(147 days)
The Non-contact Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch mode on the centre of the forehead as the measurement site on people of all ages.
The Non-contact Forehead Thermometer (Model TH1009N) is a hand-held, battery powered device designed to measure human body temperature. The TH1009N is a kind of medical device that utilize infrared radiation to measure body temperature. The Non-contact Forehead Thermometer is intended to measure forehead temperature.
The Non-contact Forehead Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, and an infrared distance sensor for detection of contact or non-contact (at a distance of approximately 0-5cm) use and compensation of the temperature reading.
The provided document is a 510(k) Summary for a Non-contact Forehead Thermometer (Model TH1009N). Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the information provided:
1. Table of acceptance criteria and the reported device performance
| Criteria Category | Acceptance Criteria (Stated by standard or implicitly accepted by FDA) | Reported Device Performance (from the document) |
|---|---|---|
| Accuracy | ±0.2 °C (0.4°F) for 35.0°C (95.0°F)-42.0°C (107.6°F), ±0.3 °C (0.5°F) for other ranges (This matches the predicate's accuracy range in the comparison table, implicitly setting the acceptance criteria) | ±0.2 °C (0.4°F) for 35.0°C (95.0°F)-42.0°C (107.6°F), ±0.3 °C (0.5°F) for Other range |
| Body Measuring Range | Wider than 34.4 - 42.2 °C (93.9 -108 °F) (Predicate's range, the subject device aims to meet or exceed relevant standards) | 32.0-42.9 °C (89.6-109.3°F) |
| Ambient Range | Wider than 15 °C - 40°C (59.0°F-104.0°F) (Predicate's range, the subject device aims to meet or exceed relevant standards) | 5.0 °C-59.9°C (41.0°F-104°F) |
| Operating Temperature | 15.0°C - 40.0°C (59.0°F - 104.0°F) with a relative humidity of 15%~85%, Atmosphere pressure: 700hPa-1060hPa | 15.0°C - 40.0°C (59.0°F - 104.0°F) with a relative humidity of 15%~85%, Atmosphere pressure: 700hPa-1060hPa |
| Storage & Transport Temperature | Wider than -25 °C to 60 °C (-13 °F to 140 °F) Humidity: 15 - 95% non condensing, 700-1060hPA (0.7-1.06 atm) (Predicate's range, the subject device aims to meet or exceed relevant standards) | -20°C - 55°C (-4°F - 131°F) with a relative humidity of 15%~90%, Atmosphere pressure: 700hPa-1060hPa |
| Electrical Safety | Compliance with IEC 60601-1:2005+A1:2012 and ISO 80601-2-56:2009 | "Results of these tests demonstrate compliance to the requirements..." for these standards. |
| EMC | Compliance with IEC 60601-1-2:2007 | "Results of these tests demonstrate compliance to the requirements..." for this standard. |
| Biocompatibility | Compliance with ISO 10993-5:2009 and ISO 10993-10:2010 | "Results of these tests demonstrate compliance to the requirements..." for these standards. |
| Software Verification & Validation | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (FDA guidance) and IEC 62304 for a "Moderate" level of concern. | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... IEC 62304 was followed." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for the clinical evaluation. The document mentions a "clinical evaluation..." conducted in compliance with ASTM E1965-98. ASTM E1965-98 specifies the clinical accuracy requirements for infrared thermometers (e.g., in Section 8), which typically involves a minimum number of subjects (e.g., 50 subjects for clinical accuracy studies, as per older versions of similar standards, but the exact number isn't in this document).
- Data Provenance: The "Clinical evaluation of Non-contact Forehead Thermometer was conducted by Shenzhen Dongdixin Technology Co., Ltd". This implies the study was conducted by the manufacturer, likely in China. The document does not specify if the data was retrospective or prospective, but clinical evaluations are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. For thermometer accuracy, "ground truth" is typically established by comparing the device reading against a highly accurate reference thermometer (e.g., an oral or rectal thermometer with known accuracy, or a blackbody simulator), rather than expert interpretation.
4. Adjudication method for the test set
- This information is not applicable and therefore not provided, as the ground truth for thermometer accuracy is typically a direct measurement from a reference device, not an interpretation requiring adjudication.
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
- This is not applicable. This device is a non-contact forehead thermometer, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable in the context of "algorithm only" performance as commonly discussed for AI/ML devices. The device itself is standalone in that it provides a temperature reading without human interpretation for the result. Its "performance" is its accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the clinical evaluation, the ground truth would be established by measurements from a highly accurate reference clinical thermometer (e.g., an oral or rectal thermometer) as specified by the ASTM E1965-98 standard. The document states the clinical evaluation was in compliance with this standard.
8. The sample size for the training set
- This information is not applicable and therefore not provided. The device described does not appear to involve machine learning or AI that would require a "training set" in the conventional sense. Its function is based on infrared sensing and internal algorithms, not on learning from a large dataset.
9. How the ground truth for the training set was established
- This information is not applicable as there is no mention of a training set for machine learning or AI algorithms within the provided documentation.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.