(102 days)
It is an electronic thermometer used for clinical temperature measurement. It is intended for use at home and hospital environment for both children and adult.
The Rapid Digital Thermometer is an electronic thermometer by using a thermistor as the temperature sensor. The thermometer uses a 1.5V button battery for operation.
The provided text describes the 510(k) summary for the Rapid Digital Thermometer, Model RDT-18-XY. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific performance metric against acceptance criteria in the way a clinical trial for an AI diagnostic device would.
Therefore, many of the requested categories for AI device studies (e.g., sample size for test set/training set, number of experts, adjudication methods, MRMC studies, standalone performance with AI assistance, type of ground truth) are not applicable to this submission as it's for a simple electronic thermometer.
However, I can extract the acceptance criteria and performance information that is relevant.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (from submission) |
|---|---|---|
| Voluntary Standards Compliance | Compliance with applicable voluntary standards | "Both the predicted device and the Rapid Digital Thermometer (RDT-18 series) are in compliance to applicable voluntary standards." |
| ASTM E1112 Standards | Various performance testing data conducted according to ASTM E1112 standards, such as temperature range test, accuracy test, resolution test, cleaning test, "demonstrate the same safety and effectiveness as that of cleared device." | |
| IEC 60601-1 | "Both devices conform to IEC 60601-1" | |
| IEC 60601-1-2 | "IEC 60601-1-2 requirements" | |
| ISO 10993-1:2003 (Biocompatibility) | "ISO 10993-1:2003 biocompatibility testing on skin irritation, in vitro cytotoxicity and sensitivity." | |
| Safety & Effectiveness | "Same safety and effectiveness" as predicate device | Demonstrated through compliance with voluntary standards and performance testing. |
Study Information (Relevant to this device type)
- Sample size used for the test set and the data provenance: Not explicitly stated as a clinical study with a specific test set. Performance testing was conducted according to ASTM E1112 standards, which typically involve a specified number of measurements or devices for testing, but the exact sample size for these non-clinical tests is not detailed in the provided summary. The data provenance would be from internal lab testing based on the standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a digital thermometer, "ground truth" would be established by reference temperature standards and measurement protocols, not expert consensus.
- Adjudication method for the test set: Not applicable. Performance testing for a thermometer involves direct measurement against known standards.
- 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 diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a standalone electronic device, not an AI algorithm. Its performance is inherent to its design and calibration.
- The type of ground truth used: For accuracy and other performance metrics, the ground truth would be established by reference temperature standards and calibrated measurement equipment as per ASTM E1112.
- The sample size for the training set: Not applicable. This device does not use machine learning or require a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.