Search Results

The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. The system is intended for armpit temperature monitoring for persons with all ages.

The products can be used in hospital and at home.

The MCU chip in the wireless electronic thermometer collects the voltage value of the NTC thermal resistor, a thermo-sensitivity resistance, whose resistance will change according to temperature. After collecting and filtering algorithm, a resistance value data is obtained. After that, the Bluetooth chip performs a table lookup operation to find the Celsius temperature value corresponding to the resistance value. The temperature data is transmitted through the Bluetooth transmission to the compatible smart phone, in order to achieve the function of temperature measurement.

The wireless thermometer is composed of a Patch and a Mobile App.

Patch: One side of Patch is medical adhesive which is used to fix the patch on the armpit of patients. The other side is foam. There is a circuit board inside the patch. The patch is used for detecting of human body temperature and then transferred to Mobile App for display and further management. There is no display function on the patch, except for a indicator to indicating power on/off status.
Patches are single use only, and available in different configuration. The models ECH-b1-S, ECH-b1-M and ECH-b1-L all share the same design principles, materials, mechanism of actions. However they are different in size and intended patient.

Mobile APP: The APP is intended for display and management of obtained human body temperature data.

The provided text is a 510(k) Summary for a Wireless Thermometer. It outlines the device description, intended use, and comparison to a predicate device to establish substantial equivalence.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: The device described is a clinical electronic thermometer, not an AI-powered diagnostic device. Therefore, many of the typical criteria for AI/ML medical devices (such as MRMC studies, ground truth establishment by experts, and sample sizes for training/test sets for algorithm performance) do not apply to this submission. The "study" here refers to non-clinical testing and benchmarking against established standards and a predicate device.

Acceptance Criteria and Reported Device Performance

Study Details (Focusing on the type of device)

1. A table of acceptance criteria and the reported device performance: See table above.

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

   • Test Set Sample Size: Not applicable in the context of an AI/ML test set. For non-clinical tests (e.g., biocompatibility, electrical safety, EMC, accuracy testing), the sample sizes are determined by the specific standards (e.g., number of units tested, number of in vitro samples). These details are not provided in the 510(k) summary but would be in the full test reports.
   • Data Provenance: Non-clinical test data generated at the manufacturer's or contracted testing facilities (not specified in detail, but standard for medical device testing). No direct patient data provenance (country, retrospective/prospective) is relevant as no clinical study was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device relying on human expert annotation for ground truth. Ground truth for thermometer accuracy is established by reference measurement instruments following metrological standards. For other tests (e.g., biocompatibility), results are determined by laboratory analysis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept applies to human expert review for AI/ML ground truth, not device performance testing.

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 device is a standalone thermometer, not an AI-assisted diagnostic tool that supports human readers. The submission explicitly states: "No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in essence, the device's accuracy and safety were evaluated as a standalone product through non-clinical testing against standards. The "algorithm" here is the embedded firmware that converts sensor readings to temperature, and its performance (accuracy) was assessed.

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

   • For temperature accuracy: The ground truth is established by traceable reference temperature measurement apparatus and methods, as per ISO 80601-2-56. This is a metrological standard, not expert consensus or pathology.
   • For safety (biocompatibility, electrical safety): Ground truth/acceptance is based on compliance with the quantitative and qualitative acceptance criteria specified in the relevant international standards (ISO 10993, IEC 60601 series).

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in the typical sense. The device's internal algorithm is designed and calibrated based on engineering principles and sensor characteristics, not machine learning from a large dataset.

9. How the ground truth for the training set was established: Not applicable. As above, there is no "training set" for an AI/ML algorithm. The calibration and design of the thermometer are based on established physical laws and engineering practices for NTC thermistors.

Ask a specific question about this device

The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons over two years old.

The wireless thermometer, WT701, which is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously. For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measures the body temperature by means of testing the NTC resistance value and calculates the body temperature every 4 seconds continuously and sends the temperature data to the receiver through Bluetooth connection. The wireless thermometer uses a CR2032 battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.

Here's the analysis of the provided text, focusing on acceptance criteria and supporting study details:

Acceptance Criteria and Device Performance Study for Wireless Thermometer (K132761)

The provided document describes the 510(k) submission for the Raiing Medical Company Wireless Thermometer, Model WT701. The core of the information regarding acceptance criteria and device performance is found in the "Comparison of Technology Characteristics" table and the "Non-Clinical Test Conclusion" section.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Wireless Thermometer WT701 are primarily outlined by its specifications, which are compared to a predicate device. The performance is reported as meeting these specifications and complying with relevant standards.

2. Sample Size and Data Provenance

The document does not specify the sample size used for any of the tests, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature). The tests are categorized as "non-clinical tests" and "performance tests," suggesting laboratory-based assessments rather than patient-based clinical trials for establishing accuracy.

3. Number and Qualifications of Experts for Ground Truth

The document does not mention the involvement of experts to establish ground truth for testing. Given the type of device (thermometer) and the standards cited (e.g., ASTM E1112, EN 12470-4), the "ground truth" for temperature measurements would typically be established by calibrated reference thermometers or environmental chambers, not human experts.

4. Adjudication Method

The document does not mention any adjudication method, as it does not describe a study involving human interpretation or subjective measurements that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study involving human readers. This device is a measurement tool, not an interpretive diagnostic aid, so such a study would not be applicable.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted. The "Non-Clinical Test Conclusion" section states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and complied with various standards (IEC, FCC, ASTM, EN). These tests assess the algorithm's and hardware's ability to accurately measure temperature independently. Specific performance tests mentioned include:

• Dimension Test
• Weight Test
• Accuracy transmission test under a complex electromagnetic environment
• Compliance with accuracy specifications: ±0.05℃ (35℃-38.5℃) and ±0.1℃ (25℃-34.99℃ and 38.51°C-45°C).

7. Type of Ground Truth Used for Standalone Performance

The type of ground truth used for the standalone performance testing would have been calibrated reference standards and physical measurements. For temperature accuracy, this implies using highly accurate, traceable reference thermometers and controlled environments (e.g., temperature-controlled baths or chambers) to simulate body temperatures across the specified range. For other tests like dimension, weight, and signal transmission, physical measurement tools and electromagnetic compatibility testing equipment would serve as the ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is expected as the device appears to be a hardware-based electronic thermometer, not a device employing machine learning or AI that typically requires training data.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set or machine learning/AI components, this information is not applicable and is not provided in the document. The device's functionality is based on direct physical measurement of NTC resistance and conversion to temperature.

Ask a specific question about this device

The Wireless Thermometer, model WTM-B530-I, is a battery-operated elected electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and is intended for armpit temperature monitoring for persons over two years old.

The proposed device is use to measure, monitor and record the body temperature in armpit, and transmits the data recorded to receiver for display by wireless (blue tooth) way in real time.

The provided text describes a 510(k) submission for the Raiing Medical Company Wireless Thermometer, Model WTM-BT30-I. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with detailed acceptance criteria and performance data for the proposed device itself.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly define "acceptance criteria" for clinical performance in the context of a new study for the WTM-BT30-I, but rather implies meeting established standards through conformity to recognized performance standards.

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

The document does not describe a specific clinical test set and therefore does not provide information on its sample size or data provenance. The assessment is based on conformity to existing standards.

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

Not applicable, as no described clinical test set for the proposed device.

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

Not applicable, as no described clinical test set for the proposed device.

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. The device is a thermometer, not an AI-assisted diagnostic tool for human readers.

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

This refers to the performance of the device itself (the thermometer) independent of human interpretation. The claim is that the device "Conformed to ASTM E1112" for performance, which is a standard for electronic thermometers. This implies standalone performance testing against recognized accuracy standards, but the specific results are not detailed beyond conformity.

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

For the performance claim (conformity to ASTM E1112), the ground truth would be established by the reference measurement standards and methods defined within the ASTM E1112 standard itself for evaluating thermometer accuracy. This typically involves comparison to highly accurate reference thermometers in controlled environments.

8. The sample size for the training set

Not applicable. This device is a thermometer, not a machine learning model requiring a training set in the typical sense.

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

Not applicable.

Ask a specific question about this device