(121 days)
The Digital Thermometer DMT-4756 is intended to measure the human body temperature in regular mode orally, rectally or under the arm, and the device is reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The digital thermometer DMT-4756 is hand held device which can measure human body's temperature orally, axillary (under the arm), and rectally. The results can be displayed on LCD. The flexible tip is foldable,when the flexible tip folded, DMT-4756 is used to measure human body's temperature rectally, while the flexible tip unfolded, it is used to measure temperature orally and axillary (under the arm). The digital thermometer have several functions,such as beep alarm,unit switchable, low battery detection,memories,backlight,auto power off functions. DMT-4756 is a predictive digital thermometer. Users only need 10 seconds for predictive quick read and 30 seconds for final temperature readings.
This document is a 510(k) summary for the Joytech Healthcare Co., Ltd. Digital Thermometer, Model DMT-4756. It outlines the device's characteristics, its comparison to a predicate device, and the testing conducted to demonstrate its substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (from predicate or standard) | Reported Device Performance (DMT-4756) |
|---|---|---|
| Accuracy (Temperature) | ±0.1°C between 35.5°C to 42.0°C (±0.2°F, 95.9°F-107.6°F) | |
| ±0.2°C under 35.5°C or over 42.0°C (±0.4°F under 95.9°F or over 107.6°F) | Identical to predicate device. | |
| Clinical performance test protocol and data analysis conducted in accordance with ISO 80601-2-56. | ||
| "The test report showed the clinical performance of the subject device complied with the requirement of ISO 80601-2-56." | ||
| Measurement Range | 32.0°C~43.9°C (89.6°F-111.0°F) | Identical to predicate device. |
| Display Resolution | 0.1 °C/0.1 °F | Identical to predicate device. |
| Measurement Time | Predicate: Approximate 5 ~ 10s | DMT-4756: 10s Predictive read, 30s Final read. |
| "Performance test including clinical test shows the subject device complies with performance standard." | ||
| Predictive Mode | Predicate: Optional | DMT-4756: Yes (has this function). |
| "Performance test including clinical test shows the subject device complies with performance standard." | ||
| Construction (Foldable Probe) | Predicate: Flexible Digital Thermometer | DMT-4756: The probe is foldable into the body of the thermometer. |
| "Performance testing shows the subject device complies with standard ISO 80601-2-56." | ||
| Biocompatibility | Comply with ISO 10993-5 and ISO 10993-10 | Complied with ISO 10993-5 and ISO 10993-10. |
| "Biocompatibility test and performance bench test met the requirements in the standards." | ||
| Electrical Safety | Complied with IEC 60601-1 / AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012, ISO 80601-2-56:2017, ASTM E1112:00(Reapproved 2011) | Complied with IEC 60601-1 / AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012, ISO 80601-2-56:2017, ASTM E1112:00(Reapproved 2011). |
| "Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 met all requirements of related international standards, including electrical safety... Results of these tests demonstrate compliance to the requirements of the below consensus standards." | ||
| Electromagnetic Compatibility (EMC) | Complied with IEC 60601-1-2:2014 | Complied with IEC 60601-1-2:2014. |
| "Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 met all requirements of related international standards, including ... EMC... Results of these tests demonstrate compliance to the requirements of the below consensus standards." | ||
| Home-used medical equipment requirements | Complied with IEC 60601-1-11:2015 | Complied with IEC 60601-1-11:2015. |
| "Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 met all requirements of related international standards... Results of these tests demonstrate compliance to the requirements of the below consensus standards." | ||
| Software Validation | "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005 | "The software/firmware verification and validation was provided in accordance with the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,' dated May 11, 2005." |
2. Sample size used for the test set and the data provenance:
- Sample Size: 450 subjects for the clinical tests. These were divided into three groups:
- Infants: newborn to one year
- Children: greater than one to five years
- Adults: greater than five years old
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "The clinical tests were conducted on the DMT-4756 for each measurement site." Without further information, it's not possible to determine the geographical origin of the subjects. The description of the test as "clinical tests were conducted" implies a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The clinical performance was evaluated against the requirements of ISO 80601-2-56, which are standards for clinical thermometers.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method. The clinical performance was evaluated against a standard (ISO 80601-2-56) rather than against expert consensus on individual cases.
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 applicable. The device is a digital thermometer, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable in the context of a digital thermometer. The device itself is standalone in its function of measuring temperature. The clinical tests evaluate the device's accuracy in direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical tests, the ground truth is implicitly established by the performance standard ISO 80601-2-56. This standard defines the acceptable accuracy limits for clinical body temperature measurement devices. The study aimed to show that the device's readings fell within these established accuracy criteria.
8. The sample size for the training set:
- This information is not applicable. This is a traditional medical device (digital thermometer) and does not involve machine learning or AI models that require a separate "training set" in the conventional sense. The device's calibration and internal algorithms are developed through engineering and testing, not by training on a dataset of patient readings.
9. How the ground truth for the training set was established:
- This information is not applicable, as there is no "training set" for an AI model in this context.
§ 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.