(136 days)
The device measures the body temperature of a patient by means of a sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The with an Cicottonio orginal and intended for oral, axillary or rectal temperature measurements for home use on people of all ages.
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Here's an analysis of the provided text regarding the Clinical Electronic Thermometer and its acceptance criteria and study:
It's important to note that the provided documents (K013779) are from an FDA 510(k) clearance letter for a Clinical Electronic Thermometer. This type of device is typically cleared based on substantial equivalence to a predicate device, and the details of clinical studies, as commonly understood for AI/ML or more complex diagnostic devices, are often not extensively detailed in the clearance letter itself. Instead, performance data is usually submitted in a separate 510(k) summary or report.
Based on the provided text, a comprehensive study description as requested for AI/ML devices is not present. However, I can extract the available information and highlight what is not present.
Acceptance Criteria and Device Performance (Based on available information and common thermometer standards):
For a clinical electronic thermometer, the primary acceptance criteria revolve around accuracy and precision according to recognized standards. While the specific numerical acceptance criteria and reported performance are NOT EXPLICITLY STATED in the provided documents, I will infer them based on typical requirements for this type of device and what would generally be tested to establish substantial equivalence. The document primarily focuses on the regulatory clearance itself.
| Acceptance Criteria | Reported Device Performance | Comments from Document |
|---|---|---|
| Accuracy (e.g., within ±0.1°C or ±0.2°F) | Not explicitly stated in the provided text. However, for substantial equivalence, the device's accuracy would need to meet or exceed that of the predicate device and relevant industry standards (e.g., ASTM E1112 for electronic thermometers). The 510(k) submission would have contained this data. | The document indicates "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This implies that the performance data (including accuracy) was found to be comparable to a legally marketed predicate device. |
| Repeatability/Precision | Not explicitly stated in the provided text. This would also be a critical parameter, demonstrating consistent readings under identical conditions. | Similar to accuracy, this would have been part of the technical data submitted for substantial equivalence. |
| Response Time | Not explicitly stated in the provided text. The time taken to display a stable reading. | |
| Operating Range (e.g., 32-43°C) | Not explicitly stated in the provided text. The range of temperatures the device can accurately measure. | |
| Environmental Conditions (Temperature, Humidity) | Not explicitly stated in the provided text. Performance under varying environmental conditions. | |
| Biocompatibility | Not explicitly stated in the provided text. Materials in contact with the patient are safe. | This is a general control requirement for medical devices. |
| Electrical Safety (e.g., IEC 60601-1) | Not explicitly stated in the provided text. Ensures safe operation regarding electrical hazards. | This is a general control requirement for medical devices. |
| Electromagnetic Compatibility (EMC) | Not explicitly stated in the provided text. Ensures the device does not interfere with or is not interfered by other electronic devices. | This is a general control requirement for medical devices. |
| Durability/Lifetime | Not explicitly stated in the provided text. The expected lifespan and robustness of the device. | |
| Readability of Display | Not explicitly stated in the provided text. The clarity and ease of reading the digital display. | The "digital LCD (display) unit" is mentioned, implying a visual display for temperature readings. |
| Intended Use Fulfilled (Oral, Axillary, Rectal for home use) | "The device measures the body temperature of a patient... for oral, axillary or rectal temperature measurements for home use on people of all ages." | This is directly from the Indications for Use statement, confirming the device is intended for these specific measurement sites and user environment. |
Detailed Study Information (Based on provided text):
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided documents.
- Data Provenance: Not specified in the provided documents (e.g., country of origin, retrospective or prospective). For a thermometer, testing is typically prospective under controlled laboratory and simulated clinical conditions.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Specified: For a clinical electronic thermometer, ground truth is typically established by physical reference standards (e.g., certified temperature baths, black body sources) or comparison to highly accurate reference thermometers, rather than expert human interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Specified: Adjudication methods like 2+1 or 3+1 are used for tasks involving human interpretation or subjective assessment (e.g., image analysis, diagnosis). For a thermometer, "adjudication" is not typically relevant as the output is a direct numerical measurement.
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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:
- No, not specified/applicable. This type of study is relevant for AI-assistant devices or diagnostic tools where human interpretation is involved. This device is a standalone temperature measurement device, not an AI assistant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself is standalone. Its "performance" refers to its accuracy, precision, and other technical specifications, independent of human interpretation or assistance in the measurement process. The operator simply places the device and reads the displayed temperature. The 510(k) submission would include data on the device's standalone performance characteristics compared to standards and the predicate device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated, but typically highly accurate reference thermometers in controlled environments. For a thermometer, ground truth is established by comparing the device's readings against well-calibrated, highly accurate reference thermometers or certified temperature standards in controlled laboratory settings (e.g., water baths at precise temperatures).
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The sample size for the training set:
- Not Applicable / Not Specified: This device does not typically involve a "training set" in the context of machine learning or complex algorithms. Its performance is based on its physical design, sensors, and electronic components, which are calibrated and verified.
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How the ground truth for the training set was established:
- Not Applicable / Not Specified: As there is no "training set" in the AI/ML sense, this question is not relevant to this device. Calibration and verification processes (using reference standards) ensure the device's intrinsic accuracy.
Summary of Limitations based on the provided text:
The provided documents are primarily the FDA 510(k) clearance letter and the Indications for Use statement. These documents confirm regulatory clearance and the intended applications of the device. They do not contain the detailed technical report, performance data, or study methodologies that would typically be found in the 510(k) summary or supporting documentation submitted to the FDA. Therefore, specific numerical acceptance criteria, reported performance values, study sample sizes, and detailed methodology are not available in this text.
§ 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.