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The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.

The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:

• Pulse Rate,
• Blood Oxygen Saturation under no-motion conditions,
• Respiratory Rate under no motion conditions,
• Peripheral Skin Temperature,
• Electrodermal Activity,
• Activity associated with movement during sleep

The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.

The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.

The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.

The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy, and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.

The Empatica Health Monitoring Platform is a wearable device and software platform composed by:

• A wearable medical device called EmbracePlus,
• A mobile application running on smartphones called "Care App",
• A cloud-based software platform named "Care Portal".

The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or WiFi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.

The Empatica Health Monitoring Platform is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters and digital biomarkers by trained healthcare professionals or researchers: Pulse Rate (PR), Respiratory Rate (RR), blood oxygen saturation (SpO2), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.

The provided FDA 510(k) clearance letter and its attachments describe the acceptance criteria and study that proves the Empatica Health Monitoring Platform (EHMP) meets those criteria, specifically concerning a new Predetermined Change Control Plan (PCCP) for the SpO2 quality indicator (QI) algorithm.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are outlined for the proposed modification to the SpO2 Quality Indicator (QI) algorithm. The reported device performance is presented as a statement of equivalence to the predicate device, implying that the acceptance criteria are met, as the 510(k) was cleared.

Note: For the pre-existing functionalities (Pulse Rate, Respiratory Rate, Peripheral Skin Temperature, Electrodermal Activity, Activity and Sleep), the document states that "no changes to the computation... compared with the cleared version" have been introduced, implying their previous acceptance criteria were met and remain valid.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated for the SpO2 algorithm modification. The document only mentions "enhancing the development dataset with new samples" for the ML-based algorithm and clinical testing was "conducted in accordance with ISO 80601-2-61... and ... FDA Guidelines for Pulse Oximeters." These standards typically require a certain number of subjects and data points, but the exact numbers are not provided in this public summary.
• Data Provenance: Not specified in the provided document. It does not mention the country of origin, nor whether the data was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document states the platform is "intended to be used by trained healthcare professionals or researchers," and later discusses "professional users" and "clinical interpretation," implying that the ground truth for clinical studies would likely involve such experts, but their specific roles, numbers, and qualifications for establishing ground truth are not detailed.

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth for the test set is not explicitly mentioned in the provided document.

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

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being conducted, nor any effect size regarding human readers improving with AI vs. without AI assistance. The device is for "retrospective remote monitoring" by healthcare professionals, implying an AI-driven data collection/analysis with human review, but not necessarily human-AI collaboration in real-time diagnostic interpretation that an MRMC study would evaluate.

6. Standalone (Algorithm Only) Performance

The acceptance criteria for the SpO2 QI algorithm include "Bench testing conducted using a functional tester to simulate a range of representative signal quality issues." This falls under standalone performance, as it tests the algorithm's ability to discriminate data quality without direct human input. Clinical testing also evaluates the algorithm's accuracy (Arms error) in comparison to an established standard, which is also a standalone performance measure.

7. Type of Ground Truth Used

• For the SpO2 QI ML algorithm: The ground truth for low-quality and high-quality data discrimination seems to be an internal standard/reference based on the "FDA-cleared SpO2 algorithm" and potentially expert labeling of data quality during the "enhancing the development dataset."
• For the SpO2 Accuracy (Arms Error): The ground truth for SpO2 values would be established in accordance with ISO 80601-2-61, which typically involves comparing the device's readings against a laboratory co-oximeter or a reference pulse oximeter for arterial oxygen saturation.

8. Sample Size for the Training Set

The document mentions "enhancing the development dataset with new samples" for the ML-based algorithm but does not specify the sample size for the training set.

9. How Ground Truth for Training Set was Established

The ground truth for training the ML-based SpO2 QI algorithm was established by "enhancing the development dataset with new samples." It also mentions performing "feature extraction and engineering on window lengths spanning a 10-30-second range." While it doesn't explicitly state the methodology, given the context of a "binary output" (high/low quality), it implies a labeling process, likely by human experts or based on predefined criteria derived from the previous FDA-cleared algorithm's performance on various data types. For the SpO2 accuracy, the ground truth would typically be established by a reference method consistent with the mentioned ISO standard and FDA guidance.

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The TeleRehab® Aermos Cardiopulmonary Rehabilitation System is intended to acquire and condition the ECG signal from a patient so that it can be transmitted wirelessly from a radiofrequency transmitter to a workstation in a hospital or a clinical setting where the data is displayed and analyzed. This device also measures heart rate and provides visual and audible alarms if the patient's heart rate goes out of a prescribed range. This device is for use with ambulatory adult patients who need monitoring while undergoing cardiovascular and/or pulmonary rehabilitation. The physiological data from monitoring and other patient information (such as patient demographics, exercise protocol and medical information) is stored in a database for tracking and reporting of the patients' progress through rehabilitation.

The TeleRehab® Aermos Cardiopulmonary Rehabilitation System ("Aermos") provides the ECG monitoring functionality required for performing rehabilitation of cardiovascular and/or pulmonary patients. Patients' ECG may be monitored using the Aermos system during exercise under clinical supervision. During monitoring, Aermos provides both visual and audible alarms if the patient's heart rate goes out of a prescribed range. The heart rate alarm indication is one of multiple inputs a clinician may use to modify and adjust rehabilitation activities such as decreasing the patient's level of physical exertion or halting the exercise entirely.

Aermos also provides the ability to plan a patient's rehabilitation program and document the patient's progress through the creation of various types of reports. The report types supported in Aermos include individual treatment plan reports, daily exercise session reports and various patient information reports. Additionally, the Aermos system provides the ability to transfer various report types to the hospital Electronic Medical Records system.

The main components of Aermos are Argus ECG transmitters, the Aermos Workstation and associated networking equipment.

This FDA 510(k) clearance letter pertains to the TeleRehab Aermos Cardiopulmonary Rehabilitation System, which is a device for monitoring ECG signals and heart rate during patient rehabilitation. The provided documentation (the 510(k) Summary) details non-clinical bench testing for performance and safety but explicitly states that clinical testing was not applicable.

Therefore, based on the provided document, the following information regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning an AI/algorithm-driven component with clinical performance metrics, cannot be fully extracted or is explicitly stated as not performed:

Here's an analysis of the provided information relative to your request:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)

Since no clinical study was performed, the "reported device performance" would pertain to the results of non-clinical bench testing against established performance standards. The document does not provide specific quantitative acceptance criteria or reported numerical performance results for the device. Instead, it states that the device's specifications were "verified through internal verification testing" and its usability "evaluated through internal validation testing," and that it complies with various international standards.

Study Details (Based on the provided 510(k) Summary)

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

   • See the table above. Specific quantitative acceptance criteria beyond "compliance with standard" are not provided in this regulatory summary.

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

   • The document explicitly states "Clinical Testing: Not applicable."
   • For the non-clinical bench testing, specific sample sizes (e.g., number of devices tested, number of test cases) are not detailed in this 510(k) summary.
   • Data provenance for non-clinical testing would typically be internal laboratory data generated during device development and verification. There is no mention of geographical origin or retrospective/prospective nature as this was not clinical data.

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

   • Not applicable, as no clinical study with human interpretation/ground truth was performed. The "ground truth" for bench testing would be defined by validated test equipment and reference standards.

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

   • Not applicable, as there was no study involving human readers or interpretation requiring adjudication.

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 was done, as clinical testing was "Not applicable." The device is a physiological signal monitor, not an AI-assisted diagnostic tool that interprets images or signals requiring human reader comparison.

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

   • The core functionality of the device (ECG acquisition, heart rate measurement, alarms) is algorithmic. The performance of these algorithms would have been assessed during the non-clinical bench testing, which is essentially "standalone algorithm" testing against known inputs and expected outputs. Specific quantitative results (e.g., algorithm accuracy for heart rate) are not provided in this summary beyond "compliance with IEC 60601-2-27" and "ANSI/AAMI EC57: 2012, Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measure Algorithms."

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

   • For non-clinical bench testing, the "ground truth" is typically established by:
     • Reference standards and calibrated test equipment: For electrical performance, signal acquisition accuracy, frequency response, etc.
     • Simulated physiological signals: For testing heart rate calculation and alarm thresholds.
     • Design specifications and established engineering principles: For software functionality and cybersecurity.

8. The sample size for the training set:

   • Not applicable. The device is a monitoring system and not primarily driven by a deep learning or machine learning algorithm that requires a "training set" in the sense of a large dataset for model development. The algorithms for heart rate calculation, etc., are likely traditional signal processing algorithms.

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

   • Not applicable, as there was no training set for a machine learning model.

Summary of Device Nature and Regulatory Pathway:

The TeleRehab Aermos Cardiopulmonary Rehabilitation System is a Class II device (Product Codes DRG, DRT) which functions as a physiological signal transmitter and receiver. It monitors ECG and heart rate and provides alarms. Its 510(k) clearance relied on demonstrating substantial equivalence to predicate devices primarily through non-clinical bench testing against recognized industry standards (e.g., IEC 60601 series, ANSI/AAMI, ISO standards) and adherence to FDA guidance documents (e.g., for software, cybersecurity, reprocessing). The explicit statement "Clinical Testing: Not applicable" indicates that the nature of the device and its intended use, combined with the comprehensive non-clinical data, satisfied the FDA's requirements for demonstrating safety and effectiveness without the need for a human-subject clinical study. This is common for devices that are evolutionary improvements on existing technologies with well-understood performance parameters.

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iBSM is a wireless monitoring system intended for the display of electrocardiography (ECG) waveform, heart rate measurements, respiratory rate measurement and waveform, functional oxygen saturation of arterial hemoglobin (SpO2), activity, body position, fall detection, skin temperature and Blood Pressure parameter measurements by qualified healthcare professionals in healthcare settings. iBSM continuously monitors the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the patient's position has not changed from a preset time threshold.

The iBSM device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment.

The iBSM device is not intended for use on critical care patients.

The iBSM BP cuff is not intended for subjects that are considered special populations.

The iBSM device is indicated for monitoring ECG waveforms and heart rate on non-ambulatory patients.

The iBSM device is intended to be used in wards and patient rooms in professional healthcare facility environment hospital settings.

The iBSM device is not intended to be used in Home environment or special environment.

The iBSM device is not intended to be used in an ambulatory environment for noninvasive blood pressure, respiratory rate and SpO2 measurement parameters.

The iBSM device is not intended to monitor or measure respiratory rate, SpO2, or noninvasive blood pressure while the patient undergoes significant motion or is active.

The iBSM device is not intended to be used in the ICU/CCU or Surgery/OT rooms

iBSM is compatible with third-party, FDA cleared devices such as ANNE Chest from Sibel Health Inc, for ECG, HR, RR, body position and skin temperature measurements; and ANNE Limb from Sibel Health Inc. for SpO2 and skin temperature measurements.

iBSM is compatible with third-party, FDA-cleared BP devices such as BP2A from Shenzhen Viatom, for non-invasive blood pressure measurements.

The iBSM device communicates with an external server for patient data communication and storage.

The iBSM device includes the ability to notify healthcare professionals when physiological data fall outside selected parameters with the use of audio and visual alarms.

The iBSM chest sensor is not intended to be used to provide diagnostic or or interpretive statements to either the patient or the clinician. The iBSM chest sensor is NOT intended to be used on critical care patients and is not a remote diagnostic device. The iBSM chest sensor is NOT intended for use on patients with implanted pacemakers. The iBSM Chest sensor is NOT intended for use on patients with known allergies, or hypersensitivities to, adhesives or nickel. The iBSM Chest Sensor is NOT intended for patients with significant cardiorespiratory disease including patients that are oxygen dependent. The iBSM Chest Sensor is NOT intended for patients with significant respiratory muscle weakness due to an underlying neuromuscular condition (e.g., myasthenia gravis, amyotrophic lateral sclerosis, or muscular dystrophies)

The data and results provided by the BP cuff device are for precheck screening purposes only and cannot be directly used for diagnosis or treatments.

The iBSM device is a wireless vital sign and physiological data monitoring device that streams real-time biosignals including electrocardiography (ECG), photoplethysmography (PPG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate(HR), respiratory rate(RR), body position, SpO2 and skin temperature. The waveforms of ECG, Respiration and PPG are also displayed.

The ECG signal is not intended for automated arrhythmia detection or classification. Rather it is intended for manual interpretation, and the automated computation of heart rate through QRS identification using the well-known Pan-Tomkins beat detection algorithm. The displayed waveform is only intended for display as a check for normal ECG rhythm. The waveform is not intended for manual discrimination of any arrhythmias or cardiac conditions.

The system features two third party FDA cleared skin-mounted, bio-integrated sensors that pair with the iBSM View application for the continuous display and storage of vital sign measurements and physiological waveforms. The two sensors viz. iBSM chest (Anne Chest from Sibel Health Inc) and iBSM limb (Anne Limb from Sibel Health Inc) sensors are used along with their respective biocompatible iBSM chest sensor adhesive and iBSM limb sensor adhesives and attached to the patient. The adhesives are intended for a single use, whereas the sensors are intended for multiple reuse with the predefined processing.

Both the chest and the limb sensors along with their adhesives are third party FDA cleared devices. The system is also compatible with a third-party FDA cleared non-invasive blood pressure measurement device (Blood Pressure monitor BP2A from Shenzhen Viatom Technologies).

The iBSM device consists of a mains powered Docking station that provides the mechanical base station for the iBSM Tablet and has a provision to charge the tablet when docked.

The USB connector provided on the Docking station is intended only to power up the sensor charger accessory and any data transfer to the USB device is disabled.

The iBSM View Application runs on the iBSM tablet in a secure Kiosk mode and is intended to display the patient's physiological parameters and waveforms. The iBSM tablet with the iBSM View Application together is termed as iBSM hub.

The physiological data obtained by the sensors are wirelessly transmitted to their respective SDK's that are part of the iBSM hub with Bluetooth (BLE) connectivity, for continuous display of waveforms and parameters on the iBSM View Application. When connected to WiFi, vital signs data can be transferred in real-time from the iBSM hub to an external Server for data storage. The iBSM system provides an FHIR-compatible interface for patient data communication and storage to an external Server.

iBSM is intended to be used only in an hospital environment within the wards or patient rooms and not in ICU/CCU nor in Surgery/OT rooms. It is intended to be used for monitoring of non critical patients. iBSM is not intended to be used in a home environment.

iBSM uses the third party FDA cleared sensors such as ANNE Chest and ANNE Limb from Sibel Health Inc. and BP2A BP Cuff from Shenzhen Viatom, that fulfill the requirements of performance parameters in the signal acquisition before transmitting the data to their SDK's integrated with the iBSM Application in the iBSM hub for displaying the waveforms and the parameters.

The provided FDA 510(k) clearance letter details the acceptance criteria for the iBSM device and largely refers to its "substantial equivalence" to predicate and reference devices, rather than a standalone clinical study report with detailed performance data derived from a specific test set. The document outlines performance specifications and cites numerous consensus standards and bench testing used to demonstrate this equivalence.

It's important to note that 510(k) clearances typically rely on demonstrating substantial equivalence, and often do not require new, full-scale clinical trials if performance can be shown through bench testing, existing clinical data for predicate devices, or limited clinical validation. This document is a summary of that submission, not a detailed clinical study report.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document specifies performance attributes for the iBSM system. These are presented as acceptance criteria and also implicitly as the reported performance, as the clearance is granted based on meeting these specifications.

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

The document does not explicitly state a specific "test set" sample size in terms of number of subjects for a new clinical study. Instead, it refers to performance verification through bench testing and compliance with various consensus standards.

• Sample Size: Not explicitly stated as a number of subjects for a clinical test set. The evaluation seems to rely on an aggregation of compliance with standards and performance data from predicate devices. For specific parameters like BP, compliance with ISO standards (e.g., IEC 80601-2-30) implies certain subject numbers were used for validation of the reference device (BP2A from Shenzhen Viatom, K193348), and the iBSM device demonstrates equivalence to its performance.
• Data Provenance: The document does not specify a country of origin for a new clinical test set. The company, iOrbit Digital Technologies Private Limited, is based in India. The predicate/reference devices are from Sibel Health Inc. and Shenzhen Viatom Technology Co. Ltd. The studies referenced for predicate devices (e.g., K240251 for ANNE Chest, K240305 for ANNE Limb, K193348 for BP2A) would have their own data provenance. The assessment presented appears to be a summary of bench testing, software verification, and compliance with standards. There is no mention of a primary prospective clinical study for the iBSM itself.

3. Number of Experts and their Qualifications for Ground Truth Establishment

The document does not describe the establishment of ground truth by human experts for a specific test set. The validation methodology relies on:

• Bench testing against defined specifications.
• Compliance with international standards (e.g., IEC, ISO, ANSI/AAMI), which often have their own established methods for ground truth, such as calibrated instruments for physiological measurements.
• Equivalence to legally marketed predicate devices (ANNE One, ANNE View, BP2A, ANNE Chest), whose ground truth would have been established during their own clearances.

Therefore, there is no mention of "experts" in the context of establishing ground truth for a diagnostic AI system, as the iBSM is a monitoring device that focuses on accuracy of physiological measurements, not diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable, as a new clinical test set requiring expert adjudication for a diagnostic output is not described. The validation focuses on the accuracy of physiological parameter measurements against established standards.

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

No MRMC study was performed or cited. The iBSM system is a physiological monitoring device that provides objective measurements, waveforms, and alerts based on preset parameters. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance to assess an effect size. The chest sensor explicitly states: "The iBSM chest sensor is not intended to be used to provide diagnostic or interpretive statements to either the patient or the clinician."

6. Standalone Performance (Algorithm Only)

The performance described (accuracy of HR, RR, SpO2, Temperature, NIBP) is the "standalone" performance of the device's algorithms for calculating these physiological parameters based on sensor inputs. The acceptance criteria table directly reflects these algorithmic capabilities.

7. Type of Ground Truth Used

The ground truth used for validating the iBSM's performance parameters is implicitly defined by:

• Reference measurement devices/calibrated instruments: This is standard for validating physiological monitoring device accuracy (e.g., a highly accurate reference ECG machine for heart rate, a pulse oximeter for SpO2, a validated sphygmomanometer for NIBP, and a calibrated thermometer for temperature).
• Compliance with international consensus standards: These standards specify accepted methods for determining accuracy and often involve phantom studies or direct comparison with reference methods.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the device's primary physiological measurement functions.

8. Sample Size for the Training Set

The document does not refer to a "training set" in the context of validating a device using machine learning or AI models with a distinct training phase. The iBSM device's core functionality appears to be based on established signal processing algorithms (e.g., Pan-Tompkins beat detection algorithm for HR) rather than deep learning requiring large, labeled training datasets in the manner of medical image analysis AI. The performance is validated through specified accuracy metrics against known physiological ranges.

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

Not applicable, as there is no specifically mentioned "training set" for an AI/ML model for which ground truth would need to be established. The core algorithms for physiological parameter extraction (e.g., ECG waveform display, HR, RR, SpO2 calculation) rely on known signal processing methods and are validated through standard performance tests, not through an AI training paradigm.

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Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals.

Not intended for home use. Intended for use by health care professionals.

The Telemetry Monitor 5500 is a battery-operated patient worn monitor with a touchscreen display. The Telemetry Monitor 5500 is intended to monitor and record, and to generate alarms for, multiple physiological parameters like ECG, SpO2, and respiration rate. It is equipped with a 1.4 GHz radio to enable wireless bi-directional data flow with Philips' Patient Information Center (PIC) iX.

This 510(k) clearance letter pertains to the Philips Telemetry Monitor 5500 Release 4.0. The provided document focuses on demonstrating substantial equivalence to a predicate device and includes information regarding performance testing against established standards. However, it does not contain specific details about acceptance criteria for particular performance metrics, nor does it describe studies proving the device meets those specific acceptance criteria in the format often associated with AI/ML device clearances (e.g., sensitivity, specificity, AUC).

Instead, the document primarily cites compliance with general medical device standards and internal testing to support its claims of performance. Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided text.

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., a specific minimum sensitivity or accuracy percentage). Instead, it states that the device was assessed for conformity with relevant standards and that "results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards."

Study Details:

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

   • Test Set Sample Size: Not explicitly stated for any specific performance metric beyond general statements of testing compliance. For the "Clinical Studies" section related to SpO2 accuracy, it only notes that studies were conducted to "support accuracy performance" and "meet the acceptance criteria laid out in the associated protocols." No sample size for patients or data points is provided.
   • Data Provenance: Not specified. The document mentions "Philips conducted clinical studies" but does not detail the country of origin of the data or whether it was retrospective or prospective.

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

   • Not Applicable. The document describes performance testing against established standards and internal "accuracy specifications". For the SpO2 accuracy claims, ground truth would typically be established by invasive measurements (e.g., CO-oximetry of arterial blood samples), not by expert review of device output. The document does not provide details on how ground truth was established for the clinical studies supporting SpO2 accuracy.

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

   • Not Applicable/Not Specified. Since expert review for ground truth is not indicated, adjudication methods are not relevant in the context described.

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. The provided text does not mention any MRMC comparative effectiveness study. This device is a telemetry monitor for physiological parameters, not an AI-assisted diagnostic tool for human readers. "Summative usability testing" was done, indicating human interaction with the device, but not in a comparative effectiveness study involving AI assistance for human "readers."

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

   • Standalone algorithm performance is implied for certain functions, but not detailed. The device uses "Philips proprietary monitoring algorithms for ECG arrhythmia monitoring" (EASI, Hexad, ST/AR Arrhythmia Monitoring, ST/AR ST Analysis Algorithm, ST/AR QT/QTc Interval Monitoring). The performance of these algorithms would constitute "standalone" performance, but the document only states "Functional and system level testing... was performed. The results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards." No specific performance metrics for these algorithms are provided.

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

   • Not explicitly stated for all performance metrics.
     • For SpO₂ accuracy, ground truth is typically established by comparing the device's SpO₂ readings to invasive arterial blood gas analysis (CO-oximetry). The document only states "Philips conducted clinical studies... to support accuracy performance."
     • For other performance metrics related to compliance with standards (e.g., electrical safety, EMC, usability), the "ground truth" is adherence to the standard's requirements, demonstrated through specific tests.

7. The sample size for the training set

   • Not Applicable/Not Specified. The document mentions "Philips proprietary monitoring algorithms," which would have been developed using training data. However, the size or nature of any training set is not disclosed in this 510(k) summary, as it's not a primary requirement for demonstrating substantial equivalence for this type of device.

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

   • Not Applicable/Not Specified. The document does not provide information on how the ground truth for any potential training sets used in the development of "Philips proprietary monitoring algorithms" was established.

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VitalRhythm is a cloud-based software application for continuous and automatic analysis of cardiac arrhythmias. VitalRhythm is compatible with the "Vista Solution" platform, which includes the VitalPatch biosensor and VistaCenter web application. VitalRhythm is intended to be used for outpatient cardiac telemetry and patient monitoring in non-critical healthcare settings for non-urgent clinical decision-making. VitalRhythm provides analysis of cardiac arrhythmias using ECG data and RR-interval from the VitalPatch in patients who are 18 years of age or older. Results of the VitalRhythm are displayed within the VistaCenter web application to be reviewed and confirmed by qualified healthcare professionals and/or cardiac technicians. VitalRhythm is not intended for use in life-supporting or sustaining systems or for critical care monitoring. The arrhythmia analysis results are not intended to be the sole means of diagnosis and are offered on an advisory basis only, in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

VitalRhythm is a cloud-based, arrhythmia detection software application that is compatible and intended to be used with the VitalConnect "Vista Solution" platform. The Vista Solution Platform consists of the VitalPatch biosensor, a phone (VistaPhone) or tablet (VistaTablet) relay device preloaded with the VistaPoint software application, VC Cloud and the cloud-based VistaCenter user interface.

VitalRhythm is intended to be used for outpatient cardiac telemetry and patient monitoring in non-critical healthcare settings for non-urgent clinical decision-making.

VitalRhythm analyzes ECG data and RR-interval from the VitalPatch biosensor for reporting of cardiac arrhythmias to be reviewed and adjudicated by qualified healthcare professionals and/or cardiac technicians.

The cloud-based VitalRhythm software application supports the analysis of ECG data and RR-interval using a proprietary algorithm developed using deep learning techniques. The application works in the following way:

1. VitalRhythm accepts ECG and RR-interval data transmitted from the VitalPatch via a secure, cloud-based API (Application Programming Interface).

2. ECG and RR-interval data are analyzed by VitalRhythm using a proprietary algorithm, which detects the following cardiac rhythms:

   • Atrial fibrillation/atrial flutter
   • AV Block (2nd degree, Type I and II)
   • Pause
   • Paroxysmal supraventricular tachycardia (PSVT)
   • Ventricular tachycardia/run
   • Sinus bradycardia
   • Sinus tachycardia
   • Normal sinus rhythm
   • Others (inconclusive)

3. For use with Mobile Cardiac Telemetry (MCT), i.e., outpatient cardiac telemetry: any of the above listed arrhythmias that are detected by the software algorithm are displayed in VistaCenter to be reviewed and analyzed by a qualified cardiac technician in the 24/7 attended Cardiac Monitoring Center, prior to transmitting a notifiable event consistent with the prescribed notification criteria to the prescribing physician during the monitoring period. An event report is generated by VistaCenter as a result of the analysis.

For use with patient monitoring in non-critical healthcare settings: any of the above listed arrhythmias that are detected by the software algorithm are displayed and notified in VistaCenter, in accordance with the notification criteria, during the monitoring period to be reviewed by the prescribing healthcare professional for non-urgent clinical decision-making.

The features, operating procedures, and mitigations in place for the compatible devices ensure continuous data collection and transmission to support the VitalRhythm application for the intended use. Further information is provided in the VitalRhythm Instructions for Use document.

Here's a detailed breakdown of the VitalRhythm device's acceptance criteria and the study that proves it meets those criteria, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

Study Details

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

   • Patient count: 3,309 patients (18 years of age or older).
   • Dataset count: 7,553 datasets.
   • Annotated arrhythmia episodes: 22,034.
   • Data Provenance: Retrospective, de-identified ECG and RR-interval data obtained from patients prescribed the VitalPatch biosensor across 7 clinical sites in the United States (US).

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
   The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the test set. However, it indicates that the results are "to be reviewed and confirmed by qualified healthcare professionals and/or cardiac technicians" in the context of device usage and implies that annotation for ground truth would follow a similar expert-driven process.

3. Adjudication Method for the Test Set:
   The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth of the test set. It only states that the generated "event report is generated by VistaCenter as a result of the analysis" and is "to be reviewed and analyzed by a qualified cardiac technician in the 24/7 attended Cardiac Monitoring Center, prior to transmitting a notifiable event consistent with the prescribed notification criteria to the prescribing physician during the monitoring period." This describes post-processing of algorithm results by human readers, not the method for establishing the ground truth used for algorithm validation.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size of how much human readers improve with AI vs without AI assistance. The study described focuses on the standalone performance of the algorithm.

5. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
   Yes, a standalone performance study was conducted. The performance metrics (Sensitivity, Specificity, PPV, NPV, Accuracy) presented in the table are explicitly for the VitalRhythm algorithm "when assessed using the independent test database," indicating standalone algorithm performance against a pre-established ground truth.

6. Type of Ground Truth Used:
   The ground truth was established through annotated arrhythmia episodes. While the specific process is not detailed, it implies expert review and labeling of ECG and RR-interval data to define the 'true' presence or absence of arrhythmias. The "results are displayed within the VistaCenter web application to be reviewed and confirmed by qualified healthcare professionals and/or cardiac technicians," suggesting human consensus or expert interpretation forms the basis of the ground truth.

7. Sample Size for the Training Set:

   • Patient count: 23,587 patients.
   • Dataset count: 81,391 datasets.

8. How the Ground Truth for the Training Set Was Established:
   The document states the training database was from 354 US clinical sites, but it does not explicitly detail how the ground truth for the training set was established. It implies a process of data collection from clinical sites and subsequent processing for training the deep learning algorithm.

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The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously, and patient posture and activity. VMS allows for the input of non-invasive blood pressure and body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.

The non-invasive Blood Pressure Tracking feature is based on Pulse Arrival Time (PAT), which is obtained utilizing ECG and PPG signals following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.

The Vios Central Station Monitor (CSM) and Central Server (CS) Software (SW) is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM SW and CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.

The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals.

The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station.

The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices.

The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use, and rechargeable sensor that acquires 3-channel ECG, bioimpedance, 2-channel pulse oximetry, and tri-axial accelerometer data. The sensor contains signal acquisition firmware (embedded software) and wirelessly communicates acquired data via standard communication protocols (Bluetooth™) to the BSM SW for analysis and display. The Chest Sensor has a button that, when pressed, sends a patient call alert to the BSM SW.

VMS Chest Sensor Adapter Models L2050F (Pulse Ox Finger Adapter) are plastic, non-sterile, patient-worn, multiple use pulse oxygenation sensors that connect to the Vios Chest Sensor and are secured to the patient via medical grade ECG electrodes.

The provided text describes a 510(k) clearance for the Vios Monitoring System Model 2050, focusing on the addition of a blood pressure tracking feature. Here's an analysis of the acceptance criteria and the study details based solely on the provided document:

Missing Information: It's important to note that the provided FDA 510(k) clearance letter is a summary document and does not contain the detailed clinical study report or the specific acceptance criteria with numerical performance targets. It states that the device meets "all consensus standards requirement" and that "results were within the acceptance criteria," but it does not define those criteria or present detailed performance data in a table format. Therefore, I will have to make assumptions about the typical acceptance criteria for Non-Invasive Blood Pressure (NIBP) devices based on the mentioned standards (ISO 81060-2, IEEE 1708, ISO 81060-3) and then state the general reported outcome from the document.

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of specific numerical acceptance criteria and performance data in the provided document, the table below will broadly reflect typical NIBP acceptance criteria based on the mentioned standards and the general statement of performance from the text.

• Mean difference $\le \text{5 mmHg}$
• Standard deviation $\le \text{8 mmHg}$
  (Requirements per ISO 81060-2) | "The results were within the acceptance criteria, similar to the predicate device." |

Explanation of Assumption: The document explicitly states that "The clinical testing and analysis is performed according to applicable clauses from ISO 81060-2, IEEE 1708, and ISO 81060-3 for validation using reference invasive blood pressure measurement on the radial artery." ISO 81060-2 is the primary standard for non-invasive sphygmomanometers, which outlines specific statistical accuracy requirements (mean difference and standard deviation). Therefore, the acceptance criteria are assumed to be those specified in ISO 81060-2. The document does not provide numerical results for the Vios Monitoring System.

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

• Sample Size for Test Set: Not explicitly stated in the provided document. The text mentions "a range of subjects, representative of the intended population."
• Data Provenance: Not explicitly stated. The document indicates a "clinical study" was performed, but does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical study for validation, it is most likely prospective.

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

This information is not provided in the document. The ground truth was established by "reference invasive blood pressure measurement on the radial artery," which is a direct, objective medical measurement, not typically requiring a panel of experts for interpretation in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the ground truth for blood pressure measurement (invasive arterial line) is an objective, quantitative measurement that does not require expert adjudication in the same manner as subjective or qualitative assessments.

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

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human reader performance with and without AI assistance) is typically performed for diagnostic imaging or similar interpretation tasks where human perception and decision-making are aided by AI. For a vital signs monitor, the primary assessment is of the device's accuracy against a known reference, not its ability to assist human readers in interpretation.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Yes, a standalone performance study was done. The clinical testing described for "Blood Pressure Tracking" assesses the algorithm's accuracy in autonomously generating blood pressure values from PAT (Pulse Arrival Time) against an invasive blood pressure reference. This is an assessment of the algorithm's standalone performance.

7. The Type of Ground Truth Used

The ground truth used for the blood pressure tracking feature was invasive blood pressure measurement on the radial artery. This is considered a gold standard and highly accurate method for blood pressure determination.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set. The descriptions focus on the validation study for the blood pressure tracking feature. It is implied that the algorithm was developed (trained) prior to this validation, but the details of that training are not included in this summary.

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

The document does not provide information on how the ground truth for any training set was established. It only describes the ground truth for the clinical validation study (invasive blood pressure measurement on the radial artery) and the calibration process. The "calibration (initialization)" step uses an "FDA-cleared oscillometric blood pressure monitor" for initial coefficient determination, which is distinct from establishing ground truth for a large-scale training set.

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The Biobeat BB-613-BPM is a noninvasive blood pressure monitor which provides a notification to the user every 15 minutes over a 24 hour period for user- initiated measurements. It includes a device and a platform (BPM) for use in adults by healthcare professionals, for collection of pulse rate and tracking changes in blood pressure based on Pulse Wave Transit Time (PWTT) in hospitals, clinics, long-term care and at home. The BB-613-BPM tracks changes in blood pressure and requires callbration using an FDA-cleared oscillometric blood pressure monitor. The data from the Biobeat BB-613-BPM can be accessed through the Biobeat platform for review by a healthcare professional or can be downloaded as a report. The device is not intended to be used on critical care patients.

The Biobeat BB-613-BPM includes a sensor device that is attached to the patient's chest to collect physiological data for later review by their healthcare provider. The device is designed to measure systolic and diastolic blood pressure and pulse rate, in adults, using a noninvasive technique using a light source (LEDs), and sensor array on the backside of the device. Identical to the method cleared in K190792 and in K222010, the LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of pulse rate, and noninvasive blood pressure. The device is a pre-programmed 24-hour blood pressure monitor (BPM), prompting the use to take measurements at fixed intervals every 15 minutes. In addition, the data is transmitted to a mobile application via Bluetooth and then uploaded to the cloud, accessed through the Biobeat platform for review by a healthcare professional. In addition, the data could be downloaded as a report. The device does not contain any alarms. The device is intended to be used by healthcare professionals and patients in clinical and patient's environments.

The provided text is a 510(k) summary for the Biobeat BB-613-BPM. It outlines the device, its indications for use, technological characteristics, and a comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain specific details about acceptance criteria, the study design (e.g., sample size, data provenance, expert qualifications, adjudication methods), or performance data results that would be typically found in a clinical study report.

The document explicitly states: "The Biobeat BB-613-BPM uses the same hardware as the cleared Biobeat Platform-2 and the BB-613WP Patch but features some software changes. The device contains the same sensor unit and uses the same algorithm to compute pulse rate and blood pressure. Therefore, these signals' evaluation testing, which was submitted in K222010 and K190792, remains applicable to the subject device. Additional testing was conducted on the updated product features, including: . Software validation per FDA guidance..."

This indicates that the primary focus of the new submission (K241066) was on software validation for the new feature (24-hour, patient-initiated measurements with notifications), rather than extensive new clinical performance studies for blood pressure or pulse rate accuracy, as those were already established for the predicate devices utilizing the same sensor unit and algorithm.

Therefore, many of the requested details about a study proving the device meets acceptance criteria are not present in the provided text. I will answer based on the information that is available.

Here's an attempt to answer your questions based only on the provided text, flagging where information is missing:

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

The document provides a comparison table of technological characteristics, including measurement ranges and accuracies, which can be interpreted as performance specifications inherited from the predicates and serving as acceptance criteria.

Note: The document states, "The device contains the same sensor unit and uses the same algorithm to compute pulse rate and blood pressure. Therefore, these signals' evaluation testing, which was submitted in K222010 and K190792, remains applicable to the subject device." This implies that the BB-613-BPM is expected to meet the same accuracy standards as its predicates for PR and BP. The primary new "performance data" mentioned is "Software validation per FDA guidance."

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

• Sample Size: Not specified in this document. The document refers to prior testing for pulse rate and blood pressure (from K222010 and K190792) and software validation.
• Data Provenance: Not specified.
• Retrospective/Prospective: Not specified.

3. 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)

• This information is not applicable or not provided. The ground truth for blood pressure and pulse rate measurements in medical devices like this is typically established using established reference methods (e.g., intra-arterial measurements, or a validated oscillometric device for calibration as mentioned in the Indications for Use). Expert readers are typically not used to establish ground truth for physiological measurements like BP or PR.

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

• This information is not applicable or not provided, as this is not a study involving human reader interpretation or adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. This type of study is relevant for AI systems that aid human interpretation (e.g., radiology AI), which is not the primary function described for this blood pressure measurement system's new feature.

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

• The document implies that standalone performance for pulse rate and blood pressure was established and deemed acceptable in prior submissions (K222010 and K190792) because the subject device uses the "same sensor unit and uses the same algorithm to compute pulse rate and blood pressure." The new submission focuses on software changes related to the 24-hour monitoring feature and notifications, rather than core measurement algorithm performance.

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

• For blood pressure and pulse rate measurements: The Indications for Use state, "The BB-613-BPM tracks changes in blood pressure and requires calibration using an FDA-cleared oscillometric blood pressure monitor." This strongly suggests that an FDA-cleared oscillometric blood pressure monitor serves as the ground truth or reference method for calibration and presumably for performance validation in the previous submissions.

8. The sample size for the training set

• Not specified. This document only pertains to a 510(k) submission, not a full scientific publication detailing model development.

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

• Not specified. As noted above, the ground truth for physiological measurements typically involves comparison to a gold standard or reference method. However, details of the training set (if any specific to this submission's new features beyond the core algorithm) are not provided. The phrase "pre-programmed" suggests the algorithms are fixed, not adaptively learning from ongoing data.

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The ANNE View application is intended for the display of physiological data from the ANNE Chest and ANNE Limb devices. The application is also compatible with third-party, FDA-cleared devices for the display of noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The ANNE View application notifies healthcare professionals when physiological data fall outside selected parameters. The ANNE View application displays the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system notifies the user when the patient's position has not changed for a preset threshold of time. The ANNE View application communicates to compatible central monitoring platforms, including the Central Hub, for the display and storage of multiple patients' physiological data. The Central Hub has the ability to notify healthcare professionals when physiological data fall outside selected parameters.

The ANNE View and Central Hub are intended for use by trained, qualified healthcare professionals in the clinical or home healthcare environment. The device is not intended for use on critical care patients.

The ANNE View application is a bedside patient monitoring device that receives vital signs and physiological data from compatible devices for display and transmission to the Central Hub. The ANNE View application operates on the ANNE Tablet. When connected to the ANNE Chest Sensor, the ANNE View application displays electrocardiography (ECG), skin temperature, heart rate, respiratory rate, and body position data. When connected to the ANNE Limb Sensor, the ANNE View application displays photoplethysmography (PPG), SpO2, pulse rate, and skin temperature data. The ANNE View application is also compatible with optional third-party devices for SpO2, non-invasive blood pressure, and body temperature measurements. The ANNE View application alarms when physiological data are outside of the configured thresholds.

When the ANNE Tablet is connected to Wi-Fi, the vital signs and physiological data are uploaded from the ANNE View application to the Central Hub. The Central Hub allows healthcare professionals to view vitals data from up to 16 beds on one screen and provides storage of up to 48 hours of data from each patient. Alarm conditions are communicated to the Central Hub from the ANNE View application for visual and audio alarms on the Central Hub.

This is a clearance memo for a medical device and does not contain the detailed study information required to answer the prompt. Specifically, it states that "The following consensus standards and bench testing were used to evaluate the safety and effectiveness of ANNE View, Central Hub as compared to the predicate," followed by a list of general standards like electromagnetic compatibility testing, wireless coexistence testing, software verification and validation, usability testing, and cybersecurity evaluation. It also mentions "Verification of the ECG waveform display per IEC 60601-2-27:2011 and IEC 60601-2-47:2012" and "Verification of the alarm system to IEC 60601-1-8:2020," and "Performance evaluation of the HL7 FHIR and IEEE 11073 SDC communication."

However, it does not provide any specific quantitative acceptance criteria or detailed study results that would allow for a table of acceptance criteria vs. reported device performance, nor does it provide information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill the request using only the provided text. The document is a regulatory approval, not a clinical study report.

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The UbiqVue 2A Multiparameter System is a wireless remote patient monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include electrocardiography (2-Channel ECG), heart Rate, SpO2%, respiration rate, pulse Rate, photoplethysmography waveform, skin temperature, body posture, body motion, R-R Interval, heart Rate variability (HRV) and blood Pressure (optional). Data is transmitted wirelessly near real time from UbigVue 2A Wearable Biosensor and 3rd party device (for Blood Pressure only) to remote central server for display, storage, and analysis.

The UbiqVue 2A Multiparameter System is intended for non-critical, adult population.

The UbiqVue 2A Multiparameter System shall include the ability to notify healthcare professionals through alerts when physiological parameters fall outside the set limits, manual trigger by the patient and to display multiple patient's physiological data for remote monitoring at home and with visual alarm for active monitoring at hospitals and out-of-hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals.

The UbiqVue™ 2A Multiparameter System is similar to LifeSignals Multiparameter Remote Monitoring Platform that is cleared under K202868 but upgraded with monitoring of additional physiological parameters, minor performance improvements and additional User Interface.

The UbiqVue™ 2A Multiparameter System consists of following components:

• 1. UbiqVue™ 2A Wearable Biosensor
• 2. UbigVue™ Single Patient Relay
• 3. UbiqVue™ Multi-Patient Relay
• 4. UbiqVue™ Central Server
• 5. UbiqVue™ Active Monitoring Portal
• 6. UbiqVue™ Relay Bridge Software (optional)
• 7. UbiqVue™ Bluetooth Gateway Software (optional)
• 8. Third-party Blood Pressure device (optional)

The UbigVue™ 2A Wearable Biosensor when attached to body acquires two channels of ECG signals, TTI respiration signals (one of the inputs for deriving Respiration Rate), resistance variation of a Thermistor attached to body (used for deriving Skin Temperature) & accelerometer data (input for deriving Respiration Rate & Posture), pre-processes them and wirelessly transmits to a paired Relay device, as cleared under K202868.

Following are additional features proposed in this submission:

• Ambient temperature sensor for Body temperature derivation.
• Acquisition of PPG (Photoplethysmography) signals using the integrated Optical sensor array.
• Derivation of SpO2% and Pulse Rate within the Biosensor, based on PPG signals acquired through the Optical sensor array.

Biosensor uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device, as cleared under K202868. The Biosensor is also additionally integrated with BLE Radio for communication with Single Patient Relay device.

As cleared under K202868, when Relay device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If Relay device is not available or if there is any interruption in the communication between Relay device and Biosensor, data shall be temporarily buffered locally in Biosensor till the wireless connection is re-established.

The UbigVue™ Single Patient Relay Device, a standard Mobile device or custom device that is installed with a UbigVue Single Patient Relay Application software, that receives the physiological data transmitted from any paired Biosensor. It shall transmit the data received from the Biosensor, immediately without any day to Central Server that is configured to receive, after necessary data encryption. The Single Patient Relay Device shall receive data from Biosensor either through WLAN or BLE and transmit it to Central Server using its mobile data network (3G, 4G, LTE, 5G, etc.)
Single Patient Relay Device function is identical to the one cleared under K202868, except it is upgraded to support additional parameters & also improvements in GUI as below:

• To handle additional data packets of Biosensor such as Ambient Temperature, PPG signals. SpO2% and Pulse Rate.
• Interactive GUI that provides feedback to Users about the signal quality of PPG signals to identify the optimal body location for affixing the Biosensor.
• Shall pair with a 3rd party Blood Pressure device using BLE and transfer the data to the Central Server.
• Allows User to enter Oral Temperature reading (for calibration) and/or manual Blood pressure data (optional if no 3td Party device is connected).

The UbiqVue™ Multi-Patient Relay Device (MPR) is an UbiqVue™ Multi-Patient Relay Application Software installed in a standard Linux platform (Physically or in cloud), that has ability to pair & receives data from multiple Biosensors, through wireless access points (WLAN) connected in its network. It shall transmit the received data from Biosensors to Central Server that is configured to receive through internet or private network (VPN), after necessary encryption & authentication. Multi-Patient Relay Device also receives data from multiple third-party Blood Pressure devices worn by the patients & connected to its network (through BLE gateway).

If the Central Server is not available or there is no connectivity, the data shall be temporarily buffered securely in the MPR device itself. There is no GUI component for this software application.

The UbigVue™ Central Server is UbiqVue™ Central Server Application software installed in a compatible Linux Server hardware Platform. The Central Server Application functions are also identical to Secure Server Application in LifeSignals Multi-parameter Remote Monitoring Platform (K202868), other than being upgraded to handle additional parameters. Also, the "Sensor Processing Library", the algorithm that derives various vital parameters is upgraded for performance improvements. The following are additional features:

• Extending the minimum skin temperature measurement capability from 32.0℃ (89.6 °F) to 15.0°C (59.0°F)
• Body Temperature estimation using Skin Temperature, Ambient temperature, Heart Rate (based on clinical condition) and Activity.
• Uses the Oral Temperature entered manually for initial / periodic calibration of derived Body temperature.
• Additional Posture classification & Body motion detection capabilities.
• Improvements in Respiration Rate & Heart Rate derivation algorithm.
• Integration with 3rd Party beat analysis & classification software for deriving Sinus Heart Rate, R-R Interval & Heart Rate Variability.
• The PPG Signal Quality Index (SQI) algorithm module for displaying the SQI on the Active Monitoring dashboard & to access the quality of SpO2 value derived by the Biosensor.
• Support for Early Warning Score (NEWS2) calculation.

Central Server shall have ability to send alert notifications to any configured one or more Users through E-mail, SMS or WhatsApp, for any Clinical, Technical or Manual Alert conditions, as cleared under K202868. However, this alert engine is upgraded to support additional parameters and improved configuration capabilities such as Acknowledgement, priority & condition delay time.

Active Monitoring Portal in UbiqVue™ 2A Multiparameter System is identical to Web UI in LifeSignals Multi-parameter Remote Monitoring Platform cleared under K202868. It is a browser-based User Interface Application that enables Clinical personnel to login to the Central server remotely and access the patient physiological data (Biosensor & derived data) and view/Acknowledge the Alert(s). The Clinical personnel, depending on the roles (normal or supervisory) can access data of multiple patients assigned to them and search them based on the recent alert status. This includes patients that are active (wearing Biosensor) and monitoring procedures completed.
It is in-built with a Monitoring Dashboard that continuously displays physiological parameters, waveforms & alert status of any assigned patients to any authenticated Clinical personnel for (quasi) real time Active Monitoring. It has the option for the User to select multiple patient tile view or Single Patient Zoom View/Hybrid view of any patient based on multiple available filter settings.

Following are the few changes in this 510(k):

• Additional parameters (SpO2%. PR, EWS, SYS, DIA, MAP, PPG, SQI, EWS).
• Visual alarm display for any Clinical, Technical, or manual alert/alarm.
• Hybrid tile view (Zoom View + Tile view) and Group tile view.
• Multi-level User Management, roles & privileges.

Note: Any Third-Party Application / Server may communicate with UbiqVue™ Central Server using a defined set of Application Programming Interface (API) for entering patient information, configuring & generating customized report or any other requirement that does not alter the intended use of the system (e.g., EMR/EHR, HIMS) or to meet the additional intended use claimed by the third-party application. UbigVue™ Active Monitoring Portal shall continue to be used for the claimed Active Monitoring intended use. However, UbiqVue™ Active Monitoring portal may be optional for integration with any other regulatory approved monitoring dashboard or different intended use claims.

Relay Bridge Software in UbiqVue™ 2A Multiparameter System when installed in a standard OpenWrt based routers, shall provide communication between Biosensor(s) & Multi-Patient Relay. Relay Bridge is an alternate for a standard access point and is intended when Multi-Patient Relay Software is hosted in the cloud. Similar to standard access point, the Relay Bridge communicates with multiple Biosensor and transfers the data to the Multi-Patient Relay without buffering the data. Since the Relay bridge transfers the data to the designated Multi-Patient Relay bridge in the cloud, it further encrypts the data for securely transmitting through the internet via ethernet, Wi-Fi or cellular network.

Bluetooth Gateway Software in UbigVue™ 2A Multiparameter System when installed in a standard OpenWrt based BLE gateway or BLE supported routers, shall provide communication between 3rd party BLE devices (e.g. BP device) & Multi-Patient Relay. Bluetooth Gateway communicates with multiple 3rd party devices and transfers the data to the Multi-Patient Relay without buffering.

LifeSignals, Inc. has developed the UbiqVue™ 2A Multiparameter System (UX2550), a wireless remote patient monitoring system. The device collects continuous physiological data including 2-Channel ECG, heart rate, SpO2%, respiration rate, pulse rate, photoplethysmography waveform, skin temperature, body temperature, body posture, body motion, R-R Interval, heart rate variability (HRV), and optionally blood pressure. The system transmits data wirelessly to a remote central server for display, storage, and analysis, and can notify healthcare professionals through alerts. It is intended for non-critical, adult populations in home and healthcare settings.

The following information describes the acceptance criteria and the study conducted to prove the device meets these criteria:

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes for all test sets. However, it does mention specific studies:

• SpO2% Accuracy: Clinical validation was performed to determine the accuracy of SpO2% with respect to SaO2 values from simultaneously drawn arterial blood as per ISO 80601-2-61 (Ed. 2.0). The specific sample size for this clinical validation is not provided in the summary.
• Body Temperature Accuracy: Validated using "non-randomized, self-control comparative on-body comparative performance with oral digital thermometer on multiple subject populations" in accordance with ISO 80601-2-56 (Ed.2.0). The specific number of subjects or populations is not provided.
• Wear-life Performance: Validated using "non-randomized, self-control comparative on-body comparative performance study for the wear period of 120 hours." The sample size for this study is not provided.
• Respiration Algorithm Improvement: Validated by comparing against "clinician manually scored end tidal CO2 (EtCO2) capnography, under spontaneous breathing & metronome breathing during normal activity conditions as part of wearlife study." The sample size is part of the wear-life study, but not explicitly stated.

Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether studies were retrospective or prospective. Given the FDA 510(k) submission, it is implied that the data is acceptable for the US market.

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

The document indicates that for the respiration algorithm validation, the comparison was made against "clinician manually scored end tidal CO2 (EtCO2) capnography." This implies that clinicians (experts) were involved in establishing the ground truth. However, the exact number of experts and their specific qualifications (e.g., years of experience, specialty) are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1, none) for the test sets. For the "clinician manually scored" data mentioned for respiration, it's not specified if multiple clinicians scored and how discrepancies were resolved.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any study evaluating the effect size of how much human readers (or healthcare professionals using the device) improve with AI vs without AI assistance. The device is a monitoring system that provides data and alerts, rather than an AI-driven diagnostic interpretation system typically evaluated with MRMC studies.

6. Standalone (Algorithm Only) Performance

The document describes specific performance tests for various parameters (e.g., heart rate, respiration rate, SpO2%, skin temperature, body temperature) that would inherently reflect the algorithm's performance in deriving these parameters from sensor data. For example:

• SpO2% accuracy was proven through "clinical validation to determine the accuracy of SpO2% with respect to SaO2 values from simultaneously drawn arterial blood." This implies a comparison of the device's output (algorithm only) to a gold standard.
• Body temperature accuracy was validated against an "oral digital thermometer."
• Respiration algorithm validation was against "clinician manually scored end tidal CO2 (EtCO2) capnography."

These tests demonstrate standalone performance metrics against established reference standards.

7. Type of Ground Truth Used

The types of ground truth used include:

• Physiological measurements from reference devices/standards:
  • SaO2 values from simultaneously drawn arterial blood (for SpO2% accuracy).
  • Oral digital thermometer (for Body Temperature accuracy).
  • Bench testing standards (e.g., ASTM E1112-00 for skin temperature, ISO 80601-2-61 for Pulse Rate).
• Clinician-established ground truth:
  • Clinician manually scored end tidal CO2 (EtCO2) capnography (for Respiration Rate algorithm).

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for training the algorithms within the UbiqVue™ 2A Multiparameter System. It discusses validation of improved algorithms and additional features, but provides no detail on the development or training phase data.

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

As the document does not provide details on the training set, it does not describe how the ground truth was established for the training set. It primarily focuses on the verification and validation (testing) of the final device/algorithms.

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The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis.

Data are securely transmitted via wireless connection for storage, review, analysis, and display.

The Device can include the ability to display data and notify healthcare professionals when physiological data fall outside clinician-specified parameters.

The data from the Device are intended as an aid to diagnosis, disease management, and treatment. The Device is intended for use on patients who are 18 years of age or older.

The Device is not intended to output physiological measurements while the patient undergoes significant motion or is active.

The Device is not intended for critical care.

The BioButton System (the "Device") is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted from the Device for storage and analysis.

The Device is an extension of the Predicate Device (K212957) with the same intended use. The Device consists of a multiple-use and rechargeable wearable hardware sensor module to collect data from a patient and other Medical Device Data System (MDDS) components that enables remote transfer of collected data. The main components of the Device include the following:

1. A wearable sensor to collect data from a patient
2. A device-based Medical Device Data System (MDDS) data gateway to transfer data from the wearable sensor to the cloud
3. A cloud-based Medical Device Data System (MDDS) for data storage and transmission
4. A cloud-based system for configuration of the wearable sensor and data analysis
5. A cloud-based system for healthcare professionals to view patient information

The Device is used to collect physiological information from a patient using the sensor for a set duration (as defined by different use cases) in home and healthcare settings. Physiological data is collected continuously while the patient is at rest. The medical physiological data collected includes:

• Heart rate at rest,
• Respiratory rate at rest, and
• Skin temperature

There are other wellness parameters that can be collected by the device that include: activity level, body position, sleep, and step and gait analysis. These wellness data types are not discussed in detail the regulatory submission since they do not meet the definition of medical device.

Upon completion of a physiological data collection period, the data offload is conducted via wireless Bluetooth connection using the Offload Software. The data offloading is performed and qualified personnel. The Device also provides a web display for healthcare professionals to view patient information.

The provided text is a 510(k) summary for the BioButton System, a remote monitoring wearable device. It describes the device, its intended use, and comparisons to a predicate device, along with performance testing conducted to support substantial equivalence.

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

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

The document provides the following performance specifications for the BioButton System:

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