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The AlarmView™ Wireless Data Network System is for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. The AlarmView™ System provides a secondary means of annunciating and displaying patient alarm information to mobile healthcare professionals.

The AlarmView™ System is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital type environments and is not for home use.

The AlarmView™ System is to supplement and not replace any part of the current device monitoring procedure.

The AlarmView™ System is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

The modified AlarmView™ Wireless Data Network System is a low powered local area wireless paging system that provides secondary annunciation of primary medical device alarms via wireless communication devices carried by healthcare professionals.

The provided text (K013156) is a 510(k) summary for a device modification, and it describes a device that provides secondary annunciation of primary medical device alarms via wireless communication devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies to establish specific acceptance criteria for diagnostic accuracy or clinical outcomes.

Therefore, the provided document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor does it describe specific studies with sample sizes, expert ground truth establishment, or comparative effectiveness studies (MRMC or standalone) in the context of diagnostic or clinical outcome performance.

The document states:

• "The safety and effectiveness of the modified AlarmView™ Wireless Data Network System described in this submission has been demonstrated through risk analysis and verification and validation testing."
• "Test results demonstrated that the modified AlarmView™ Wireless Data Network System, functionality and safety characteristics are substantially equivalent to the predicate device."

This indicates that the "study" for this submission was primarily focused on engineering verification and validation testing to ensure the modified device functions as intended and maintains the safety and effectiveness profile of its predicate. It's not a study designed to evaluate, for example, the diagnostic accuracy of an AI algorithm or the improvement in human clinical decision-making.

Given this, I cannot extract the information required for the requested table and study details from the provided text because it doesn't exist within the scope of this 510(k) summary.

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The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms.

The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is currently compatible with puise oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure.

The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the primary medical devices that are being monitored. The FlexView™ Clinical Monitoring System is not considered to be diagnostic without skilled interpretation and does not replace physician's care.

The Flex\lew™ Clinical Monitoring System is for use with patient populations being monitored by healthcare professionals utilizing compatible pulse oximeters, infusion pumps and ventilators.

The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, or free standing surgical centers.

The FlexView™ Clinical Monitoring System is a PC based central monitoring station used to acquire information from primary medical devices (pulse oximeters, infusion pumps and redisplay it on a single monitor in a central location. It allows the remote monitoring of multiple medical devices simultaneously and provides secondary annunciation of the alarms from the primary medical devices.

This device, the FlexView™ Clinical Monitoring System, is a Class II medical device (System, Network and Communication, Physiological Monitors). The 510(k) summary indicates that its safety and effectiveness were demonstrated through risk, verification, and validation testing, concluding that its performance, functionality, and safety characteristics are substantially equivalent to the predicate device (FlexView™ Clinical Monitoring System, K003998).

However, the provided text does not contain the specific details necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance in the way you've outlined. The submission focuses on substantial equivalence to a predicate device rather than presenting a novel clinical study with explicit acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.

Here's a breakdown of what information can and cannot be extracted from the provided document, based on your questions:

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

The document does not explicitly state specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity values) for its performance, nor does it present specific numerical performance results (like sensitivity or specificity) for the device. Instead, it states:

"Test results demonstrated that the modified FlexView™ Clinical Monitoring System performance, functionality and safety characteristics are substantially equivalent to the predicate device."

This implies the acceptance criterion was likely substantial equivalence in performance, functionality, and safety to the predicate device (K003998) through a series of internal verification and validation tests, rather than meeting predefined clinical performance thresholds.

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

This information is not provided in the document. The submission references "risk and verification and validation testing," but does not detail the methodology, sample sizes, or data provenance (e.g., patient data, simulated data).

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 provided. As no clinical study with a "test set" and "ground truth" derived from expert review is described, these details are absent.

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

This information is not provided.

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 conducted or described. This device is a monitoring system for secondary annunciation of alarms from other medical devices, not an AI-powered diagnostic tool requiring human interpretation or assistance for analysis. Therefore, the concept of "human readers improving with AI assistance" does not apply in this context.

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

The device's function is the "secondary annunciation of compatible primary medical device alarms" and it's stated to "supplement and not replace any part of the current primary medical device monitoring procedure." It is intended for "use by healthcare professionals." Therefore, it is not a standalone algorithm without human involvement. Its primary function is to relay information to human healthcare professionals.

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

This information is not provided. Given the nature of the device (a monitoring system for alarm annunciation), ground truth might pertain to the accuracy and timeliness of alarm relay, rather than diagnostic accuracy. It's plausible that internal engineering validation and verification tests, potentially using simulated or recorded physiological data, were used to confirm alarm processing and display accuracy, but the specifics are not detailed.

8. The sample size for the training set

This information is not provided. The device is described as a "PC based central monitoring station," and while it likely involves software, there's no mention of machine learning or AI that would require a "training set" in the context of supervised learning.

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

This information is not provided, as there is no indication of a "training set" being used for a machine learning model.

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The AlarmView™ Wireless Data Network System is for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. The AlarmView™ System provides a secondary means of annunciating and displaying patient alarm information to mobile healthcare professionals.

The AlarmView™ Wireless Data Network System is limited to use by qualified medical professionals who have been trained on the use of the device. It is for use in hospital type environments and is not for home use.

The AlarmView™ Wireless Data Network System is to supplement and not replace any part of the current device monitoring procedure.

The AlarmView™ Wireless Data Network System is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

The modified AlarmView™ Wireless Data Network System is a low powered local area wireless paging system that provides secondary annunciation of primary medical device alarms via wireless communication devices carried by healthcare professionals.

The provided text for the AlarmView™ Wireless Data Network System's 510(k) summary (JUL 24 2001) does not contain detailed acceptance criteria or a specific study demonstrating device performance against such criteria in the way a diagnostic AI device submission would. This 510(k) is for a "Wireless Data Network System" that provides secondary annunciation of medical device alarms, not an AI/ML-driven diagnostic tool.

The submission focuses on establishing substantial equivalence to an existing predicate device (AlarmView™ Wireless Data Network System, K010912), rather than proving diagnostic performance against quantitative metrics like sensitivity or specificity.

Therefore, many of the requested fields cannot be answered based on the provided document.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the 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)

• Sample Size for Test Set: Not applicable/Not provided. The document doesn't describe a "test set" in the context of diagnostic performance evaluation with patient data. The "validation testing" likely refers to engineering verification and validation of system functionality and performance characteristics rather than clinical data evaluation.
• Data Provenance: Not applicable/Not provided.

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)

• Number of Experts: Not applicable/Not provided. Ground truth establishment is not relevant for this type of device submission.
• Qualifications of Experts: Not applicable/Not provided.

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

• Adjudication Method: Not applicable/Not provided.

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

• MRMC Study: No. This is not an AI-driven diagnostic device; it's a wireless alarm notification system.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No. This is not an algorithm, but a hardware/software system designed to relay information to humans. Its function is inherently "human-in-the-loop."

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

• Type of Ground Truth: Not applicable/Not provided.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not provided. This is not an AI/ML device that requires a "training set."

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

• Ground Truth for Training Set Establishment: Not applicable/Not provided.

Summary of Study (Based on provided text):

The submission describes a "validation testing" and "risk analysis" as the basis for demonstrating safety and effectiveness. The "study" (or rather, the basis for approval) is centered around showing substantial equivalence to an already legally marketed predicate device (K010912). The key finding is: "Test results demonstrated that the modified AlarmView™ Wireless Data Network System, functionality and safety characteristics are substantially equivalent to the predicate device."

This indicates that the validation focused on ensuring the modified device performs its intended functions (receiving and annunciating alarms wirelessly) safely and effectively, similar to the predicate, and does not introduce new questions of safety or effectiveness. It's a regulatory "comparison" rather than a clinical trial or AI performance study.

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Ask a specific question about this device

Ask a specific question about this device

This device is intended for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers.

AlarmView is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital and hospital type environments and is not for home use.

AlarmView is intended to supplement and not to replace any part of the current device monitoring procedures.

AlamView is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

AlarmView is currently validated for use with the N-x9y and N-3x00 data protocols.

AlarmView™ is a paging system that interfaces with a primary patient clinical device in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers.

AlarmView reads the patient information from the output data port and does not change the primary monitor in any way. It formats the patient information into a message that can be transmitted to a pager carried by mobile health careqivers. AlarmView does not diagnose alarms.

AlarmView consists of the AV Transmitter, AV Pager, and the AC PDA (Personal Digital Assistant) used for administration.

The provided document, K992848 Summary of Safety and Effectiveness for the AlarmView™ - Physiological Monitor System, Network and Communication, does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Intended Use: AlarmView™ is a paging system for real-time monitoring of patient status and alarm events, serving as a secondary means to inform mobile healthcare providers. It is intended to supplement existing monitoring, not replace it, and is for use by trained professionals in hospital environments.
• Technological Characteristics: The document states that AlarmView™ has the same technological characteristics as its predicate devices, primarily consisting of a paging system connected to a medical device to transmit patient data.
• Safety and Efficacy: It claims AlarmView™ has the same safety and efficacy characteristics as the predicate devices.

Key points from the document regarding the "study" aspect are:

• The submission is a 510(k) for substantial equivalence to legally marketed predicate devices.
• There is no mention of a clinical study, performance study, or any specific testing with acceptance criteria for the AlarmView™ system itself described in this summary.
• The FDA approval letter from November 19, 1999, confirms the finding of substantial equivalence based on the provided information.
• The device is "validated for use with the N-x9y and N-3x00 data protocols," which implies some level of technical testing, but specifics of this validation (e.g., methodology, results, acceptance criteria) are not detailed in this summary.

Therefore, based solely on the provided text, the requested information cannot be fully extracted for the AlarmView™ device as a new study with explicit acceptance criteria and performance data is not presented.

However, to address the prompt's request for format, if such a study existed and was described in this document, the information would be presented as follows (with "N/A" for details not found in the provided text):

1. Table of Acceptance Criteria and Reported Device Performance:

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This device is indicated for use in real-time monitoring of routine patient status and alarm events. StatView is limited to use by qualified medical professionals who have been trained on the use of the device. StatView is not intended for home use.

StatView™ is a paging system that interfaces with primary patient monitoring systems (PPMS) to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers.

StatView™ has been validated for use with the following networks: Héwlett-Packard CareNet, GE Marquette Medical Unity, and Siemens Medical Systems Infinity.

StatView™ System is a paging system that interfaces with primary patient monitoring systems (PPMS) in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers.

StatView interfaces with the PPMS and reads the same alarm information that the PPMS uses, then formats that information into a message that can be transmitted to the receivers carried by mobile health caregivers. Although StatView reads the same alarm information that the PPMS LAN sends, it does not change it or modify it in any way. StatView does not diagnose alarms but transmits what the PPMS determines to be an alarm.

StatView consists of the StatView Server (WT Server), StatView Transmitter, and StatView Receiver.

In addition to the capabilities of the previous version of StatView (predicate device), users of the StatView system can send pre-programmed text messages that can be easily selected when initiating a text page as well as scheduling text messages. Semi-automatic mode is used for facilities that with their monitoring technicians to continue to filter the alarm traffic sent to the mobile caregivers.

The provided text is a 510(k) summary for the StatView™ System, a physiological monitor system, network, and communication device (alarm paging system). This type of document is focused on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing specific performance studies against defined acceptance criteria in the manner of a clinical trial for a new drug or a novel medical device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document explicitly states: "StatView has the same safety and efficacy characteristics as the predicate devices." This highlights that the approval is based on equivalence, not a standalone performance study with novel criteria.

Specifically, the following information is NOT available in the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for the StatView™ System. It focuses on functional descriptions and equivalence to predicate devices.
2. Sample size used for the test set and the data provenance: No details on a test set, its size, or origin are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information about ground truth establishment or experts is present.
4. Adjudication method for the test set: Not applicable as no test set or ground truth process is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a paging system for alarm annunciation to human healthcare providers, implying human-in-the-loop by design. No "algorithm only" performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth process is described.
8. The sample size for the training set: Not applicable; the document refers to the system's function rather than a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide:

• Intended Use: "This device is intended for use in real-time monitoring of routine patient status and alarm events... StatView™ is a paging system that interfaces with primary patient monitoring systems (PPMS) to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers."
• Technological Characteristics: States that "StatView is the same in technological characteristics as the cited predicate devices. All the predicate devices consist of a paging system connected to primary patient monitoring equipment that is used to transmit patient data to an appropriate health care provider."
• Equivalence Claim: The core of the submission is the claim that "StatView™ System is substantially equivalent to the following predicate devices: StatView™ System (previously cleared) by Data Critical Corporation, Pager-LAN by GE Marquette Medical Systems, and Palm Vue (M1490A) by Hewlett Packard, and "Paging" by Vitalcom."

In essence, for this type of medical device submission in 1999, the "study" demonstrating that the device met "acceptance criteria" was the argument for substantial equivalence to legally marketed predicate devices, based on similar intended use and technological characteristics, rather than a novel performance study against predefined quantitative metrics.

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The Cardio-Pager™ System described in this submission is a paging system that interfaces with Primary Patient Monitoring Systems in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers. This pager is intended to serves as a parallel, redundant mechanism to inform the clinical staff of patient events.

This device is indicated for use in real-time monitoring of routine patient status and alarm events. The Cardio-Pager™ is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use only in a hospital environment. The device has been validated for use with the Marquette Unity Network and the Hewlett-Packard Systems CareNet System.

The Cardio-Pager™ System (also referred to as StatView) is a secondary alarm notification system that transmits text and waveform data from patient monitoring devices to a graphical pager worn by a trained professional in a hospital environment. The system monitors the patient monitoring devices for alarm conditions, and responds by transmitting a page that includes text and waveform information from the patient. This system is not intended to be a primary alarm enunciator. The Cardio-Pager™ System alerts and informs the clinician about critical patient alarms without requiring them to be at or near the bedside or central monitors. The system can also provide periodic updates of heart rate and waveform data at intervals established by the caregivers.

The primary components in the Cardio-Pager™ System are the Critical-Server (also referred to as the WT Server) and the Transmission Subsystem. The server is a standard IBM-compatible PC that connects directly to the patient-monitoring network. The Transmission Subsystem consists of the paging transmitter, a standard serial-to-Ethernet converter, and the Cardio-Pager™ receiver units.

Software modules in the Critical-Server acquire patient information from the patient monitoring network, manage the initiation of paging messages, convert the data to proper format for transmission to the paging transmitter, and send the message to the paging transmitter via a LAN. The paging transmitter then sends the page, using standard POCSAG paging protocol. One or more of the Cardio-Pager™ receiver units may receive the page.

Addition of the Cardio-Pager™ System to the patient monitoring computer network does not in any way affect, modify, or interrupt the normal operation of the hospital patient monitoring system.

The provided text describes the Cardio-Pager™ System, a secondary alarm notification system that transmits text and waveform data from patient monitoring devices to a graphical pager. The document details the device's description, intended use, and performance data from testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be >95%"). Instead, it describes functional validation tests. The reported device performance is that it met all challenged functional requirements.

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

• Test Set Sample Size: The document does not specify a numerical sample size (e.g., number of alarms, updates, or messages) for the functional tests. It mentions "a variety of Marquette and Hewlett-Packard patient monitoring devices" were used for system-level testing.
• Data Provenance: The testing was conducted internally by Data Critical Corp. (manufacturer). No information is provided about the country of origin of the data, patient data, or whether it was retrospective or prospective, as the testing was focused on device functionality rather than clinical outcomes with actual patient data. It appears to be prospective functional testing.

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

The concept of "ground truth" as typically applied to AI/diagnostic devices (e.g., expert consensus on medical images) does not directly apply to this functional validation. The ground truth here is the expected behavior of the system based on its design specifications. The testing was against these predefined functional requirements, not against expert medical diagnoses. Therefore, no medical experts were used to establish "ground truth" for the test set in the traditional sense. The "experts" would be the engineers and QA personnel who designed and verified the system's intended functionality.

4. Adjudication Method for the Test Set

Not applicable in the AI/diagnostic sense. The testing involved verifying if the device performed as designed against its functional specifications. There was no "adjudication" between multiple interpretations of medical data. The outcomes of the tests were pass/fail based on meeting the functional requirements.

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, an MRMC comparative effectiveness study was not done. The Cardio-Pager™ System is a paging and notification system, not an AI diagnostic tool that assists human readers in interpreting medical cases. Its purpose is to deliver information, not to interpret it or improve diagnostic accuracy with AI.

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

Yes, the performance testing described is essentially standalone. The system autonomously performs its functions (acquiring, managing, converting, transmitting data, and displaying on the pager). While it interfaces with patient monitoring devices, the testing focuses on the Cardio-Pager™ System's ability to execute its programmed functions without continuous human intervention during the data transmission process. The "human-in-the-loop" aspect comes from the clinician receiving the page and acting on the information, but the system's performance in delivering that information was tested independently.

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

The ground truth used was the functional design specifications of the Cardio-Pager™ System. The device was tested to ensure it accurately received, transmitted, and displayed the expected text and waveform data according to its predefined operational logic. This is not medical ground truth (like a pathology report for diagnosing a disease), but rather engineering ground truth (does the system do what it's designed to do?).

8. The Sample Size for the Training Set

Not applicable. The Cardio-Pager™ System is not an AI/machine learning device that requires a training set. It is a predefined software and hardware system operating based on fixed algorithms and protocols.

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

Not applicable, as there is no training set for this type of device.

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The RhythmStat XL System is indicated for use in the diagnostic evaluation and recording of ECG waveforms from a cardiac event recorder. It is intended to provide remote access to ECG data by transtelephonic transmission from an ambulatory cardiac event monitor to the portable PSION palmtop computer with RhythmStat XL software, where the ECG waveforms are demodulated, recorded, displayed and stored.

The RhythmStat XL System is a telephone electrocardiograph (ECG) receiving system used for recording and reporting of ECG data from a cardiac event recorder. The System has three main components:

• . A commercially available cardiac event recorder such as the Micromedical Industries BIOLOG or the Instromedix® Heart Card™, that conditions and transmits ECG data in the form of a frequency-modulated acoustic waveform to the PSION Series 3 palmtop computer:
• Two proprietary software programs, contained in the commercially available PSION Series 3 . palmtop computer, that 1) recondition the received signal format and display the signal to the physician on the computer screen, then 2) transmit the ECG data, along with the physician's comments, from the PSION palmtop computer to the Reporting Server via modem; and
• . The Data Critical Reporting Server that accepts the ECG data and commentary and generates a printed report that is automatically transmitted to the physician's office via fax.

The provided K971650 document describes a 510(k) premarket notification for the RhythmStat XL System. This system is a telephone electrocardiograph (ECG) receiving system. The performance data section focuses on demonstrating equivalency to predicate devices, rather than establishing specific, quantified acceptance criteria and proving the device meets them in a traditional sense with statistical endpoints.

Here's an attempt to extract the requested information based on the provided text, with significant limitations due to the nature of the submission (an equivalency claim, not a de novo study with strict acceptance criteria).

Acceptance Criteria and Study Details for RhythmStat XL System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The submission does not explicitly state numerical acceptance criteria in the format typically seen in more recent device studies. Instead, it relies on a comparative assessment of "measurable comparability" and "equivalent quality" to predicate devices. The "performance" described is the outcome of this comparative assessment against a qualitative benchmark.

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "Subjects were tested" and that "ECG recordings were obtained with the BIOLOG, then played back to and recorded by the PSION/RhythmStat XL". This implies recordings from at least one subject were used, but the number of unique subjects or recordings is not quantified.
• Data Provenance: The study was conducted by Data Critical Corporation. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective. Given the testing methodology described (obtaining recordings with one device and playing them back to others), it suggests a controlled, prospective setup within the company's testing environment rather than a large-scale clinical study with patient data.

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

• Number of Experts: Not specified. The analysis of QRS segments ("amplitude and duration of the first ten QRS segments were analyzed and measured, along with the total duration of all QRS segments") does not explicitly state who performed these measurements or whether expert review was involved in establishing a "ground truth" beyond the measurements themselves. The document states the PSION displays the signal "to the physician," but this pertains to the intended use, not necessarily the ground truth establishment for the performance study.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. The study describes a direct comparison of physical output (ECG printouts) by measurement, rather than an expert review process requiring adjudication of disagreements.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on direct device output comparison, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

• Standalone Performance Study: Yes, a standalone performance assessment was conducted for the RhythmStat XL System in the context of comparing its output (ECG waveforms) to predicate devices. The system's output was directly measured and compared without human interpretation being explicitly part of the performance evaluation method, although it implicitly aims to produce output suitable for human interpretation.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this study is the direct measurement of QRS amplitude and duration from ECG printouts produced by the predicate devices. The predicate devices' outputs serve as the reference standard for "measurable comparability" and "equivalent quality." This is a measurement-based comparative standard rather than an expert consensus, pathology, or outcomes data ground truth.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not mention a training set. This system is described as a receiving and reporting system, not an AI/machine learning algorithm that typically requires a training set. If there's internal calibration or development data, it's not disclosed as a "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as no training set is mentioned in the context of an AI/machine learning algorithm.

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