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510(k) Data Aggregation
(48 days)
THERMOFINDER; THERMOCARE
The Non-Contact Infrared Thermometer is intended for measurement and monitoring of human body temperature.
The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature. Its operation is based on measuring the natural thermal radiation from the forehead and the adjacent surforms a calculation that factors in room temperature, and then a calculated temperature is displayed on the LCD.
Here's a breakdown of the acceptance criteria and study information for the Non-Contact Infrared Thermometer, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by the accuracy specifications, which are implicitly the performance requirements for the device. The reported device performance is presented as its specifications. Since this is a 510(k) submission where the device is effectively the same as its predicate, the performance criteria are met by demonstrating the device has these specifications.
| Characteristic | Acceptance Criteria (Specification) | Reported Device Performance (Value) |
|---|---|---|
| Measurement Method | Infrared measurement, Contactless measurement | Infrared measurement, Contactless measurement |
| Measurement Range | Object: 15.0°C ~ 60.0°C | |
| Body: 34.0°C ~ 42.5°C | Object: 15.0°C ~ 60.0°C | |
| Body: 34.0°C ~ 42.5°C | ||
| Accuracy (Object) | ±2.0°C (for 15.0°C ~ 60.0°C) | ±2.0°C (for 15.0°C ~ 60.0°C) |
| Accuracy (Body) | ±0.3°C (for 34.0°C ~ 35.9°C) | |
| ±0.2°C (for 36.0°C ~ 39.0°C) | ||
| ±0.3°C (for 39.1°C ~ 42.5°C) | ±0.3°C (for 34.0°C ~ 35.9°C) | |
| ±0.2°C (for 36.0°C ~ 39.0°C) | ||
| ±0.3°C (for 39.1°C ~ 42.5°C) | ||
| Humidity (FS-301) | 20 ~ 90% RH (Operating Range) | |
| ±10% (Accuracy for Humidity) | 20 ~ 90% RH (Operating Range) | |
| ±10% (Accuracy for Humidity) | ||
| Display Format | LCD display | LCD display |
| Display Unit | 0.1°C | 0.1°C |
| Power Idle Mode | After 60 seconds | After 60 seconds |
| Measurement Time | Less than 2 seconds | Less than 2 seconds |
| Battery Life | At least 5,000 measurements | At least 5,000 measurements |
| Weight | 120g (without holder and batteries) | 120g (without holder and batteries) |
| Safety & Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, ISO 14971 (General requirements for medical electrical equipment safety, EMC, programmable systems, risk management) | The device "has been manufactured and tested to meet the following safety and effectiveness requirements" (listing the standards as fulfilled), indicating compliance (This is explicitly stated as being met, not just a goal) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" or a sample size beyond stating that the device "has been manufactured and tested to meet" the listed standards. This implies that the testing for these specifications was conducted, but the details of how many units were tested or what specific individuals were tested on are not provided.
The provenance of this data is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned for any clinical testing. The core argument for substantial equivalence relies on the fact that the device is "exactly same as its predicate device (K101912)", meaning its performance is considered equivalent to the predicate's established performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given that this is a thermometer and the key performance metrics are accuracy against defined temperature ranges, it's highly probable that ground truth would be established using NIST-traceable reference thermometers or controlled temperature environments, rather than expert human interpretation in a clinical context.
4. Adjudication Method for the Test Set
This information is not provided in the document. As mentioned above, the nature of thermometer testing typically involves direct measurement comparisons, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for image-based diagnostic devices where human readers interpret results, comparing their performance with and without AI assistance. This is not applicable to a non-contact infrared thermometer.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone measurement device with no explicit "algorithm" in the sense of a complex AI or diagnostic algorithm that would require a separate standalone performance study. Its performance as an independent device is described by its accuracy specifications. The device includes a "calculation that factors in room temperature," but this is a standard engineering control, not an AI algorithm requiring a standalone study in the context of device approval.
7. The Type of Ground Truth Used
The ground truth used for verifying the accuracy of a non-contact infrared thermometer would typically be established by controlled laboratory conditions using calibrated reference thermometers (e.g., fluid baths, blackbody simulators) and/or potentially comparison with invasive core body temperature measurements in clinical studies. The document does not explicitly state the specific method of ground truth establishment, but it refers to meeting specific accuracy claims.
8. The Sample Size for the Training Set
No training set is referenced or relevant to this device. This device is a hardware measurement tool, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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