(244 days)
The Digital Thermometer is intended to measure oral temperature of human body. It can be used in home environment or at a doctor's clinic. It is indicated for use by people of all ages.
The Digital Thermometer consists two parts. The thermometer probe part is a compact, small, light-weight, and battery-powered unit with thermometer sensor for oral temperature measurements. The thermometer probe must be connected to a compatible mobile phone device through its headphone jack for displaying measured temperatures.
The mobile application could be conducted for operation and display temperature measurement when the Digital Thermometer connects with mobile device. The mobile application can be conducted on iOS operating system and Android operating system of mobile device.
The mobile application could perform the functionality on mobile device screen including measurement activity, historical data activity, trend activity, basic setting and initial setting activity.
The provided text describes a digital thermometer, Model 2180, and its substantial equivalence to a predicate device, the Basal Digital Thermometer (K141505). The information primarily focuses on the device's characteristics, intended use, and compliance with various standards.
Here's an analysis of the acceptance criteria and the study information as requested, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists several standards and requirements that the Digital Thermometer complies with, implying these act as acceptance criteria. The reported performance is that the device "complies" or "met the endpoints."
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Measurement Accuracy | |
| ±0.1°C (35.5°C to 42.0°C) | Digital Thermometer: ±0.1°C (35.5°C to 42.0°C) |
| ±0.2°C (other range) | Digital Thermometer: ±0.2°C (other range) |
| Display Resolution | |
| 0.1°C (°F) | Digital Thermometer: 0.1°C (°F) |
| Displayed Temperature Range | |
| (Implicit from ASTM E1112-00) | Complies with ASTM E1112-00 displayed temperature range requirements |
| Environmental (Operating) | |
| 10°C~40°C (50 ~ 104°F) | Digital Thermometer: 10°C~40°C (50 ~ 104°F) |
| 15%-95% RH | Digital Thermometer: 15%-95% RH |
| Environmental (Storage) | |
| -20°C ~50°C (-4.0 ~ 122°F) | Digital Thermometer: -20°C ~50°C (-4.0 ~ 122°F) |
| 15%-95% RH | Digital Thermometer: 15%-95% RH |
| Biocompatibility (Cytotoxicity) | |
| No Cytotoxicity (ISO 10993-5) | Met endpoints for cytotoxicity |
| Biocompatibility (Sensitization & Irritation) | |
| No Sensitization & Irritation-negligible (ISO 10993-10) | Met endpoints for sensitization & irritation-negligible |
| Electrical Safety (AAMI / ANSI ES60601-1) | Complies with general requirements, protection against electrical/mechanical hazards, excessive temperatures, etc. |
| Electromagnetic Compatibility (AAMI / ANSI/ IEC 60601-1-2) | Complies with radiated emission, electrostatic discharge immunity, RF electromagnetic field immunity, etc. |
| Human Interface and Mechanical Test (ASTM E1112-00) | Complies with ASTM E1112-00 requirements |
| Software Guidance (Premarket Submissions for Software) | Complies with guidance requirements including level of concern, software description, V&V documentation. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for any specific test set, nor does it mention data provenance (e.g., country of origin, retrospective/prospective). It generally states that the device was "verified and validated" or "complies" with standards.
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 in the document. The document refers to compliance with established standards (e.g., ASTM E1112-00 for accuracy), which inherently have their own defined test methodologies, but details about specific expert involvement in this device's testing ground truth establishment are absent.
4. Adjudication method for the test set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth for a test set.
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 is not applicable as the device is a digital thermometer, not an AI-assisted diagnostic tool involving human readers. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone digital thermometer that provides a temperature reading. Its performance criteria (e.g., accuracy) were assessed in this context. The "software validation" mentioned indicates evaluation of the algorithm within the device and mobile application, which can be seen as a standalone performance assessment for its accuracy and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance of the thermometer, the "ground truth" would be established by reference standards or calibrated equipment used in accordance with the specified testing methodologies of standards like ASTM E1112-00. The text does not detail the specifics of such "ground truth" generation for its internal testing beyond stating compliance with the standard.
8. The sample size for the training set
This information is not applicable. The device is a digital thermometer, not a machine learning model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this type of device.
§ 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.