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510(k) Data Aggregation
(158 days)
The infrared thermometer is intended for the measurement and monitoring of human body temperature by physician or lay person. The device is not intended for infants less than three months.
Breeze Infrared Thermometer measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display.
The device is intended to be used in the home setting and medical institutes.The product is mainly composed of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2 X 1.5 AAA batteries.It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer.When measuring the ear temperature, the ear cover provided by the manufacturer must be used.
Here's an analysis of the acceptance criteria and study information for the Suzhou Melodicare Medical Technology Co., Ltd. Infrared Thermometer, Breeze model, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for accuracy are derived from the referenced standards, primarily ASTM E 1965-98 and ISO 80601-2-56.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Breeze model) |
|---|---|
| Accuracy: ±0.2℃ (0.4℉) (ASTM E 1965-98, ISO 80601-2-56) | ±0.2℃ (0.4℉) |
| Measurement Range: Covers human body temperature range during intended application (implied by clinical testing per ASTM E 1965-98 and ISO 80601-2-56) | 34.0℃~42.4℃ (93.2℉~108.3℉) (Verified to meet accuracy requirements within this range) |
| Electrical Safety & EMC | System complies with IEC 60601-1: 2012, IEC 60601-1-11: 2015, and IEC 60601-1-2: 2014 |
| Biocompatibility | Cytotoxicity, Skin Sensitization, and Skin Irritation tests conducted per ISO 10993-1 |
| Reprocessing: Cleaning and Disinfection | Validation testing results for cleaning and disinfection are adequate and acceptable. |
| Software Verification & Validation | Documentation provided in accordance with FDA Guidance for software with a moderate level of concern. |
| Risk Analysis | Conducted in accordance with ISO 14971: 2007. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: A minimum of 144 subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical data. It describes the clinical study as "randomized, with a simple blind homologous control." It doesn't specify if it was retrospective or prospective, but clinical studies for device submissions are typically prospective.
3. Number of Experts Used to Establish 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 in the clinical study. For clinical thermometers, ground truth often refers to a reference thermometer reading taken by trained personnel (e.g., nurses or doctors) rather than an "expert concensus" in the diagnostic imaging sense.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. For simple clinical measurements like temperature, an adjudication process involving multiple experts for ground truth is generally not applicable in the same way it would be for complex image interpretation. The ground truth is typically a direct measurement from a reference device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to measure the effect size of AI on reader performance. This device is a direct measurement clinical thermometer.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done for the device's accuracy. The "Bench Testing" section confirms that the system complies with ISO 80601-2-56: 2009 for "performance effectiveness" and the "Clinical data" section states that "Clinical testing was conducted per ASTM E 1965-98 (2009) Standard Specification for Infrared Thermometers For Intermittent Determination Of Patient Temperature." These standards directly evaluate the device's measurement accuracy against reference standards.
7. Type of Ground Truth Used
The ground truth used for the clinical study would be the measurements from a recognized reference thermometer or method as specified by the ASTM E 1965-98 standard. This standard outlines procedures for determining the accuracy of infrared thermometers against a reference temperature measurement in a clinical setting.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" or its size. Clinical thermometers, especially non-AI-driven ones, are typically calibrated during manufacturing and then validated for accuracy with a test set, rather than "trained" in the machine learning sense. If there are internal algorithms for temperature compensation or conversion, their development might involve internal data, but this is not typically disclosed or referred to as a "training set" in this context.
9. How Ground Truth for the Training Set Was Established
As no "training set" in the machine learning sense is described for this device, the establishment of ground truth for such a set is not applicable or detailed in the document. The device's performance relies on robust engineering, calibration against traceable standards, and validation of its accuracy.
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