The DataTherm® II Continuous Temperature Monitor is intended to continuously measure, display and monitor human body temperature updating every 4 seconds. Additionally, it stores up to 140 temperature/time/day data sets that may be stored at a user-selected frequency range from once per minute to once every 24 hours in one minute intervals. The current temperature and stored information may be viewed on the LCD screen that is integrated into the instrument or, from a PC computer screen after installation of the DataTherm software to a PC. The DataTherm II is intended to be used on patients of all ages.

The DataTherm® II Continuous Temperature Monitor is used to measure and monitor human body temperature and for storing temperature data at adjustable, preset time intervals.

Device Description

The DataTherm II Continuous Temperature Monitor (model HD-2300) consists of four components.

1. A control / display assembly measuring 3.16'' X 2.37' X 0.71" with an LCD screen and 5 control keys (On/Off, Mode Selection, &(increase), (decrease) and keyboard Lock). The interior electronic components consist of a circuit board, a battery compartment housing 2 - AAA batteries, a buzzer and LED alert light.
1. A disposable flexible temperature probe having a plug-in connector at one end and thermistor sensor at the other.
1. A USB interface connector cable that permits the transfer of stored and real-time temperature/time/day information to a PC computer screen.
1. Proprietary software that permits an individual patient's current temperature to be viewed and temperature/time/date information to be displayed and archived, if desired.

AI/ML Overview

The provided text describes the DataTherm® II Continuous Temperature Monitor and its regulatory submission (K070878). Unfortunately, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Specifically, the document states:

"Discussion of Clinical Tests Performed: Not Applicable" (page 2, Section 8). This is a crucial point, as it indicates a clinical trial demonstrating the device's performance against specific acceptance criteria was not part of this 510(k) submission. Instead, the submission relies on substantial equivalence to a predicate device and non-clinical (bench) testing.

Therefore, for aspects related to clinical study design, sample sizes, expert involvement, and ground truth in human subject testing, the information is not present. I can, however, extract details regarding performance standards, which implicitly define some acceptance criteria, and what non-clinical testing was performed.

Here's an analysis based on the available information:

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

The document references compliance with specific performance standards, which serve as the implicit acceptance criteria for the non-clinical performance of the device. However, specific numerical performance results (e.g., accuracy in degrees Celsius) of the DataTherm® II are NOT provided in the text. The document only states that the device "complies with" and "conforms to" these standards.

Acceptance Criteria (Standard)	Reported Device Performance
ASTM E1112-00 (2006): Electronic Thermometer for Intermittent Determination of Patient Temperature	"The DataTherm II (model KD-2300) complies with...ASTM E1112-00"
EN 60601-1-2: Electromagnetic Compatibility	"The DataTherm II (model KD-2300) complies with EN 60601-1-2"
US FCC Part 15: Harmonized standard for electronic safety	"the DataTherm II conforms to the harmonized standard...US FCC Part 15"

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

Test Set Sample Size: Not applicable/Not specified for clinical data, as no clinical tests were performed or presented. For non-clinical (bench) testing, the sample size is not disclosed.
Data Provenance: The non-clinical "bench testing" was performed by the submitting company (RG Medical Diagnostics/Geratherm Medical AG). The origin country or retrospective/prospective nature of this unspecified bench testing data is not detailed beyond being "bench testing contained in this submission."

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

Not applicable, as no clinical tests were performed with human subjects requiring expert ground truth establishment.

4. Adjudication method for the test set

Not applicable, as no clinical tests were performed with human subjects requiring adjudication.

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 MRMC or AI-related study was mentioned. The device is a continuous temperature monitor, not an AI diagnostic tool.

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

While the device functions as a standalone electronic thermometer, the document does not describe "standalone performance" in the context of an algorithm's performance without human interaction in a diagnostic sense (which is common for AI/imaging devices). Its performance is assessed against the aforementioned standards for electronic thermometers.

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

For compliance with standards like ASTM E1112-00, the ground truth would typically be a highly accurate reference thermometer or temperature measurement system in a controlled laboratory environment. The document does not explicitly state the specific ground truth used for these compliance tests, but it would not involve expert consensus, pathology, or outcomes data in this context.

8. The sample size for the training set

Not applicable. The device is a physical electronic thermometer, not an AI/machine learning model that requires a training set.

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

Not applicable. (See point 8)

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo with the letters 'RG' stacked on top of each other in a bold, sans-serif font. Below the letters is a zig-zag line. Underneath the zig-zag line, the word 'DIAGNOSTICS' is printed in a smaller, sans-serif font. The logo appears to be for a diagnostics company.

RG Medical Diagnostics

K070878

Pa 1 of 3

JUN - 5 2007

Premarket 510(k) Summary

DataTherm® II

Submitter information:

Sponsor:

RG Medical Diagnostics 21130 Bridge Street Southfield, MI 48034 1-248-750-0181 ph 1-248-750-0187 fax Contact Person: Ronald G. Le Tourneau Date Prepared: 26 February, 2007

Device Name:

1. Classification:	General Hospital
2. Common Name:	Clinical Electronic Thermometer
3. Proprietary Name:	DataTherm® II Continuous TemperatureMonitor
4. Classification:	FLL - CFR 880.2910
5. Performance Standards:	ASTM E1112-00 (2006),EN60601-1-2 (harmonized)

6. Predicate Device Information:

K001281, Geratherm Babywatch Temperature Monitor

Manufactured by: Geratherm Medical AG Fahrenheitstrasse 1 D-98716 Geschwenda, Germany

Device Description: 21130 Bridge Street • Southfield, MI 48034 1 of 4 Phone: 888-596-9498 • Fax: 248-750-0187 • Website: www.rgmd.com

{1}------------------------------------------------

The DataTherm II Continuous Temperature Monitor (model HD-2300) consists of four components.

1. A control / display assembly measuring 3.16'' X 2.37' X 0.71" with an LCD screen and 5 control keys (On/Off, Mode Selection, &(increase), (decrease) and keyboard Lock). The interior electronic components consist of a circuit board, a battery compartment housing 2 - AAA batteries, a buzzer and LED alert light.
1. A disposable flexible temperature probe having a plug-in connector at one end and thermistor sensor at the other.
1. A USB interface connector cable that permits the transfer of stored and real-time temperature/time/day information to a PC computer screen.
1. Proprietary software that permits an individual patient's current temperature to be viewed and temperature/time/date information to be displayed and archived, if desired.

5. Intended Use:

The DataTherm II Continuous Temperature Monitor is intended to continuously measure, display and monitor human body temperature updating every 4 seconds. Additionally, it stores up to 140 temperature/time/day data sets that may be stored at a user-selected frequency range from once per minute to once every 24 hours in one minute intervals. The current temperature and stored information may be viewed on the LCD screen that is integrated into the instrument or, from a PC computer screen after installation of the DataTherm software to a PC. The DataTherm II is intended to be used on patients of all ages.

6. Comparison to Predicate Device

The subject device is substantially equivalent to the predicate device, the Babywatch (marketed as DataTherm®) K001281. Both the subject and predicate devices are designed and engineered by the same company, Geratherm AG. The two devices employ the same technology, display information, and use the same controls. The subject device differences include disposable temperature probes, larger batteries, added visual temperature alert LED, improved water repellency, expanded memory, expanded storage interval alternatives and the ability to view and archive time/temperature/date data on a PC computer in user named files.

{2}------------------------------------------------

Ko708 78

Py 3 of B

7. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The DataTherm II (model KD-2300) complies with EN 60601-1-2 "Electromagnetic Compatibility" and ASTM E1112-00 " Electronic Thermometer for Intermittent Determination of Patient Temperature" standards. In addition, the DataTherm II conforms to the harmonized standard for electronic safety established by the US FCC Part 15.

8. Discussion of Clinical Tests Performed:

Not Applicable

9. Conclusions:

The subject device and predicate devices provide the same functions and controls through employment of the same technology. Moreover, bench testing contained in this submission demonstrate that any differences in their characteristics do not present any new questions of safety or effectiveness. Thus, the DataTherm® II Continuous Temperature Monitor is substantially equivalent to the predicate device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services - USA. The logo features a stylized image of a human figure, with three overlapping profiles facing to the right. The profiles are simple and abstract, with no facial details. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ronald G. Le Tourneau President RG Medical Diagnostics 21130 Bridge Street Southfield, Michigan 48034

JUN -5 2007

Re: K070878

Trade/Device Name: DataTherm® II Continuous Temperature Monitor Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 04, 2007 Received: May 07, 2007

Dear Mr. Le Tourneau:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{4}------------------------------------------------

Page 2 – Mr. Le Tourneau

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

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

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K070878

Device Name: _ DataTherm® II Continuous Temperature Monitor

Indications For Use:

The DataTherm® II Continuous Temperature Monitor is used to measure and monitor human body temperature and for storing temperature data at adjustable, preset time intervals.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sion Sign-Off)
vision of Anesthesiology, General Hospital,
Infection Control, Dental Devices	Page 1 of
510(k) Number:	K470878

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.