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510(k) Data Aggregation
(381 days)
The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The DT-100 infrared thermometer can be used by consumers in household environment.
The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The operation principle is based on infrared sensor technology. IR sensor can put out different signal when measuring the different object temperature or body temperature. An ASIC can turn the signal from IR sensor to a digital value and display it by LCD. The DT-100 noncontact infrared thermometer can measure body temperature at maximum 40cm between patient and product. The thermometer stores temperature measurement value up to 30, a user can compare prior measurement value and uses an alkaline battery AAA type for operation.
Here's a breakdown of the acceptance criteria and study information for the DT-100 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM E1965-98 Standard) | Reported Device Performance (DT-100) |
|---|---|
| Temperature range: 36 to 39 °C (96.8 to 102.2 °F), accuracy ± 0.2 °C (0.4 °F) | Clinical bias: 0.02 °C (within ±0.2°C) |
| Temperatures < 36 °C (96.8°F) or > 39 °C (102.2 °F), accuracy ± 0.3 °C (0.5 ° F) | Clinical bias: 0.02 °C (within ±0.3°C) |
| Repeatability (standard deviation) | Clinical repeatability (S): 0.12 (considered reasonably small) |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample size for the clinical test set is not explicitly stated. The text mentions "all participants" in reference to repeatability, suggesting a cohort of individuals.
- Provenance: The clinical investigation was conducted at Yonsei University Severance Hospital, Republic of Korea. The study was prospective as it involved a clinical investigation to evaluate the device's accuracy and repeatability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth. It states that the clinical investigation was conducted at an "Accredited by IRB" hospital, implying ethical oversight and likely involvement of medical professionals in the data collection process. However, the exact method for determining "ground truth" temperature (e.g., comparison to rectal thermometer, other validated method) is not detailed.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "clinical bias" and "clinical repeatability" were calculated based on the measurements obtained during the clinical investigation, implying a direct comparison to a reference standard rather than an adjudicated interpretation of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. This device is a thermometer, and the evaluation focuses on its accuracy and repeatability against a reference, not on how it assists human readers in interpreting images or data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done for the device. The clinical accuracy and repeatability validation test reports, which are part of the listed performance testing, would reflect the device's intrinsic performance. The clinical investigation directly assessed the device's ability to measure temperature.
7. Type of Ground Truth Used
The type of ground truth used was likely a clinical reference standard for temperature measurement, against which the DT-100's readings were compared. While not explicitly stated, in a clinical thermometer validation, this typically involves a highly accurate and validated method (e.g., rectal thermometer, or another established core body temperature measurement technique) as the "truth." The document mentions that the clinical bias and repeatability were evaluated against requirements of the ASTM E1965-98 standard, which specifies reference thermometry.
8. Sample Size for the Training Set
The document does not provide information about a training set since this is a medical device (thermometer) and not a machine learning/AI algorithm that requires a separate training phase. The discussion focuses on the validation of the device's performance through clinical and bench testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no mention of a training set for this device.
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