The M5T is non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.

Device Description

The M5T is a compact predictive clinical thermometer designed to measure human body temperature by detecting heat from three different body sites: axilla, rectum and mouth, by using the heat conduction principle and prediction.

The M5T is designed to calculate the maximum temperature of a probe in contact with the body site. The temperature reading range is from 35.0℃ to 42.0℃ (95.5°F to 107.6°F) and the time of measurement varies between 8 to 10 seconds.

The LCD, push button, battery, microprocessor and the PCB are located in one housing, which includes upper cover, lower cover and the battery cover. The entire device is compact, lightweight, small in size, easy to use and portable,

AI/ML Overview

Here's an analysis of the provided text regarding the M5T Instant Fever Thermometer, focusing on acceptance criteria and study details:

The provided document is a 510(k) summary, which largely focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a comprehensive study report with specific performance metrics and statistical analyses. Therefore, much of the requested information regarding detailed acceptance criteria, specific performance numbers, multi-reader studies, and training set details is not present in this document.

Acceptance Criteria and Reported Device Performance

The document states: "A clinical study was performed in order to evaluate the safety and performance of the M5T following the heater removal. The study results demonstrated that the M5T is safe and effective without raising new safety and/or effectiveness issues."

This is a very high-level statement and does not provide specific quantitative acceptance criteria or detailed performance metrics. The implicit acceptance criterion is that the device is "safe and effective" and comparable to the predicate device. Without further details, we cannot create a table with specific numerical acceptance criteria and reported performance values.

However, based on the general context of clinical thermometers, typical acceptance criteria would involve accuracy (e.g., within a certain deviation from a reference standard) and precision. The document doesn't provide these specific values for the M5T or its predicate.

Study Details

Given the limited information in a 510(k) summary, much of the requested detail is not available.

Category	Information from Document
1. Acceptance Criteria & Performance	Acceptance Criteria: Implicitly, "safe and effective without raising new safety and/or effectiveness issues" when compared to the predicate device (Up-Grade and Up-Grade Pro Thermometer). Reported Performance: "The study results demonstrated that the M5T is safe and effective without raising new safety and/or effectiveness issues." (No specific quantitative performance metrics provided).
2. Sample size (test set) & Data Provenance	Sample Size: Not specified.
	Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). A "clinical study was performed," suggesting prospective data, but "where" is not mentioned.
3. Number of Experts & Qualifications (Ground Truth)	Not specified.
4. Adjudication Method (Test Set)	Not specified.
5. MRMC Comparative Effectiveness Study	No. This is a medical device (thermometer) and not an AI or imaging diagnostic device where MRMC studies are typically performed. The study likely focused on direct measurement accuracy and safety.
6. Standalone Performance Study	Yes (implicitly). The "clinical study" evaluated the M5T's performance as a standalone device. There is no mention of a human-in-the-loop component.
7. Type of Ground Truth	Not explicitly stated, but for a clinical thermometer, the ground truth would typically be established using a highly accurate reference thermometer (e.g., a calibrated mercury thermometer or a high-precision electronic standard) for temperature measurement.
8. Sample Size (Training Set)	Not applicable/not specified. The M5T is a hardware device with a simple predictive algorithm, not a machine learning model that would require a "training set" in the conventional sense. The "prediction" aspect likely refers to a pre-defined algorithm rather than a learned model.
9. How Ground Truth for Training Set was Established	Not applicable/not specified (refer to point 8).

Additional Notes:

Device Type: The M5T is an electronic clinical thermometer. The "prediction" mentioned ("using the heat conduction principle and prediction") likely refers to an internal algorithm that extrapolates the final stable temperature from a short measurement period, rather than a complex AI model requiring extensive training with labeled data.
510(k) Context: This document is a 510(k) premarket notification. Its primary goal is to show "substantial equivalence" to a currently marketed device, not to provide an exhaustive clinical trial report with all statistical details and raw data. The level of detail often found in publications for novel AI algorithms is typically not present in these regulatory submissions for established device types.
Missing Information: The lack of specific numerical data for clinical performance (e.g., accuracy, bias, precision against a reference standard in degrees Celsius/Fahrenheit) means we cannot fully assess the device's adherence to typical thermometer performance expectations. A more detailed clinical study report would contain such data.

Summary

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AUG 1 2001

K012217

510(K) SUMMARY

M5T Instant Fever Thermometer

Applicant's Name:

Medisim Ltd. The Technology Park Manhat Jerusalem 96251, Israel Tel: 972-2-679-9204 Fax: 972-2-679-9198

Contact Person:

Shoshana Friedman, RAC Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9-7718130 Fax: 972-9-7718131

Date Prepared:

July, 2001

Trade Name:

M5T Instant Fever Thermometer

Classification Name:

Thermometer, Electronic, Clinical

Classification:

Class II; Product Code 80FLL; Regulation No. 880.2910.

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Statement of Substantial Equivalence:

The is substantially equivalent in all aspects, MST e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available Up-Grade and Up-Grade Pro Thermometer. The changes between the two thermometers include removal of the heater, the preheating control and overheating protection, prolonged measuring time, and subsequently slight change in the thermometer design.

Device Description:

Indications:

The M5T is non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.

Performance Data:

A clinical study was performed in order to evaluate the safety and performance of the M5T following the heater removal. The study results demonstrated that the M5T is safe and effective without raising new safety and/or effectiveness issues

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its wings or feathers.

1 2001 AUG

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medisim Limited C/O Ms. Dorin Teich Quality Assurance Manager Push-med Limited 117 Ahuzah Street Ra'ananna , ISREAL

K012217 Re : M5T Instant Fever Thermometer Trade/Device Name: 880.2910 Requlation Number: Requlatory Class: II Product Code: FLL July 10, 201 Dated: Received: July 16, 2001

Dear Ms. Teich:

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 Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Ms. Teich

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 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 requlation (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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K012217

Device Name:

M5T Instant Fever Thermometer

Indications for Use:

The M5T is non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.

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

510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over the Counter Use

Patricio Ciuenti

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