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The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.

The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.

VitalPatch is a wearable biosensor which may be used as part of the VitalConnect Platform. The device is a disposable, battery-powered, adhesive patch containing sensors used to gather patients' physiological data, which are transmitted wirelessly. The modification proposed in this 510(k) increases the wear duration for the VitalPatch wearable biosensor from 96 hours to 120 hours.

The provided text is a 510(k) summary for a modification to the VitalPatch® VitalConnect Platform. This submission focuses on extending the wear duration of the device from 96 hours to 120 hours. As such, the detailed information typically found in a comprehensive clinical study report, like specific acceptance criteria for diagnostic performance, sample sizes for test and training sets, expert qualifications, and adjudication methods, is not explicitly present for all physiological parameters. However, the document does list performance tests performed and the nature of the modification.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for each physiological parameter (heart rate, ECG, etc.) in the context of this specific 510(k) for extended wear duration. The focus of this submission is primarily on extending the wear duration and ensuring the device continues to function as intended without raising new questions of safety or effectiveness. The performance data mentioned relates to engineering and wear-duration aspects.

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

The document states that "internal performance testing" was conducted for battery performance, skin adherence/wear duration, and wear performance (sensor functionality) in support of extending the wear duration to 120 hours. However, it does not specify the sample size for this testing.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given it was "internal performance testing" for a 510(k) for a modification (wear duration extension), it was likely prospective testing conducted by the manufacturer, Vital Connect, Inc., to validate the extended wear duration.

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

The document does not provide information regarding the use of experts or their qualifications for establishing ground truth related to the performance of physiological parameters or the extended wear duration. The performance tests mentioned (electrical safety, EMC, battery, adherence, sensor functionality, firmware) typically use objective measurements against established standards or internal benchmarks rather than expert-derived ground truth in the way a diagnostic AI algorithm might.

4. Adjudication Method for the Test Set

As no "ground truth" established by experts or human readers is explicitly mentioned for the performance tests conducted, no adjudication method is described in this document.

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

An MRMC study was not conducted as described in this document. The submission is for a device modification (wear duration extension) of a physiological remote monitoring system, not for a diagnostic AI algorithm that typically necessitates such studies to compare human reader performance with and without AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone performance study in the context of an "algorithm only" for diagnostic purposes was not explicitly described in this 510(k) summary. The VitalConnect Platform transmits physiological data for healthcare professionals' use, and the performance tests mentioned are related to the hardware's safety, functionality, and wear duration, not a standalone diagnostic algorithm.

7. Type of Ground Truth Used

For the specific performance tests conducted in support of this 510(k) (battery performance, skin adherence/wear duration, wear performance (sensor functionality)), the ground truth would have been established through objective measurements and engineering criteria rather than expert consensus, pathology, or outcomes data. For example, battery performance would be measured against expected discharge curves, skin adherence against defined detachment thresholds, and sensor functionality against known physical or electrical standards.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This 510(k) is for a hardware modification (extended wear duration) and not for the development or modification of an AI/ML algorithm that typically requires a training set. The "firmware verification and validation" mentioned refers to ensuring the software components function correctly for the extended duration, not to the training of a learning algorithm.

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

Since no training set is mentioned as part of this 510(k) submission, this information is not applicable and not provided in the document.

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The Vital Connect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. The Vital Connect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.

The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the Vital Connect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.

The Vital Connect Platform is a wireless data collection system that monitors physiological data and consists of the following sub-systems:

• Vital Connect Sensor (includes Adhesive Patch and Sensor Module) .
  • a) Adhesive Patch

The Adhesive Patch is designed as a disposable self-adhesive interface to the body.

• b) Sensor Module
  The Sensor Module performs processing functions related to capture of physiologic data and also performs bi-directional communication with the Relay Software Library.

• Relay Software Library
  The Relay Software Library manages communication with the Vital Connect Sensor. The Relay Software Library also manages the communication with the Secure Server when the Secure Server is deployed. The Relay Software Library is installed on a relay device.

The Vital Connect Platform offers an optional sub-system:

• . Secure Server
  The Secure Server manages the upload, processing and storage of sensor data, as well as real-time configuration and notification communications with the Relay Software Library.

The Vital Connect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. The Vital Connect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.

The Vital Connect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via bi-directional communication to the relay device when in range of the relay. The encrypted wireless data provided by the Sensor may be downloaded from the relay device for storage, or integrated into a Third-Party Relay Application via the APIs of the Relay Software Library. In addition, the wireless data may be transferred to the Vital Connect Secure Server where they are stored for analysis with the deployment of the server.

During normal operation, data are collected on the Vital Connect Sensor and transmitted to the Relay immediately. A continuous connection is needed between the Sensor and the Relay in order to facilitate continuous data transmission. The continuous wireless transmission of the data occurs with a delay or latency of seconds between continuous data collection and transmission. Data can be stored and downloaded from the Relay. Data can continue to be transferred to the Vital Connect Server with a server connection. If an interruption occurs between the Sensor and the Relay, data will be stored on the Sensor for several hours until the connection is re-established.

The provided text is a 510(k) summary for the Vital Connect Platform. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device. However, it does not contain specific acceptance criteria or an explicit study proving the device meets those criteria for its physiological monitoring functions (heart rate, ECG, respiratory rate, etc.) in a traditional sense.

Instead, the document focuses on:

• Biocompatibility testing: Conducted according to ISO 10993-1.
• Electrical safety and EMC testing: Compliance with IEC 60601 series standards and FCC CRF47 Part 15 Subpart C.
• Software verification and validation: Following FDA guidance for "moderate" level of concern software.
• Bench testing: In-vitro tests for shelf life, packaging, water resistance, static load, compression, and drop test.
• Reliance on prior clinical testing: Stating that "Prior clinical testing was performed to support the clearance of the predicate device and is still relevant to the proposed device."

Given this, I cannot construct a table of acceptance criteria and reported device performance from the provided text for the physiological monitoring aspects. The document asserts that the device met "all acceptance criteria" during bench testing and that "safety and performance characteristics" were established through verification and validation, but it does not detail those criteria or the specific performance results for the physiological measurements.

Here's a breakdown of what can be extracted or inferred based on your request, with explicit notes on what is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified for any physiological data validation. The document states "Prior clinical testing was performed to support the clearance of the predicate device," but the sample size for that prior predicate testing is not provided. For bench testing, "in vitro bench testing" was conducted, but sample sizes for these tests are not specified.
• Data Provenance: Not specified for any physiological data. The previous clinical data would be from the predicate device's clearance. The current document does not specify country of origin or whether it was retrospective/prospective for any data related to physiological performance.

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

• Not Applicable/Not Provided: The document does not describe a study involving expert-established ground truth for physiological measurements for the modified device nor for the predicate device's clinical testing.

4. Adjudication method for the test set

• Not Applicable/Not Provided: No adjudication method is mentioned as there's no described study involving human readers or expert consensus for the physiological data.

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: No MRMC study or study demonstrating human reader improvement with AI assistance is mentioned. The device is a "wireless remote monitoring system" for continuous collection of physiological data, not an AI diagnostic aid for human readers.

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

• Implied: The device is a standalone physiological data collection system (Vital Connect Sensor) that transmits data. Its performance is assessed through its ability to accurately capture and transmit these physiological parameters. However, specific standalone performance metrics (e.g., accuracy of HR measurement against a gold standard) are not detailed in this document; it relies on the "substantial equivalence" of its technology and the predicate device's prior clinical validation.

7. The type of ground truth used

• Not explicitly detailed for physiological data: For biocompatibility, electrical safety, software, and bench testing, the "ground truth" is adherence to established standards and successful verification/validation. For physiological measurements, it's implied that the predicate device's clinical testing used appropriate reference methods (e.g., clinical monitoring equipment for heart rate, ECG, respiratory rate) to establish ground truth.

8. The sample size for the training set

• Not Applicable/Not Provided: The document does not mention any machine learning or AI components that would require a separate training set. It describes a system for collecting and transmitting physiological data.

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

• Not Applicable/Not Provided: As no training set is mentioned, the method for establishing its ground truth is also not applicable.

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The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability (R-R interval), respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The Vital Connect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients.

The VitalConnect Platform is a wireless data collection system that monitors physiological data and consists of the following sub systems:
• VitalConnect Sensor (includes adhesive Patch and Sensor Module)
• Relay Software Library
• Server Software Library

VitalConnect Platform sub-system includes:
• VitalConnect Sensor
a) Adhesive Patch
The Patch is designed as a disposable self-adhesive interface to the body.
b) Sensor Module
Residing within the patch, the sensor module performs processing functions related to capture of physiological data and also performs bi-directional communication with the relay device.
• VitalConnect Relay Software Library
The Relay Software Library manages bi-directional communication between the Sensor Module and the Server Software Library and is installed on a relay device.
• VitalConnect Secure Server Software Library
The Server Software Library is installed on a central server, manages the upload, processing and storage of sensor data, as well as configuration of and notifications from the VitalConnect Platform.

The VitalConnect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via a bi-directional relay to the central server. During normal operation, continuous wireless transmission occurs with a delay or latency of seconds between continuous data collection and transmission. However, for continuous transmission of data to a healthcare professional, a continuous connection is needed between the module, the relay, and the server. Data can be stored on the VitalConnect Sensor for several hours and then transferred once connectivity is reestablished.

The VitalConnect Sensor is a battery-operated adhesive patch with integrated sensors and wireless transceiver module, worn on the torso to record heart rate, electrocardiography (ECG), heart rate variability (R-R interval), respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall).

The provided text describes the VitalConnect Platform, a wireless remote monitoring system. While it mentions non-clinical bench testing for various physiological parameters and a "Long-term Field Study for Home Use," it does not provide specific acceptance criteria or reported device performance values in a table. It also does not present a formal clinical study designed to prove the device meets pre-defined acceptance criteria with detailed statistical analysis.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's an attempt to answer based on the available information, with clear indications of what is not present:

Acceptance Criteria and Study Details for VitalConnect Platform (K141161 JIII 2 9 2014)

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or reported device performance values are provided in the document. The non-clinical testing section lists various parameters that were tested (e.g., ECG, Heart rate, Respiration rate, etc.), but does not give quantitative thresholds or specific results.

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

• Test Set (Clinical Study):
  • Sample Size: 76 participants
  • Data Provenance: The study was conducted by Vital Connect, likely in the USA. It was a "Long-term Field Study for Home Use." The context implies it was a prospective study focused on usability and wearability in a home setting.

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

This information is not provided in the document. The clinical study described is focused on "usability" and "long-term wearability," rather than diagnostic accuracy against an expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided as the study described does not appear to involve expert adjudication for ground truth.

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

No MRMC comparative effectiveness study is mentioned. The study described focuses on the device's performance (usability, wearability) in a home setting rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

While "Non-clinical bench testing" was performed for various physiological parameters, the document does not report standalone algorithm performance metrics (e.g., sensitivity, specificity, accuracy) that would demonstrate the algorithm's performance in isolation without human intervention. The mention of "Measurement accuracy" in non-clinical testing suggests this was assessed, but no results are given.

7. Type of Ground Truth Used

For the "Long-term Field Study for Home Use," the "ground truth" implicitly relates to the successful use and wearability in a real-world setting, as assessed by participants and potentially monitored by the study conductors. It does not mention a gold standard for physiological measurement accuracy, pathology, or specific clinical outcomes data as the primary ground truth for the clinical study described. The non-clinical testing likely used calibrated reference instruments for accuracy assessments, but this is not explicitly stated for a "ground truth" as typically understood in clinical validation studies.

8. Sample Size for the Training Set

The document does not mention any details about a training set for an AI algorithm. It refers to a "VitalConnect Platform," which suggests an integrated system rather than a separately described AI component with a distinct training phase.

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

Since no training set is mentioned for an AI algorithm, this information is not provided.

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The VitalConnect Platform is a wireless monitoring system intended for use by healthcare professionals for unattended surveillance of physiological data within healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The VitalConnect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters.
The device is not intended to be used on critical care patients and is intended to supplement vital signs monitoring by healthcare professionals, not to replace current standards of care. The device is intended for use on general care patients and on patients who are 18 years of age or older. It is not intended for home use.

The VitalConnect Platform is a wireless data collection system that monitors physiological data and consists of the following sub systems:
• VitalConnect Sensor (includes adhesive Patch and Sensor Module)
• Relay Software Library
• Server Software Library
VitalConnect Platform sub-system includes: VitalConnect Sensor . a) Patch The Patch is designed as a disposable self-adhesive interface to the body. b) Sensor Module Residing within the patch, the sensor module performs processing functions related to capture of physiological data and also performs bi-directional communication with the relay device. VitalConnect Relay Software Library ● The Relay Software Library manages bi-directional communication between the Sensor Module and the Server Software Library and is installed on a relay device. VitalConnect Secure Server Software Library . The Server Software Library is installed on a central server, manages the upload, processing and storage of sensor data, as well as real-time configuration of and notifications from the VitalConnect Platform. The VitalConnect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via a bi-directional relay to the central server. The VitalConnect Sensor is a battery-operated adhesive patch with integrated sensors and wireless transceiver module, worn on the torso to record heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall) for in-patient use.

The VitalConnect Platform (K132447) is a wireless monitoring system intended for use by healthcare professionals for unattended surveillance of physiological data within healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall).

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria for each physiological parameter. Instead, it states that "The results of the non-clinical and clinical studies demonstrate that the VitalConnect Platform is safe and effective for its intended use" and that the device is "substantially equivalent to the currently marketed predicate devices" based on intended use and product performance.

However, the non-clinical testing section lists the parameters for which testing was conducted, implying that the device's performance for these parameters was evaluated for accuracy and safety. For the purpose of this analysis, we will infer the "reported device performance" as the successful completion of these tests, leading to the substantial equivalence determination.

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

The 510(k) summary states that "Clinical study was performed on human subjects" but does not provide any details regarding the sample size used for the test set.

The data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided document. It only indicates that the study was "performed on human subjects."

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

The 510(k) summary does not provide information on the number of experts used, their qualifications, or how ground truth was established for the clinical study. Given the nature of physiological monitoring, ground truth would likely be established by simultaneously using validated, reference-standard monitoring equipment.

4. Adjudication Method for the Test Set

The 510(k) summary does not describe any adjudication method used for the test set.

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

No, an MRMC comparative effectiveness study was not mentioned or implied. The device is a physiological monitoring system, not an imaging diagnostic device that typically involves human readers interpreting cases. Therefore, the concept of human readers improving with AI assistance is not directly applicable in the context of this device as described.

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

The device is a physiological monitoring system that captures and processes data. The non-clinical "bench testing" of parameters like heart rate, ECG, respiratory rate, etc., represents a standalone performance evaluation of the device's algorithms and sensors without direct human intervention in the continuous data capture and processing (though humans would be setting up the test and evaluating the output). The clinical study, while involving human subjects, evaluates the device's performance in a real-world setting, also largely as a "standalone" system in terms of its ability to collect and transmit physiological data. The system is designed to provide unattended surveillance and notify healthcare professionals, implying its algorithms operate independently to detect deviations.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used. However, for physiological monitoring devices, ground truth for parameters like heart rate, ECG, respiration rate, and temperature would typically be established using:

• Reference standard medical devices: e.g., a calibrated ECG machine for heart rate and ECG, a capnograph or spirometer for respiration, a precision thermometer for skin temperature.
• Direct observation/manual counting: for respiration rate.
• Known physical movements/positions: for activity and posture.

While not stated, it is highly probable that validated, higher-accuracy reference devices were used in parallel during the clinical study to establish ground truth for comparison.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a separate training set or its sample size. This device is primarily a physiological sensor and data transmission platform, not a machine learning-based diagnostic algorithm that typically requires a distinct training phase on a large dataset. While its internal algorithms (e.g., for heart rate variability, or detecting fall) would have been developed and tested, the document focuses on the validation studies rather than the development phase data.

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

As no specific training set is mentioned (see point 8), the method for establishing its ground truth is not provided. If internal algorithm development involved data, it would logically follow similar ground truth establishment methods as for the clinical validation, likely using reference standard devices.

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