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The Withings ECG App is a software-only device intended for use with the ScanWatch to create, record, store, transfer and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The Withings ECG App determines the presence of atrial fibrillation (AFib), sinus rhythm and high heart rate (no signs of AFib with heart rate 100-150 bpm) on a classifiable waveform. The Withings ECG App is not recommended for users with other known arrhythmias.

The Withings ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the Withings ECG App is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.

The Withings ECG App is intended to supplement rhythm classification for the purposes of discriminating AFib from normal rhythms. The device is not intended to replace traditional methods or diagnosis.

The ECG acquired by ScanWatch is not intended for manual and/or automated measurement of QT-interval.

The Withings ECG app is not intended for use by people under 22 years old.

The Withings ECG App is a software only mobile medical application that has two components:

• Withings ECG Watch App
• Withings ECG Phone App

The Withings ECG Watch App is integrated on the Withings ScanWatch, model number hwa10. The Withings ECG Watch App analyzes the data collected by electrodes on the Withings ScanWatch to generate an ECG waveform similar to a Lead I, calculate the average heart rate and provide rhythm classification to the user for a given 30 second session.

Withings ECG Watch App consists of a software library called ECG-SW2 library. The ECG-SW2, is a software library that includes an algorithm that processes the raw ECG signals and a tracing filter that filters the ECG signal to provide the user an output on the user interface (watch and smartphone).

The Withings ECG Phone App contains the installation steps, tutorial and the instructions for use that the user must review prior to taking an ECG reading. The Withings ECG Phone App is included in the Withings App, which displays the ECG results and also allows the user to store, manage and share health data.

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter for the Withings ECG App:

Overall Summary of the Study:

The Withings ECG App's performance was evaluated through a pivotal, prospective, multi-center clinical trial. This trial assessed the device's ability to accurately classify ECG recordings into Atrial Fibrillation (AFib), sinus rhythm, and high heart rate (no AFib) compared to a cardiologist's rhythm classification from a simultaneously collected 12-lead ECG (the ground truth). Non-clinical testing, including database testing of the algorithm and human factors studies, also supported the device's safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The clearance letter does not explicitly state pre-defined "acceptance criteria" as distinct numerical thresholds to be met. Instead, it describes the results achieved by the device, which implicitly serve as the demonstration of acceptable performance to the FDA. The performance metrics presented are sensitivity and specificity for AFib and sinus rhythm classification.

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

• Sample Size for Clinical Test Set: Approximately 626 subjects.
  • 219 in the Atrial Fibrillation cohort
  • 369 in the normal sinus rhythm cohort
  • 33 had other arrhythmias
  • 5 were uninterpretable
• Data Provenance:
  • Clinical Trial: Pivotal, prospective, multi-center clinical trial. The specific countries are not mentioned for the clinical trial itself, but the training data (Deep Train) is described as being from the European Union, and Heartbeats from the United States. Given the FDA clearance, it's highly probable the pivotal clinical trial included data from the U.S. or other regions acceptable to the FDA.

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

• Number of Experts: At least one cardiologist was used for ground truth establishment. The use of "a cardiologist" in the singular suggests a primary determination, though it's common practice for such a determination to be peer-reviewed or confirmed by a panel in high-stakes clinical trials. The document explicitly states: "Rhythm classification of a 12-lead ECG by a cardiologist was compared to the rhythm classification of a simultaneously collected ECG from the Withings ECG App."
• Qualifications of Experts: Cardiologist. Further details on experience (e.g., years of experience, board certification) are not specified in the provided text.

4. Adjudication Method for the Test Set

The adjudication method is implied as comparison to a cardiologist's 12-lead ECG interpretation. While it states "Rhythm classification of a 12-lead ECG by a cardiologist was compared...", it doesn't describe a multi-reader adjudication process (e.g., 2+1 or 3+1). It points to a direct comparison with a single cardiologist's interpretation of the 12-lead ECG as the reference standard.

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

No, an MRMC comparative effectiveness study involving human readers improving with AI vs. without AI assistance was not described in this document. The study focused on the device's standalone performance in classifying ECG rhythms against a clinical gold standard (cardiologist's 12-lead interpretation).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The core of the clinical trial directly assessed the "Withings ECG App's ability to accurately classify an ECG recording" which is its algorithmic performance in classifying AFib, sinus rhythm, and high heart rate. The sensitivity and specificity numbers (99.7% and 99.8% respectively) are metrics of the algorithm's performance in this standalone capacity relative to the ground truth.

7. The Type of Ground Truth Used

The primary ground truth used was expert consensus / clinical diagnosis from a 12-lead ECG. Specifically, "Rhythm classification of a 12-lead ECG by a cardiologist" served as the reference standard.

8. The Sample Size for the Training Set

The document mentions two "user datasets" used for training and testing (via 4-Fold Cross Validation for hyperparameter tuning):

• "Deep train": n = 11,701
• "Heartbeats": n = 5,089

It's important to note that these datasets were used for initial training and hyperparameter tuning (4-Fold cross validations and act as train and test sets). The "clinical study datasets" (HWA08 test, HWA08 CE, WEFA HWA09 part 1) were used as a "first layer of validation sets" to check generalization, and "WEFA HWA09 part 2" was a "second layer of validation after the software freeze". The pivotal clinical trial data (626 subjects) described under "Clinical Testing" was the independent, locked algorithm validation set for regulatory submission.

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

The document provides the following for the "ML algorithm training and testing" datasets ("Deep train" and "Heartbeats"):

• It states these datasets were "user datasets".
• It does not explicitly detail how the ground truth for these training datasets was established. While the clinical trial's ground truth was a cardiologist's 12-lead ECG interpretation, the method for labeling the much larger training datasets is not provided in this excerpt. This is a common omission in 510(k) summaries which focus on the final validation. It's plausible they were labeled by a similar expert review process, potentially leveraging a larger pool of retrospectively acquired data.

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Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA).

The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner.

The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions.

This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations.

The Withings Sleep Rx is a device intended as an aid for diagnosis of obstructive sleep apnea (OSA). It is intended for home use. The device is placed under the mattress and is contactless with the user. It provides a Withings index based on breathing (sound, variations of pressure in the bladder) and heart rate measured in a contactless manner. The number of breathing events per hour is displayed to the user in the companion app. The results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation.

In addition, the device records heart rate and movement during sleep in an automatic contactless manner. The recordings are displayed in the companion app.

Withings Sleep Rx is composed of the following components: (1) Mat (hardware); (2) Withings Sleep Rx embedded software included in the Mat and (3) Companion App included in a companion mobile application.

The Withings Sleep Rx device is cleared for recording a patient's "Withings index" during sleep as an aid for diagnosing obstructive sleep apnea (OSA), and for recording heart rate and movement in an automatic, contactless manner. It is intended for home screening of adults with suspected sleep breathing disorders, to assist healthcare professionals in determining the need for further diagnosis.

Here's a breakdown of the acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Withings Index (OSA Screening):
  • Sample Size: 118 patients.
  • Data Provenance: The study was conducted with patients referred to a PSG test in a sleep laboratory, suggesting a clinical setting in a specific geographic location (publication mentions "J Clin Sleep Med," and authors are from various institutions, potentially implying an international or multi-center European study due to authors' affiliations). The study involved simultaneous polysomnography (PSG), making it a prospective (or at least concurrent data collection) study.
• Heart Rate Estimation:
  • Sample Size: Data pooled from two clinical studies (ESAS and VPASS). Specific combined sample size not directly stated, but the studies were described as enrolling patients with suspected sleep apnea syndrome referred for a sleep study analysis.
  • Data Provenance: Both studies were conducted with the subject device and involved simultaneous polysomnography (PSG), implying prospective or concurrent data collection in a clinical setting related to sleep studies.
• Movement Detection:
  • Sample Size: Participants in an internal human study. Specific sample size not stated.
  • Data Provenance: Internal study with predetermined movements, suggesting a controlled, laboratory-like setting.

3. Number of Experts and Qualifications for Ground Truth - Test Set

• Withings Index (OSA Screening):
  • Number of Experts: Not explicitly stated, but "simultaneous polysomnography (PSG) manually scored by certified specialists" implies multiple certified specialists.
  • Qualifications: "Certified specialists" in manual scoring of PSG, following AASM guidelines.
• Heart Rate Estimation:
  • Number of Experts: Not explicitly stated, but "simultaneous polysomnography (PSG) scored by a qualified investigator following AASM guidelines" implies qualified investigators.
  • Qualifications: "Qualified investigator" following AASM (American Academy of Sleep Medicine) guidelines.
• Movement Detection: Not applicable as the ground truth was based on predetermined movements by participants.

4. Adjudication Method for the Test Set

• Withings Index (OSA Screening) and Heart Rate Estimation: The information provided does not specify an explicit adjudication method (e.g., 2+1, 3+1). It states "manually scored by certified specialists" or "scored by a qualified investigator," which might imply single scoring or an internal consensus process, but no detail on a formal adjudication protocol is given.
• Movement Detection: Not applicable, as ground truth was based on pre-defined movements.

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

• No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study to assess the effect size of human readers improving with AI vs. without AI assistance. The studies focused on the performance of the device itself against established clinical standards (PSG).

6. Standalone (Algorithm Only) Performance

• Yes, the studies primarily assessed the standalone performance of the Withings Sleep Rx device.
  • The "Withings Index" for OSA screening was compared directly against PSG.
  • The heart rate estimation was compared against simultaneous PSG data.
  • The movement detection was evaluated based on the device's ability to identify pre-defined participant movements.

7. Type of Ground Truth Used

• Withings Index (OSA Screening) and Heart Rate Estimation: Expert Consensus (PSG scoring). Polysomnography (PSG) manually scored by certified specialists/qualified investigators following AASM guidelines is considered the gold standard for sleep disorder diagnosis.
• Movement Detection: Predefined movements/experimental protocol. The ground truth was based on the participants performing known, predetermined movements for specific durations, allowing for unambiguous identification.

8. Sample Size for the Training Set

• The document explicitly states regarding heart rate estimation:
  • "ESAS was designed to train the algorithm calculating the Withings index of Sleep Rx, but not to train the estimation of heart rate."
  • "VPASS was designed to validate the Withings index, but not to train the estimation of heart rate."
• While these studies mention their role in training or validating the Withings index algorithm, the specific sample size used solely for algorithm training for the Withings Index, heart rate, or movement detection is not provided. The 118 patient study listed under "Clinical study for the validation of the Withings' index" is explicitly for validation of the Withings' index.

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

• For the ESAS study, which was "designed to train the algorithm calculating the Withings index," the ground truth would have been established through simultaneous polysomnography (PSG) manually scored by certified specialists, similar to the validation studies. However, the exact details of the ground truth establishment specifically for the training set are not fully elaborated in this document, beyond stating its purpose was for training.

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The Withings Scan Monitor 2.0 is intended to record, store and transfer lead II and lead-III of a twochannel electrocardiogram (ECG). In addition, it calculates and displays leads I, aVF, aVL. The Withings Scan Monitor 2.0 also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under care of a physician).

The Withings Scan Monitor 2.0 is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.

The Withings Scan Monitor 2.0 is intended for adult patients in hospitals, clinics, long-term care facilities, and homes.

The Withings Scan Monitor 2.0 is a connected smart scale with a retractable handle, with Bluetooth and Wi-Fi capabilities that connects to a companion mobile application. The Withings Scan Monitor 2.0 is intended to create, record, store, transfer and display lead-III of a two-channel electrocardiogram (ECG).

When a user stands on the scale and holds the handle attached to it, a 30 second ECG recording begins. The Withings Scan Monitor 2.0 software analyzes data collected by the electrical sensors present on the scale to generate lead-III simultaneously and derive lead-I and leads aVR, aVF and aVL, calculate heart rate, and provide a rhythm classification to the user that is displayed on the scale. The companion application is intended to display, store, manage and share data.

The Withings Scan Monitor 2.0 classifies ECG signals as follows:

• Normal Sinus Rhythm
• Atrial Fibrillation
• Inconclusive
• Noise - Inconclusive

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

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

The document defines acceptance criteria primarily through the clinical study results and comparison to the predicate device.

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The Scan Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Scan Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under the care of a physician). The Scan Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.

The Scan Monitor is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2). The Scan Monitor is intended for spot-checking of adult patients in hospitals, clinics, long-term care facilities, and homes.

The Scan Monitor is a wearable, Bluetooth-connected wrist-worn watch that records two medical measurements-heart activity (electrocardiogram (ECG)) and oxygen saturation (SpO2)-as well as other measurements including step cycles, running, biking, and walking. The Scan Monitor has a companion mobile application called Health Mate. The Scan Monitor is available in two sizes, 38 mm and 42 mm, which have different watch faces but are otherwise identical.

The Scan Monitor has two stainless steel electrodes integrated on the back case of the watch and are always in contact with the skin. One of these two electrodes is used to obtain a reference signal and reduce the noise on the ECG signal. A third electrode is accessible by the free hand (the hand that does not wear the device) on the top of the device.

The Scan Monitor classifies ECG signals as follows:

• 0 Normal Sinus Rhythm;
• Atrial Fibrillation; .
• . Inconclusive;
• 0 Noisy.

The SpO2 measurements are obtained by a photoplethysmograph sensor located at the backcase of the product. This sensor is composed of three LEDs (green, red, and infrared) and two photodiodes (one large band and one with a green filter). The Scan Monitor is validated for an SpO2 range of 70% to 100% and an SpO2 range between 85% to 100% is displayed on the gauge.

All measurements obtained by the Scan Monitor are available in the companion Health Mate app.

The Withings Scan Monitor has two main functionalities: ECG rhythm recording and Atrial Fibrillation (AFib) detection, and SpO2 measurement. Here's a breakdown of the acceptance criteria and study information for each:

ECG Rhythm Recording and Atrial Fibrillation (AFib) Detection

1. Table of Acceptance Criteria and Reported Device Performance (AFib Detection)

2. Sample Size and Data Provenance

• Test Set Sample Size: 262 participants
• Data Provenance: Prospective, multicentric, comparative, cross-over study. The document does not specify the country of origin of the data.

3. Number and Qualifications of Experts for Ground Truth

The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience) used to establish the ground truth for the ECG study. It implicitly refers to "clinical performance" evaluation, suggesting medical professionals were involved in defining the ground truth for AFib and normal sinus rhythm.

4. Adjudication Method

The document does not specify the adjudication method (e.g., 2+1, 3+1, none) for the test set's ground truth.

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

A MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly mentioned. The study focused on the performance of the Scan Monitor software itself.

6. Standalone Performance

Yes, a standalone performance study was done for the AFib detection algorithm. The reported sensitivity and specificity are for the device's software detecting AFib.

7. Type of Ground Truth Used

The ground truth for the AFib detection study was established through clinical evaluation, likely by expert interpretation of reference ECGs, given its "clinical performance" context.

8. Sample Size for Training Set

The sample size for the training set is not provided in the document.

9. How Ground Truth for Training Set was Established

The document does not provide details on how the ground truth for the training set was established.

SpO2 Measurement

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 15 participants
• Data Provenance: Clinical study. The document does not specify the country of origin or whether it was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth

The document does not explicitly state the number of experts or their specific qualifications used to establish the ground truth for the SpO2 study. Ground truth for pulse oximetry is typically established using a reference oximeter or arterial blood gas analysis in a controlled setting.

4. Adjudication Method

The document does not specify the adjudication method for the SpO2 test set.

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

A MRMC comparative effectiveness study was not mentioned for the SpO2 functionality.

6. Standalone Performance

Yes, a standalone performance study was done for the SpO2 functionality, as the device's measurement performance was evaluated against established standards and a reference device.

7. Type of Ground Truth Used

The ground truth for the SpO2 study was established in accordance with IEC 80601-2-61:2017 and FDA's guidance for pulse oximeters, which typically involves comparing the device's readings to a validated reference method, such as arterial blood gas analysis or a highly accurate laboratory oximeter.

8. Sample Size for Training Set

The sample size for the training set is not provided in the document.

9. How Ground Truth for Training Set was Established

The document does not provide details on how the ground truth for the training set was established.

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The Withings Thermo (Model SCT01) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch mode over the measurement site on people of all ages.

The Withings Thermo (Model SCT01) is a hand-held, battery powered device designed to measure human body temperature. The SCT01 device is an infrared thermometer that, when placed in contact with the user's skin over the temporal artery, measures the natural infrared energy emitted from the surface of the skin and convert it to an oral equivalent temperature.

The Withings Thermo (Model SCT01) thermometer uses a thermopile sensor for the target reading, a thermistor-like pin junction for ambient temperature readings, and a silicon lens to focus the radiated energy on the thermopile sensor. It embeds a 20x5 LEDs matrix for display of results, and also a Wi-Fi/ Bluetooth module for optional usage of a smartphone application to log results

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

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • The document states that clinical testing was conducted "according to the requirement set out on ASTM 1965: 2009 standard." However, it does not explicitly mention the sample size (number of participants) used in this clinical test.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, clinical testing implies prospective data collection for the purpose of validating the device.

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

   • Not specified. The ground truth in this context would typically be a highly accurate reference thermometer measurement. The document doesn't detail how this reference was established or if human experts were involved in defining the "ground truth" for temperature readings as opposed to simply performing the reference measurements.

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

   • Not applicable/Not specified. For a temperature measurement device, adjudication methods like 2+1 are typically used for subjective diagnoses or interpretations (e.g., radiology). For a quantitative measurement like temperature, the ground truth is typically a direct measurement from a highly calibrated and accurate reference device, not an expert consensus process.

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, an MRMC study was not done. This type of study is relevant for devices that assist human interpretation (e.g., AI in medical imaging). The Withings Thermo is a standalone measurement device, not an AI-assisted diagnostic tool that requires human interpretation.

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

   • Yes, a standalone performance study was done. The clinical testing evaluated the "accuracy of body temperature measurement between Withings Thermo (Model SCT01) and Braun NTF3000US." This is a direct comparison of the device's output against a predicate device, which itself is a standalone measurement tool. The device is designed for standalone use for temperature measurement.

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

   • The ground truth for temperature measurement would be measurements from a highly accurate and calibrated reference thermometer, conforming to established standards (e.g., ASTM 1965: 2009). The document compares the SCT01's readings to those of the Braun NTF3000US, which is presumably used as a proxy for, or in direct comparison to, such a reference.

7. The sample size for the training set:

   • Not specified. The document does not provide details about a training set. Infrared thermometers often use predictive algorithms, but the text focuses on clinical validation, not the development or training of such algorithms. It mentions "predictive algorithms to estimate the body temperature" for both the subject and predicate devices, implying these are established and refined during product development, but specific training set sizes are not disclosed for regulatory submission.

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

   • Not specified, as training set details are not provided. If a training set were used to refine predictive algorithms, its ground truth would typically be established through highly precise measurements using reference standards in controlled environments, often including invasive core body temperature measurements for correlation. The document does not elaborate on this aspect.

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The Withings Blood Pressure Monitor, Upper Arm Type: BP-801 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9 to 17 inches (22cm-42cm) for Upper Arm type.

The Withings BP-801 is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 to 17 inches (22 - 42 cm) via an arm cuff. It is designed and manufactured according to IEC 80601-2-30, Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. The operational principle is based on oscillometric and silicon integrates pressure sensor technology it can calculate the systolic and diastolic blood pressure, the measurement results can also be classified by the function of blood pressure classification indicator. The Withings BP-801 is a blood pressure monitor achieves its function by integrate the device with an iPhone 4S. As it does not include a LCD or other display components, it is necessary for the new device to connect to an iPhone 4S containing a support software to constitute a complete blood pressure measurement system. And the new device connects iPhone 4S through Bluetooth or USB cable.

Here's a breakdown of the acceptance criteria and study details for the Withings Blood Pressure Monitor BP-801, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the ANSI/AAMI/ISO 81060-1:2007 & ANSI/AAMI/ISO 81060-2:2009 & ANSI/AAMI/IEC 80601-2-30:2009 protocols.

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The Withings Blood Pressure Monitor, Upper Arm Type: HP-800 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9'' 7' (22cm42cm) for Upper Arm type.

Withings Blood Pressure Monitor, Upper Arm Type:BP-800 uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

The provided document is a 510(k) summary for the Withings Blood Pressure Monitor, Upper Arm Type: BP-800. It focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study report with specific acceptance criteria and outcome measurements as might be found in a clinical trial publication.

Based on the information provided, here's a breakdown of the requested elements:

1. Table of Acceptance Criteria and Reported Device Performance

The document references "AAMI / ANSI SP10" as the performance standard. While it states "Withings believes this information and referred document to be sufficient...", it does not explicitly list the specific acceptance criteria defined by AAMI/ANSI SP10 or the device's reported performance against those criteria in a table format within this document.

AAMI/ANSI SP10 is a standard for automated sphygmomanometers, and it sets limits for accuracy (e.g., mean difference and standard deviation between the device and a reference method). However, these specific numerical criteria and the device's measured performance are not provided in this 510(k) summary. The summary only states "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10" implying that the device was tested per this standard, but the results are not detailed.

Key Missing Information: Specific numerical acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation as per AAMI/ANSI SP10) and the actual performance results of the BP-800 device against these criteria.

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

The document references "AAMI / ANSI SP10" for performance and clinical tests. This standard typically requires a specific number of subjects for clinical validation. However, the sample size used for the test set is not explicitly stated within this 510(k) summary.

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

The document does not provide details on the number of experts used to establish the ground truth for the test set or their qualifications. For an AAMI/ANSI SP10 validation, typically multiple independent observers (often with specific training in auscultatory blood pressure measurement) are used to establish reference measurements.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set. In AAMI/ANSI SP10 validation, often a consensus of multiple observers or a specific protocol for resolving discrepancies between observers' measurements is employed.

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

A MRMC comparative effectiveness study, which typically evaluates human reader performance with and without AI assistance, is not applicable to this device. This is a standalone blood pressure monitor, not an AI-powered diagnostic imaging tool that assists human readers.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was done, implicitly, as the device is an automated blood pressure monitor. The "AAMI / ANSI SP10" standard is specifically for validating the accuracy of such automated devices against Riva-Rocci/Korotkoff auscultation (the traditional "human-in-the-loop" method with a stethoscope). The document states the device "uses the Oscillometric method... and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure." This describes its standalone algorithmic operation. The lack of specific results, however, prevents a quantitative answer here.

7. Type of Ground Truth Used

Based on the reference to "AAMI / ANSI SP10," the standard ground truth for automated blood pressure monitors is typically auscultatory blood pressure measurement performed by trained human observers using a stethoscope and sphygmomanometer, often referred to as the "reference method" or "gold standard" for non-invasive blood pressure.

8. Sample Size for the Training Set

The document describes the device as being "substantially equivalent" to predicate devices and mentions the use of the oscillometric method and microcomputer calculations. It does not mention or provide details about a "training set" in the context of machine learning or AI models. This device is a traditional electronic medical device, not one that relies on a machine learning model trained on a dataset.

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

Since there is no mention of a "training set" for a machine learning model, this question is not applicable in the context of this device's description. The device's operation is based on an established oscillometric algorithm rather than a data-trained AI model.

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