(69 days)
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
The E-Care Technology Corporation Infrared Ear Thermometer, Model LCT-200 is an electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.
The E-Care Technology Corporation Infrared Ear Thermometer, Model LCT-200 consists mainly of four parts - an IR detector with a built in ambient temperature sensor, a barrel, an LCD display, and the associated circuit.
The ear canal quides sound to the eardrum. which is thin and flooded with blood at the core temperature. The barrel, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer canal without contacting the eardrum. When measuring, the radiative fluxes transfer from the tympanum through or reflected by the inner surfaces of the barrel to the IR detector. The ambient sensor is built-in and mounted near the IR sensor element to monitor the ambient temperature.
To measure core temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a display. The total operation takes a few seconds.
The provided text describes the E-Care Infrared Ear Thermometer, Model LCT-200, and its substantial equivalence to predicate devices, but lacks detailed acceptance criteria and study results in a format that directly addresses all the requested points. The document focuses on regulatory submission and comparison to existing devices rather than a standalone clinical study report with specific performance metrics.
Based on the available information, here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Study Details for E-Care Infrared Ear Thermometer, Model LCT-200
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions compliance with "applicable voluntary standards includes ASTM E1965 as well as IEC 60601-1 and IEC 60601-1-2 requirements." ASTM E1965-98 is the "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature." This standard specifies accuracy requirements for clinical thermometers, which would serve as the acceptance criteria. However, the exact performance values measured for the E-Care LCT-200 thermometer against these criteria are not explicitly detailed in the provided text, beyond the general statement that "clinical testing supplied demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
To illustrate, typical ASTM E1965-98 accuracy requirements for clinical infrared thermometers are:
| Temperature Range | Maximum laboratory error (±) |
|---|---|
| 35.0 °C to 42.0 °C | 0.2 °C |
| Below 35.0 °C and above 42.0 °C | 0.3 °C |
Since the document states compliance with ASTM E1965, it is implied that the device met these or similar accuracy criteria for "laboratory error." However, the reported device performance in terms of specific measurement errors or agreement with reference thermometers is not quantified in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "The patient population is well represented (neonatal, pediatrics and adults), and the number of patients have been statistically justified." The exact number of patients is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the data. It also does not specify if the study was retrospective or prospective. Given that "Controlled human clinical studies were conducted," it strongly suggests a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document mentions that clinical data compared "IR thermometers to standard oral/rectal thermometers with readings representing a conventional/currently accepted reading, i.e., rectal or oral." This implies that the 'ground truth' was established by readings from these conventional thermometers. No human experts were explicitly mentioned for establishing a ground truth based on their expert opinion for temperature readings, as temperature measurement relies on physical instruments.
4. Adjudication Method for the Test Set:
Not applicable, as temperature measurement relies on instrument readings, not subjective expert assessment requiring adjudication. The comparison was to "standard oral/rectal thermometers."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study is typically for evaluating diagnostic imaging systems where human readers interpret medical images. This study concerns the accuracy of a temperature-measuring device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the described "Controlled human clinical studies" evaluated the device's performance directly by comparing its readings to conventional thermometers. The device (thermometer) itself is the "algorithm only" in this context, as it automatically processes infrared signals to output a temperature reading. There isn't a human actively "in the loop" making diagnostic decisions based on the device's output that would require a "human-in-the-loop" study in the typical sense.
7. The Type of Ground Truth Used:
The ground truth used was comparative measurements against established clinical standards: "standard oral/rectal thermometers with readings representing a conventional/currently accepted reading, i.e., rectal or oral."
8. The Sample Size for the Training Set:
This information is not provided. Clinical studies for medical devices like thermometers often focus on validation (test set) rather than a "training set" in the machine learning sense. The device's underlying physics-based algorithms are typically designed and calibrated internally by the manufacturer rather than through a distinct, externally validated "training data set."
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. As noted above, the concept of a separate "training set" with ground truth in the machine learning sense is not explicitly discussed for this type of device in the provided document. The device's internal calibration and algorithm development would have been based on engineering principles and potentially internal testing, but specific details are absent.
§ 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.