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510(k) Data Aggregation
(119 days)
This device is a non-sterile, reusable, contact Infrared Forehead Thermometer (Model IR-FT) intended for intermittent determination of human body temperature through a touch on the center of the forehead as the measurement site on people of all ages. The Infrared Forehead Thermometer (Model IR-FT) can be used in clinical and home environments.
The Infrared Forehead Thermometer (Model IR-FT) is a hand-held, battery powered device designed to measure human body temperature. This Forehead Thermometer takes the body temperature by measuring the infrared energy emitted from the forehead skin above the evebrows. The Forehead Thermometer adopts gentle-touch, user friendly and non-invasive measurement design. It instantly displays the reading of the body temperature with a forehead touch.
Based on the provided FDA 510(k) summary for the Infrared Forehead Thermometer (Model IR-FT), here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them:
Core Information Regarding Acceptance Criteria and Study Performance
The device under review is an Infrared Forehead Thermometer, and its performance is primarily evaluated against established standards for temperature measurement accuracy. The predicate device (K134043) sets the benchmark for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The primary performance aspect tested for this device is temperature measurement accuracy. The acceptance criteria are derived from the referenced voluntary standards, particularly ASTM E1965 and ISO 80601-2-56.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance | Source of Criteria |
|---|---|---|---|
| Temperature Range | 32.0°C ~43.0°C (89.6°F - 109.4°F) | 32.0°C ~43.0°C (89.6°F - 109.4°F) | Device Specification (note: this is a stated operating range, not an accuracy criterion to meet for equivalence, but it's compared to predicate) |
| Accuracy for Body Temp (35°C - 42°C / 95°F - 107.6°F) | ≤±0.2°C (0.4°F) | ≤±0.2°C (0.4°F) | ASTM E1965, ISO 80601-2-56 (Based on comparison to predicate device's accuracy standards) |
| Accuracy for Body Temp (32°C - 34.9°C / 89.6°F - 94.8°F) | ≤±0.3°C (0.5°F) | ≤±0.3°C (0.5°F) | ASTM E1965, ISO 80601-2-56 (Based on comparison to predicate device's accuracy standards) |
| Accuracy for Body Temp (42.1°C - 43°C / 107.8°F - 109.4°F) | ≤±0.3°C (0.5°F) | ≤±0.3°C (0.5°F) | ASTM E1965, ISO 80601-2-56 (Based on comparison to predicate device's accuracy standards) |
| Resolution of Display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Device Specification (Same as predicate) |
| Clinical Acceptability (Bias & Repeatability) | Within clinical acceptability as defined in ISO 80601-2-56 | Demonstrated "highly related" temperatures and within clinical acceptability. | ISO 80601-2-56 (Clinical Comparison Study) |
| Safety (Electrical/EMC) | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Compliance achieved | ANSI/AAMI ES60601-1, AAMI/ANSI ES60601-1-2, IEC 60601-1-11 |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 | Compliance achieved | ISO 10993-1, -5, -10 |
| Cleaning Validation | Cleaning method meets requirements | Validation result shows method meets requirements | Instruction for Use (IFU) Protocol |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set (Clinical Accuracy Validation): The document states that a "comparison study and clinical repeatability testing was performed on the following three age groups: 0-12 months, 12 months - 5 years - 5 years older".
- Specific Sample Size: The exact number of subjects within each age group, or the total number of subjects, is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin for the clinical data. It also does not explicitly state whether the study was retrospective or prospective, but clinical comparison studies for medical device clearance are typically prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This device is a thermometer, and the ground truth for temperature measurement is typically established using a calibrated reference thermometer (e.g., a Vitreous thermometer as mentioned), rather than expert consensus on interpretation of diagnostic images. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists for imaging studies) is not directly applicable here. The "experts" in this context would be the technicians or clinicians trained in using the reference thermometer and conducting the study according to the specified standards (ISO 80601-2-56).
- Qualifications: Not specified for the personnel conducting the clinical validation, but it's implied they followed standard clinical trial and instrument calibration procedures as per the referenced ISO standard.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation of data (e.g., medical images) is subjective and requires consensus. For a physical measurement device like a thermometer, the "ground truth" is established by a more precise, calibrated measurement standard.
- Adjudication Method: Not applicable in the sense of expert consensus on interpretation. The "adjudication" is the direct numerical comparison of the device's readings against the reference thermometer's readings, as outlined by the standards.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic aids where the AI assists human readers (e.g., radiologists interpreting images). This device is a standalone measurement tool.
- Effect Size: Not applicable.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: While the device relies on embedded algorithms/firmware for temperature calculation, the performance study described is the standalone performance of the device itself (measurement accuracy), without a human interpretation "loop" in the sense of a diagnostic aid. The "human-in-the-loop" for this device would be the user taking the temperature reading, but the study focuses on the instrument's accuracy regardless of the interpretive skill of the user. The "clinical accuracy validation" assesses the device's inherent ability to measure temperature correctly compared to a standard.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the clinical accuracy validation was established using a Vitreous thermometer. This implies an established, highly accurate reference measurement tool as the gold standard for body temperature.
- This falls under the category of using a clinical reference standard/device rather than expert consensus, pathology, or outcomes data directly.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable/Not stated. This device is a physical measurement instrument, not a machine learning (AI) algorithm that requires a separate training set of data. Its "training" is inherent in its design and manufacturing, and its performance is validated through non-clinical and clinical testing, not model training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As mentioned above, there isn't a "training set" for a traditional AI algorithm in the context of this device. The accuracy of the device is validated against the specified standards using a reference thermometer, not "trained" on a dataset with ground truth.
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