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The devices are intended to measure the human body temperature using the forehead as measurement site. It can be used with adult or pediatric patients.

The Digital Forehead Thermometer, Model KD -2200, consists of a probe with thermister sensor and stainless steel plate, a PC board with ASIC circuits, a LCD display, a plastic main body, an ON/OFF power key, a buzzer and two AAA type batteries for the determination of human body temperature. The tip of probe is made with a thermister sensor and stainless steel plate which may sense the temperature changing. The electronic signal was transferred to ASIC circuit on PC board through sensor of probe. The LCD displays the predictive temperature or last temperature recorded and warning information during measurement.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

Disclaimer: This document is a 510(k) summary from 2007 for a medical device. The level of detail provided in such summaries is often limited, focusing on demonstrating substantial equivalence to a predicate device rather than a comprehensive disclosure of all study specifics. Therefore, some information requested might not be explicitly available in the provided text.

Description of Acceptance Criteria and Proving Study

The K-jump Health Co., Ltd. Digital Forehead Thermometer, Model KD-2200, demonstrates compliance with acceptance criteria primarily through adherence to established international standards for electronic thermometers. The study mentioned focuses on demonstrating this compliance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the device "complies with" the ASTM E1112-00 standard, which implies a performance study was conducted according to that standard's testing requirements. The ASTM E1112 standard would define the required sample size and methodology for testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The provided text does not provide any information regarding the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The provided text does not specify any adjudication method for the test set. Given the nature of a thermometer, ground truth is typically established through a calibrated reference standard, not expert consensus or adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a thermometer, not an AI-powered diagnostic tool, so the concept of human readers improving with or without AI assistance is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The provided text indicates that the device's performance was assessed in a standalone fashion conforming to the ASTM E1112-00 standard. A thermometer, by its nature, operates in a "standalone" mode, measuring temperature directly. The output (the temperature reading) is the direct result of the device's internal algorithms and sensors. There is no "human-in-the-loop" performance in the sense of interpreting an output that requires cognitive processing from a human.

7. The Type of Ground Truth Used

The ground truth used for assessing the performance of the thermometer would be calibrated reference temperatures. The ASTM E1112-00 standard dictates specific testing methodologies that involve comparing the device's readings to highly accurate and traceable reference thermometers or temperature sources. The text doesn't explicitly state "calibrated reference temperatures," but compliance with ASTM E1112-00 inherently implies this type of ground truth.

8. The Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or artificial intelligence models. This device is a traditional electronic thermometer, and therefore, there is no training set in the AI sense. Its "training" would be inherent in its design, calibration, and manufacturing processes.

9. How the Ground Truth for the Training Set was Established

As there is no training set for this type of device in the context of AI/ML, this question is not applicable. The device's accuracy is established through design validation and verification against calibrated standards during its development and manufacturing, not through a "training set" with established ground truth.

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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.

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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."

• 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.

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