(156 days)
The digital thermometers MT series 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.
Digital Thermometer MT series enable fast and reliable measurements. These thermometers provide very high clinical accuracy, and have been designed to provide maximum user-friendliness. Digital Thermometer MT series can be used in conjunction with or without a disposable probe cover, when preferred. The basic principle of these thermometers is that a change of thermistor resistance, caused by changes of temperature, is converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of the oscillator. For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
The provided text describes a 510(k) premarket notification for the SEJOY Digital Thermometer MT series. The document asserts the device's substantial equivalence to previously cleared predicate devices. While it mentions compliance with standards and the performance of clinical studies, it does not provide detailed acceptance criteria or the specific results of those studies in a format that allows for the extraction of the requested information.
Specifically, the document states:
- "Controlled human clinical studies were conducted using the digital thermometer MT series. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline."
However, it does not provide the acceptance criteria for these metrics (e.g., maximum allowable bias, uncertainty, or repeatability), nor does it report the observed performance of the device against any such criteria.
Therefore, I cannot populate the table of acceptance criteria and reported device performance.
Furthermore, without the detailed study report, the following information cannot be extracted:
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer, not expert consensus.
- Adjudication method: Not applicable for a thermometer accuracy study.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for a thermometer.
- Standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a thermometer, and its primary performance is standalone measurement. While clinical studies were done, the details of how "standalone performance" (e.g., in a laboratory setting with a reference standard) compared to human-in-the-loop (e.g., actual clinical use) are not discussed in this summary. The summary focuses on "clinical bias, clinical uncertainty and clinical repeatability."
- The type of ground truth used: Not explicitly stated, but for thermometer accuracy, it would be a reference thermometer and/or a controlled thermal environment.
- The sample size for the training set: Not applicable; this device is a hardware product, not an AI/algorithm-based device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of available information:
| Information Requested | Details from the Document |
|---|---|
| Acceptance Criteria & Reported Performance | Not provided in the document. The document mentions "clinical bias, clinical uncertainty, and clinical repeatability" were evaluated, but the specific numerical acceptance criteria and the device's achieved performance against these criteria are not disclosed. |
| Sample size (test set) | Not specified. |
| Data provenance (country, retrospective/prospective) | Not specified. "Controlled human clinical studies were conducted," implying prospective, but location is not mentioned. |
| Number of experts / qualifications (ground truth) | Not applicable in the context of thermometer accuracy. Ground truth would be established by a reference standard. |
| Adjudication method | Not applicable. |
| MRMC comparative effectiveness study | No, not applicable for this device type. |
| Standalone performance study | Yes, the clinical studies evaluate the device's performance, which is inherently standalone for a thermometer. Specific separate "standalone" studies vs. "human-in-the-loop" are not detailed. |
| Type of ground truth | Not explicitly stated, but for a thermometer, this would typically involve highly accurate reference thermometers in controlled environments or during clinical measurements. |
| Sample size (training set) | Not applicable; this is a hardware device, not an AI/algorithm. |
| Ground truth for training set | Not applicable. |
In conclusion, while clinical studies were performed to evaluate the SEJOY Digital Thermometer MT series, the provided 510(k) summary does not contain the detailed quantitative acceptance criteria or the specific results required to populate the requested table and answer the study-specific questions. The summary focuses on declaring substantial equivalence based on overall design, intended use, and compliance with general standards (ASTM E 1112, IEC60601-1, IEC60601-1-2 and ISO10993-1).
§ 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.