Search Results

The Infrared forehead thermometer (Models JZK-602, JZK-603) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 1-5cm for people of all ages. The device is reusable for home use and clinical use.

Infrared forehead thermometers (includes model JZK-602, JZK-602, JZK-603) are intended to measure the body temperature through receiving infrared energy radiation via the forehead for people of all ages. These thermometers have the capability to measure temperature via body mode or object mode, and the temperature is directly shown on the LCD display. These thermometers have the following features:

1. The device is intended to be reusable for home use and clinical use.
2. The device is mainly composed of infrared sensor, signal receiving processor, kevs, buzzer, LCD display.
3. Switching of temperature unit between °C and °F.
4. The latest 32 sets of memory for measuring human body and object; the user can view or delete the previous measurement results.
5. Buzzer on or off to set the prompt tone on or off.
6. Prompt tone function and backlights function.
7. The prompt limit setting function.
8. Low battery indication, and auto power-off.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text for the Infrared Forehead Thermometer (Models JZK-601, JZK-602, JZK-603):

Device: Infrared Forehead Thermometer (Models JZK-601, JZK-602, JZK-603)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 200 subjects were evaluated in the clinical study.
  • 50 newborns (0 to 3 months)
  • 50 infants (older than 3 months up to 1 year)
  • 50 children (older than 1 year and younger than 5 years)
  • 50 adults (older than 5 years old)
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It merely describes the study design and its findings. It was a clinical investigation, implying a prospective data collection, rather than retrospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical study. It refers to a "randomization, simple blind homologous control, pairing design of clinical investigation" that evaluated the device against the requirements of ASTM E1965-98 (Reapproved 2016). This standard itself defines the acceptable reference methods for temperature measurement (e.g., oral, rectal, axillary, tympanic) and their accuracy, which would serve as the defacto "ground truth" rather than direct expert consensus reading of the device's output.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method in the traditional sense of multiple reviewers resolving discrepancies, as might be found in imaging studies. Given it's a thermometer study comparing to a reference method, the "ground truth" is likely established by the reference thermometer measurements as per ASTM E1965-98, negating the need for complex expert adjudication of device readings. The study design is described as "randomization, simple blind homologous control, pairing design."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typical for diagnostic AI tools where human readers interpret medical images with and without AI assistance to measure improvement in diagnostic performance. For a temperature measurement device, the objective is to accurately measure temperature against a reference standard, not to assist human interpretation of complex data. Therefore, an MRMC study is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the primary performance evaluation appears to be a standalone (algorithm only) assessment. The device's accuracy and performance criteria (measurement range, accuracy, response time) are tested directly against performance standards (ISO 80601-2-56, ASTM E1965-98) and in a clinical study where its readings are compared to a reference method, without explicit human interpretation being part of the primary performance metric beyond using the device as intended. The "human-in-the-loop" here is the user taking the temperature, but the device's measurement itself is the standalone output being validated.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was based on reference temperature measurements as required by the ASTM E1965-98 (Reapproved 2016) standard. This typically involves using highly accurate reference thermometers (e.g., direct contact electronic thermometers, mercury-in-glass thermometers at a core body site) as the "true" temperature against which the infrared forehead thermometer's readings are compared.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set. This is a medical device, not an AI/ML diagnostic algorithm in the sense of requiring separate training datasets. While internal calibration or factory data might be used in manufacturing, it's not a "training set" in the context of deep learning models.

9. How the Ground Truth for the Training Set Was Established

As this is a physical measurement device (infrared thermometer) and not a machine learning model requiring a distinct training phase with annotated data, the concept of a "training set" and its ground truth establishment in the AI/ML sense does not apply. The device's internal algorithms are likely based on physical principles of infrared detection and calibrated during manufacturing, rather than "trained" on a dataset of patient temperatures.

Ask a specific question about this device