(278 days)
The Digital Thermometers DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. The devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
The Digital Thermometers DMT series are used to measure the human body temperature in regular mode orally, rectally, or under the arm. They have the same test principles, performance specifications and intended use as the Predicate device. The Digital Thermometers DMT series consists of a temperature sensor, low power consumption integrated circuit (IC), LCD display, and buzzer. The resistance of the sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD. The products have similar structural designs and the patient contacting materials are the same as the Predicate devices (Stainless Steel, TPE and Acrylonitrile Butadiene Styrene (ABS)).
The document provided describes the Joytech Healthcare Co., Ltd. Digital Thermometer, DMT Series (K163518) and its substantial equivalence to a predicate device (K153149). The information requested pertains to the acceptance criteria and study details for the device's performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance (as listed in document) |
|---|---|
| Accuracy (between 35.5°C to 42.0°C) | ±0.1°C (±0.2°F, 95.9°F-107.6°F) |
| Accuracy (under 35.5°C or over 42.0°C) | ±0.2°C (±0.4°F under 95.9°F or over 107.6°F) |
| Electrical Safety and essential performance (AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012, ISO 80601-2-56:2009) | "met all requirements of related international standards, including electrical safety...Results of these tests demonstrate compliance to the requirements of the below consensus standards." In the SE Comparison table, it also states: "Complied with IEC 60601-1" |
| Home-used medical equipment requirements (IEC 60601-1-11:2015) | "met all requirements of related international standards, including...product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards." |
| Electromagnetic compatibility (IEC 60601-1-2:2014) | "met all requirements of related international standards, including...EMC...Results of these tests demonstrate compliance to the requirements of the below consensus standards." In the SE Comparison table, it also states: "Complied with IEC 60601-1-2" |
| Biocompatibility (ISO 10993-5:2009 and ISO 10993-10:2010) (for patient contacting components: Stainless Steel, TPE and Acrylonitrile Butadiene Styrene (ABS)) | "met all requirements of related international standards, including...biocompatibility...Results of these tests demonstrate compliance to the requirements of the below consensus standards." In the SE Comparison table, it also states: "Comply with ISO 10993-5 and ISO 10993-10" |
| Software/firmware verification and 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." |
| Clinical performance (ISO 80601-2-56) | "The clinical performance test protocol and data analysis followed the requirements of ISO 80601-2-56." and "Based on the performance testing and bench data the submit digital thermometers DMT series are substantially equivalent to the predicate thermometers..." Note: The specific clinical accuracy results are not explicitly stated in this section, but the table above provides the general accuracy claims which are presumably substantiated by this clinical performance testing. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The document states, "The clinical performance test protocol and data analysis followed the requirements of ISO 80601-2-56," but does not explicitly mention the number of subjects or temperature readings used.
- Data Provenance (country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the device is a digital thermometer, and the "ground truth" for temperature measurement typically refers to reference standards or highly accurate measurement techniques rather than expert consensus on interpretation. For clinical performance, the ground truth would typically be a reference thermometer reading. The document mentions "clinical performance test protocol and data analysis followed the requirements of ISO 80601-2-56," which would define the method for establishing the reference temperature.
4. Adjudication method for the test set
- Not applicable as the device measures a quantitative value (temperature) directly, rather than relying on interpretation that would require 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
- Not applicable. This is not an AI-assisted device requiring human reader interpretation. It is a standalone digital thermometer.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, performance testing was done on the device (digital thermometer) itself, which functions as a standalone instrument. The "Performance data" section describes testing conducted to verify and validate that the Digital Thermometers, DMT series met "all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications." The accuracy claim of ±0.1°C / ±0.2°C is a standalone performance metric.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the accuracy and clinical performance testing, the ground truth would be established by a reference thermometer or a highly accurate temperature measurement system as defined by the standards (e.g., ISO 80601-2-56). The document does not specify the exact method but indicates compliance with relevant standards.
8. The sample size for the training set
- Not applicable. Digital thermometers are typically calibrated and validated, not "trained" in the machine learning sense. The device's operation is based on physical principles (resistance change with temperature) and a programmed algorithm, not a learning model.
9. How the ground truth for the training set was established
- Not applicable for the reason stated above. The device does not have a "training set." Calibration and validation are instead performed against known temperature references.
§ 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.