(293 days)
The ARC InstaTemp™ is an infrared thermometer that measures from the forehead in both infants and adults without contacting the human body.
The ARC InstaTemp MD™ is an infrared thermometer that measures from the forehead in both infants and adults without contacting the human body. It is intended for use by a Health Care Professional in a clinical environment. This device is not intended for home use.
The ARC Non-Touch Thermometer is a fast, accurate and non-intrusive device for measuring a person's temperature. It uses infrared sensor technology to detect the radiated infrared energy emitted from the forehead. Therefore as soon as the sensor is held near the forehead and activated, the temperature measurement is taken by detection of the emitted infrared heat generated by the arterial blood flow.
The ARC Non-Touch Thermometer uses sensor technology that detects the emitted heat from the temporal artery in the forehead from a distance of approximately 1 inch. Once recorded an internal algorithm converts this forehead surface temperature into human body temperature and it is this temperature that is then presented to the user on the LCD screen. This temporal artery detection mechanism and the resulting conversion to body temperature characterizes the ARC Non-Touch Thermometers as an adjusted mode clinical thermometer as per ISO 80601-2-56.
The document describes the acceptance criteria and the study that proves the device meets the criteria for the ARC InstaTemp™ Non-touch Thermometer and ARC InstaTemp™ MD Non-touch Thermometer.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (Predicate Device K090361) | Reported Device Performance (ARC InstaTemp™ / ARC InstaTemp MD™) | Notes |
|---|---|---|---|
| Accuracy | ± 0.3ºC | ± 0.2ºC | The sponsor states that this was "Verified by compliance testing to IEC 60601-1." This indicates that the new device meets or exceeds the accuracy of the predicate, and this was confirmed through a standardized compliance test. The clinical performance data confirms the accuracy and reproducibility for both febrile and non-febrile patients, indicating that the device's enhanced accuracy is validated in a real-world setting. This suggests that the device's accuracy is not just a theoretical improvement but one that performs robustly across different patient states. |
| Precision | ± 0.3ºC (34-35.9ºC) | ||
| ± 0.2ºC (36-39ºC) | |||
| ± 0.3ºC (39-42.5ºC) | ± 0.2ºC | The sponsor states that this was "Verified by compliance testing to IEC 60601-1." This indicates that the new device meets or exceeds the precision of the predicate, and this was confirmed through a standardized compliance test. The clinical performance data confirms the accuracy and reproducibility for both febrile and non-febrile patients, indicating that the device's enhanced precision is validated in a real-world setting. | |
| Measurement Method | Infrared sensor detecting emitted heat from temporal artery, converts forehead surface temperature to body temperature. | Infrared sensor detecting emitted heat from temporal artery, converts forehead surface temperature to body temperature. | Same. This indicates that the fundamental technology for temperature measurement and conversion is identical to the predicate, which supports the claim of substantial equivalence. |
| Range (Body Mode) | 32-42.9ºC | 32-42.8ºC | Same. Although there's a slight difference in the upper limit (42.9ºC vs 42.8ºC), this minor variation is generally considered acceptable within the context of clinical thermometry, especially since the overall operating range covers typical fever temperatures. As stated by the sponsor, the range is considered "same," which suggests clinical equivalence. |
| Measurement Distance | 5-8cm | 1-3cm | The sponsor states this is "acceptable" and notes that "Reduction of the measurement distance reduces the noise due to ambient temperature. 1-3cm is a comfortable distance for the user to operate these thermometers." This indicates a design improvement that enhances usability and potentially measurement accuracy by minimizing environmental interference. |
| Power Supply | 2 x AA Battery | 2 x AAAA Battery | The sponsor states this is "acceptable" and notes that "The batteries were verified as being acceptable as part fulfillment of compliance testing to IEC 60601-1." This change in battery type is a non-clinical difference that does not impact the core function or safety when verified through a recognized standard. |
| Operating Temperature | 10ºC to 40ºC | 10ºC to 40ºC | Same. |
| Display | LCD | LCD | Same. |
| Display Resolution | 0.1ºC | 0.1ºC | Same. |
| Celsius/Fahrenheit | Yes | Yes | Same. |
| LED Backlight | Yes | Yes | Same. |
| Automatic Stop | 5 seconds | 4 + 0.5 seconds | Same. A minor difference in automatic shut-off time, but still consistent in offering an automated power-saving feature. The sponsor states "Same." |
| Dimensions | 196x150x50mm (LxWxH) | 129x35x13mm (LxWxH) | The sponsor states this is "acceptable" and notes that "The changes in dimensions have no effect on functionality of the thermometer. The modified dimensions are deemed acceptable as the unit can be used by a single operator in the same way as the predicate." The smaller dimensions likely represent an improvement in design and portability and do not negatively impact the device's core function. |
| Material in contact with operator's hand | ABS | Polycarbonate | The sponsor states this change is acceptable, noting that "Both ABS and Polycarbonate are used widespread in the medical device field and neither have any concerns from a user safety viewpoint. In addition the material does not affect the performance of the device." Biocompatibility testing was successfully completed per ISO 10993-5:2009 and ISO 10993-10:2010. This indicates that despite the material change, the device adheres to safety standards for patient interaction. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 136 subjects.
- Data Provenance: Not explicitly stated, but the "clinical trial" suggests prospective data collection specifically for validating the device's clinical performance. The country of origin for the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. The term "ground truth" as it relates to expert consensus for a test set is typically used in the context of diagnostic imaging or AI applications where human interpretation needs to be validated. For a thermometer, the "ground truth" would typically be established by a reference temperature measurement method, not through expert consensus on the device's reading. The document refers to "clinical accuracy validation as defined in ISO 80601-2-56," which implies comparison against a calibrated reference temperature source, likely in a controlled clinical setting.
4. Adjudication Method for the Test Set:
- Adjudication method for the test set is not applicable and therefore not provided as this is a device for measuring temperature, not for making subjective diagnoses based on images or other complex data requiring expert review and consensus. The accuracy is assessed against a traceable reference standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs. without AI Assistance:
- An MRMC comparative effectiveness study is not applicable as this describes a standalone thermometer device, not an AI-assisted diagnostic tool that would involve human readers interpreting data. Therefore, no effect size of human improvement with AI is provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, a standalone performance study was done. The device itself (ARC InstaTemp™ / ARC InstaTemp MD™) is a standalone infrared thermometer. Its performance, including accuracy and precision, was evaluated directly through bench testing (ASTM E1965-98) and a clinical trial. The "algorithm" here refers to the internal conversion of forehead surface temperature to human body temperature.
7. The Type of Ground Truth Used:
- The ground truth for the device's accuracy and precision was established through clinical accuracy validation as defined in ISO 80601-2-56. This standard typically requires comparison against a highly accurate and traceable reference thermometer, often an electronic thermometer measuring core body temperature, in a controlled environment with human subjects. The aim is to verify that the device's measurements reflect actual body temperature with acceptable deviation.
8. The Sample Size for the Training Set:
- The document does not specify a separate training set or its sample size. This type of device relies on a fixed algorithm (converting surface temperature to body temperature) rather than a machine learning model that would require a distinct training set. The algorithm itself is likely based on physiological principles and validated against extensive prior research or internal data during its development, not through a 'training set' in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established:
- Since a separate "training set" in the context of machine learning is not applicable to this device as described, the method for establishing its ground truth is not provided. The device's internal algorithm for converting forehead temperature to body temperature would have been developed and refined based on established thermophysiological models and potentially internal empirical data, validated through bench and clinical testing against reference standards.
§ 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.