(153 days)
The device is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home.
IR Ear/Forehead thermometer, which includes models DX6635, DX6637, TH1081 and TH1091, are a hand-held, reusable, battery operated device that can measures human body temperature by two ways:
- On forehead, the skin temperature on people's forehead
- In ear, the tymperature in people's ear
The working principle based on infrared sensor technology. It utilizes infrared technology to receive infrared energy emitted from the eardrum or the surface of the object and convert to a voltage. The voltage value is responsible with the different temperature between the target object and infrared sensor. Then MCU will convert this value to digital data by an analog to digital (A/D) circuit. This data will be changed to the finalized temperature data by algorithms and displayed on LCD.
Here's a breakdown of the acceptance criteria and study information for the IR Ear/Forehead thermometer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Reference) | Device Performance (Model: DX6635, DX6637, TH1081, TH1091) |
|---|---|
| Accuracy (35.5℃ ~ 42.0℃) | ±0.2℃ (0.4℉) |
| Accuracy (Other range) | ±0.3℃ (0.5℉) |
| Measurement Temperature Range | 32.0℃ ~ 42.9℃ (89.6℉ ~ 109.2℉) |
| Ambient Range (Ear) | 10℃ ~ 40℃ (50.0℉ ~ 104.0℉) |
| Ambient Range (Forehead) | 15℃ ~ 40℃ (59.0℉ ~ 104.0℉) |
| Storage Range | -20℃ ~ 55℃ (-4℉ ~ 131℉) |
| Applicable Standards Conformance | ASTM E1965-98 (2003), IEC 60601-1, IEC 60601-1-2 |
Note: The provided text primarily focuses on demonstrating substantial equivalence to a predicate device and conformance to standards rather than detailing a specific clinical study with granular raw performance data. The "Reported Device Performance" in the table reflects the specified accuracy and operational ranges claimed for the device, which are presented as being equivalent to the predicate device and in conformance with relevant standards.
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective) for clinical performance. The focus of this 510(k) summary is on substantial equivalence to a predicate device through technological characteristics and adherence to recognized standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a ground truth for a test set. This type of information would typically be found in a detailed clinical study report, which is not provided in this 510(k) summary.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method for a test set. This suggests that a multi-reader or expert-adjudicated test set in the traditional sense was not performed or at least not detailed in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, the document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The submission relies on demonstrating substantial equivalence to a predicate device and conformance to standards, rather than proving improved human reader performance with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
The document describes the device as a "hand-held, reusable, battery operated device that can measures human body temperature" and the working principle is "based on infrared sensor technology." This is a hardware device with an embedded algorithm for temperature conversion. The performance evaluation presented is intrinsically standalone in the sense that the device itself, functioning autonomously to measure temperature, is the subject of conformity to standards. There's no explicit mention of a separate "algorithm-only" performance study distinct from the device's overall operation. The device is the algorithm in this context.
7. The Type of Ground Truth Used:
The ground truth for this device's performance is implicitly based on established metrological standards and physical measurements rather than clinical outcomes or expert consensus on interpretations. The reliance on standards like ASTM E1965-98 (2003) for "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature" implies that the device's accuracy claims are benchmarked against reference thermometers or controlled temperature environments as defined by these standards.
8. The Sample Size for the Training Set:
The document does not provide any information regarding a training set sample size. This is a medical device that measures temperature using infrared technology, not a machine learning or AI algorithm that typically requires a large training dataset for model development in the way one might think of image recognition or diagnostic AI. The "algorithms" mentioned are for converting voltage to digital temperature data, likely based on known physics and calibration data, not iterative machine learning from a vast dataset.
9. How the Ground Truth for the Training Set was Established:
As there is no mention of a training set in the context of machine learning, there is no information on how a ground truth for such a set was established. The device relies on established physical principles and calibration against known temperature references (as per standards like ASTM E1965-98) during its manufacturing and design, rather than learning from labeled training data.
§ 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.