(382 days)
The TRULYL Infrared thermometer TET-351 is intended for the intermittent measurement of human body temperature from the auditory canal and from the forehead for people of all ages used in the home setting. The non-contact thermometer detects infrared heat from the forehead at distance of about 1-2cm.
The TRULYL Infrared thermometer TET-351 is a hand-held, battery powered device designed to measure the body temperature through receiving infrared energy radiation via the ear canal or forehead. The thermometer has the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display. The results measured by TET-351 can also be transmitted to APP to record and display through Bluetooth.
This is an infrared thermometer (TET-351) that measures human body temperature from the auditory canal and forehead. The device is intended for home use for people of all ages.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the standard ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. While the document states that the clinical study demonstrated compliance, it does not explicitly list the specific numerical acceptance criteria (e.g., accuracy limits) from ASTM E1965-98 within the provided text, nor does it provide detailed numerical results for the device's performance against those criteria beyond a general statement of compliance.
However, the comparison table with the predicate device does offer some insight into the accuracy specification, which would likely be the basis of the acceptance criteria:
| Feature | Predicate Device (K190873) Accuracy | TET-351 (Subject Device) Accuracy | Note |
|---|---|---|---|
| Accuracy | Ear/Forehead mode: ±0.2°C (0.4°F) during 35.5°C ~ 42.0°C (95.9°F ~ 107.6°F) at 15°C | Ear/Forehead mode: ±0.2°C (0.4°F) (Outside 34~42°C (93.2°F ~ 107.6°F) measurement range, accuracy ±0.3°C (0.5°F)). | Different |
Note: The "Different" note here implies that while the general accuracy ranges are similar, there might be slight variations in the specified temperature ranges where the higher accuracy applies. The report states that the clinical study demonstrated compliance with ASTM E1965-98 (Reapproved 2016), which would inherently define the specific acceptance criteria for accuracy.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: A minimum of 150 subjects.
- 1/3 children
- 1/3 adults
- The remaining 1/3 (implicitly infants) are not explicitly stated but are covered by the age categories: "Infants---newborn to one year; Children--- greater than one to five years; Adults--- greater than five years old."
- Data Provenance: The document does not explicitly state the country of origin of the data. It refers to "This clinical study" without specifying the location.
- Retrospective or Prospective: Not explicitly stated, but the description "This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation" strongly suggests a prospective study.
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 study involves measuring patient temperature, which typically involves comparing the device's readings against a highly accurate reference thermometer (e.g., rectal or oral core temperature measurement, depending on the standard). The role of "experts" as ground truth adjudicators in the sense of image interpretation is not directly applicable here.
4. Adjudication Method for the Test Set
This information is not explicitly provided in the context of "adjudication" as it might apply to subjective assessments. For temperature measurement studies, the ground truth is typically established by measurements from a validated reference device, not by expert consensus or adjudication. The study design is described as "randomization, simple blind homologous control, pairing design," but this refers to the overall study methodology rather than a specific ground truth adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted in the traditional sense of evaluating human readers with and without AI assistance, as this device is a standalone thermometer, not an AI-powered diagnostic imaging tool.
6. Standalone (Algorithm Only) Performance
A standalone performance study was done. The entire clinical study for the Infrared Thermometer TET-351 is a standalone performance evaluation, as it assesses the accuracy of the device itself (algorithm + hardware) against a reference standard in patients.
7. Type of Ground Truth Used
The ground truth implicitly used for clinical accuracy assessment for thermometers is a reference temperature measurement obtained from a highly accurate clinical reference device (e.g., glass thermometer, electronic thermometer, or other gold-standard method for core body temperature measurement). The standard ASTM E1965-98 outlines how these reference measurements should be obtained. The document does not explicitly state the specific reference method used, but it's central to the standard's methodology.
8. Sample Size for the Training Set
This information is not provided. As this is a medical device and not an AI/ML imaging algorithm that requires a separate training set, the concept of a "training set" in this context is not directly applicable for the device's primary function of temperature measurement. Any internal calibration or algorithm development would have been done prior to the clinical validation.
9. How the Ground Truth for the Training Set Was Established
Given that this is an infrared thermometer and not an AI/ML imaging algorithm, a separate "training set" with established ground truth in the AI sense is not applicable. The device's underlying physics and calibration would be based on established temperature measurement principles.
§ 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.