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510(k) Data Aggregation
(156 days)
The Infrared Forehead Thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.
The subject device Infrared Forehead Thermometer has three models: LFR30B, LFR50 and LFR60. The three modes have same operation principle. A thermopile sensor is employed to detect the infrared energy emitted from the surface of the skin of the forehead which is converted into temperature measurement with the unit of degree C or degree F. The results can be displayed on LCD. The measurement is non-contact with the patient. The measuring distance is 0~5 cm to the forehead and the measuring time is 1s. The Infrared Forehead Thermometer is battery powered.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets those criteria:
Device: Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
1. Table of Acceptance Criteria and Reported Device Performance
The provided document refers to compliance with performance standards rather than explicitly listing acceptance criteria with numeric targets for all aspects. However, based on the discussions and the standards invoked, we can infer some key performance criteria.
| Acceptance Criteria Category | Specific Criteria (Target/Standard) | Reported Device Performance |
|---|---|---|
| Measurement Accuracy | ±0.3°C (±0.5°F) within 34.0 | The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965 for measuring accuracy. |
| Measuring Range | 32-43°C/89.6-109.4°F (as per IEC 80601-2-56) | The performance testing shows that the subject device complies with performance standard IEC 80601-2-56. |
| Measurement Distance | Ability to measure accurately within 0-5 cm (as per IEC 80601-2-56 and ASTM E1965) | The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. |
| Operating Condition | Functionality within 5°C | The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. |
| Storage/Transport Condition | Functionality within -20°C~+55°C, Relative Humidity < 95% (as per IEC 80601-2-56 and ASTM E1965) | The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. |
| Biocompatibility | No cytotoxicity, no sensitization, negligible irritation (as per ISO 10993-5 and ISO 10993-10) | In Vitro Cytotoxicity Study: MEM test extracts considered no cytotoxicity potential. Skin Sensitization Study: No evidence of causing delayed dermal contact sensitization. Skin Irritation Study: Irritation response classified as Negligible for polar and non-polar extracts. |
| Software Validation | Developed, documented, and validated in accordance with IEC 62304 and FDA guidance. | Software was validated according to FDA's software guidance. |
| Clinical Repeatability | Within clinical acceptability as defined in ISO 80601-2-56. | Clinical repeatability as defined in the ISO 80601-2-56 standard were within clinical acceptability. |
| Clinical Bias | Within clinical acceptability as defined in ISO 80601-2-56. | Clinical bias with stated uncertainty as defined in the ISO 80601-2-56 standard were within clinical acceptability. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): The clinical study involved "four age groups: 0 up to 3 months, 3 months up to 1 year, older than 1 year and younger than 5 years and older than 5 years". The exact number of subjects within each group or total subjects is not specified in this document.
- Data Provenance: Not explicitly stated (e.g., country of origin). However, the sponsor is Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. from Shenzhen, Guangdong, China. It is highly probable the data originates from China.
- Retrospective or Prospective: Not explicitly stated, but clinical comparison studies are generally prospective. The text "A comparison study and clinical repeatability testing was performed" suggests a prospective collection of data for this study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document states that a clinical comparison study was performed "to compare the Infrared Forehead Thermometer with Mercury thermometer." This implies the Mercury thermometer served as the reference standard (ground truth). The text does not mention human experts establishing ground truth for individual measurements, but rather the objective measurement from a validated reference device.
4. Adjudication Method for the Test Set
Not applicable/not mentioned, as the ground truth was established by comparison to a Mercury thermometer, not by expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study described is a clinical comparison study of the device against a reference measurement tool (Mercury thermometer) for temperature measurement, not a study involving human readers interpreting results with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the studies described are standalone performance evaluations. The device's measurement accuracy, range, and other characteristics were tested directly against standards and a reference thermometer. The clinical study compares the device's output (algorithm only) to the Mercury thermometer.
7. The Type of Ground Truth Used
The primary ground truth for the clinical study was the measurement obtained from a Mercury thermometer. This serves as a widely accepted clinical standard for body temperature measurement.
8. The Sample Size for the Training Set
The document does not mention a distinct "training set" in the context of device development or performance testing for regulatory submission. It refers to a "software" and indicates it was developed, documented, and validated according to IEC 62304 and FDA guidance. This suggests the software development process involved appropriate internal testing, but no specific "training set" for an AI/ML algorithm is detailed, given this is primarily a hardware device with embedded control software.
9. How the Ground Truth for the Training Set Was Established
Not applicable/not mentioned, as no explicit training set for an AI/ML model for temperature measurement is described. The control software likely operates based on physical principles and calibration rather than a trained AI model.
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