(153 days)
The FT101 Forehead Thermometer is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.
The FT101 Forehead Thermometer is an over-the-counter, non-sterile, reusable, nonpredictive clinical electronic thermometer designed to measure and assess the temperature of humans of all age ranges using an infrared detector to detect heat emission from the forehead. The measured temperature correlates to axillary temperature, and is displayed on a built-in LCD display. Calendar/clock functions are provided, and a memory function stores up to 10 temperature readings. The temperature reading range is 34 °C – 42.2 °C (92.3 F to 108.0 F), and the time of measurement is approximately 2 seconds, with a recommended cycle time of at least 30 seconds between readings. The unit operates in an ambient temperature range of 16 C – 35 C (61 F to 95 F). The FT101 Forehead Thermometer is entirely self-contained within one housing, and is battery-powered. The device is compact in size and weight, easy to use, portable and may be used in a variety of home or clinical settings.
The provided documentation is a 510(k) summary for the FT101 Forehead Thermometer, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel efficacy claims. As such, information regarding comprehensive clinical trials with specific acceptance criteria, sample sizes for training/test sets, expert qualifications, and detailed statistical analysis often found in studies for new drugs or high-risk devices is generally not included in this format.
Based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria or a detailed breakdown of reported device performance as one might expect from a formal efficacy study. However, it states compliance with voluntary standards, which implicitly define performance criteria.
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Implied Acceptance Criteria (from standard compliance):
- Accuracy: Conformance with ASTM E1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature). This standard likely specifies accuracy limits (e.g., maximum permissible error at certain temperature ranges).
- Safety: Conformance with EN 60601-1/A13 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and EN 60601-1-2 (Electromagnetic compatibility - Requirements and tests).
- Specific Temperature Range: The device claims a reading range of 34 °C – 42.2 °C (92.3 F to 108.0 F).
- Measurement Time: Approximately 2 seconds, with a recommended cycle time of at least 30 seconds between readings.
- Ambient Temperature Range: Operates in 16 C – 35 C (61 F to 95 F).
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Reported Device Performance: The document only generally states that "safety and efficacy performance of the device has been established clinically and non-clinically through comparative testing to market-cleared devices in accordance with ASTM E1965-98 and prEN 12470-5 voluntary standards, and without raising new safety or effectiveness issues." No specific accuracy figures (e.g., mean difference, standard deviation of error) or sensitivity/specificity values are provided.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for clinical testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "comparative testing to market-cleared devices." For a 510(k), often the clinical data requirement is less stringent than for a PMA, sometimes relying on equivalence to a predicate device's performance rather than large-scale de novo efficacy trials.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided in the document. Given that the device measures a physical parameter (temperature), the "ground truth" would likely be established by a reference thermometer standard (e.g., a calibrated contact thermometer) rather than expert consensus on interpretation.
4. Adjudication Method
The document does not mention any adjudication method, which is typically relevant for studies involving subjective interpretation (e.g., reading medical images) rather than objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. This type of study is usually conducted for diagnostic imaging devices where human readers interpret outputs, often with AI assistance. The FT101 is a direct measurement device, not an interpretation aid.
6. Standalone Performance Study (Algorithm Only)
The FT101 is a standalone device in the sense that it performs the temperature measurement directly without human interpretation of an algorithm's output. The performance data refers to the device's ability to measure temperature, not an algorithm's ability to process data, so this question isn't directly applicable in the typical sense of AI/algorithm performance. Its "standalone performance" is implicitly covered by the "safety and efficacy performance" mentioned as being established through testing against standards.
7. Type of Ground Truth Used
The ground truth for temperature measurement would be established by:
- Calibrated reference thermometers: This is the most common method for validating the accuracy of clinical thermometers, where the device's reading is compared against a highly accurate and calibrated reference.
- Axillary temperature: The indication states the output "correlates to axillary temperature," suggesting that axillary temperature taken with a validated method was likely used as a comparative ground truth in some part of the "clinical" testing.
8. Sample Size for the Training Set
The concept of a "training set" is usually applicable to machine learning algorithms. While the FT101 uses an infrared detector, it's not described as an AI-driven device requiring a training set in the typical sense. Therefore, no training set sample size is mentioned.
9. How the Ground Truth for the Training Set was Established
As there's no mention of a training set or an AI algorithm, this information is not applicable and not provided.
In summary: The provided 510(k) summary states that the FT101 Forehead Thermometer meets performance criteria by conforming to voluntary standards (EN 60601-1/A13, EN 60601-1-2, ASTM E1965-98, prEN 12470-5) through "comparative testing to market-cleared devices clinically and non-clinically." However, it does not provide detailed quantitative results, sample sizes for testing, or information about how ground truth was specifically quantified beyond compliance with these broad standards. This is typical for a 510(k) where the focus is on demonstrating substantial equivalence to a predicate device rather than novel efficacy studies.
§ 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.