(92 days)
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature over the temporal artery on the forehead. It is intended for people of all ages.
hand held, battery operated device that measures the skin temperature of the skin over the temporal artery. Operation is based on measuring the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery.
The provided text is a 510(k) summary for the Digital Forehead Thermometer FS-100, which is seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.
Crucially, the document provided does not contain a study or data proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device, or for a device requiring more rigorous validation.
Instead, the provided text relies on demonstrating substantial equivalence to a predicate device (Exergen Corporation's Temporal Scanner Thermometer K 011291). The assessment of substantial equivalence involves comparing the new device's technological characteristics, intended use, and materials to a predicate, to argue that it raises no new questions of safety and effectiveness.
Therefore, the requested information elements related to detailed study results, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance are not present in this document because the regulatory pathway chosen (510(k) for substantial equivalence) typically focuses on comparative analysis rather than extensive de novo clinical trials with detailed performance metrics and acceptance criteria in the context implied by your questions.
However, based on the information provided, I can infer some aspects relevant to your request regarding the basis for acceptance as described in the 510(k) process:
Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Claim):
The acceptance criteria for the Digital Forehead Thermometer FS-100, as understood within the 510(k) framework, are that its technological characteristics, intended use, and general design are sufficiently similar to a legally marketed predicate device such that it raises no new questions of safety and effectiveness.
Since no specific performance data or a formal study with statistical acceptance criteria is detailed for the device itself in this submission, I cannot populate a table with "reported device performance." The "performance" being evaluated implicitly is its ability to meet the same intended use as the predicate device without introducing new risks.
| Acceptance Criterion (Inferred from 510(k) principles) | Reported Device Performance (Inferred/Claimed from 510(k) Summary) |
|---|---|
| Intended Use: Intermittent measurement of human body temperature of people of all ages. | The Digital Forehead Thermometer FS-100 shares the same intended use. |
| Technological Characteristics: Measurement of natural thermal infrared radiation from skin over temporal artery. | The Digital Forehead Thermometer FS-100 uses the same operational basis (measuring thermal infrared radiation). |
| General Design: Similar design and performance characteristics to predicate. | The Digital Forehead Thermometer FS-100 has the "same general design and performance characteristics" as the predicate. |
| Materials/Components: Incorporates similar materials and components. | The Digital Forehead Thermometer FS-100 incorporates "similar materials and components." |
| Safety and Effectiveness: Raises no new questions of safety and effectiveness compared to predicate. | The submitter concludes that the device is "substantially equivalent" to the predicate, implying no new safety or effectiveness concerns. |
Study Information (Based on the provided K093331/K043331 document):
Given the nature of a 510(k) summary for a thermometer seeking substantial equivalence, information typically associated with complex clinical studies for novel diagnostic or treatment devices is not present. The "study" here is primarily a comparative analysis against a predicate device, as described in the 510(k) submission.
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1. Table of Acceptance Criteria and Reported Device Performance: Already addressed above. Specific quantitative performance data (e.g., accuracy, precision) for the FS-100 are not provided in this document. The "performance" is implicitly deemed equivalent to the predicate.
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2. Sample size used for the test set and the data provenance: Not applicable/Not provided. This document does not describe a test set with a specific sample size in the context of performance metrics for the FS-100. The comparison is against the established characteristics of the predicate device.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment by experts for a test set is not detailed as part of this substantial equivalence claim.
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4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. Adjudication methods are not described in this regulatory submission.
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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: Not applicable. This device is a digital forehead thermometer, not an AI-assisted diagnostic tool for human readers.
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6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. While the thermometer operates without human interpretive input for temperature readings, the detailed performance of the underlying "algorithm" (i.e., the infrared sensing and processing) is not independently evaluated and reported in this document beyond the claim of substantial equivalence.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided in the context of a specific study for the FS-100. For a thermometer, "ground truth" would typically involve highly accurate reference temperature measurements, but no such study is detailed here.
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8. The sample size for the training set: Not applicable/Not provided. This device is not described as involving machine learning or AI that would require a "training set."
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9. How the ground truth for the training set was established: Not applicable/Not provided. As there's no described training set, this question is not relevant to the provided text.
Summary of the "Study" (or Basis for Acceptance) from the Document:
The "study" in this context is the 510(k) premarket notification process, where the manufacturer (Hubdic Company Limited, via Media Trade Corporation) submitted an application to the FDA. The core of this submission, as summarized, is a comparative analysis demonstrating that the Digital Forehead Thermometer FS-100 is:
- Intended Use: Identical to the predicate device (intermittent measurement of human body temperature of people of all ages).
- Technological Characteristics: Based on the same principles (measuring natural thermal infrared radiation from the temporal artery).
- General Design: Similar general design and performance characteristics, with main differences being physical size, shape, and weight (which are not considered to impact safety or effectiveness negatively for this type of device).
- Materials and Components: Incorporates similar materials and components.
The conclusion is that these similarities mean the device "should therefore raise no new questions of safety and effectiveness." The FDA's review of this submission resulted in a substantial equivalence determination, allowing the device to be marketed. This regulatory approval itself serves as the "proof" that the device is deemed to meet the necessary criteria for market entry based on the chosen regulatory pathway.
§ 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.