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The Upper Arm Blood Pressure Monitor, Model BP3K V 1-5K is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm for a circumference range from 17 to 52cm.

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 device can be used in connection with a smart phone via Bluetooth or with a personal computer (PC) via USB. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App) or a PC running the Microlife BP Analyzer+ (BPA+) software.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5K is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 17-52 cm by using a noninvasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but using a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement, and the symbol " " is displayed with the reading. The device can be used in connection with smart mobile devices running the APP and via Bluetooth.

The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.

This document is a 510(k) Premarket Notification for a blood pressure monitor, not an AI/ML powered medical device. Therefore, the information typically requested regarding acceptance criteria, study design for AI models, and clinician performance with/without AI assistance cannot be extracted from this document, as it is not applicable.

The document discusses the substantial equivalence of the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5K, to predicate devices. The acceptance criteria in this context refer to engineering and clinical performance standards for blood pressure monitors as defined by various international standards (e.g., AAMI/ANSI/IEC 80601-2-30 for non-invasive sphygmomanometers), rather than performance metrics for an AI algorithm.

Below, I'll structure the answer to address the prompt's points based on the information available in the document for a traditional medical device, noting where AI-specific information is not present.

Device: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5K

This device is a traditional non-invasive blood pressure monitor that uses an oscillometric technique. It does not employ artificial intelligence or machine learning for its core blood pressure measurement function. Therefore, many of the questions asked, which are relevant to AI/ML powered devices, are not applicable here.

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

The document states that the device was tested to meet relevant national and international standards for electrical, mechanical, environmental performance, and basic safety and essential performance of automated non-invasive sphygmomanometers. While specific numerical acceptance criteria (e.g., mean difference and standard deviation per ISO 81060-2) are not provided in this summary, the document asserts that the device met all relevant requirements.

Table: General Acceptance Criteria and Stated Performance (Based on Document)

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

The document states that repeated clinical testing for the subject device (BP3KV1-5K) was not necessary. Instead, the clinical validation of the predicate devices (BP3MW1-4Y and BP3MS1-4A), performed according to ANSI/AAMI/ISO81060-2, was deemed applicable.

Therefore, the specific sample size for a test set for the subject device's core BP measurement accuracy is not mentioned as a new study was not performed. The data provenance would be from the original clinical validation studies performed for the predicate devices. The document does not specify country of origin or whether these prior studies were retrospective or prospective.

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

This question is not applicable to this device, as it is not an AI/ML device requiring expert consensus for ground truth or interpretation. The "ground truth" for blood pressure measurement devices is typically a reference measurement method (e.g., auscultatory method by trained observers) used during clinical validation studies (like those following ISO 81060-2). The document does not provide details on the number or qualifications of experts involved in the predicate device's clinical validation.

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

Not applicable, as this refers to adjudication for expert labeling/ground truth in AI/ML model validation, which is not relevant for this traditional blood pressure monitor.

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 not an AI-powered diagnostic tool, so an MRMC study comparing human performance with and without AI assistance was not performed.

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

This refers to the performance of an AI algorithm intrinsically. For this traditional blood pressure monitor, the "algorithm" is the oscillometric measurement technique. Its performance is evaluated through clinical validation against a reference method (human observers using auscultation), which is essentially a standalone performance evaluation of the device's measurement accuracy. The document states that the clinical validation for the predicate devices is applicable and meets the ANSI/AAMI/ISO81060-2 standard.

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

For traditional blood pressure monitors, the ground truth in clinical validation studies is typically established by simultaneous measurements using a recognized reference method, such as the auscultatory method performed by trained human observers using a mercury sphygmomanometer or validated electronic reference device. This is the standard approach for studies structured according to ISO 81060-2.

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no AI/ML training set for this device.

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The Upper Arm Blood Pressure Monitor, Model BP3KV1-5W is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm for a circumference range from 22 to 52cm.

The device is suitable for use by adults with conditions of diabetes, pregnancy, or pre-eclampsia.

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 device can be used in connection with a smart phone via Bluetooth or with a personal computer (PC) via USB. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App) or a PC running the Microlife BP Analyzer+ (BPA+) software.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 -52 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but using a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement, and the symbol " "\\ "is displayed after the measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.

The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that a clinical study was conducted using the BP3KT1-3N (European Device) for validation. This study was a "prospective, open-label, non-randomized, single-center validation study." The study followed the ANSI/AAMI/ISO 81060-2:2019 test standard.

While the exact sample size for the test set is not explicitly stated in the provided text, the ANSI/AAMI/ISO 81060-2:2019 standard typically requires a minimum of 85 subjects for validation of blood pressure devices (as referenced in the acceptance criteria regarding absolute differences).

The data provenance is prospective, single-center, and from a European Device (BP3KT1-3N). The specific country is not mentioned beyond "European Device."

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. However, for a clinical validation study following the ANSI/AAMI/ISO 81060-2:2019 standard, the ground truth for blood pressure measurements is typically established by at least two trained observers (experts) using a mercury sphygmomanometer or an equivalent reference device, meticulously following standardized auscultatory procedures. These observers are usually trained and certified in blood pressure measurement techniques.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method. In clinical validation studies conforming to the ANSI/AAMI/ISO 81060-2 standard, when multiple observers are used for ground truth, a common adjudication method involves taking the average of the observers' readings, or in cases of significant discrepancy, a third observer might be used to mediate or resolve differences. The standard itself outlines specific requirements for how observer readings should be handled.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. The provided information describes a clinical validation study for the device's accuracy against a reference standard, not a study comparing human reader performance with and without AI assistance.

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

Yes, a standalone performance study was done for the blood pressure measurement component. The clinical study for the BP3KT1-3N device validated its accuracy according to the ANSI/AAMI/ISO 81060-2:2019 standard. This standard assesses the device's ability to accurately measure blood pressure on its own, without direct human interpretation or modification of the measurement itself during the process (though a human activates the device and applies the cuff). The study concluded that "The Microlife device has passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard," which is a testament to its standalone measurement accuracy.

7. The Type of Ground Truth Used

The ground truth used for the clinical validation study was auscultatory measurement (reference sphygmomanometry). This is implied by the ANSI/AAMI/ISO 81060-2:2019 standard which compares the automated device's readings against a series of auscultatory measurements by trained observers.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. The clinical study mentioned is a validation study, which typically involves a separate set of subjects from any training data used for algorithm development.

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

The document does not provide information on how the ground truth for the training set was established, as details about the training process and data are not included.

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The Microlife Upper Arm Automatic Digital Blood Pressure and Cardiovascular Screening Monitor Model WatchBP Office Vascular (TWIN200 VSR) is a non-invasive digital blood pressure device using the oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14-52 cm (5.5-20.5 inches).

The device can accurately measure in pregnant patients including those with known or suspected preeclampsia.

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected.

The device provides aortic blood pressure parameters, including central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff. This was validated against invasive blood pressure measurement and showed that the device determines central blood pressure measurement with high accuracy.

The device provides a validated method for determining the ankle-brachial index (ABI) which may be useful in diagnosing Peripheral Artery Disease (PAD).

The device is only intended to provide a numerical value of brachial-ankle pulse wave velocity (baPWV) for blood flow inside the intended blood vessel, without any diagnosis.

The memory data can be transferred to the PC running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth.

The device is intended for use by healthcare professionals in clinical practice.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office Vascular (TWIN200 VSR) is designed to measure svstolic and diastolic blood pressure, pulse rate, and mean arterial pressure (MAP) of the "adults and pediatrics (but not neonates)" populations with arm circumference sizes ranging from 14 -52 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, mean arterial pressure (MAP), central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP) which is a well - known technique in the market called the "oscillometric method".

The device has two settings of measurement. One setting is for measurement on one arm or on both arms simultaneously. The measurement program of the device can be set when the measurement of one arm or both arm is selected, including Number of Measurements. Resting Time (Countdown Time), Interval Time, AFIB Detector, CBP Measurement, and Average Calculation (Discard 1st measurement or not). The other setting is for measurement on one arm with one leq, this measurement is selected when assessing brachial-ankle Pulse Wave Velocity (baPWV) and Ankle Brachial Index (ABI) measurement.

In addition, the device can be used in connection with your personal computer (PC) running the WatchBP Analyzer software. The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable or Bluetooth.

The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.

The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected.

The device provides aortic blood pressure parameters, including central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff.

The device provides a validated method for determining the ankle-brachial index (ABI) which may be useful in diagnosing Peripheral Artery Disease (PAD).

The device is only intended to provide a numerical value of brachial-ankle pulse wave velocity (baPWV) for blood flow inside the intended blood vessel, without anv diagnosis.

The device is for hospital use only.

Here's an analysis of the acceptance criteria and the studies mentioned for the Microlife WatchBP Office Vascular (TWIN200 VSR) device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria for various performance metrics, except for the implication that the clinical tests were designed to show "substantial equivalence" and "high accuracy" for specific functions. Instead, it leverages the clinical validation of predicate devices for many functions, implying their established performance meets acceptance criteria. For the newly validated feature (baPWV), the performance is described qualitatively.

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

• Brachial-Ankle Pulse Wave Velocity (baPWV) Assessment:

  • Sample Size: 97 subjects
  • Data Provenance: The document does not specify the country of origin, but it is a "clinical investigation report" (VOL 010.002), implying a prospective study.

• Other features (Brachial BP, AFIB, Central BP, ABI, Pregnant Patients, Pediatrics):

  • The document states that the performance of these features are "substantially equivalent" to predicate devices (K200297 and K112845), and thus no repeated clinical testing was required for the WatchBP Office Vascular (TWIN200 VSR). The sample sizes for the original predicate device studies are not provided in this document.

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

• Brachial-Ankle Pulse Wave Velocity (baPWV) Assessment:

  • The ground truth reference was "reference cfPWV (Complior device)." This is a device, not human experts, used as the gold standard. Therefore, the concept of "number of experts" and their qualifications for establishing ground truth isn't applicable in the traditional sense for this specific test.

• Other features: The document does not provide details on the ground truth establishment for the predicate devices' clinical studies.

4. Adjudication Method for the Test Set

• Brachial-Ankle Pulse Wave Velocity (baPWV) Assessment: No explicit adjudication method is described. The comparison was automated baPWV vs. Complior device's cfPWV.
• Other features: Not specified for the predicate device studies.

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 MRMC study is mentioned. The device is an automatic digital blood pressure monitor, 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

Yes, the device operates in a standalone manner. The measurements (systolic, diastolic, pulse rate, MAP, AFIB detection, cSBP, cPP, cDBP, ABI, baPWV) are determined by the device's algorithms without human intervention in the measurement process itself. The clinical validation of baPWV, for instance, compared the device's output to a reference device.

7. The Type of Ground Truth Used

• Brachial-Ankle Pulse Wave Velocity (baPWV) Assessment: The ground truth for baPWV was established by a reference device: cfPWV (Complior device). This is a form of device-based reference standard, often considered a clinical reference standard in this domain.
• Central Blood Pressure (cSBP, cPP, cDBP): Stated to be "validated against invasive blood pressure measurement," which is a clinical reference standard/gold standard for blood pressure.
• Other features (Brachial BP, AFIB, ABI, Pregnant Patients, Pediatrics): Not explicitly stated in this document for the predicate studies, but for blood pressure monitors, the typical ground truth involves auscultation by trained observers or invasive measurements by clinicians.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for an AI or machine learning model. The device's core oscillometric technology and algorithms are described as similar to or identical to existing predicate devices, implying a long history of algorithm development rather than a modern machine learning training approach with a distinct training set.

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

As no training set is described for an AI/ML model, this information is not provided. The algorithms are based on established oscillometric principles and prior clinical validations of predicate devices.

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The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home. The device can be used in connection with a smart phone running the «Microlife Connected Health +» APP. The memory data can be transferred to the smart phone via Bluetooth.

The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is an electronic thermometer using an infrared sensor, which is composed of thermistor and thermopile, to measures infrared energy radiated from the forehead as well as objects. This energy is collected through the lens and converted to a temperature value. The thermistor measures the ambient temperature of the sensor by changing the resistance. The function of thermopile is to measure the voltage difference between the temperature corresponding to the infrared radiation induction and the temperature difference measured by thermistor. Based on the voltage difference, difference temperature can be calculated, and the target temperature can be obtained by adding thermistor's temperature. The Microlife Non-Contact Infrared forehead thermometer, Model FR1MF1-B (NC150 BT), consists of the following parts: a) Thermopile Sensor b) Microcontroller Unit c) LCD and Backlight d) 4 buttons ("START" button, "ON/OFF" button, "M" button, "MODE" button) e) Alkaline batteries; size AAA, 2 x 1.5 V f) Lens g) Bluetooth module

The provided text is a 510(k) summary for the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT). It focuses on demonstrating substantial equivalence to a predicate device (Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200)) rather than describing an independent study of the device's acceptance criteria and proven performance.

Therefore, much of the requested information regarding acceptance criteria, specific study design details (sample size, data provenance, expert numbers/qualifications, adjudication, MRMC studies, standalone performance), and ground truth establishment for this specific device's test set (FR1MF1-B) is not explicitly present in the provided document.

Instead, the document primarily leverages the equivalence to its predicate device (FR1DG1), whose clinical validation is referenced indirectly. The key argument is that because the core measurement technology and algorithm are the same as the predicate which has already undergone clinical testing, a new clinical test for the identical measurement algorithm in the subject device is not required.

However, I can extract the following information that is available or implied:

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

The document refers to the accuracy specifications shared between the subject device and the predicate device. These can be considered the performance criteria.

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

• Sample Size: Not explicitly stated for the FR1MF1-B (NC150 BT) in a direct clinical test. The document states that a new clinical test is "not necessary" for this device because its measurement algorithm is identical to the predicate (FR1DG1).
• Data Provenance: Not specified for a direct clinical test on FR1MF1-B (NC150 BT). The predicate device's clinical test report (Clinical Test Report of FR1DG1 NC200) is referenced but not detailed. It is implied that any relevant clinical data comes from the predicate's validation.

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

• Not applicable/Not specified for this submission, as a new clinical test for FR1MF1-B (NC150 BT) was deemed unnecessary. This information would be found in the clinical test report for the predicate device (FR1DG1), which is not included here.

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

• Not applicable/Not specified, as a new clinical test for FR1MF1-B (NC150 BT) was deemed unnecessary.

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 thermometer, not an AI-assisted diagnostic imaging tool that would involve "human readers" or "AI assistance" in the context of MRMC studies.

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

• The device itself is a standalone clinical electronic thermometer. Its performance is based on its measurement algorithm and hardware. The document implies that the "measurement algorithm" (which is the core of its standalone performance) for the subject device is "identical" to that of the predicate, which has been validated to standards like ASTM E1965-98 and ISO 80601-2-56. These standards typically involve rigorous standalone testing.

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

• For clinical thermometers, the "ground truth" for temperature measurement is typically established using highly accurate reference thermometers or direct invasive methods (e.g., rectal or oral core temperature) in a controlled clinical setting, as specified by standards like ASTM E1965-98 and ISO 80601-2-56. The document mentions "Body mode/laboratory" accuracy, indicating the use of controlled laboratory conditions.

8. The sample size for the training set:

• Not applicable. This is a non-AI/ML device. There is no concept of a "training set" in the context of this 510(k) submission for a clinical electronic thermometer.

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

• Not applicable (see point 8).

Summary of Device Performance Study (as implied for the predicate device, and by extension the subject device):

The document references that the predicate device (Model FR1DG1 (NC200)) has been validated in accordance with ISO 80601-2-56 and ASTM E1965-98. These are international and US standards for clinical thermometers, which prescribe specific methodologies for clinical accuracy testing.

• ASTM E1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature): This standard outlines clinical accuracy requirements and test methods for infrared thermometers, including specifics on how to conduct a clinical study to assess performance against a reference temperature. It defines statistical requirements for accuracy (e.g., mean difference, standard deviation) when compared to a reference temperature.
• ISO 80601-2-56 (Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement): This international standard also details requirements for clinical accuracy validation of thermometers, including clinical study design, patient population, and statistical analysis.

The "Clinical Test Report of FR1DG1 NC200" is cited as evidence for the predicate's validation, and thus, indirectly for the subject device's. While the details of that report are not present, it would contain the specific sample sizes, methods for ground truth establishment (likely using high-precision reference thermometers in a clinical setting), and other study parameters. The core argument for K211776's substantial equivalence is that the critical components (IC, sensor, measuring algorithm) affecting temperature measurement performance are identical to the already-cleared predicate.

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The Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm. 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 device can be used in connection with a smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.

Microlife Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.

The provided text does not contain information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics like accuracy for the subject device (Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B).

Instead, it states that:

• The subject device is considered "identical" to a predicate device (BP3NN1-3E, K151330) from a clinical validation standpoint for blood pressure measurement.
• Therefore, "no repeated clinical testing was required for blood pressure measurement to support BP3GK1-4B as the subject device can leverage the clinical validation of BP3NN1-3E that was proven in K151330."

To answer the request fully, the clinical validation study for the predicate device (BP3NN1-3E, K151330) would need to be reviewed. The provided document points to "AAMI / ANSI/IEC81060-2" as the standard for clinical validation, but it does not detail the specific results for the predicate or subject device against those criteria within this submission.

Therefore, I cannot populate the table or answer all the sub-questions directly from the provided text for the subject device.

However, I can extract the general accuracy criteria typically expected for such devices, as mentioned in the comparison table for Pressure and Pulse Rate Accuracy, which is shared between the subject device and Predicate device No.1.

Here's what can be extracted based on the provided text's limited information regarding performance for the subject device, and an acknowledgement of assumptions made based on shared specifications with the predicate device:

Acceptance Criteria and Device Performance (Based on shared specifications with Predicate Device No.1, as a clinical study was not performed on the subject device due to substantial equivalence claim):

There is no specific clinical study detailed for the subject device (BP3GK1-4B) in this document to prove it meets acceptance criteria, as the manufacturer claims substantial equivalence to a predicate device (BP3NN1-3E, K151330) and leverages its clinical validation. The acceptance criteria listed below are common performance specifications for such devices, and for this submission, the subject device is considered to meet these based on its substantial equivalence to the predicate device which presumably met these in its own 510(k) submission (K151330).

1. Table of Acceptance Criteria and the Reported Device Performance (for clinical accuracy)

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

• Not provided for the subject device (BP3GK1-4B). The document explicitly states: "There was no repeated clinical testing required for blood pressure measurement to support BP3GK1-4B as the subject device can leverage the clinical validation of BP3NN1-3E that was proven in K151330."
• To obtain this information, the 510(k) submission K151330 for the predicate device BP3NN1-3E would need to be reviewed.

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

• Not provided for the subject device. This information would be within the clinical validation study of the predicate device (K151330), if detailed. Blood pressure monitor validation studies typically involve comparison against reference measurements taken by trained operators.

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

• Not provided for the subject device. This information would be within the clinical validation study of the predicate device (K151330), if detailed. Standards like AAMI/ANSI/IEC 81060-2 specify requirements for comparing automated blood pressure measurements against auscultatory measurements by human observers.

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 an automated blood pressure monitor for direct blood pressure and pulse rate measurement, not an AI-assisted diagnostic tool for human readers. It does not involve "human readers" in its primary function for diagnosis, but rather provides direct readings to the user.

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

• Yes, implicitly. The device operates standalone to provide blood pressure readings. The claim of substantial equivalence for blood pressure measurement performance means the device's algorithm performs its intended function without human intervention in the measurement process itself. The clinical validation referenced by the predicate (K151330) against the AAMI / ANSI/IEC81060-2 standard would have assessed this standalone performance against reference measurements.

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

• Presumed to be reference blood pressure measurements. For blood pressure monitors, the ground truth is typically established using a reference method, such as auscultatory measurement by trained observers using a mercury sphygmomanometer or another validated reference device, following international standards like AAMI/ANSI/IEC 81060-2.

8. The sample size for the training set:

• Not applicable / Not provided. For a hardware device with an embedded algorithm like this, there isn't typically a "training set" in the machine learning sense for the end-user product. The algorithm development may have involved internal data for calibration and optimization, but this is distinct from a clinical validation "test set." The document does not provide details on algorithm development data.

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

• Not applicable / Not provided. (See point 8).

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor,Model WatchBP O3 (BP3SZ1-1) is a non-invasive 24 hour ambulatory blood pressure monitor (ABPM) using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for or use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm.

The device can accurately measure in pregnant patients including those with known or suspected preeclampsia.

The device provides aortic blood pressure parameters, includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff.

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected.

The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth.

The device is intended to be used by healthcare professionals and patient's environments.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3SZ1-1) is designed to measure systolic and diastolic blood pressure, pulse rate, and mean arterial pressure (MAP) of the adults and pediatrics (but not neonates) populations with arm circumference sizes ranging from 14 -52 cm by using a noninvasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, mean arterial pressure (MAP), central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP) which is a well - known technique in the market called the "oscillometric method".

The device is a 24 hour ambulatory blood pressure monitor (ABPM) .It's selected for fully programmable 24-hour patient out-of-office blood pressure measurement, the device automatically takes measurements at fixed intervals programmed by the physician.

The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.

The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected.

In addition, the memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth.

The device is intended to be used by healthcare professionals and patients in clinical and patient's environments.

The medical device referenced is the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3SZ1-1).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood pressure monitors generally follow established standards such as ISO 81060-2. While the exact numerical criteria aren't explicitly stated in a table format within the provided document, the text mentions compliance with ISO 81060-2:2018 for clinical validation. This standard outlines the accuracy requirements for intermittent automated measurement types of non-invasive sphygmomanometers.

Reported Device Performance:
The document states that the clinical validation reports for the subject device, following ISO 81060-2:2018, demonstrate the accuracy of blood pressure measurement in the general population across a wide range of arm sizes and for ambulatory blood pressure monitoring (VOL 10, 002 and VOL 10, 003).

Additional performance features and claims for which the device's accuracy is asserted (by leveraging predicate device validation or by implication of compliance with standards) include:

• Accurate measurement in pregnant patients, including those with known or suspected pre-eclampsia.
• Detection of atrial fibrillation.
• Measurement of aortic blood pressure parameters (cSBP, cPP, cDBP).

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

The document does not explicitly state the numerical sample size for the clinical test sets. It refers to "clinical validation reports of the subject device following ISO 81060-2:2018 for use in general population across a wide range of arm sizes (VOL 10, 002) and intended for ambulatory blood pressure monitoring (VOL 10, 003)".

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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

This information is not provided in the given text. For non-invasive blood pressure monitors, the ground truth for accuracy studies is typically established by trained observers taking auscultatory measurements using a mercury sphygmomanometer, not usually by "experts" in the sense of physicians establishing diagnoses. The methodology of ISO 81060-2:2018 would dictate the number and training of these observers.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly mentioned. For blood pressure measurement validation studies, ground truth is typically established by simultaneous measurements or sequential measurements by multiple trained observers, with specified acceptable differences between their readings.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable and was not conducted as this is a device for automated measurement of blood pressure, not an imaging or diagnostic AI system requiring human reader interpretation. Thus, the concept of "how much human readers improve with AI vs without AI assistance" does not apply here.

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

Yes, the primary clinical validation conducted falls under a standalone performance evaluation. The device is an "Automatic Digital Blood Pressure Monitor" using an "oscillometric technique." The clinical validation according to ISO 81060-2:2018 assesses the accuracy of the device's automated measurements against a reference standard (typically auscultatory measurements). This evaluates the algorithm's performance directly, as it automatically determines systolic and diastolic blood pressure, pulse rate, MAP, cSBP, cPP, cDBP, and atrial fibrillation detection.

7. The Type of Ground Truth Used

For the blood pressure measurement accuracy (ISO 81060-2:2018), the ground truth is established by a reference standard measurement, typically simultaneous auscultatory measurements performed by trained observers using a mercury sphygmomanometer or equivalent, as per the standard's protocol.

For the atrial fibrillation detection, the ground truth would likely be established by a reference ECG recording interpreted by a cardiologist, although this specific detail is not provided.

8. The Sample Size for the Training Set

The document describes this as a premarket notification for a predicate device. It explicitly states that the subject device (BP3SZ1-1) uses "the same software algorithm to determine the systolic and diastolic blood pressure, pulse rate, mean arterial pressure (MAP), central systolic blood pressure (cSBP) and central diastolic pressure (cDBP), central pulse pressure (cPP) and Atrial Fibrillation Detection" as the predicate device (BP3SK1-3B). This indicates the algorithm was already developed and validated with prior data, likely from the predicate device's development or other studies that are not mentioned in this submission.

Therefore, the sample size for a "training set" for the algorithm itself is not provided in this document, as the focus is on clinical validation of the device using an existing algorithm.

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

As stated above, the document doesn't provide information on the training set for the algorithm. However, given that the algorithm is the "same" as a predicate device, its original ground truth would have been established through a similar process of comparing automated blood pressure readings against reference standard auscultatory measurements (for blood pressure) and likely expert-adjudicated ECGs (for AFib detection) during its development and initial validation.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual with arm cuff circumference sizes ranging from 22 -42 cm by using a non-invasive oscillometric technique in one inflatable cuff being wrapped around the upper arm.

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.

The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer Home software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.

The device is intended for use by patient at home or by health care givers in primary care settings.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) is designed to measure systolic and diastolic blood pressure and pulse rate of an adult individual with arm circumference sizes ranging from 22 -42 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method".

The device has > and > measurement modes. The > mode is selected for a regular single measurement. The > mode is selected for diagnosis or follow-up.

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected. If atrial fibrillation is detected during all readings of the triple measurements in usual mode or all four readings of one day in diagnostic mode, the Afib icon is displayed.

In addition, the memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer Home software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.

The device is intended for use by patient at home or by health care givers in primary care settings.

The provided text is a 510(k) Summary for a medical device, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C). This summary focuses on establishing substantial equivalence to a predicate device, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home N (BP3MX1-4) (K100763).

The document does not contain a new study that proves the device meets specific acceptance criteria based on independent clinical data for the subject device (BP3MX1-3C). Instead, it leverages the clinical validation of the predicate device (BP3MX1-4) to argue for substantial equivalence.

Therefore, for the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for the subject device (BP3MX1-3C), the answer is that a new clinical study was not performed to independently prove the subject device's performance against specific acceptance criteria.

The document explicitly states:

"From a clinical validation standpoint, the subject device is identical to the 510(k) cleared predicate device, WatchBP Home N (BP3MX1-4), K100763, in blood pressure measurement and atrial fibrillation detection."
"Therefore the performance of the WatchBP Home A BT (BP3MX1-3C) in terms of blood pressure measurement and atrial fibrillation detection would be essential equivalent with performance of the predicate device WatchBP Home N (BP3MX1-4). There was no repeated clinical testing required for blood pressure measurement and atrial fibrillation detection to support WatchBP Home A BT (BP3MX1-3C) as the subject device can leverage the clinical validation of WatchBP Home N (BP3MX1-4) that was proven in K100763."

Given this, it is not possible to provide the requested details for the subject device's independent clinical study as it was asserted that such a study was not warranted due to substantial equivalence to the predicate.

Information that CANNOT be Extracted from the Provided Text:

• A table of acceptance criteria and the reported device performance for the subject device's own clinical study: No such study was reported for the subject device.
• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) for the subject device's own clinical study.
• 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) for the subject device's own clinical study.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set for the subject device's own clinical study.
• If a multi reader multi case (MRMC) comparative effectiveness study was done for the subject device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done for the subject device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the subject device's own clinical study.
• The sample size for the training set for the subject device’s algorithm (if applicable).
• How the ground truth for the training set was established for the subject device’s algorithm (if applicable).

Information that MAY be Inferred or Found in the Referenced Predicate Device (K100763):

The document states that the predicate device (WatchBP Home N, K100763) had its clinical validation for blood pressure measurement and atrial fibrillation detection proven. Therefore, the requested information (acceptance criteria, study details, ground truth, etc.) would likely be found in the 510(k) submission for K100763. The current document only refers to that previous clearance.

The only "acceptance criteria" presented are the non-clinical tests performed to demonstrate safety and effectiveness, based on recognized international standards. These are not clinical acceptance criteria for performance in measuring blood pressure or detecting AFib.

Non-Clinical Testing Standards (from section 7):

The device underwent non-clinical testing according to the following standards, demonstrating it met the requirements of these standards:

• IEC 60601-1 / AAMI / ANSI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 And A2:2010/(R) 2012 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 (Electromagnetic Disturbances - Requirements And Tests)
• ISO 14971: 2007 (Medical devices Application of risk management)
• AAMI/ANSI/ISO 10993-1:2009/(R)2013, -5:2009/(R)2014, -10:2010/(R)2014 (Biological evaluation of medical devices)
• AAMI/ANSI/IEC 80601-2-30: 2013 (Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers)
• IEC 60601-1-11:2015 (Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment)
• AAMI/ANSI /ISO 81060-2: 2013 (Non-Invasive Sphygmomanometers Part 2: Clinical Validation of Automated Measurement Type) - This standard is the relevant one for clinical performance, but the document states that the subject device leveraged the predicate's validation for this, rather than performing a new one.

In summary, the provided text does not contain a report of a new clinical study for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) to prove its performance against acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a previously cleared device (K100763) which had already undergone such clinical validation.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor,Model WatchBP Office (BP3SK1-3B) is a noninvasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm.

The device can accurately measure in pregnant patients including those with known or suspected preeclampsia.

The device provides aortic blood pressure parameters. includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff.

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected.

The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth.

The device is for hospital use only.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (BP3SK1-3B) is designed to measure systolic and diastolic blood pressure, pulse rate, and mean arterial pressure (MAP) of the adults and pediatrics (but not neonates) populations with arm circumference sizes ranging from 14 -52 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, mean arterial pressure (MAP), central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP) which is a well - known technique in the market called the "oscillometric method".

The device has two measurement modes that can be used :> mode and > mode. It has number of measurements setting function, resting time setting function, measurement intervals setting function, atrial fibrillation detection function, Central Blood Pressure (CBP) measurement function etc. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP Analyzer software. The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable or Bluetooth.

The measurement program in > mode of the device can be set, includes Number of Measurements, Resting Time (Countdown time), Interval Time, AFIB detector, CBP measurement, HIDE and Average calculation (Discard 1st measurement). Select > mode, press the Ubutton to perform automatic measurements based on the settings of > mode. The device shows all the settings and then starts counting down the Resting Time before the first measurement. The average measurement reading is displayed and saved after the measurements are complete.

The measurement program in > mode can be set to preferences. The program includes setting the Highest Cuff Pressure and Hide Cuff Pressure during deflation. Select the >mode if auscultatory blood pressure measurement is preferred above oscillometric blood pressure measurement. In > mode, the device serves as a pressure gauge. No oscillometric measurements will be taken. Systolic and diastolic Korotkoff sounds are determined by the physician using a stethoscope placed over the brachial artery.

The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.

The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected.

The device is for hospital use only.

This document is a 510(k) summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (BP3SK1-3B).

The information provided does not contain specific acceptance criteria or detailed study results for the device itself. Instead, it focuses on demonstrating substantial equivalence to two predicate devices (ProBP 2400 and WatchBP Office Central (TWIN200 CBP)) by explaining that the new device shares the same fundamental scientific technology and algorithms for blood pressure measurement, AFIB detection, and central blood pressure measurement.

The document claims that no repeated clinical testing was required for the subject device because it leverages the clinical validation of the predicate devices. Therefore, it does not provide original acceptance criteria or study data for the Model WatchBP Office (BP3SK1-3B).

However, it does mention that the predicate device ProBP 2400 was proven in K152770 and the predicate device WatchBP Office Central (TWIN200 CBP) was proven in K171937, implying that these earlier submissions would contain the clinical study data and acceptance criteria for those devices, which the current device is deemed equivalent to.

Based on the provided text, I cannot complete the requested tables and information directly for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (BP3SK1-3B) as it does not present its own clinical study results or acceptance criteria.

The document explicitly states:

• "Repeat clinical testing in accordance with the standard AAMI / ANSI/ISO81060-2 for the subject device WatchBP Office (BP3SK1-3B) regarding brachial blood pressure measurement in pregnant patients including those with known or suspected preeclampsia, adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm is therefore not necessary."
• "There was no repeated clinical testing required for brachial blood pressure, AFIB detection and CBP&CPP measurement to support WatchBP Office as the subject device WatchBP Office (BP3SK1-3B) can leverage the clinical validation of WatchBP Office Central (TWIN200 CBP) that was proven in K171937.Repeat clinical testinq in accordance with the standard AAMI / ANSI/IEC81060-2 for the subject device WatchBP Office (BP3SK1-3B) regarding brachial blood pressure measurement, AFIB detection and CBP&CPP measurement for use in adults is therefore not necessary."

To answer your request thoroughly, one would need access to the 510(k) submissions K152770 and K171937 for the predicate devices, which would contain the original clinical study data and acceptance criteria.

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The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200) is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.

The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The device uses CapSense Technology to detect distance this technology is used to assist measurement. The concept of proximity sensor detects human electrical proximity level to transform to distance. The distance control feature is added to the user interface to identify the measurement distances are in the correct parameter. In other words, the device will enter into measurement mode after the correct measurement distance is detected. This device can take a measurement automatically when the device detects the distance is appropriate within 5 cm.

The provided text describes the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200), and its comparison to a predicate device (Microlife Non-Contact Infrared Forehead Thermometer FR1DZ1, K100953) for substantial equivalence in an FDA 510(k) submission.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200) intends to meet the accuracy requirements of the ISO 80601-2-56: 2017 standard (implicitly, as it's listed as a standard the device was tested against and clinical testing was done according to ASTM E1965-98, which typically defines accuracy limits for clinical thermometers).

The device's reported laboratory accuracy is as follows:

The document also mentions that "the test report demonstrated that the clinical data, represented by clinical bias met the acceptance criteria of the clinical study protocol." However, the specific numerical acceptance criteria for clinical bias are not explicitly stated in the provided text.

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

• Sample Size for Test Set: 116 subjects.
  • 38 infants (newborn to one year)
  • 41 children (greater than one to five years)
  • 37 adults (greater than five years old)
• Data Provenance: The document does not explicitly state the country of origin. It describes a "clinical study" which implies prospective data collection, but does not explicitly state "prospective."

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 study is described as a "randomization, simple blind homologous control, pairing design of clinical investigation," and it states that "clinical bias met the acceptance criteria," suggesting a comparison against a reference thermometer measurement taken by an expert, but the number and qualifications of such experts are not detailed.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. The study design mentions "simple blind homologous control" and "pairing design," but doesn't specify how ground truth discrepancies (if any) were resolved or if multiple readers were involved in establishing the ground truth measurements.

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

This information is not provided. The text describes a clinical study to assess the accuracy of the device itself, not a comparative effectiveness study involving human readers with and without AI assistance. The device is a thermometer, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The clinical testing described is primarily focused on the device's ability to measure temperature directly, without human interpretation of complex images or data where "human-in-the-loop" would typically apply. The "clinical bias met the acceptance criteria" refers to the instrument's performance.

7. Type of Ground Truth Used

The ground truth used was clinical data obtained from a "randomization, simple blind homologous control, pairing design of clinical investigation." In thermometer studies, this typically involves comparing the device's readings against a highly accurate reference thermometer (e.g., a rectal or oral mercury/electronic thermometer, or another gold standard for body temperature measurement) by an expert under controlled conditions. The term "clinical bias" supports this interpretation.

8. Sample Size for the Training Set

This information is not provided. The document makes no mention of a "training set," as the device is a medical measurement instrument. While it has algorithms (e.g., PH15.0 Algorithm for temperature calculation), these are typically developed through engineering and calibration, not through machine learning training sets in the same way an AI diagnostic algorithm would be.

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

This information is not provided, as the concept of a "training set" with established ground truth in the context of machine learning does not directly apply to the development and validation of this type of electronic thermometer. The algorithms for temperature calculation would be based on physical principles, calibration, and engineering, rather than a data-driven training process with labeled ground truth data.

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The Microlife Digital Infrared Ear Thermometer, Model IRIDNI (IR210) device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediation used in the home setting.

The Microlife Digital Infrared Ear Thermometer, Model IR1DN1 (IR210) is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.

The provided text describes the Microlife Digital Infrared Ear Thermometer, Model IR1DN1 (IR210), and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 114 subjects.
• Data Provenance: The study was a clinical investigation, implying prospective data collection specifically for this study. The location of the clinical study is not explicitly stated, but it's a "clinical investigation" and a "clinical study" was conducted.

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

The document does not specify the number or qualifications of experts used to establish ground truth. It states that "clinical data, represented by clinical bias, with uncertainty of bias, and clinical repeatability, met the acceptance criteria of the clinical study protocol," which implies a comparison against a reference standard or method for temperature measurement, likely managed by clinical professionals, but their specific roles, number, or qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes the clinical study as a "randomization, simple blind homologous control, pairing design," but this refers to the study design rather than a reader adjudication process. For temperature measurement, ground truth is typically established by high-precision reference thermometers rather than expert consensus on interpretation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a digital infrared ear thermometer, and its performance is evaluated directly against known temperature standards and clinical correlations, not through human reader interpretation.

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

Yes, the performance testing described in the various standards (e.g., ASTM E1965-98, ISO 80601-2-56) and the accuracy in blackbody mode inherently represent standalone performance. The device provides a direct temperature reading. The clinical study then validated this standalone reading in a real-world setting.

7. The Type of Ground Truth Used

The ground truth for the device's accuracy is established through objective measurement against:

• Blackbody mode accuracy: For measuring the device's inherent precision against a controlled and known temperature source.
• Clinical Study Protocol: Which would involve comparing the device's readings to established clinical reference temperature measurement methods. The document mentions "clinical bias, with uncertainty of bias, and clinical repeatability," which are standard metrics for comparing a device to a reference measurement in a clinical setting.

8. The Sample Size for the Training Set

The document does not mention a training set or machine learning models. This device is a traditional electronic thermometer that uses an infrared sensor and an algorithm to convert infrared energy into a temperature value. It doesn't appear to use learning-based AI or require a training set in the conventional sense.

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

As no training set is indicated, this question is not applicable.

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