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

HD 3161 Blood Pressure Monitor is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.

This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to be 9.44 to 16.9 inches (24cm〜43cm).

HD 3161 Blood Pressure Monitor measures both systolic and diastolic blood pressure and heart pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcomputer to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing.

The provided document is a 510(k) premarket notification for the BioCare Asia HD 3161 Blood Pressure Monitor. It presents a comparison of the proposed device with a predicate device, the U-RIGHT TD-3127 Blood Pressure Monitoring System (K100658), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses the predicate device's performance as the acceptance criteria for most metrics, aiming for substantial equivalence. The key performance criteria for blood pressure monitors are accuracy and measurement range.

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

The document mentions "PERFORMANCE & CLINICAL TEST" under IEC 80601-2-30:2013 and AAMI / ANSI / ISO 81060-2:2013. However, it does not explicitly state the sample size used for any clinical test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature) for any clinical study mentioned. It only indicates that these tests were performed and passed.

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

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications for any clinical test. For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a reference invasive or non-invasive method.

4. Adjudication Method for the Test Set:

The document does not provide any information about the adjudication method used for any clinical test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is not typically applicable to a standalone blood pressure monitor, which directly measures physiological parameters rather than requiring human interpretation of medical images or data.

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

Yes, the regulatory submission is for a standalone device (the HD 3161 Blood Pressure Monitor). Its performance, as demonstrated by meeting the listed standards, is a standalone performance validation. The device itself performs the measurement and provides the readings without needing human interpretation of the underlying signal for the final blood pressure value.

7. The Type of Ground Truth Used:

While not explicitly detailed, for blood pressure monitor validation according to standards like AAMI/ANSI/ISO 81060-2, the ground truth is typically established through simultaneous or near-simultaneous measurements by a validated reference method, often using auscultation by trained observers (using a stethoscope and sphygmomanometer) or sometimes invasive arterial pressure monitoring in specific clinical settings. The document implies that the device's accuracy was compared against such a standard in the "PERFORMANCE & CLINICAL TEST."

8. The Sample Size for the Training Set:

The product is a blood pressure monitor that uses an oscillometric method. This method usually involves pre-programmed algorithms based on physiological principles and validated against clinical data. The document does not specify a "training set" sample size in the context of machine learning, as this device does not appear to be an AI/ML product in the sense of continuously learning from a vast dataset. Instead, its accuracy is validated against established medical device performance standards.

9. How the Ground Truth for the Training Set was Established:

As explained in point 8, the concept of a "training set" in the context of machine learning is generally not applicable here. The fundamental algorithms for oscillometric blood pressure measurement are based on established physiological understandings and bioengineering principles. The "ground truth" for the development and validation of these algorithms would historically have involved extensive clinical studies comparing oscillometric readings to direct intra-arterial measurements or meticulous auscultatory readings. The document implies that the device's design and fixed algorithm adhere to the principles validated by the predicate device and the relevant international standards (IEC 80601-2-30:2013, AAMI / ANSI / ISO 81060-2:2013).

Ask a specific question about this device

FORA Diamond Nexus Mini Thermometer is intended for the intermittent measurement and monitoring of human body temperature from forehead measurement at home.

FORA Diamond Nexus Mini Infrared Forehead Thermometer is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FORA Diamond Nexus Mini Infrared Forehead Thermometer:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on non-clinical performance characteristics validated against existing standards (ASTM E1965-98 and EN12470-5). Clinical accuracy is also reported.

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

• Sample Size for Clinical Accuracy Test: 120 subjects (labeled as "Sample size" for the clinical bias and repeatability tables).
• Data Provenance: Not explicitly stated in the provided summary (e.g., country of origin). It is also not specified whether the data was retrospective or prospective.

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

This information is not provided in the document. The method for establishing ground truth is not detailed beyond the use of standards. For clinical accuracy, it can be inferred that a reference thermometer was used as a comparative ground truth, but the details of its operation or the involvement of experts in establishing that ground truth are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

• No, an MRMC comparative effectiveness study was not done. This device is a standalone thermometer, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data alongside AI.

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

• Yes, a standalone performance assessment was done. The entire submission describes the performance characteristics of the thermometer itself, independently measuring and displaying temperature. There is no human-in-the-loop component for reading or interpreting the thermometer's direct output.

7. The Type of Ground Truth Used

• The ground truth for the performance tests (clinical and laboratory accuracy) is implicitly based on established metrological standards and reference devices compliant with those standards (ASTM E1965-98, EN-12470-5). For clinical accuracy, this would typically involve comparison against a highly accurate reference thermometer. For laboratory accuracy, it would involve comparison against calibrated temperature sources. The document does not specify a separate "expert consensus," "pathology," or "outcomes data" as ground truth beyond adherence to these technical standards.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a traditional infrared thermometer, not an AI/machine learning algorithm that requires a training set in that context. The "training" here would be the device's calibration and design against engineering principles and standards, not a dataset in the AI sense.

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

This information is not applicable as there is no "training set" in the context of an AI algorithm. The device's accuracy and performance are established through adherence to and testing against the specified international standards (ASTM E1965-98 and EN-12470-5).

Ask a specific question about this device