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Fora Care Blood Pressure Monitoring System is a system designed 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. It is intended for individuals age 18 and above use at home and in clinical settings. The device is not to be used for the diagnosis of hypertension or for testing on newborns.

Fora Care Blood Pressure Monitoring System (Model: P80) can be operated by the device itself or with the TDLink BP App. TDLink BP App is designed to assist in blood pressure testing, recording, tracking and monitoring in easy.

Here's a breakdown of the acceptance criteria and study information for the Fora Care Blood Pressure Monitoring System, Model P80, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance:

The 510(k) summary explicitly states that the Fora Care Blood Pressure Monitoring System (Model P80) "meets the same performance specifications as the predicate device" and that "the accuracy has been demonstrated in the predicate 510(k) submission according to the requirements of ANSI/AAMI SP10:2002."

Therefore, the acceptance criteria and reported device performance are derived from the predicate device (U-RIGHT TD-3128 Blood Pressure Monitoring System, K112216) as required by ANSI/AAMI SP10:2002. While the exact numerical acceptance criteria are not provided in this document, the standard typically requires that the device's blood pressure measurements be within a certain mean difference and standard deviation compared to reference measurements.

Study Details:

1. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not explicitly stated for the subject device (Fora Care Blood Pressure Monitoring System). The submission leverages the performance data of the predicate device (U-RIGHT TD-3128), which would have had its own test set size to meet ANSI/AAMI SP10:2002.
   • Data Provenance: Not specified for the subject device or the predicate's original study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not specified. For blood pressure monitors tested against ANSI/AAMI SP10, ground truth is typically established using simultaneous auscultatory measurements by trained observers.

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

   • Not specified, but for ANSI/AAMI SP10, it's common to have at least two trained observers taking simultaneous readings, with a third if there are significant discrepancies.

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 MRMC comparative effectiveness study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, a standalone performance assessment was conducted, or rather, the performance of the algorithm (oscillometric method) embedded in the device was demonstrated through its substantial equivalence to a predicate device that had undergone such testing. The document states: "No clinical study was performed using the subject device since the subject device's blood pressure monitoring capability was duplicated from the predicate, K11216 submitted by TaiDoc." This means the standalone performance is inherited from the predicate.

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

   • The ground truth for blood pressure monitors adhering to ANSI/AAMI SP10:2002 is typically established through auscultatory measurements performed by trained observers (experts) using a mercury sphygmomanometer or validated reference device.

7. The sample size for the training set:

   • Not applicable as this is a blood pressure monitor based on a physical measurement principle (oscillometric method) rather than a machine learning algorithm requiring a separate training set. The algorithm itself
     is a well-established method.

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

   • Not applicable for the reason stated above. The "training" for the oscillometric method's development would have historically involved extensive empirical data collection and validation against auscultatory readings.

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FORA V10 No Code Blood Glucose Monitoring System, model TD-4244, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. The meter contains some speaking functions but has not been validated for use by visually impaired users. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

This system is intended to be used by a single patient and should not be shared.

FORA V10 test strips are for use with FORA V10 No Code Blood Glucose meter model TD-4244 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm, upper arm calf and thigh.

The FORA control solutions can only be used with FORA V10 No Code Blood Glucose meter, model TD-4244 and the FORA V10 test strips to check that meter and test strips are working together properly.

The alternative site testing in FORA V10 No Code Blood Glucose Monitoring systems model TD-4244 can be used only during steady-state blood glucose conditions.

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA V10 test strips and FORA control solutions with the FORA V10 No Code Blood Glucose Monitoring System, model TD-4244.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FORA V10 No Code Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical thresholds (e.g., accuracy percentages, precision values) that the device must meet. Instead, the submission for the FORA V10 No Code Blood Glucose Monitoring System, model TD-4244, relies on demonstrating substantial equivalence to a predicate device (FORA V10 Blood Glucose Monitoring System, K093035).

The core of the "performance" claim is that it has the "same performance characteristics as the predicate device" and that "Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V10 No Code Blood Glucose Monitoring System are equivalent to the predicate device."

Therefore, the implied acceptance criterion is that its performance is equivalent to the predicate. The "reported device performance" is essentially that it is equivalent to the predicate device, which would have had its performance demonstrated in its own 510(k) submission.

Table of (Implied) Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the sample size used for any test set (accuracy, precision, etc.). It only mentions that the system was "compared to the YSI 2300 Glucose Analyzer in the Accuracy studies."
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: This information is not provided in the document.

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

• MRMC Study Done? No. This device is a blood glucose meter, not an imaging or diagnostic device typically requiring MRMC studies for human reader performance. The "performance characteristics" typically refer to analytical accuracy and precision in comparison to a reference method, rather than human interpretation of results.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done? Yes, indirectly. The core of the performance evaluation is the device's ability to quantitatively measure glucose, which is its standalone analytical performance. The document states: "The FORA V10 No Code Blood Glucose Monitoring System is compared to the YSI 2300 Glucose Analyzer in the Accuracy studies." This confirms a standalone performance evaluation against a reference standard.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the accuracy studies was established by the YSI 2300 Glucose Analyzer. This is a laboratory reference method widely accepted for determining glucose concentrations. The YSI itself is stated to be "calibrated with NIST (SRM) 917A reference material," confirming a traceable and high-quality reference standard.

8. Sample Size for the Training Set

• Sample Size: The document does not provide information on a training set sample size. This is common for devices like blood glucose meters, as their underlying electrochemical biosensor technology isn't "trained" in the same way a machine learning algorithm is. The "development" and "testing" would involve product development, calibration, and verification/validation, rather than a distinct "training set."

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

• Ground Truth Establishment for Training Set: As there's no mention of a "training set" in the context of an algorithm that learns, this question is not directly applicable. The device's calibration and design would rely on established laboratory methods and reference materials (like the NIST (SRM) 917A) during its development and manufacturing, but not in the sense of a machine learning training process with ground truth labels.

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FORA ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.

FORA ComfortScan Ear Thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body.

The provided document describes the acceptance criteria and the study conducted for the FORA ComfortScan Ear Thermometer, model TD-1261A/B.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was validated by tests according to ASTM E1965-98 and met the requirements of prEN12470-5:2000 standards. While specific numerical acceptance criteria (e.g., maximum allowed error) are not explicitly stated in the provided text, the reported performance is that the device met the requirements of these standards for various tests. For the clinical accuracy test, the performance metrics reported are "Clinical bias" and "Clinical repeatability."

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

The document does not explicitly state the sample size used for the test set in either laboratory or clinical accuracy studies. It only mentions that the device was validated according to ASTM E1965-98 and prEN12470-5:2000. These standards typically outline requirements for sample sizes, but the specific numbers used in this particular study are not provided in the summary.

The data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided text.

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

This information is not provided in the 510(k) summary. Given that the device is a thermometer for measuring body temperature, the "ground truth" for clinical accuracy would typically involve a reference thermometer (e.g., a highly accurate hospital-grade rectal thermometer or a calibrated blackbody for laboratory testing), rather than expert interpretation of images or clinical findings that would require a panel of experts.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically relevant for studies involving subjective interpretations, such as medical imaging where multiple readers independently review cases and then reconcile their findings. For a device like an ear thermometer, which measures a physical quantity, this type of adjudication method is not applicable and therefore not mentioned in the document.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which assesses how human readers improve with AI assistance, is not applicable to a standalone medical device like an ear thermometer. This device directly measures temperature without human interpretation of complex data or AI assistance in diagnostic tasks. Therefore, no such study was done or reported.

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

The device itself is a standalone (algorithm only) device in the sense that it provides a direct temperature reading without requiring a human-in-the-loop for interpretation or modification of its core function. The performance assessment described (laboratory and clinical accuracy) evaluates the device's standalone capability to measure temperature. So, yes, the described performance characteristics are a standalone assessment of the device.

7. The Type of Ground Truth Used

For "Laboratory accuracy" and "Clinical accuracy" tests, the ground truth would typically be established using:

• Laboratory Accuracy: A highly accurate and calibrated reference thermometer or a blackbody temperature standard in a controlled laboratory setting.
• Clinical Accuracy: A reference body temperature measurement obtained from a primary site (e.g., rectal, oral) using a highly accurate and calibrated clinical reference thermometer, often performed by qualified medical personnel.

The document implicitly refers to these by stating compliance with ASTM E1965-98 and prEN12470-5:2000, which define how such ground truth is established for thermometer testing.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning or AI-based devices. As the FORA ComfortScan Ear Thermometer is an infrared sensor-based device that directly measures temperature and does not involve AI or machine learning algorithms that require a training phase, there is no training set in the conventional sense for this device.

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

Since no training set is applicable for this device (as explained in point 8), the question of how its ground truth was established is not relevant.

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The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System is a device intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual. The blood pressure is measured by using an inflatable cuff wrapped around the arm. This system should be used for the testing on people over age of 18.

The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.

The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System.uses the oscillometric method to measure the systolic, diastolic blood pressure and pulse rate with a inflatable arm cuff on adults.

The device has single measurement mode, averaging mode and auscultatory mode of blood pressure measurements. The single measurement mode functions like a regular blood pressure monitor. The averaging mode is selected for performing three consecutive measurements with a fixed resting period between each measurement and displays the averaged result on LCD. The auscultatory mode is selected for trained persons to measure with a stethoscope.

The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System was validated against the ANSI/AAMI SP10 standard for non-invasive blood pressure (NIBP) devices.

Here's a breakdown of the available information regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that the device "met the requirements of ANSI/AAMI SP10" but does not explicitly list the specific numerical acceptance criteria or the precise reported device performance metrics (e.g., mean difference, standard deviation, percentage within 5 mmHg) from the ANSI/AAMI SP10 test.

2. Sample Size and Data Provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). To meet ANSI/AAMI SP10, a clinical study on a human subject population typically involves a minimum number of subjects (usually at least 85 subjects with a well-defined distribution of blood pressures).

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used or their qualifications for establishing ground truth, as an expert consensus method is not explicitly mentioned for the blood pressure measurements. For clinical validation under ANSI/AAMI SP10, the ground truth is typically established by trained human observers using auscultation with a stethoscope, not through a panel of experts.

4. Adjudication Method

The document does not mention an adjudication method for the test set. In the context of ANSI/AAMI SP10, blood pressure measurements from the test device are compared against simultaneous auscultatory measurements obtained by trained observers. Discrepancies are handled within the statistical analysis prescribed by the standard, rather than through a separate adjudication process as might be seen for visual interpretation tasks.

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

No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any mention of an effect size for human readers improving with or without AI assistance. This type of study is not typically applicable to a blood pressure monitoring device validated by the ANSI/AAMI SP10 standard.

6. Standalone Performance Study

Yes, a standalone performance study was done. The validation against ANSI/AAMI SP10 assesses the algorithm's (device's) ability to accurately measure blood pressure against a reference method (auscultation), without human-in-the-loop assistance for the measurement itself.

7. Type of Ground Truth Used

The ground truth for blood pressure measurements under ANSI/AAMI SP10 is typically established by auscultation, performed by trained observers using a stethoscope and sphygmomanometer. This is considered the reference method for non-invasive blood pressure measurement.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. For medical devices, particularly those using traditional algorithms (as stated for this device), the development often involves engineering and physiological modeling, with validation on a test set (clinical study). If any machine learning or AI components were involved in the algorithm's development, a dedicated training set would be common, but the document describes the algorithm as "traditional."

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

Since no separate training set is mentioned in the provided text, information on how its ground truth was established is not available.

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