Search Results

Digital Thermometer is intended to measure body temperature in axillary, oral or rectum and to be used by medical professionals in clinical and hospital environments or consumers in a home environment. It is intended for use on people of all ages.

The Digital Thermometers, 1004/1005, enable easy and accurate measuring over the body temperature range. It must be used in conjunction with a disposable probe cover when measuring temperature. From the construction point of view, the digital thermometer comprises of a thermistor for temperature sensing, a reference resistor for comparison of temperature, a buzzer for sounding effect, an application specified IC for calculating, and an LCD for displaying the measured temperature reading which the thermistor contacts and senses.

This document is a 510(k) Summary of Safety and Effectiveness for the Digital Thermometer, Models 1004 & 1005, manufactured by Biocare Asia Corporation Ltd. It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily assessed against the standards ASTM E1112-00:2011 and EN 12470-3:2000+A1:2009.

2. Sample size used for the test set and the data provenance

• Test Set (Clinical Accuracy & Repeatability): 120 samples.
• Test Set (Lab Accuracy, Drop, Operating Environment, Storage Environment tests): The document does not explicitly state the number of devices tested for each of these bench tests, but implies multiple devices were tested to report the "maximum calculated error".
• Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given that Biocare Asia Corporation Ltd. is located in Jiangsu, China, it is likely the testing was conducted in China. The clinical accuracy tests, with "pooled clinical bias" and "pooled clinical repeatability," suggest a clinical study was performed, which would be prospective in nature. The other performance tests are bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the device is a digital thermometer, and the ground truth for temperature measurement is established by calibrated reference standards (e.g., water baths, and for clinical accuracy, potentially reference thermometers). Experts are not typically involved in establishing the "ground truth" for physical measurements like temperature in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a digital thermometer as ground truth is based on physical scientific measurements with calibrated equipment, not subjective expert assessment.

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

Not applicable. This is a digital thermometer, not an AI-powered diagnostic imaging device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is a standalone device in the sense that it provides a temperature reading without a human interpreting an algorithm's output. The "algorithm" here is the device's internal signal processing of the thermistor input. The performance tests (e.g., accuracy against reference temperatures) evaluate the standalone performance of the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance tests (accuracy, repeatability, environmental robustness) is established by calibrated reference standards (e.g., water baths at precisely controlled temperatures) as defined by the mentioned international standards (ASTM E1112-00:2011, EN 12470-3:2000+A1:2009). For clinical accuracy, it would be a comparison to a highly accurate reference thermometer.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model that requires a training set. It is a traditional electronic device based on physical principles.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

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 for intermittent monitoring of human body temperature in the home setting.

The Radiant Innovation Inc., Infrared Ear Thermometer, Models THK09, IRT 3020 are electronic thermometers that use an infrared detector (thermopile detector) to detect body temperature using infrared radiantion from the auditory canal. Its operation is based on measuring the natural infrared thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.

To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is amplified by hardware and processed by the microprocessor. The temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.

Here's a breakdown of the acceptance criteria and the study details for the Radiant Innovation Infrared Ear Thermometer (Models THK09, IRT 3020) based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a clinical evaluation to ascertain the accuracy of the THK09 Infrared Ear thermometer.

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state the sample size (number of participants or measurements) used for the test set.
   • The data provenance is not specified (e.g., country of origin). The study is described as a "clinical evaluation," implying it was prospective, but this is not explicitly stated.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided. The study compares the device to "legally marketed thermometers" rather than expert consensus on thermometry.

3. Adjudication method for the test set:

   • The document does not describe any adjudication method. The comparison appears to be direct against established reference thermometers.

4. 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:

   • No, this was not an MRMC comparative effectiveness study. This device is a medical thermometer, and the study focuses on its accuracy against reference thermometers, not on improving human reader performance with AI. The device itself is an IR thermometer, not an AI diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in a sense. The clinical evaluation assesses the performance of the THK09 Infrared Ear thermometer as a standalone device. Its measurement output is directly compared to reference devices rather than being an input to a human interpretive process.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" was established by two legally marketed reference thermometers in the US:
     • MC 341 Omron Digital Thermometer (K091676)
     • Braun IRT 3020 Ear Thermometer (K983295)
   • The study was conducted in accordance with ASTM E1965:2003, which defines standards for clinical accuracy of IR thermometers.

7. The sample size for the training set:

   • This device is an infrared ear thermometer, which is a hardware device with embedded software for processing, not a machine learning or AI algorithm that typically requires a distinct "training set" in the computational sense. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here.

8. How the ground truth for the training set was established:

   • As explained above, the concept of a training set for an AI/ML algorithm does not apply to this device. Therefore, no ground truth was established for a training set.

Ask a specific question about this device