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Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.

The Advocate Non-Contact Infrared Thermometer, model EF001S, measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS. The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, "F/"C unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, auto shut-off when the device is idle for 60 seconds and voice function.

Here's a breakdown of the acceptance criteria and study information for the Advocate Non-Contact Infrared Thermometer, Model EF001S, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the referenced standards, and the reported device performance is indicated by the "Pass" verdict for all tests. Specific numerical criteria are provided for measuring accuracy.

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

• Sample Size for Test Set (Clinical Accuracy): 120 subjects
  • 40 subjects in each age group: infants (0-1 year), children (1-5 years), and adults (>5 years).
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It only mentions "EF001 Clinical Test" and that it "had been clinically assessed."

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 study description focuses on meeting the criteria of the referenced standards rather than on a ground truth established by experts in a typical diagnostic AI setting. For a thermometer, the "ground truth" for temperature measurement is typically a highly accurate reference thermometer measurement, not an expert's interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for subjective diagnostic tasks involving human readers, which is not directly applicable to a thermometer's performance evaluation against a reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 type of study is relevant for AI-assisted diagnostic tools where human interpretation is involved. The Advocate Non-Contact Infrared Thermometer is a direct measurement device; its performance is assessed against a technical standard for accuracy, not against human readers.

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

• Yes, a standalone performance assessment was done. The device's accuracy was tested against the standards ASTM E1965-98(2016) and ISO 80601-2-56:2017 directly, without a human in the loop for the temperature measurement itself. The "Clinical Accuracy" testing evaluates the device's ability to accurately measure body temperature.

7. The Type of Ground Truth Used

• The ground truth for the clinical accuracy testing is implicitly the reference measurements of body temperature taken concurrently with the device being tested, as required by the ASTM E1965-98(2016) standard. This standard outlines procedures for evaluating the accuracy of infrared thermometers for intermittent determination of patient temperature, which involves comparing the device's readings to established, highly accurate temperature measurements.

8. The Sample Size for the Training Set

• This information is not provided as this is not an AI/machine learning device that typically involves a distinct training set. The "software validation report" mentioned relates to the device's embedded software functionality, not a learning algorithm trained on data.

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

• This information is not applicable as there is no mention of a training set for a learning algorithm. The software validation ensures the embedded software functions as intended and meets regulatory guidelines.

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Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.

The Advocate Non-Contact Infrared Thermometer model EF001A measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS.

The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, 9F/℃ unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, and auto shut-off when the device is idle for 60 seconds.

The device under consideration is the Advocate Non-Contact Infrared Thermometer, Model EF001A. The provided information details its acceptance criteria and the studies conducted to prove it meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for infrared thermometers is accuracy, as defined by standards such as ASTM E1965-98.

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

The primary study mentioned is a "Clinical test."

• Sample Size: 120 subjects, categorized into:
  • 40 infants (0-1 year)
  • 40 children (1-5 years)
  • 40 adults (>5 years)
• Data Provenance: Not explicitly stated from which country or location the subjects were sourced. The study is described as a "Clinical test" which typically implies prospective data collection, but it is not definitively stated whether it was prospective or retrospective.

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

This information is not provided in the document. The document refers to "Clinical Test" and compliance with standards like ASTM E1965-98, which outlines methods for determining clinical accuracy. However, it does not specify the number or qualifications of experts involved in establishing the ground truth measurements against which the device was compared.

4. Adjudication Method for the Test Set

This information is not provided in the document. The clinical test section describes the assessment criteria for clinical accuracy but does not detail any adjudication methods.

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

No, an MRMC comparative effectiveness study was not done. The device is a thermometer, and its performance is evaluated against established temperature measurement standards, not through comparison with human readers or AI assistance in interpretation.

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

The device itself is a standalone thermometer. The performance tests ("Performance testing" and "Clinical test") demonstrate the device's accuracy in measuring temperature without human intervention other than the act of taking the measurement. Therefore, the reported performance is inherently standalone performance.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy test was established by assessing the device's measurements against the requirements of specific standards. For temperature measurement, the ground truth is typically a highly accurate reference thermometer or a standardized method as outlined in the referenced clinical accuracy standards. In this case, the "Clinical test" methods and criteria were assessed to meet the requirements of clinical accuracy per the referenced standard ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometer for Intermittent Determination of Patient temperature. This standard itself would describe the method for establishing ground truth, likely involving comparative measurements with an accepted standard.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. As a non-AI/ML device (a digital infrared thermometer), there is no "training set" in the context of algorithms that learn from data.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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The BroadMaster HealthCare System is a software accessory compatible with legally marketed BroadMaster Biotech glucose meters, such as the Glucose Shepherd Blood Glucose Monitoring System and ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The BroadMaster HealthCare System receives via USB, stores, and uses patient data for display and reporting, sets meter date, time and alarm. The software is designed for multiple users use and only compatible with personal computer. It's not compatible with other devices such as PDAs or smartphones.

The BroadMaster HealthCare System is a software designed to collect user glucose raw data, analyze results with easy-to-read trend graphs and save glucose raw data to .csv file for report. This system is very easy and friendly to use, even if user has a little computer experience. The BroadMaster HealthCare System Software works with its own behind-the-scene database to store glucose raw data from the glucose device. Glucose raw data downloaded to the software system are stored under the user profile that was selected before the download. In short, the BroadMaster HealthCare System will help user to store the blood glucose device readings, analyze results with easy-to-read trend graphs, and save glucose raw data to .csv file for report.

The provided text describes a software device, the BroadMaster HealthCare System, an accessory to glucose meters. The document asserts that the device meets performance requirements but does not provide specific acceptance criteria or detailed results from a study proving these criteria are met.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The performance of the BroadMaster HealthCare System Software was studied in the laboratory settings. The studies have demonstrated that this system meets the performance requirements of its intended use."

However, no specific acceptance criteria (e.g., accuracy metrics, specific thresholds for data integrity, speed of processing, or reliability measures) are listed, nor are any quantitative performance results reported. Therefore, such a table cannot be constructed from the provided text.

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

The document mentions "laboratory settings" for performance studies. However, it does not specify the sample size used for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

The document describes a software system that processes glucose meter data. In this context, "ground truth" would likely refer to the accuracy of the glucose meter readings themselves or the correct interpretation of data for display and reporting. The text does not mention the use of any human experts to establish ground truth for the test set, nor does it detail their qualifications.

4. Adjudication Method for the Test Set:

Given that there's no mention of experts establishing ground truth, there is no information provided on any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

The BroadMaster HealthCare System is a data management and analysis software for glucose readings. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or complex data with and without AI assistance. Therefore, it is highly unlikely that an MRMC comparative effectiveness study was done, and the document does not report any such study or effect size related to human reader improvement with AI assistance.

6. Standalone Performance Study:

The document states, "The performance of the BroadMaster HealthCare System Software was studied in the laboratory settings." This implies a standalone study of the algorithm's performance in processing and presenting data. However, no specific performance metrics or outcomes of such a study are provided beyond the general statement that it "meets the performance requirements."

7. Type of Ground Truth Used:

For a system that handles glucose data, the "ground truth" would be the actual glucose readings from the connected meters, and the software's ability to accurately store, display, and report these values. The document does not explicitly state how this "ground truth" was established, but it implicitly relies on the accuracy of the legally marketed glucose meters it interfaces with. It is not expert consensus, pathology, or outcomes data in the usual sense.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. This type of software, performing data storage, display, and basic trend analysis, is typically rule-based or uses standard data processing algorithms rather than machine learning that requires large training datasets.

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

As there's no mention of a training set, there's no information provided on how ground truth for a training set was established.

Summary of Missing Information:

The provided document offers a high-level overview of the BroadMaster HealthCare System and its intended use but lacks specific technical details regarding its performance studies, including:

• Quantitative acceptance criteria.
• Actual performance results against these criteria.
• Sample sizes of test and training data.
• Methods for establishing ground truth or expert involvement.
• Details on study design (e.g., retrospective/prospective).
• Any mention of AI, MRMC studies, or specific standalone performance metrics beyond a general statement of compliance.

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ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf, and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In additional, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis of diabetes, or for the testing of neonates.

The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring Systems consists of the ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose meter and the ADVOCATE® Redi-Code BMB-BA006A Blood Glucose test strips. The ADVOCATE® Redi-Code* BMB-EA001S meter are used only with ADVOCATE® Redi-Code+ BMB-BA006A Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh. The meter also included speaking functions but has not been validated for use by the visually impaired.

The ADVOCATE® Redi-Code* control solutions are for use with the ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System consists of the ADVOCATE® Redi-Code BMB-EA004S Blood Glucose meter and the ADVOCATE® Redi-Code* BMB-BA006A Blood Glucose test strips, ADVOCATE® Redi-Code control solutions, lancing device, and commercially available sterilized lancets. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose presented in the sample, providing a quantitative measure of glucose level in whole blood.

Here's a breakdown of the acceptance criteria and study information for the ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the statement "Same accuracy for both systems" and the reference to "Attachment 13.1 System Accuracy Study," which is stated to prove the system meets the performance requirements. While the specific numerical acceptance criteria (e.g., ISO standards for blood glucose meters) are not explicitly detailed in the provided text, the comparison to the predicate device K102316 suggests that the performance requirements are aligned with previously cleared devices.

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

The provided text does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the accuracy, precision, and linearity studies. It only mentions that these studies were conducted and their results are comparable to the predicate device. For the "Lay user evaluation," it mentions an "evaluation report from Arkansas," implying some data was collected within the USA. However, specific numbers for participants or the nature of the data (retrospective/prospective) are not given.

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

The document does not provide information on the number or qualifications of experts used to establish the ground truth for any of the studies. For blood glucose monitoring systems, ground truth is typically established using a reference laboratory method.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set. For blood glucose measurements, ground truth is usually determined by a highly accurate laboratory method, removing the need for expert adjudication in comparing device readings to the reference.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable to this device. This type of study is relevant for imaging devices or diagnostics where human interpretation is involved. The ADVOCATE® Redi-Code+ BMB-EA001S is a blood glucose monitoring system that provides a quantitative measurement, not requiring human interpretation of results in the way an MRMC study would assess. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

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

Yes, the primary performance studies (Accuracy, Precision, Linearity, Interference, Altitude, EMC testing) are inherently standalone studies. The device itself performs the measurement and provides a quantitative result. The "Lay user evaluation" focuses on usability and understanding of the speaking function, but the core accuracy is assessed in a standalone manner by comparing device output to reference measurements. The "Blood glucose detection and data analysis algorithm is identical" to the predicate, implying standalone performance.

7. The Type of Ground Truth Used

The ground truth used for performance validation (accuracy, precision, linearity) for blood glucose meters is typically established by laboratory reference methods/instruments. The text refers to "System Accuracy Study" and "Method Comparison Report," which strongly indicates that the device's readings were compared against a gold standard laboratory method for glucose measurement. The nature of the device (quantitative blood glucose meter) makes expert consensus or pathology less relevant for "ground truth" of the measurement itself, though clinical outcomes are relevant for the overall impact of monitoring.

8. The Sample Size for the Training Set

The document does not provide any explicit information about the sample size of a training set. As this device is based on an amperometric method and uses a glucose oxidase enzyme, the "algorithm" for blood glucose concentration calculation, noted as being "Same" as the predicate, is likely a well-established scientific principle rather than a machine learning model requiring a distinct training set in the modern sense. If any form of "training" or calibration data was used for the algorithm, it is not separately detailed.

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

Since an explicit "training set" and its ground truth establishment are not discussed (as per point 8), this information is not provided in the document. The system relies on a physical-chemical principle and an established algorithm, not a machine learning model that learns from a distinct training dataset with its own ground truth.

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A.) Glucose Shepherd Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The Glucose Shepherd Blood Glucose Monitoring System consists of the Glucose Shepherd Blood Glucose meter and the Glucose Shepherd Blood Glucose test strips. The Glucose Shepherd Blood Glucose meter is used only with Glucose Shepherd Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh.

The Glucose Shepherd Control Solutions are for use with the Glucose Shepherd Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

B.) Glucose Shepherd Pro Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Pro Blood Glucose Monitoring System may be used for multiple patients in a professional healthcare setting. I is intended for use as an aid in monitoring the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing devices. It should not be used for the diagnosis or screening of diabetes, for the testing of neonates, or for testing of arterial blood.

The Glucose Shepherd Pro Blood Glucose Monitoring System consists of the Glucose Shepherd Pro Blood Glucose meter and the Glucose Shepherd Pro Blood Glucose test strips. The Glucose Shepherd Pro Blood Glucose meter is used only with Glucose Shepherd Pro Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh.

The Glucose Shepherd Pro control solutions are for use with the Glucose Shepherd Pro Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

A.) Glucose Shepherd Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions(Level 1, 2 and 3), lancing device, and commercially available sterilized lancets. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose presented in the sample, providing a quantitative measure of glucose level in whole blood.

B.) Glucose Shepherd Pro Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions(Level 1, 2 and 3) and single-use lancing devices. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose level presented in the sample, providing a quantitative measure of glucose level in whole blood.

This 510(k) summary provides limited information regarding the performance studies. Therefore, a comprehensive description of acceptance criteria and the entire study that proves the device meets those criteria cannot be fully extracted.

However, based on the provided text, here's what can be gathered and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that both the Glucose Shepherd Blood Glucose Monitoring System and the Glucose Shepherd Pro Blood Glucose Monitoring System were studied in laboratory and clinical settings, and these studies "have demonstrated that this system meets the performance requirements of its intended use."

While explicit numerical acceptance criteria are not detailed in this summary, in the context of blood glucose monitoring systems, "performance requirements" typically refer to accuracy standards. For example, ISO 15197 (In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus) is a commonly referenced standard. A key part of this standard's accuracy requirement is that a certain percentage of results (e.g., 95%) must fall within a defined range of a reference method (e.g., within ±15 mg/dL for glucose concentrations

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