The Baby Pacifier Digital Thermometer is a non-sterile, reusable thermometers. They are intended for the measurement of oral body temperatures of infants and young children.

Device Description

The Baby Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.

AI/ML Overview

The provided text describes a 510(k) submission for a Baby Pacifier Digital Thermometer. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.

The document states that:

"In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature"."
"The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers."

This indicates that the device's performance is expected to meet the specifications outlined in ASTM E1112 for electronic thermometers and relevant safety standards for pacifiers. However, the specific acceptance criteria and the results of a study demonstrating adherence to these criteria are not explicitly detailed in the provided text.

Therefore, I cannot populate the requested table and provide information about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for a specific study from the provided text.

To answer your request, here's what could be inferred from the provided information, but it's important to note the significant limitations due to the lack of a detailed study report:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from ASTM E1112)	Reported Device Performance (Inferred to be compliant with ASTM E1112)
Accuracy (e.g., within ±0.1°C or ±0.2°F)	The device conforms to ASTM E1112, which specifies accuracy requirements for electronic thermometers for intermittent determination of patient temperature.
Response Time	The device conforms to ASTM E1112, which specifies response time requirements.
Repeatability	The device conforms to ASTM E1112, which specifies repeatability requirements.
Readout Resolution	The device conforms to ASTM E1112, which specifies readout resolution requirements.
Environmental Conditions (e.g., temperature, humidity)	The device conforms to ASTM E1112, which specifies performance under various environmental conditions.
Safety Standards for Baby Pacifiers	The device meets Safety Standards for Baby Pacifiers.

Note: The specific numerical values for accuracy, response time, etc., from ASTM E1112 are not listed in the provided document, nor are the direct results of testing the Baby Pacifier Digital Thermometer against these standards. The statement "thermomenter conforms to ASTM E1112" is a general claim of compliance.

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

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text. It's implied that testing was done to ensure compliance with ASTM E1112 and safety standards, likely by the manufacturer, K-Jump Health Co., Ltd., which is based in Taiwan. Whether this involved a specific "test set" of patients or a standardized laboratory testing protocol is not detailed.

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

Not applicable/Not specified. The assessment against ASTM E1112 typically involves metrological calibration and performance testing rather than expert-established ground truth in a clinical setting in the way an AI diagnostic device would.

4. Adjudication method for the test set

Not applicable/Not specified.

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

No. This type of study is not relevant for a simple digital thermometer.

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

Yes, implicitly. The thermometer's performance is standalone in that it directly measures and displays temperature. Its accuracy is evaluated as a standalone device against metrological standards, not as an algorithm's output requiring human interpretation.

7. The type of ground truth used

Metrological Standards: The ground truth for temperature measurement would be established by calibrated reference thermometers or other metrological standards as part of the testing to conform to ASTM E1112.
Safety Standards: Compliance with baby pacifier safety standards would involve physical and material testing against those specific standards.

8. The sample size for the training set

Not applicable/Not specified. This device does not use a "training set" in the context of machine learning or AI. Its operation is based on established thermodynamic principles and electronic sensor technology, not data-driven training.

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

Not applicable. The device does not have a "training set."

In summary, the provided document is a 510(k) summary for a digital thermometer, which mainly states compliance with existing industry standards (ASTM E1112 and Baby Pacifier Safety Standards) rather than presenting a detailed clinical study with specific acceptance criteria and performance data as would be typically found for more complex medical devices or AI-based solutions.

Summary

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JUL 2 1998

リ

K981456

510(k) Baby Pacifier Digital Thermometer K-Jump Health Co., Ltd.

Page 65

510(k) Summary

Proprietary Name:	Baby Pacifier Digital Thermometer
Common Name:	Pacifier Digital Thermometer
Classification:	Unknown
Submitter Details:	Polygreen Company, Ltd.a subsidiary of K-Jump Health Co., Ltd.136 Wu Kung Road, Wu Ku Industrial ParkTaipei, HsienTaiwan, R.O.C.Tele.: 011-886-2-2991378-82Fax: 001-886-2-2991386Contact: Mr. Tseng Chao Man (Daniel)

The Baby Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.

In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.

The Baby Pacifier Digital Thermometer is substantially equivalent to PolyMedica Corporation's Basis® Baby-Temp Digital Thermometer.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1098 JUL

K-Jump Health Company, Limited C/O Mr. Tseng Chao Man (Daniel) President PolyMedica Healthcare, Incorporated 581 Conference Place Golden, Colorado 80401

Re : K981456 Baby Pacifier Digital Thermometer Trade Name: Regulatory Class: II Product Code: Firit Dated: April 23, 1998 April 23, 1998 Received:

Dear Mr. Tseng Chao Man:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Tseng Chao Man

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamaip.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .......

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510(k) Baby Pacifier Digital Thermometer K-Jump Health Co., Ltd.

PRE-MARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510(k) Number:

Unassianed K-Jump Health Co., Ltd.

Baby Pacifier Digital Thermometer Device Name:

Indications for Use:

The Baby Pacifier Digital Thermometer is a non-sterile, They are intended for the reusable thermometers. measurement of oral body temperatures of infants and young children.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Patricio Cuesite

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

510(k) Number K9814576

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.