(233 days)
The Digital Thermometer is used for the measurement and monitoring of human body temperature. Body temperature can be measured with the Digital Thermometer by oral, axillary (under the arm) and rectal methods. The device is for adult and pediatric use.
The Digital Thermometer is a hand-held electronic thermometer comprised of an electronic thermoresistor (thermistor) sensor connected to a printed circuit board (PCB) with liquid crystal display (LCD) user readout. These components are held in a plastic housing with stainless steel metal cap. The housing is a rigid plastic. The Digital Thermometer is supplied with a clear plastic storage case to protect the thermometer.
The provided document is a 510(k) summary for a Digital Thermometer. It does not contain a study that proves the device meets specific acceptance criteria in the manner typically presented for AI/ML or diagnostic devices. Instead, it demonstrates substantial equivalence to a predicate device based on non-clinical tests and adherence to voluntary standards.
Therefore, many of the requested elements (acceptance criteria table with reported performance, sample sizes for test/training sets, ground truth methodology, expert adjudication, MRMC studies, standalone performance, and how ground truth for training was established) are not applicable or cannot be extracted from this document, as it describes a traditional medical device submission, not a study for a new AI/ML or complex diagnostic device with specific performance metrics defined against a ground truth.
However, I can provide information based on what is present in the document regarding the device's characteristics and the basis for its safety and effectiveness claims.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards)
This submission relies on demonstrating substantial equivalence to a predicate device and compliance with established voluntary standards rather than presenting a performance study against novel acceptance criteria. The "acceptance criteria" here are implicitly met by showing conformity to these standards and equivalence to the predicate.
| Acceptance Criteria (Implied by Standards & Equivalence) | Reported Device Performance / Basis of Acceptance |
|---|---|
| Safety and Effectiveness | Verified through non-clinical tests demonstrating compliance with: |
| - ASTM E1112-00 (Standard for Clinical Electronic Thermometers) | Not explicitly detailed, but stated as compliant. |
| - IEC 60601-1 (Medical Electrical Equipment - General requirements for basic safety and essential performance) | Not explicitly detailed, but stated as compliant. |
| - IEC 60601-1-2 (Medical Electrical Equipment - Electromagnetic compatibility) | Not explicitly detailed, but stated as compliant. |
| - ISO 10993-1 (Biological evaluation of medical devices) | Materials tested in accordance with ISO 10993 and compared to predicate. |
| Functional Equivalence (to Predicate Device) | |
| - Intended Use | Identical to predicate device. |
| - Means of measuring temperature | Similar to predicate device. |
| - Technology | Similar to predicate device. |
| - Materials | Tested per ISO 10993 and compared to predicate. |
| - Environment for Use | Identical to predicate device. |
| - Patient Population | Identical to predicate device (adult and pediatric). |
Study Details (Where Applicable, based on provided document)
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Sample size used for the test set and the data provenance:
- Not applicable. This submission relies on "non-clinical tests" and compliance with standards, not a clinical study with a specific test set of patient data. The document does not describe patient data, but rather tests against engineering standards.
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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. Ground truth, in the context of diagnostic accuracy, is not mentioned as part of this submission, which focuses on engineering standards and equivalence.
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Adjudication method for the test set:
- Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This device is a digital thermometer, a direct measurement tool, not an imaging or diagnostic device requiring human interpretation that could be assisted by AI.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a digital thermometer, not an algorithm. Its "performance" is its ability to accurately measure temperature according to established engineering standards.
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The type of ground truth used:
- The "ground truth" implicitly refers to the accuracy and performance specifications outlined in the voluntary standards (e.g., ASTM E1112-00 for temperature accuracy), and the safety requirements of IEC 60601-1 and ISO 10993-1. These are engineering and biological safety standards, not a ground truth derived from clinical pathology or expert consensus on patient outcomes.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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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.