(17 days)
The Digital Clinical thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030's intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.
Not Found
This document is a 510(k) clearance letter from the FDA for a digital clinical thermometer, not a study report or clinical trial. Therefore, it does not contain the detailed information about acceptance criteria or a study proving device performance as typically described for software or AI-based medical devices.
The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined that the device is as safe and effective as a device already on the market, but it does not detail the specific performance metrics or studies used to demonstrate this equivalence.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not specify acceptance criteria for performance (e.g., accuracy, precision) or report specific device performance data. It is a clearance letter, not a performance report.
2. Sample sized 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 any sample sizes for test sets or data provenance.
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 information is not relevant to a thermometer's performance evaluation and is not present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This detail is not included in the 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
- Cannot be provided. This type of study is not applicable to a digital clinical thermometer, which is a standalone measurement device, and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be directly answered in the context of "algorithm" performance as understood for AI. The device itself is a standalone clinical thermometer. Its performance would be evaluated in a standalone manner (e.g., accuracy tests against a reference standard). However, the document does not detail these tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. While a thermometer's ground truth would typically be a highly accurate reference thermometer, the specific method used for this device's testing is not mentioned.
8. The sample size for the training set
- Cannot be provided. This device is a digital clinical thermometer, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Cannot be provided. As above, there is no training set for this type of device.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for a "Digital Clinical Thermometer." The FDA determined the device to be substantially equivalent to legally marketed predicate devices (K010238). This decision is based on an assessment that the device is as safe and effective as existing devices; however, the letter itself does not contain the detailed performance data, acceptance criteria, or study designs that would typically be provided in a clinical study report for an AI-enabled device. The information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, training sets, and how ground truth was established is not available in this document because it outlines a regulatory clearance, not a scientific study report for an AI/ML product.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 7 2003
Mr. Richard Hsieh Vice President Actherm, Incorporated 6″ F, No. 85 Kuan-Min 6 Road Jubei 302 Hsinchu, CHINA (Taiwan) 302
Re: K031905
Trade/Device Name: Digital Clinical Thermometer, Model ACT 2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 6, 2003 Received: June 23, 2003
Dear Mr. Hsieh:
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.
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Page 2 - Mr. Hsieh
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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Bunce
Susan Runner, DDS, MA Interim 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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Attachment 2
Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | Digital Clinical Thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030 |
| Indications for Use | The Digital Clinical thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030's intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801. 109)
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(Division, City or RM
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031905
§ 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.