(21 days)
The device measures the body temperature of a patient by means of a sensor coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements for home use on people of all ages.
The device measures the body temperature of a patient by means of a sensor coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements for home use on people of all ages.
The provided text is a 510(k) clearance letter from the FDA for a Clinical Electronic Thermometer. It confirms the device is substantially equivalent to a predicate device and outlines general regulatory information. However, it does not contain the detailed information necessary to answer most of your questions about acceptance criteria and a specific study proving the device meets those criteria.
The document grants market clearance based on a determination of "substantial equivalence" to a predicate device, which implies that the new device performs as safely and effectively as a legally marketed device. This process typically involves showing that the device meets recognized standards and performs similarly to the predicate, but it doesn't usually include a detailed "stand-alone" clinical study report with the level of detail you're requesting for acceptance criteria and specific performance metrics.
I can, however, extract what little information is available:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The letter only states that the device is "substantially equivalent" to a predicate device. To get this, one would need to see the full 510(k) submission, which would likely include performance data comparing the new device to the predicate, often against recognized standards for medical thermometers (e.g., ASTM standards for accuracy).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided document.
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):
This information is not present in the provided document. Clinical electronic thermometers typically rely on objective measurements against a reference standard (e.g., a highly accurate laboratory thermometer), not expert consensus for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
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:
This information is not present in the provided document. MRMC studies are typically for devices that assist human interpretation of diagnostic images, not for a simple electronic thermometer. "AI" assistance is not relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not explicitly detailed in the provided document. For a clinical electronic thermometer, "standalone performance" refers to the accuracy and reliability of the device's measurement function itself, without human interpretation for the result. While the 510(k) implies this was assessed for substantial equivalence, the specific details of a standalone study are not included.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a clinical electronic thermometer, the "ground truth" would typically be established by a highly accurate, calibrated reference thermometer (e.g., a laboratory standard thermometer). This information is not explicitly stated but is implied by the nature of the device.
8. The sample size for the training set:
This information is not present in the provided document. For a traditional electronic thermometer, there isn't a "training set" in the machine learning sense. The device's calibration and accuracy are established through manufacturing and testing processes.
9. How the ground truth for the training set was established:
This information is not present in the provided document. As mentioned for #8, a "training set" is not relevant for this type of device.
In summary: The provided document is a regulatory clearance letter, not a detailed technical study report. It confirms the device's market authorization based on substantial equivalence to a predicate, but it does not contain the specific performance data, study designs, sample sizes, or expert qualifications you've requested. To obtain such information, one would typically need access to the full 510(k) submission or associated test reports that were provided to the FDA.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters and is arranged in a circular fashion to match the shape of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2001
Mesure Technology C/O Mr. Phil Zulueta Z7 International P.O. Box 2249 Mission Viejo, California 92690
K011585 Re : Clinical Electronic Thermometer Trade/Device Name: 880.2910 Requlation Number: Regulatory Class: II Product Code: FLL Dated: May 19, 2001 Received: May 23, 2001
Dear Mr. Zulueta:
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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 — Mr. Zulueta
this response to your premarket notification submission does this response to your promobility have under sections 531 not allect any obligation you might under the Electronic Chrough 542 OF the not 10 provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Inis lecter will arrow your market notification. The FDA described in your srown provilence of your device to a legally Illuling of substancial equice in a classification for your marketed predicate device robates to proceed to the market.
If you desire specific advice for your device on our labeling If you desire bpcorner and additionally 809.10 for in regulation (21 crk rares), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compriance at (50), dvertising of your device, please contact the promocron and adversibling on Journal (1301) Also, please note "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance oblained from the Bivibion or billion (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.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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1 Statement of Indications for Use
Page 1 of 1.
510(k) Number (if known)
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Clinical Electronic Thermometer Device Name: ____________________________
Indications for Use:
ィ
The device measures the body temperature of a patient by means of a sensor coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements for home use on people of all ages.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pauline Cucente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Z7 International
"Serving the Electronics Industry"
510(k) ST713 - Page 1-5
§ 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.