(114 days)
The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use.
The Infrared Thermometer, Models RN-60A and RN-60B are hand-held device powered by 2*AAA batteries and designed to measure human body temperature without contacting patient' forehead. The Infrared Thermometers RN-60A and RN-60B measure the temperature by using the principle of receiving infrared. An object with a temperature higher than absolute zero will radiate a certain amount of infrared energy. According to the infrared energy and wavelength, the surface temperature of the object can be determined. The temperature of human forehead is relatively constant, so the temperature of human forehead can be measured according to this principle. The thermometer adopts a new CMOS compatible thermopile sensor with good sensitivity. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then display on the LCD screen in digital form. The measurement distance of the subject device is 3~5 cm from the forehead. The only differences among the RN-60A and RN-60B thermometers are size, weight, shape of enclosure.
The provided document describes the FDA 510(k) clearance for an Infrared Thermometer (Models RN-60A, RN-60B). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a novel device meets specific performance criteria against a predefined standard of care.
Therefore, the information required to fully describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device (as implied by the detailed questions about sample size for training/test sets, expert adjudication, MRMC studies, etc.) is largely not applicable (N/A) to this specific device (an infrared thermometer) or the type of 510(k) submission described.
However, I can extract the relevant performance data for the infrared thermometer and discuss the "acceptance criteria" and "study" as presented in the document for this traditional medical device.
Key points from the document regarding "acceptance criteria" and "study":
- Acceptance Criteria: For this device, the primary "acceptance criteria" are compliance with established performance standards for infrared thermometers, specifically ASTM E1965-98 (Reapproved 2016), and demonstrating substantial equivalence to a predicate device (Shenzhen Calibeur Industries Co., Ltd. Infrared Thermometer, Model DT-8836T, DT-8836P, K191251).
- Study Proving Acceptance: A "clinical accuracy validation test" was conducted per ASTM E1965-98.
Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for a non-AI device:
1. A table of acceptance criteria and the reported device performance
For a traditional device like a thermometer, "acceptance criteria" are typically defined by recognized standards and "reported device performance" demonstrates adherence to these.
| Criterion Type | Acceptance Criteria (from ASTM E1965-98 as referenced) | Reported Device Performance (as stated in comparison) |
|---|---|---|
| Accuracy | Specified by ASTM E1965-98 | Forehead mode: USD ±0.2°C (0.4°F) within (96.8°F ~ 102.2°F), USD ±0.3°C (0.5°F) when 39.0°C (102.2°F). (The document states the device "complied with the requirement of ASTM E1965-98 (2016)" which implies this accuracy was met.) |
| Measurement Range | Specified by ASTM E1965-98 | Forehead mode: 32.0°C ~42.9°C (89.6 to 109.2 ° F). (The document notes this is different from the predicate but states "the measurement range of subject devices meet the requirements of ASTME1965-98.") |
| Response Time | Not explicitly stated as an acceptance criterion | 1 second |
| Measurement Distance | Not explicitly stated as an acceptance criterion | 3~5 cm (The document notes this is different from the predicate but states "the performance test result of subject device shows the accuracy meets the requirements within the distance range.") |
| Operational and Storage Environment | Specified by IEC60601-1 and ISO80601-2-56 | Operation: 5.0°C |
| Storage: -25.0℃ | ||
| Safety and EMC | Compliance with IEC 60601-1, IEC 60601-1-2 | Non-clinical tests demonstrated compliance with IEC 60601-1:2012, IEC 60601-1-2:2014, and IEC 60601-1-11:2015. |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 | Tests confirmed compliance with ISO 10993-5:2009 and ISO 10993-10:2010. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: A clinical study included a minimum of 178 subjects. These subjects were divided into three age groups:
- Group A1: 1 month up to 3 months
- Group A2: 3 months up to 1 year
- Group B: greater than 1 to 5 years old
- Group C: Above 5 years old
- Each group had at least 30 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from a Chinese company (Ningbo Ranor Medical Science & Technology Co., Ltd.) and the correspondent is in Shanghai. The study design is described as a "randomization, simple blind homologous control, pairing design of clinical investigation." It is not specified if it was retrospective or prospective, but clinical accuracy studies for new devices are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. For an infrared thermometer, "ground truth" for body temperature measurement typically involves a highly accurate reference thermometer (e.g., a rectal thermometer for core body temperature) used in a clinical setting, rather than expert interpretation of images or data. The document does not mention the use of experts in this capacity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. This concept is primarily relevant for studies involving human interpretation (e.g., radiologists reading images). For a thermometer's accuracy study, the "ground truth" is typically a direct physiological measurement, and adjudication methods like 2+1 are not applicable.
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
- N/A. This is a traditional thermometer device, not an AI/ML device. Therefore, no MRMC study involving human readers or AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in concept. The "clinical accuracy validation test" described for the thermometer is essentially a standalone performance evaluation of the device itself against a reference standard, without human-in-the-loop assistance for measurement interpretation (as the device provides a direct digital readout). There is no "algorithm" in the AI/ML sense, but the device's internal processing to convert infrared signals to temperature is tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the clinical accuracy validation test would be established using a highly accurate reference thermometer (e.g., a rectal thermometer or other core body temperature measurement device) as per the requirements of ASTM E1965-98. The document specifically states "Clinical tests were conducted per ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature," which outlines the methodology for ground truth establishment.
8. The sample size for the training set
- N/A. This is a hardware device (infrared thermometer) with no mention of machine learning or deep learning algorithms that would require a "training set" in the context of AI.
9. How the ground truth for the training set was established
- N/A. As no training set for AI was used.
§ 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.