinical instrument for measuring patient temperatures by oral, axillary or rectal means. The digital thermometer is a hand-held, reusable, multi-user, battery operated device. It has one model DT100.

AI/ML Overview

The provided text is an FDA 510(k) summary for a digital thermometer (DT100). It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results for novel AI-powered diagnostic devices. Therefore, a direct answer to the request regarding AI acceptance criteria, specific test set details, expert ground truth, MRMC studies, or standalone algorithm performance, as typically seen in AI/ML device submissions, cannot be fully provided from this document.

However, I can extract the relevant information from the document that pertains to the device's performance and the non-clinical testing performed to demonstrate its safety and effectiveness.

Here's a breakdown of the information that can and cannot be extracted:

Information that can be extracted related to acceptance criteria and performance:

Acceptance Criteria (Accuracy) and Reported Device Performance: This is explicitly stated in the substantial equivalence table.
Non-Clinical Performance Data: The document lists the standards the device was tested against (Biocompatibility, Electrical Safety/EMC, Performance Testing, Software V&V). While it doesn't give specific results for each test (e.g., exact current leakage values), it states the device was evaluated according to these standards, implying it met their requirements.
Ground Truth Type for Non-Clinical Testing: For performance, it relies on established standards (e.g., ASTM E1112 for accuracy).

Information that cannot be extracted (as it's beyond the scope of this 510(k) for a conventional thermometer):

Sample sizes for a test set (as no clinical test set in the AI/ML sense was used for performance evaluation).
Data provenance (not applicable for a simple thermometer's non-clinical testing).
Number of experts, qualifications, or adjudication methods (not applicable as no expert-review based ground truth was established for "cases").
MRMC comparative effectiveness study (not applicable).
Standalone algorithm performance (not applicable, as it's a hardware device, not an algorithm).
Sample size for training set (not applicable, as it's not an AI/ML device).
How ground truth for training set was established (not applicable).

Based on the provided document for the DT100 Digital Thermometer:

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

Acceptance Criteria	Reported Device Performance (DT100 Digital Thermometer)
Accuracy	32°C (89.6°F) - 42.9°C (109.2°F): +/- 0.1 °C (+/- 0.2°F)

Notes on Acceptance Criteria and Performance:
The document states that the DT100 Digital Thermometer's accuracy is the same as the predicate device (Fudakang Digital thermometer; Model: BTA41-CN). The non-clinical testing performed (against standards like ASTM E1112) would have implicitly confirmed that the device met this accuracy requirement.

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

Sample Size for Test Set: Not applicable. For this type of conventional electronic thermometer, performance is demonstrated through non-clinical laboratory testing against recognized standards (e.g., ASTM E1112), not a "test set" in the context of an AI/ML algorithm requiring patient data.
Data Provenance: Not applicable. The testing is laboratory-based and performed to international and national standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for a digital thermometer's accuracy is established by highly accurate reference temperature measurements in a controlled laboratory environment, not by expert consensus on clinical cases.

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

Not applicable. This is a standalone digital thermometer, not an AI-assisted diagnostic tool.

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

Yes, in a sense. The device's performance (accuracy, electrical safety, biocompatibility, etc.) was evaluated as a standalone product through non-clinical laboratory testing according to relevant standards. The "algorithm" here essentially refers to the device's internal temperature measurement and display mechanism, which operates without human intervention beyond taking the measurement.

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

For performance (accuracy): The ground truth is established by highly precise and calibrated reference thermometers and temperature baths/devices, as per the requirements of standards like ASTM E1112. This is an objective, physical measurement standard rather than a subjective human interpretation.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. See point 8.

Summary

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September 26, 2021

Smart Technology Co., Ltd. % Yulan Gao Overseas Registration Assistant Specialist Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China

Re: K203731

Trade/Device Name: DT100 Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 20, 2021 Received: August 24, 2021

Dear Yulan Gao:

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203731

Device Name DT100 Digital Thermometer

Indications for Use (Describe)

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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K203731 - 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

SUBMITTER INFORMATION l.

Smart Technology Co., Ltd.

No. 8 Xingcheng East Road, Fuwan Industrial Area, Gaoming District, Foshan,

Guangdong Province, China

Phone: +86-0757-88818786

Primary Contact Person:	Mag Mei
	General manager
	Smart Technology Co., Ltd.
	Tel: +86-0757-88818786
Consultant:	Olivia Meng
	Regulatory Affairs Manager
	OSMUNDA Medical Device Consulting Co., Ltd.
	Tel: (+86)-20-6231 6262
	Fax: (+86) -20-8633 0253

Date Prepared:

September 24, 2021

II. SUBJECT DEVICE

Name of Device:	DT100 Digital Thermometer
Model:	DT100
Common/Usual Name:	Clinical electronic thermometer
Classification Names:	Thermometer, Electronic, Clinical
Regulation Number:	21 CFR 880.2910
Device Class:	II
Product Code:	FLL

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lll. PREDICATE DEVICE

Sponsor: Fudakang Industrial Co., Ltd Device Name: Fudakang Digital thermometer; Model: BTA41-CN 510(k) Number: K101387

IV. DEVICE DESCRIPTION

V. INDICATION FOR USE

DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or customers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided non-sterile. The device is for people of all ages.

VI.

VII. SUBSTANTIAL EQUIVELENCE

Specification	Proposed Device	Predicate Device	DiscussionofDifferences
Device name	DT100 Digital Thermometer	Fudakang Digital thermometer(BTA41-CN)
K number	K203731	K101387

Indications for Use	DT100 Digital thermometer isintended for the measurement ofhuman body temperature bydoctor or customers in thehospital or home. It can be usedfor axillary, oral and rectalmeasurement. The product isreusable and provided non-sterile. The device is for people ofall ages.	Fudakang Digital thermometerare intended for themeasurement and monitoring ofhuman body temperature bydoctor or consumers in thehospital or home.	Similar
Measurement site	axillary, oral and rectalmeasurement.	axillary, oral and rectalmeasurement.	Same
Use of probe cover	Measure oral or rectal position:Use probe coverMeasure axillary position: norequire of probe cover	Measure oral or rectal position: noUse probe coverMeasure axillary position: norequire of probe cover	Same
TemperatureMeasurementTechnology	NTC thermistor resistancetechnology	NTC thermistor resistancetechnology	Same
Power source	1.55V, LR41 alkaline or SR41 silveroxide type	1.5V button battery	Similar
composition	Main part, display screen, controlbutton, probe tip	Main part, display screen, controlbutton, probe tip	Same
Display resolution	0.1	0.1	Same
Material	Enclosure: Acrylonitrile ButadieneStyreneprobe: stainless steelbutton: silicone	Enclosure and button:Acrylonitrile Butadiene Styreneprobe: stainless steel	Same
Measurement Range	32°C (89.6°F)- 42.9°C(109.2°F)	32°C (89.6°F)- 42.9°C(109.2°F)	Same
Accuracy	32°C (89.6°F)-42.9°C(109.2°F) : +/-0.1 °C (+/-0.2°F)	35°C (95.0°F)- 39.0°C (102.0°F):+/-0.1 °C (+/-0.2°F)	Same
Response time	60 seconds	60 seconds	Same
Lowbatteryindicator	Yes	Yes	Same
Memory function	Yes	Yes	Same
Memory capacity	Last one measurement record	Last one measurement record	Same
Reusable device	Yes	Yes	Same
TemperatureMeasurementTechnology	NTC thermistor resistancetechnology	NTC thermistor resistancetechnology	Same
Keytemperaturesensor	NTC thermistor	NTC thermistor	Same
Power requirement	LR41 button cell	LR41 button cell	Same
Scale	Switchable	Switchable	Same
Biocompatibility	Comply with ISO 10993-1ISO10993-5 ISO10993-10	Comply with ISO 10993-1ISO10993-5 ISO10993-10	Same
Voluntary Standardsfor clinical ElectronicThermometer	ASTM E1112	ASTM E1112	Same
Medical ElectricalSafety and EMC	IEC 60601-1IEC60601-1-2	IEC 60601-1IEC60601-1-2	Same
Operatingandstorage condition	Operation: 16 to 40° C(60.8 to104° F) and 15 to 95% humiditynoncondensing;Storage: -20 to 50° C (-4 to 120°F) and 15 to 95% humiditynoncondensing	Operation: 16 to 40° C(60.8 to104° F) and 15 to 95% humiditynoncondensing;Storage: -20 to 50° C (-4 to120° F) and 15 to 95% humiditynoncondensing	Same

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Substantial equivalence conclusion:

Technical parameters are the same/similar between the proposed and predicate device. We believe that the Digital thermometer is as safe and effective, and performs in a substantially equivalent manner to the predicate device.

VIII. NON-CLINICAL PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence:

Biocompatibility:

The thermometer has been evaluated according to ISO 10993-5 and ISO 10993-10, and has been demonstrated as biocompatible safety.

Electrical Safety and EMC:

The device was tested in accordance with:

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। IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.

IEC 60601-1-2 Medical Electrical Equipment -- Part 1-2: General Requirements for Basic Safety and Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements and Tests
IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Performance Testing:

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.
ASTM E1112 Standard specification for electronic thermometer for intermittent determination of patient temperature

Software Verification and Validation:

Per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", Smart Technology has provided appropriate software documentation based on Level of Concern. A system levelsoftware verification and validation protocol were developed to test each requirement. Results of each test are recorded and compared to the pass/fail criteria. All software verification and validation activities show that the software meets product requirements documentation.

IX. CLINICAL TESTING DATA

No clinical testing data is included in this submission.

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CONCLUSION x.

The DT100 digital thermometer is substantially equivalent to the Fudakang Digital thermometer with respect to the technological characteristics, Indications for use, non-clinical and performance testing.

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.