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The Capsule Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

The Capsule Vitals Plus Patient Monitoring System which is the subject of this submission is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by.

It operates with the Capsule Medical Device Information Platform (CMDIP) a Medical Device Data System to present patient information to the clinical user for active monitoring purposes at the point of care.

The proposed Capsule Vitals Plus Patient Monitoring System consists of the following components:

• -Capsule Neuron Mobile Platforms
• Capsule Vitals Plus Application |
• Capsule Vitals Plus NIBP Monitoring Modules -
• Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02 —
• Capsule Capnography Interface Module -
• Nellcor SpO2 Oximetry Module -
• Masimo uSpO2 Pulse Oximetry Cable
• -Exergen TAT-5000S Temperature Scanner
• -Capsule Early Warning Scoring System

The provided text is a 510(k) summary for the Capsule Vitals Plus Patient Monitoring System. It describes the device, its intended use, comparison to a predicate device, and performance testing. However, it explicitly states that clinical studies were not required to support substantial equivalence. Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving the device meets those criteria, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, or training set details.

The summary focuses on demonstrating substantial equivalence by showing that the proposed device has the same intended use and similar technical characteristics as the predicate device (SmartLinx Vitals Plus Patient Monitoring System, K200856), with minor differences that do not raise new questions of safety or effectiveness. The performance testing mentioned refers to hardware and software verification and validation, as well as conformance with FDA recognized consensus standards (listed in Table 4).

Based on the provided text, it is not possible to answer the detailed questions about acceptance criteria and a study proving the device meets them because such a study involving clinical performance with specific metrics (like sensitivity, specificity, or human reader improvement) was not part of this 510(k) submission.

Here's a breakdown of why each requested point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on showing equivalence to a predicate device and conformance to standards, not on demonstrating performance against specific clinical metrics.
2. Sample sized used for the test set and the data provenance: Not present. The performance testing described is primarily engineering verification and validation and compliance with standards, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not present. No clinical ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not done. This device is a patient monitoring system, not an AI diagnostic tool requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a monitoring system intended for use by clinical physicians or appropriate medical staff.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not present.
8. The sample size for the training set: Not applicable/Not present. The document describes a medical device, not a machine learning model that would typically have a training set.
9. How the ground truth for the training set was established: Not applicable/Not present.

Conclusion stated in the document: "The subject of this premarket submission, Capsule Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence." (Page 15)

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The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System operates with the SmartLinx Medical Device Information Platform (MDIP) a Medical Device Data System to present patient information to the clinical user for active monitoring purposes at the point of care.

The proposed SmartLinx Vitals Plus Patient Monitoring System consists of the following components:

• SmartLinx Neuron Mobile Platform
• SmartLinx Vitals Plus Application
• SmartLinx Vitals Plus NIBP Monitoring Module
• Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02
• Nellcor SpO2 Oximetry Module
• Masimo uSpO2 Pulse Oximetry Cable
• Exergen TAT-5000S Temperature Scanner
• SmartLinx Early Warning Scoring System

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria. Instead, it describes a "SmartLinx Vitals Plus Patient Monitoring System" which is a medical device data system that integrates various vital signs modules.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving performance against specific acceptance criteria through a clinical study for a new, novel device.

The "Performance Testing" section mentions adherence to FDA recognized consensus standards (Table 4), which are often general safety and performance standards for similar types of medical devices (e.g., electrical safety, electromagnetic compatibility, usability, software lifecycle, and particular requirements for specific monitoring components like non-invasive blood pressure, pulse oximetry, and respiratory gas monitors). This is a different type of "acceptance criteria" than what might be established for a novel AI/ML-based diagnostic device.

Crucially, the document explicitly states:

• "The subject of this premarket submission, SmartLinx Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence."

Therefore, I cannot extract the specific information requested about acceptance criteria and a study proving the device meets them from this document, as there was no such clinical study performed or required for this 510(k) submission.

To directly answer your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document refers to conformance with recognized consensus standards (Table 4) rather than specific performance acceptance criteria for a novel functionality.
2. Sample sized used for the test set and the data provenance: Not applicable, as no clinical study was required or performed. Performance testing involved hardware and software verification, validation, and testing against consensus standards, not a "test set" of patient data in the typical sense of an AI/ML study.
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 was required or performed that involved expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/ML-based diagnostic or assistive technology that would typically undergo an MRMC study. It is a patient monitoring system integrating existing vital sign modules.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The device relies on the established accuracy and ground truth of its component modules (e.g., NIBP, SpO2, CO2 sensors) which are themselves regulated and have their own performance specifications.
8. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable.

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The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

The predicate device, SmartLinx Vitals Plus Patient Monitoring System, was cleared in K180734. The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. The proposed SmartLinx SmartLinx Vitals Plus Patient Monitoring System is similar to the predicate SmartLinx Vitals Plus Patient Monitoring System, cleared in K180734. The change being proposed is to integrate the SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus Alarm Hub and Nellcor SpO2 Pulse Oximetry Module into one module or backpack configuration; and the alternative Masimo SpO2 pulse oximetry cable will continue to be connected to the same place as with the predicate. There is no change to the performance or functionality of the device. There is no change to the indications for use or intended use.

The provided text describes a 510(k) submission for a patient monitoring system, focusing on a configuration change rather than a new AI algorithm for diagnosis or treatment. Therefore, many of the requested elements for AI-based device studies (like sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies) are not applicable or explicitly mentioned in this document.

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

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" in this submission revolve around demonstrating substantial equivalence to a previously cleared predicate device. This is achieved by showing that the proposed device, despite a configuration change, does not raise new questions of safety and effectiveness and performs equivalently to the predicate.

• Electromagnetic Compatibility, Electrical Safety, and Safety Standards (e.g., ANSI AAMI ES 60601-1, IEC 80601-2-30 for NIBP, IEC 60601-1-2 for EMC, IEC 60601-2-49 for multifunction monitoring, ISO 80601-2-61 for pulse oximetry, IEC 60601-1-8 for alarms)
• Usability (IEC 60601-1-6, IEC 62366-1)
• Software (IEC 62304:2006)
• Batteries (IEC 62133:2012) |
  | Equivalence in Design, Features, and Functionality to Predicate | The study concluded that the proposed system results in an equivalent design, features, and functionality with "few exceptions that do not raise new questions of safety or effectiveness." |

Study Information (based on provided text):

1. Sample size used for the test set and the data provenance: This information is not provided in the document. The testing described is primarily focused on demonstrating physical and functional equivalence of hardware and software components through bench testing and adherence to standards, rather than evaluating performance against a clinical test set in the way an AI algorithm would be. The document does not specify the number of devices or scenarios used in the "performance testing."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable to this submission. The device is a patient monitoring system, not an interpretive AI algorithm that requires expert-established ground truth for performance evaluation in a clinical test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable for the reasons mentioned above.

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: This is not applicable. This submission is for a patient monitoring system with a configuration change, not an AI-assisted diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is a monitoring system intended for use by clinical physicians or appropriate medical staff, inherently involving human interaction. The submission does not describe a standalone algorithm performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance testing conducted, the "ground truth" would be established by the specifications and expected outputs of the individual physiological parameter modules (NIBP, SpO2, Temperature) as defined by their respective recognized standards (e.g., accuracy requirements for NIBP monitors per IEC 80601-2-30). The document refers to "bench testing," "testing to FDA recognized consensus standards," and "software verification and validation testing," inferring that these standards define the expected "truth" or acceptable performance ranges.

7. The sample size for the training set: This is not applicable. The device is not an AI/ML model that undergoes a training phase.

8. How the ground truth for the training set was established: This is not applicable for the reasons mentioned above.

Summary of the Study:

The "study" in this context is a comprehensive set of performance testing designed to demonstrate that a design configuration change to an existing, cleared patient monitoring system (SmartLinx Vitals Plus Patient Monitoring System, K180734) does not negatively impact its safety, effectiveness, or functionality.

The study involved:

• Bench Testing: To ensure the modified hardware and integrated components perform as expected.
• Software Verification and Validation Testing: To confirm the software (SmartLinx Vitals Plus Application, SmartLinx EWSS) functions correctly with the new configuration.
• Conformance to FDA Recognized Consensus Standards: This involved extensive testing against standards such as those for electrical safety (ANSI AAMI ES 60601-1), NIBP accuracy (IEC 80601-2-30), SpO2 accuracy (ISO 80601-2-61), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 62366-1), alarm systems (IEC 60601-1-8), and software lifecycle processes (IEC 62304).

The document explicitly states: "This Special 510(k) for the proposed SmartLinx Vitals Plus Patient Monitoring System did not require clinical studies to support substantial equivalence." This reinforces that the focus was on technical and functional equivalence through non-clinical testing.

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The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. It consists of the SmartLinx Vitals Plus Application (a mobile medical application operating on the SmartLinx Neuron 2 Mobile Platform), SmartLinx Vitals Plus NIBP Module, Masimo uSpO2 Pulse Oximetry Cable, Exergen TAT-5000S Thermometer, Covidien FILAC 3000 Thermometer, SmartLinx Vitals Plus Alarm Hub, SmartLinx Neuron 2 Mobile Platform, and optionally the SmartLinx Early Warning Scoring System (EWSS). The system collects vital signs data from sensors connected to the SmartLinx Neuron 2 Mobile Platform, which serves as the user interface and supports connectivity with the electronic medical record (eMR). The proposed device is identical to the predicate device (K171751) with the addition of the option for Nellcor SpO2 Pulse Oximetry solution and software upgrades.

The provided document is a 510(k) summary for the SmartLinx Vitals Plus Patient Monitoring System. It outlines changes to an already cleared device, primarily the addition of Nellcor SpO2 pulse oximetry solution and software upgrades.

The document explicitly states that "clinical studies to support substantial equivalence" were not required. Therefore, there is no information in this document regarding:

• Acceptance criteria expressed as performance metrics or targets.
• A specific study proving the device met such acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number of experts or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used or how it was established for training or testing sets.

Instead, the submission relies on:

1. Comparison to a legally marketed predicate device (SmartLinx Vitals Plus Patient Monitoring System, K171751) and a reference device (Zoe Medical's 740 Select, K130411). The core argument is that the modifications (primarily the addition of Nellcor SpO2) do not raise new questions of safety and effectiveness, as the reference device already supports Nellcor SpO2.
2. Performance testing: This is described as "hardware and software verification and validation, as well as testing to FDA recognized consensus standards."
3. Conformance with FDA recognized consensus standards: A table of standards (such as ANSI AAMI ES 60601-1, IEC 60601-1-2, ISO 80601-2-61, IEC 62304, etc.) is provided to demonstrate adherence to established safety and performance requirements for medical electrical equipment, including pulse oximeters and software.

Therefore, the tables and information requested cannot be derived from the provided text, as this 510(k) relies on substantial equivalence through design and standards conformance, rather than new clinical performance data for the specific changes.

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The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. SmartLinx Vitals Plus consists of the following components: SmartLinx Vitals Plus Application, SmartLinx Vitals Plus NIBP Module, Masimo uSpO2 Pulse Oximetry Cable, Exergen TAT-5000S Thermometer, Covidien FILAC 3000 Thermometer, SmartLinx Vitals Plus Alarm Hub, SmartLinx Neuron 2 Mobile Platform, and SmartLinx Early Warning Scoring System.

The provided text does not contain enough information about acceptance criteria or a study proving that the device meets specific performance metrics. It primarily focuses on the device's substantial equivalence to predicate devices and adherence to recognized safety and performance standards.

The document discusses:

• Device Description: What the device is and its components.
• New Functionality: The additions to the SmartLinx Vitals Plus Application, such as Intervals Mode for NIBP, physiological alarms, continuous SpO2 monitoring features, and integration of the Covidien FILAC 3000 Thermometer.
• Comparison to Predicate Devices: Tables detailing technical characteristics and their differences, and a discussion of why these differences do not raise new questions of safety or effectiveness.
• Safety and Performance Testing: A list of FDA recognized standards that the device complies with (e.g., for general safety, EMC, usability, alarms, software, NIBP, temperature, SpO2, battery, patient monitoring).
• Clinical Studies: A clear statement that clinical studies were not required to support substantial equivalence.

Therefore, I cannot extract the specifically requested information about acceptance criteria, detailed device performance, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone performance, because this information is not present in the provided text.

The document states:

• "Extensive performance testing ensures that the SmartLinx Vitals Plus Patient Monitoring System performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications."
• "The subject of this premarket submission, the SmartLinx Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence."

This indicates that while performance testing was done against specifications, the specific details of those tests, the acceptance criteria used, and the quantitative results are not included in this summary document.

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The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in healthcare facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System consists of the SmartLinx Vitals Plus mobile medical application and externally integrated vital signs modules operating on the SmartLinx Neuron 2 mobile platform. The application controls the modules at the point of care through interfaces on the SmartLinx Neuron 2 mobile platform and presents this to the monitoring purposes. The supported physiological parameters are: non-invasive blood pressure (systolic, diastolic, mean arterial pressure (MAP)), pulse rate, functional arterial oxygen saturation (SpO2), and temperature.

The SmartLinx Vitals Plus Patient Monitoring System is composed of multiple products:

• The SmartLinx Vitals Plus mobile medical application
• The SmartLinx Vitals Plus NIBP Module with SunTech Medical cuffs and hoses
• The Masimo SET uSpO2 Pulse Oximetry Cable
• The Exergen TAT-5000S infrared thermometer
• The SmartLinx Neuron 2 Mobile Platform
• The SmartLinx Vitals Plus Roll Stand

The provided document details the 510(k) premarket notification for the SmartLinx Vitals Plus Patient Monitoring System. It describes the device, its intended use, and a comparison to a predicate device, focusing on functional equivalence. However, the document does not contain detailed acceptance criteria for specific performance metrics (like accuracy or precision for NIBP, SpO2, or temperature) nor does it provide a study report proving the device meets said criteria with specific quantitative results.

Instead, the document generally states that the device "complies with its predetermined specification" based on various types of testing, often referencing compliance with established electrical safety, EMC, and software standards, as well as a clinical performance standard for NIBP (ISO 81060-2:2013).

Therefore, I cannot populate the table or answer all the requested questions with specific data from the provided text. I will indicate where information is not available.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Test Set Sample Size: Not specified in the document. For clinical performance testing (referencing ISO 81060-2:2013), this standard typically requires a certain number of subjects (e.g., 85 subjects for NIBP accuracy) and measurements, but the document does not report the actual sample size used for this specific device's clinical performance trial.
   • Data Provenance: Not specified. The document does not indicate the country of origin, nor whether the data was retrospective or prospective.

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

   • Not specified. The document indicates clinical performance testing was done "in accordance with ISO 81060-2:2013". For NIBP validation studies, ground truth (reference measurements) are typically established by trained technicians using a reference device (e.g., auscultation with mercury sphygmomanometer), but the number and qualifications of these individuals are not detailed in this submission.

3. Adjudication method for the test set:

   • Not specified. If ground truth involved multiple measurements or experts, an adjudication method would typically be used, but this information is absent.

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. This device is a vital signs monitor, not an AI-assisted diagnostic imaging device that involves "human readers" or "AI assistance" in that context. Therefore, an MRMC study and AI improvement effect size is not applicable to this type of device and was not conducted.

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

   • Yes, to an extent. The performance testing described (Software Testing, Electrical Safety, EMC Testing, Bench Performance Testing, and Clinical Performance Testing conforming to standards like ISO 81060-2:2013) essentially evaluates the device's inherent performance. While the device is intended for use by healthcare providers, these tests assess the accuracy and reliability of the device's measurements and functions independent of a human's interpretation of those measurements in a diagnostic workflow (which is the typical context for "standalone AI performance"). The software and hardware perform their functions (measuring NIBP, SpO2, temp) without direct "human-in-the-loop" assistance for the measurement process itself.

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

   • For NIBP, the ground truth would typically be established by simultaneous auscultatory measurements by trained observers using a reference device, as per the methodology specified in ISO 81060-2.
   • For SpO2, ground truth is usually established by CO-oximetry of arterial blood samples.
   • For temperature, ground truth would be from a precisely calibrated reference thermometer or other established method.
   • The document does not explicitly state the ground truth methodology beyond referencing the ISO standards, but these standards define the accepted methods for ground truth establishment.

7. The sample size for the training set:

   • Not applicable. This document describes a traditional medical device (a vital signs monitor) and its validation. It does not refer to an AI/Machine Learning model that requires a "training set" in the conventional sense. The software development process mentioned is likely for deterministic software, not a learned model.

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

   • Not applicable, as there is no "training set" for an AI/ML model described in this document.

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The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Based on an open-architecture design, DataCaptor is a data acquisition and distribution software, using ActiveX and the Distributed Component Object Model. This tool retrieves data from serial, network or analog devices and, via an ActiveX control, makes this data available over network or any other type of communication for use in software applications. We do not supply any hardware - our customers can buy cable and connect the devices directly to the COM port (we provide a wiring diagram that shows them pin configurations) or they can use a multiport box or card, an RS-232 to Ethernet converter is used if several devices need to be connected to the network and there are not necessarily computers next to each one. We don't recommend hardware suppliers. The change enables interface to additional models of connected medical devices. Also the DataCaptor Solution now includes the DMM Server module and the DataPortal module. The DMM Server module allows one to process the data originating from the devices and decoded by DataCaptor, i-e, it allows users to create averages, to suppress some data, to streamline the frequency of data that come out of DataCaptor. The DataPortal module converts a dataflow from a Microsoft COM (Component Object Model) container into a TCP/IP Sockets container

The provided text describes a 510(k) premarket notification for a medical device called DataCaptor™. This submission is for an upgrade to an existing product, K013019 and K020197, adding compatibility with additional medical devices and upgrading basic capabilities.

However, the 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device. This type of submission generally relies on demonstrating that changes made to the device do not alter its fundamental functionality, safety, or effectiveness, thus not requiring new clinical performance studies.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. The document does not describe any specific test set or data used to evaluate the upgraded DataCaptor™ system's performance beyond internal verification that the new interfaces function as intended.

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)

• Not applicable. No expert review or ground truth establishment is described in this submission.

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

• Not applicable. No adjudication method is mentioned as there is no specific test set of data presented.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is data collection software and is explicitly stated not to be for "monitoring purposes" or for "controlling any of the clinical devices." It is not an AI-assisted diagnostic or interpretive tool that would involve human readers or MRMC studies.

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

• Not applicable in the context of diagnostic performance. While the software operates without human-in-the-loop for data collection, a standalone performance study in the sense of diagnostic accuracy (which is often what this question implies) was not conducted or reported. Its performance is related to its ability to acquire and distribute data, not to make clinical interpretations.

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

• Not applicable. No ground truth in the context of clinical or diagnostic performance is mentioned. The "truth" here would likely be the accurate and reliable transfer of data from medical devices, which is verified through engineering tests rather than clinical expert consensus or pathology.

8. The sample size for the training set

• Not applicable. This software is described as data acquisition and distribution software using ActiveX and Distributed Component Object Model. It does not appear to be an AI/ML device that requires a training set in the conventional sense for learning patterns from data.

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

• Not applicable. As no training set is described (see point 8), no method for establishing its ground truth is provided.

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The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Based on an open-architecture design, DataCaptor is a data acquisition and distribution software, using ActiveX and the Distributed Component Object Model. This tool retrieves data from serial, network or analog devices and, via an ActiveX control, makes this data available over network or any other type of communication for use in software applications. We do not supply any hardware - our customers can buy cable and connect the devices directly to the COM port (we provide a wiring diagram that shows them pin configurations) or they can use a multiport box or card, an RS-232 to Ethernet converter is used if several devices need to be connected to the network and there are not necessarily computers next to each one. We don't recommend hardware suppliers.

This submission is a 510(k) summary for the DataCaptor™ Data Acquisition and Distribution Software. The purpose of this 510(k) is to demonstrate substantial equivalence to a previously cleared device (K013019) with the primary change being added compatibility with additional medical devices.

Therefore, the submission does not include any studies related to acceptance criteria or device performance because it relies on the predicate device's established safety and effectiveness. The FDA's letter (Exhibit 3) also confirms that the device is substantially equivalent to legally marketed predicate devices without requiring a PMA.

As a result, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or MRMC studies, as these were not part of this 510(k) submission.

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The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Based on an open-architecture design, DataCaptor is a data acquisition and distribution software, using ActiveX and the Distributed Component Object Model. This tool retrieves data from serial, network or analog devices and, via an ActiveX control, makes this data available over network or any other type of communication for use in software applications. We do not supply any hardware - our customers can buy cable and connect the devices directly to the COM port (we provide a wiring diagram that shows them pin configurations) or they can use a multiport box or card, an RS-232 to Ethernet converter is used if several devices need to be connected to the network and there are not necessarily computers next to each one. We don't recommend hardware suppliers.

This submission is a 510(k) premarket notification for the DataCaptor™ Data Acquisition and Distribution Software. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive studies with acceptance criteria and performance metrics typically seen for novel or higher-risk devices.

Therefore, the provided text does not contain the acceptance criteria or a study directly proving the device meets acceptance criteria in the format requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

However, I can extract the relevant information regarding the equivalence comparison, which serves as the basis for the FDA's decision to allow the device to market.

Summary of Device Equivalence and FDA Determination:

The DataCaptor™ Data Acquisition and Distribution Software's acceptance is based on its substantial equivalence to a legally marketed predicate device, the Hewlett-Packard M2376A DeviceLink System (K000635). The FDA determined that the device is substantially equivalent for the stated indications for use.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) based on substantial equivalence, there are no explicit "acceptance criteria" in the sense of quantitative performance thresholds that the device had to meet through a specific study. Instead, the "acceptance criteria" can be inferred from the comparison areas used to demonstrate equivalence to the predicate device. The device "performance" is implicitly deemed acceptable because it is "substantially equivalent" to a device already deemed safe and effective.

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

• Not Applicable. This submission does not describe a test set or data provenance in the context of performance testing for acceptance criteria. The equivalence demonstration relies on a comparison of intended use, technological characteristics, and operational environment with a predicate device.

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

• Not Applicable. There was no "ground truth" to establish for a test set in this type of submission. The ground truth for regulatory acceptance is the established safety and effectiveness of the predicate device.

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

• Not Applicable. No test set or expert adjudication process is described in this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI/CAD device. It is data collection software. No MRMC study was conducted or described.

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

• Not Applicable. This is data collection software, not an algorithm with performance metrics measured in a standalone fashion. Its function is to acquire and distribute data, not to make diagnostic or prognostic predictions.

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

• For the purpose of this 510(k) submission, the "ground truth" is the established safety and effectiveness of the predicate device, the Hewlett-Packard M2376A DeviceLink System, K000635, as accepted by the FDA. The new device demonstrates substantial equivalence to this established "truth."

8. The sample size for the training set:

• Not Applicable. This submission does not describe a training set as it is not a machine learning or AI-driven device requiring model training.

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

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