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510(k) Data Aggregation
(282 days)
Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 2-5cm for people of all ages. The device is reusable for home use and clinical use.
Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead temperature when measure from 2-5 cm of the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings. lt composed by a measuring sensor, PCB, 4 buttons, an LCD and an enclosure. The functions of the five models are same. Press the measurement key to turn on the device. The screen of the device lights up. The LCD screen has the power status, measurement mode, temperature unit and measurement temperature. Press the "Setting" key to open the F1: The function of "Temperature Unit" can be set. When measuring body temperature, users need to measure in body mode from 2-5 cm from their forehead. Press the trigger, after 1 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 17 sec. The difference between these models is only the model's name.
The provided text describes the regulatory clearance for an infrared thermometer and includes sections on non-clinical and clinical testing. However, it does not contain the specific level of detail requested for a comprehensive breakdown of acceptance criteria and study particulars, especially regarding AI/ML device performance.
Therefore, for aspects directly related to the performance of the infrared thermometer and its compliance with standards, I can extract information. For aspects like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Sample size for the training set," the document does not provide this level of detail as it pertains to a medical device clearance, not an AI/ML algorithm study.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the standards the device claims to meet, particularly ISO 80601-2-56 and ASTM E1965-98. The reported performance is that the device "complied" with these standards. Specific numerical values for criteria and performance are given for "Measuring accuracy."
| Acceptance Criteria (from ASTM E1965-98 / ISO 80601-2-56 compliance) | Reported Device Performance (as stated in comparison table) | Additional Detail from Comparison Table |
|---|---|---|
| Measuring Accuracy: | ||
| (Implicitly meets standard requirements) | $32°C ~ 39°C: ±0.2°C (89.6°F ~ 102.2°F: ±0.4°F)$ | Predicate Device Accuracy: |
| $32°C ~ 34.9°C: ±0.3°C (±0.5°F)$ | ||
| $35°C ~ 42°C: ±0.2°C (±0.4°F)$ | ||
| $42.1°C ~ 42.9°C: ±0.3°C (±0.5°F)$ | ||
| $39°C ~ 42.9°C: ±0.3°C (102.2°F ~ 109.2°F: ±0.5°F)$ | Note: The subject device's accuracy specifications are slightly different from the predicate but both comply with the reference standards. | |
| Measuring Range: | $32.0°C ~ 42.9°C (89.6°F to 109.2°F)$ | Same as predicate |
| Display Resolution: | $0.1°C/0.1°F$ | Same as predicate |
| Measurement Distance: | 2-5cm (meets standard requirements, within predicate's range) | Predicate: 1-5cm |
| Operational Environmental Conditions: | Temperature: 10°C ~ 40°C (50 ~ 104°F) | |
| Humidity: ≤85% | Predicate: Temperature: 10 ~ 40°C (50 ~ 104°F) | |
| Humidity: ≤95% (Subject device has stricter humidity range) | ||
| Storage Environmental Conditions: | Temperature: -25°C ~ 70°C (-13 ~ 219.2°F) | |
| Humidity: ≤95% | Predicate: Temperature: -20°C ~ 60°C (-4 ~ 140°F) | |
| Humidity: ≤95% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 240 subjects.
- Data Provenance: The document does not explicitly state the country of origin but implies a clinical setting ("clinical tests were conducted"). It is a prospective clinical performance test ("clinical performance test protocol and data analysis is conducted as a requirement of ASTM E1965-98 (2016)").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The context is a clinical thermometer, where ground truth is typically established by direct measurement of body temperature using a reference standard thermometer (e.g., a rectal thermometer or other highly accurate clinical thermometer) at the same time and under controlled conditions, not by expert consensus on image interpretation.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided and is not typically relevant for a clinical thermometer performance study.
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 type of study is relevant for AI/ML-driven diagnostic tools where human readers interpret medical images or data. The device in question is a standalone infrared thermometer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The clinical performance test evaluated the device (models YRK-002A, T8, T9, T10, T11) directly by measuring human body temperature. The report states that "the clinical performance of the subject device complied with ASTM E1965-98 (2016)." This indicates the device's performance was assessed as a standalone unit.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth in clinical thermometer studies is typically a simultaneous measurement from a highly accurate reference thermometer (e.g., a rectal or oral thermometer, traceable to national standards) in a controlled clinical setting. The document only states "The clinical performance test protocol and data analysis were conducted in accordance with the ASTM E1965-98 (2016)," which would implicitly define the ground truth methodology.
8. The Sample Size for the Training Set
- Not applicable / not provided. This device is a traditional infrared thermometer, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / not provided. As mentioned above, this is not an AI/ML device.
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