This device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral, armpit and rectal in the neonatal pediatric and audit population used in the clinical and home testing.

Device Description

The device Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001 which is based on the 510(k) 042202 model DT-312 is designed to measure the human body temperature in the mouth or rectum. This device is used under the condition(s) or disease(s) to be screened, monitored, treated, or diagnosed: Fever, Hypothermia. The device is intended use at the following conditions: Age: newborn to geriatric, Weight: > 2.5 kg. The device operating conditions is between 10°C to 40°C (50°F to 104°F). The Fundamental Scientific technology of the modified device remains the same as that of the 510(k) cleared device.

AI/ML Overview

The provided text describes a 510(k) summary for a clinical electronic thermometer and does not include information about AI/ML device performance, acceptance criteria, or studies to prove acceptance criteria for such a device. This document is for a traditional medical device, not an AI/ML powered one.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

Cannot be fully provided. The document states compliance with ASTM E1112-00 for performance specifications but does not detail specific acceptance criteria values or reported performance metrics against those criteria. It only states the device complies with the standard.

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

Cannot be provided. The document does not mention a specific test set sample size or data provenance for any studies. It refers to "bench testing" but provides no details.

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)

Cannot be provided. This is not relevant for a clinical electronic thermometer as there is no "ground truth" established by experts in the context of AI/ML.

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

Cannot be provided. Not applicable 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

Cannot be provided. This is not applicable to a non-AI clinical electronic thermometer.

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

Cannot be provided. Not applicable to a non-AI clinical electronic thermometer.

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

Cannot be provided. Not applicable for this type of device in the context of AI/ML. For a thermometer, "ground truth" would relate to a highly accurate reference thermometer, but the document does not detail this.

8. The sample size for the training set

Cannot be provided. This is not relevant for a clinical electronic thermometer as there is no "training set" in the context of AI/ML.

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

Cannot be provided. Not relevant for this type of device.

Summary based on the provided text for a non-AI device:

The Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001 is a clinical electronic thermometer designed to measure human body temperature orally, rectally, and in the armpit.

Acceptance Criteria and Device Performance:

Acceptance Criteria Category	Specific Criteria (as implied/referenced)	Reported Device Performance
Performance Standard	Compliance with ASTM E1112-00	Device demonstrated compliance.
Safety Standard	Compliance with IEC60601-1	Device demonstrated compliance.
EMC Standard	Compliance with IEC60601-1-2	Device demonstrated compliance.
Intended Use	Measuring body temperature in various sites (oral, armpit, rectal) for neonatal, pediatric, and adult populations in clinical and home settings.	Device is intended for this use and is substantially equivalent to predicate device.
Operating Conditions	Operating temperature between 10°C to 40°C (50°F to 104°F)	Not explicitly reported as meeting this, but implied by substantial equivalence

Study Details:

Study Type: Non-clinical tests were performed to demonstrate substantial equivalence to a predicate device (TEMPTELLER, Model DT-312, K042202). These tests included "bench testing."
Sample Size: Not specified for any testing.
Data Provenance: Not specified for any testing.
Ground Truth/Expert Involvement/Adjudication/MRMC/Standalone: These concepts are not applicable to the type of device and testing described in the document. The device's performance is gauged against recognized industry standards (ASTM E1112-00, IEC60601-1, IEC60601-1-2) rather than through AI/ML performance metrics against expert-labeled ground truth datasets.
Training Set: Not applicable.

Summary

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K101232

JUL 2-1 2010

EXHIBIT #1

510(k) Summarv

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

Date prepared: April 29, 2010.

1. Applicant: Joinsoon Electronics MFG. Co., Ltd. 19F., No. 79, Sec. 1. Sintai 5th Rd., Sijhih City, Taipei County 221, Taiwan, R.O.C. Phone: +886-2-2698-4882 Fax: +886-2-2698-4883

2. Submitter:

Mr. Jigar Shah Official Correspondent for Joinsoon Electronics MFG. Co., Ltd. mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: 516-482-9001 Fax: 516-482-0186 Jigar@mdiconsultants.com

3. Trade/proprietary Name:

Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001

4. Classification name:

Common Name: Clinical Electronic Thermometer Requiation: 21 CFR Part 880.2910

1. Product Code: FLL
1. Predicate Devices:

TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302. DT-312, DT-412, DT-502 Previously cleared 510(k) number: K042202

7. Device Description

Fever -

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i Hypothermia
The device is intended use at the following conditions:
Age: newborn to geriatric -
Weight: > 2.5 kg

The device operating conditions is between 10°C to 40°C (50°F to 104°F).

The Fundamental Scientific technology of the modified device remains the same as that of the 510(k) cleared device.

8. Intended Use:

9. Substantial Equivalence Discussion:

The Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001 is substantially equivalent to the original 510(K) 042202, Model DT-312 in all aspects, e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc.,

The only differences in the predicate version of the Digital thermometer are PCB layout involving Performance Specifications and Housing for Ergonomics of the Patient-UI.

The Fundamental Scientific technology of the modified device remains the same as that of the 510(k) cleared device.

10. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ASTM E1112-00, as well as IEC60601-1 and IEC60601-1-2 requirements.

Guidance documents included the "FDA Guidance on the content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers".

11. Conclusion:

The Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001 has the same intended use and similar technological characteristics as the Predicate device. Moreover, bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus the Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001, is substantially equivalent to the predicate device.

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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

Joinsoon Electronics Manufacturing Company, Limited C/O Mr. Jigar Shah MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

JUL 2-1 2010

Re: K101232

Trade/Device Name: Joinsoon Electronics Manufacturing Company, Limited High Speed Digital Thermometer. Models TC-001 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 24, 2010 Received: June 25, 2010

Dear Mr. Shah:

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.Shah

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/ucml15809.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/ReportalProblem/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.

Rh for

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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Exhibit 3

Indications for Use

Page 1 of of 1

510(k) Number (if known):

Device Name: Joinsoon Electronics Mfg. Co., Ltd. High Speed Digital Thermometer. Models TC-001

Indications For Use:

Prescription Use (Per 21 CFR 801 Subpart D)

X Over-The Counter Use (21 CFR 807 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)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K101232 510(k) Number:

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.