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The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The NUVANT System monitors, derives and displays:

• ECG
• Heart Rate

The NUVANT MCT System consists primarily of the PiX monitoring device and the zLink data transmission device. Once activated, the wearable PiX sensor continuously monitors the heart and automatically collects ECGs. When rhythm abnormalities are detected, data are automatically transmitted from the PiiX device to the zLink, which then automatically transmits the data to the Corventis Monitoring Center. Patients can also trigger transmission of ECGs when they experience cardiac symptoms by using the Patient Trigger Button. Certified cardiographic technicians at the Corventis Monitoring Center review received data and document symptoms reported by patients. Clinical reports, prepared by the Corventis Monitoring Center, are delivered and made available at www.corventis.com to provide data to prescribing physicians for the diagnosis and identification of various clinical conditions, events and/or trends.

The provided document is a 510(k) summary for the NUVANT MCT System (K133701). This submission is for a special 510(k) due to device modifications, where the new device is compared to a previously cleared predicate device (NUVANT Mobile Cardiac Telemetry System, K113372). Therefore, the acceptance criteria and study information provided mainly focus on demonstrating that the modified device performs as well as the predicate device.

Here's a breakdown of the requested information based on the document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state a table of "acceptance criteria" with numerical performance metrics for the modified device in comparison to the predicate. Instead, it strongly emphasizes that the modified device operates identically to the predicate device in terms of fundamental scientific technology and intended use. The testing performed aimed to demonstrate that the changes did not negatively impact safety or effectiveness and that the system performs "as well as or better than the predicate device."

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

The document does not specify the sample size used for clinical test sets or the provenance (country of origin, retrospective/prospective) of any clinical data. The submission focuses on verification and validation testing of the device modifications, not a new clinical study. The changes described (increased memory, two-part PiiX, button instead of magnet) are primarily hardware and software modifications.

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 in the document. Given that this is a 510(k) for device modifications and not a new clinical trial, it's unlikely that external experts were used in this specific context to establish ground truth for a test set of clinical arrhythmias. The "certified cardiographic technicians at the Corventis Monitoring Center" are mentioned as reviewing data from the deployed system, but this relates to the operational use of the device, not the ground truth establishment for the pre-market testing of the modifications themselves.

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

The document does not describe any adjudication method for a test set. This type of detail is typically associated with clinical studies involving human interpretation of data, which is not the primary focus of this submission for device modifications.

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 comparative effectiveness study was done or reported. The device is an "Arrhythmia detector and alarm," and its algorithms automatically detect and transmit ECGs. While algorithms are a core part of its function, the document does not mention any "AI assistance" provided to human readers, nor does it quantify any improvement in human reader performance. This submission focuses on validating the hardware and software changes, ensuring the device's automatic detection capabilities remain equivalent to the predicate.

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

Yes, a form of standalone performance assessment was implicitly done. The "proprietary algorithms based on rate, rhythm and morphology to continuously analyze rhythm abnormalities and to initiate automatic ECG transmission to the Server" are central to the device's function. The "Firmware Verification Testing" and "Software Verification Testing" likely assessed these algorithms' performance in a standalone context to ensure they continued to function correctly after the modifications. However, specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection) of these algorithms are not detailed in this summary. The document states that the "subject NUVANT MCT system uses the same sensors, in the same scientific methods (algorithms for detection and transmission methods), as the predicate NUVANT MCT System," suggesting that the algorithmic performance itself was not changed but rather confirmed to remain consistent.

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 for algorithm validation. For arrhythmia detectors, ground truth typically involves manually annotated ECGs by cardiologists or other qualified medical professionals. Given that the algorithms are stated to be "identical to the predicate," it's reasonable to infer that the ground truth used for validating the original predicate device's algorithms would have been applied, and confirmed to perform similarly post-modification.

8. The sample size for the training set

The document does not provide any information regarding the sample size for a training set. This is a 510(k) for modifications to an existing device, and details about the original algorithm training would typically be in the initial 510(k) for the predicate device.

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

The document does not provide any information on how the ground truth for a training set was established. Similar to the previous point, such details would pertain to the development of the original algorithms in the predicate device.

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The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.

The NUVANT system model monitors, derives and displays:

• ECG

· Heart Rate

The NUVANT MCT System is a wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), NUVANT MCT enables arrhythmia detection for up to 7.5 days for each PiiX application.

The NUVANT system components are:

• PiiX® (aka: Adherent Device) a patient-worn device which is applied to the . patient's torso. It contains the ECG electrodes for recording ECG and heart rate data.
• Patient Trigger Magnet used by the patient to manually trigger the ECG . collection when he/she experiences symptoms.
• . zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology.
• Server The Server receives sensor data from the PiiX via zLink. ECG and . heart rate are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians

The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.

This document is a 510(k) premarket notification for an administrative change to the NUVANT Mobile Cardiac Telemetry (MCT) System (K113372). It details the substantial equivalence to a predicate device (K111917) and mentions performance testing for safety standards but does not present an independent study with acceptance criteria and device performance for the subject device beyond compliance with general safety and performance standards.

The document explicitly states: "This Special 510(k) proposes to add a framework that will reserve space for recording ECG strips for each event type; limiting the redundant recording of certain event types. This change does not change to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and does not affect the safety and effectiveness of the device when used as labeled [807.92(a){5}]. The indications for use of the subject NUVANT are unchanged from the predicate NUVANT. The modification does not impact the fundamental scientific technology of the device."

Therefore, the device's performance and acceptance criteria are considered to be met by its substantial equivalence to the predicate device and its compliance with recognized safety and performance standards. The submission doesn't include a new, independent study to "prove the device meets acceptance criteria" for arrhythmia detection performance, but rather asserts that the modification does not negatively impact the existing demonstrated safety and effectiveness.

Here’s a breakdown of the requested information based on the provided document, with an emphasis on what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria (e.g., sensitivity, specificity for arrhythmia detection) or direct performance data for arrhythmia detection of the subject NUVANT system are presented in this document. The document states that the subject NUVANT system meets the requirements of listed performance standards (IEC 60601-1, IEC 60601-1-2, AAMI/ANSI EC38, AAMI/ANSI EC57) and is substantially equivalent to its predicate. The predicate device (K111917) would have had such performance data, but it is not included in this document.

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

Not applicable as an independent performance study for arrhythmia detection was not conducted or reported in this 510(k) submission for the subject device. The submission focuses on a modification that does not impact the device's fundamental scientific technology or indications for use.

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

Not applicable as an independent performance study for arrhythmia detection was not conducted or reported in this 510(k) submission for the subject device. Compliance with AAMI/ANSI EC57 implies that ground truth would have been established by qualified experts during the development and testing of the predicate device's algorithms, but details are not in this document.

4. Adjudication Method for the Test Set

Not applicable as an independent performance study for arrhythmia detection was not conducted or reported in this 510(k) submission for the subject device.

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

No MRMC comparative effectiveness study was mentioned or conducted as part of this 510(k) submission.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Not explicitly presented in this document for the subject device. The document mentions compliance with AAMI/ANSI EC57, which outlines methods for testing cardiac rhythm algorithms, but no specific results from such testing for the subject device are provided here. The NUVANT system description explicitly states that "interpretation services provided by learned intermediaries in the Corventis Monitoring Center" are part of the system, indicating a human-in-the-loop component for the overall clinical use.

7. Type of Ground Truth Used

Not applicable as specific performance data from a new study is not provided. For arrhythmia detection algorithms compliant with AAMI/ANSI EC57, ground truth is typically established by expert cardiologists/electrophysiologists manually reviewing and annotating ECG recordings.

8. Sample Size for the Training Set

Not applicable as this document does not describe the development or training of new algorithms. It concerns a modification to an already cleared device.

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

Not applicable as this document does not describe the development or training of new algorithms.

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The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for patients:

• with fluid management problems .
• taking diuretic medication .
• living with heart failure .
• living with end-stage renal disease .
• suffering from recurrent dehydration .
• who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but . not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.

The AVIVO Mobile Patient Management System also monitors, derives and displays:

• ECG .
• Heart Rate (including HR variability) .
• . Activity
• . Posture
• Respiration rate (including RR variability)
• Body fluid status

The AVIVO System is wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias and monitor physiologic signals. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), AVIVO enables arrhythmia detection and other physiological data monitoring for up to 7 days for each PiiX application.

The AVIVO system components are:

• . PiiX® (aka: Adherent Device) - a patient-worn device which is applied to the patient's torso. It contains the ECG electrodes for recording ECG, heart rate and other physiological data.
• . zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology.
• Server The Server receives sensor data from the PiiX via zLink. ECG, heart . rate and other physiological parameters are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians

The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.

This submission is for an abbreviated 510(k) for the AVIVO® Mobile Patient Management System. The purpose of this submission is to add clarifying language to the indications for use, aligning it with language used in a predicate device (NUVANT) for non-lethal arrhythmias and with another predicate device (ZOE) for fluid status measurements. The manufacturer states that these changes are for clarification and do not alter the intended use, safety, or effectiveness of the device. Consequently, the performance testing details provided focus on compliance with recognized medical device standards rather than a study demonstrating new device performance against acceptance criteria for specific clinical outcomes or algorithm accuracy.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity for arrhythmia detection or fluid status accuracy) and corresponding reported performance from a dedicated clinical study for the subject device. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to established performance standards for medical electrical equipment.

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

The document mentions "bench tests" (Section 4, "SUMMARY OF PERFORMACE TESTING" and Section 4, "CONCLUSION") but does not provide details on sample sizes for any test sets related to specific clinical performance. The focus is on meeting general safety and performance standards for existing medical devices, rather than a clinical study with a patient test set for the device's diagnostic or monitoring accuracy. Therefore, information on data provenance (country of origin, retrospective/prospective) is not provided.

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

Not applicable. No clinical test set and associated ground truth establishment process are described for the subject device in this submission, as the submission relies on substantial equivalence and adherence to general performance standards mentioned in Section 4.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication is described in this submission.

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

Not applicable. The document does not describe an MRMC study comparing human readers with and without AI assistance, nor does it provide an effect size for human reader improvement. The device described transmits physiological data to "learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians." This implies human interpretation as part of the overall system, but not a comparative effectiveness study of AI assistance.

6. Standalone (Algorithm Only) Performance:

Not explicitly detailed as a separate study for the subject device. The device is part of a system that includes human interpretation ("learned intermediaries"). While the device's algorithms for parameters like heart rate and respiration rate would operate in a standalone manner within the device, a dedicated "standalone performance" study comparing its algorithmic output to a ground truth (independent of human interpretation) is not presented in this document as a part of the evidence for this 510(k) submission. The performance is tied to the overall system's ability to "continuously record, store, and periodically transmit physiological data" and meet general device standards.

7. Type of Ground Truth Used:

For the performance testing mentioned (compliance with standards), the ground truth would be the defined specifications and measurement methodologies within those standards (e.g., standard signal inputs for ECG accuracy tests as per AAMI/ANSI EC38/EC57). There is no mention of a clinical ground truth (e.g., pathology, outcomes data, or expert consensus from patient data) specifically generated for this 510(k) submission.

8. Sample Size for the Training Set:

Not applicable. The document does not describe the development or training of a specific artificial intelligence or machine learning algorithm that would require a dedicated training set. The device is being submitted as an updated version of an existing device (predicate AVIVO), with clarifications to its indications for use, and its performance relies on established engineering principles and adherence to recognized standards.

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

Not applicable, as no training set for an AI/ML algorithm is described.

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The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.

The NUVANT MCT System is wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), NUVANT MCT enables arrhythmia detection for up to 7.5 days for each PiiX application.

The NUVANT system components are:

• PiiX® (aka: Adherent Device) - a patient-worn device which is applied to the patient's torso. It contains the ECG electrodes for recording ECG and heart rate data.
• Patient Trigger Magnet used by the patient to manually trigger the ECG collection when he/she experiences symptoms.
• zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology.
• Server - The Server receives sensor data from the PiiX via zLink. ECG and heart rate are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians

The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.

The provided text describes an Abbreviated 510(k) submission for the NUVANT Mobile Cardiac Telemetry (MCT) System, focusing on adding clarifying language to its indications for use. It asserts that this clarification does not alter the fundamental safety and effectiveness of the device compared to its predicates. However, the document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.

The document refers to the device meeting general performance standards, but it does not provide the specific data from a study to demonstrate this.

Therefore, I cannot fulfill all parts of your request with the provided information. I can, however, extract related details:

Missing Information:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set.
• Data provenance for the test set (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI vs. without AI.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
• The sample size for the training set.
• How the ground truth for the training set was established.

Information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The document only mentions "bench tests" for supporting the claim of safety and effectiveness.

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

• Not specified. The document mentions "learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only)" for real-world operation, but this is not tied to establishing ground truth for a test set in the context of the device's validation for this submission.

4. Adjudication method for the test set:

• Not specified.

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 specified. The NUVANT system involves human interpretation (Corventis cardiographic technicians and prescribing physicians), but the document does not describe an MRMC study or quantify human improvement with AI assistance. The system itself is characterized as an "arrhythmia detection system" that, in combination with human interpretation services, enables arrhythmia detection.

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

• The document implies the algorithm performs "arrhythmia detection" and transmits data. However, the statement "In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data... NUVANT MCT enables arrhythmia detection" suggests that the full "arrhythmia detection" capability for clinical use involves a human-in-the-loop. A standalone performance study of only the algorithm is not explicitly described with metrics.

7. The type of ground truth used:

• Not specified. The document refers to meeting performance standards and "bench tests" without detailing how ground truth data for these tests were derived.

8. The sample size for the training set:

• Not specified. The document does not mention an "AI" or machine learning component in a way that suggests a distinct training set. It focuses on the device hardware and its embedded detection capabilities.

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

• Not specified, as a training set is not explicitly mentioned.

Summary of what the document DOES state regarding "proving" criteria:

The document relies on the following to demonstrate the device's safety and effectiveness:

• Substantial Equivalence: The primary assertion is that the "subject NUVANT" is "as safe and as effective as the predicate devices" (NUVANT K091971 and CardioNet CN1005). This is a foundational premise of 510(k) submissions.
• Conformance to Industry Standards: The device meets the requirements of:
  • IEC 60601-1 (General Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • AAMI/ANSI EC38 (Ambulatory Electrocardiographic Systems)
  • AAMI/ANSI EC57 (Cardiac Rhythm and ST-segment Measurement Algorithms)
• Bench Tests: The document states that the conclusion of safety and effectiveness is "As supported by the descriptive information and the bench tests". However, no details about these bench tests or their results are provided.
• Minor Change: The core argument for this specific 510(k) is that the proposed change (clarifying language in the indications for use) does not alter the fundamental scientific technology, intended use, safety, or effectiveness of the device.

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The AVIVO™ Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO Mobile Patient Management System also monitors, derives and displays:

• ECG
• Heart Rate (including HR variability)
• Activity
• Posture
• Body Temperature
• Respiration rate (including RR variability)
• Body fluid status

The NUVANT™ Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The NUVANT system model monitors, derives and displays:

• ECG
• Heart rate

The Systems may also monitor, derive and display:

• Activity
• Posture
• Body temperature
• Respiration rate (including RR Variability)
• Body fluid status
• Heart rate variability

The NUVANT is essentially the AVIVO with the addition of a patient trigger magnet. The following are the system components of both models:

• PiiX™ (aka Adherent Device)
• Patient Trigger Magnet (specific to NUVANT)
• zLink™ (aka Gateway)
• Server

The PiiX is a patient-worn device which is applied to the patient's torso. It contains the ECG electrodes for recording ECG and heart rate data; the impedance sensor for collecting respiration and body fluid data; the accelerometer for collecting activity and posture. Additionally, resided in the PiiX is a heart rate, timing and morphology based arrthythmia detection algorithm which allows the system to discriminate waveforms based on morphology and also count ectopic beats (such as PVCs and PACs) and calculate atrial fibrillation burden of the patient.

Specfic to the NUVANT is the Magnet, which is part of the Patient Trieger feature. This external piece accompanying the PiiX and is used by the patient to manually trigger the ECG collection when he/she experiences symptoms. Patient triggers the ECG collection by swiping the Magnet across the PiiX. The ECG waveform will then be transmitted to the Server via zLink.

zLink receives information from the PiiX and transmits them to the Corventis Server. It also interacts with the Corventis Server to receive configuration updates and other relevant hardware diagnostic information.

The Server receives sensor data from the PiiX via zLink. Data from the accelerometer is derived into activity and posture; data from the impedance sensor is derived into respiration rate, respiration variability and body fluid status. ECG and heart rate are presented without derivation.

Additionally, the secure server performs the following functions:

• Display the physiological parameters in trend graphs format.
• Display ECG waveform that corresponds to a detected arrhythmia
• Provide patient's Afib burden, if applicable
• Provide visual notifications for the detected arrhythmia.
• Provide the users the ability to acknowledge or dismiss events.

The communication between the PiiX and the zLink is enabled via the BlueTooth™ Technology. The zLink transmits the data to the Server via cellular technology, where healthcare professionals can access with standard browsers.

This document describes a Special 510(k) submission for modifications to the AVIVO™ Mobile Patient Management System and NUVANT™ Mobile Cardiac Telemetry System. The primary modification involves an enhanced arrhythmia detection algorithm that incorporates morphology and timing of waveforms, in addition to heart rate, to discriminate waveforms, count ectopic beats (PVCs, PACs), and calculate atrial fibrillation (Afib) burden.

Unfortunately, the provided text does not contain a dedicated section detailing acceptance criteria or specific study results that prove the device meets these criteria. It asserts that the devices are "as safe and as effective as the predicate devices" based on "descriptive information and the design verification tests," but does not present the data from these tests.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as this information is not present in the provided text.

Based on the available information, here's what can be inferred:

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

• Acceptance Criteria: Not explicitly stated in the document. The document implies the acceptance criteria were met by demonstrating substantial equivalence to predicate devices, particularly in the modified arrhythmia detection algorithm.
• Reported Device Performance:
  • The modified algorithm allows the devices to:
    • Discriminate waveforms based on morphology.
    • Count ectopic beats (PVCs and PACs).
    • Calculate atrial fibrillation burden.
  • The intent of the subject devices remains the same as the predicate devices: to monitor ECG and other vital parameters.
  • No change has been made to the Indication for Use Statements, implying performance is at least equivalent to the predicate performance for those indications.

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.

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 in the document.

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

• This information is not provided in the document.

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:

• An MRMC study is not mentioned in the document. The submission focuses on the algorithm's performance and equivalence to predicate devices, not on human-AI collaboration.

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

• Yes, implicitly. The document describes modifications to an "arrhythmia detection algorithm" (page 3) and refers to demonstrating substantial equivalence based on "descriptive information and the design verification tests" (page 5). While direct performance metrics for the algorithm are not provided, the claim of "discriminating waveforms based on morphology and also count ectopic beats (such as PVCs and PACs) and calculate atrial fibrillation burden" implies internal testing of the algorithm itself.

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

• This information is not provided in the document. Given the context of arrhythmia detection, it is highly likely that cardiologist review or a validated ECG database would be used, but this is not explicitly stated.

8. The sample size for the training set:

• This information is not provided in the document.

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

• This information is not provided in the document.

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The NUVANT" Cardiac Event Monitor (CEM) System and the NUVANT "Mobile Cardiac Telemetry (MCT) System are intended to continuously measure, record, and periodically transmit physiological data. The Systems are indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. Both NUVANT system models monitor, derive and display:

• ECG
• Heart rate

The Systems may also monitor, derive and display:

• Activity
• Posture
• Respiration rate (including RR Variability)
• Body fluid status
• Heart rate variability

The NUVANT™ Cardiac Event Monitor System and the NUVANT™ Mobile Cardiac Telemetry System include the following components:

• PiiX™ (a patient worn adherent device) with Magnet
• zLink
• Server

The PiiX is a patient-worn device which is applied to the patient's torso. The Adherent Device monitors the patient's ECG in a looping mode. There are three circumstances under which the ECG data will be recorded: (i) when the device is first applied and activated, a baseline ECG is collected, (ii) when the detection algorithms residing in the Adherent Device trigger the collection, or (iii) when the patient activates the collection using the magnet. When the ECG collection is triggered, a total of 45 seconds of ECG signals will be collected, with 15 seconds of pre-event and 30 seconds post-event. Same as the AVIVO™ Mobile Patient Management System (predicate device), the PiiX has additional sensors which monitor other physiological parameters described in the Indications for Use Statement. The collected ECG signals and the other sensor data will be transmitted to the Server via the zLink.

The zLink receives information from the PiiX and transmits them to the Corventis Server. It also interacts with the Corventis Server to receive configuration updates and other relevant hardware diagnostic information.

The Server of the CEM/MCT receives information from the PiiX via zLink. The secure server performs the following functions:

• Derive physiological parameters using the raw data collected by the Adherent Device.
• Display the physiological parameters in trend graphs format.
• Display ECG waveform when the heart rates are beyond the specified threshold.
• Provide visual notifications when healthcare professionals need to be aware of heart rates that are beyond the specified threshold.
• Provide the users the ability to select CEM vs. MCT prescription.
• Provide the users the ability to acknowledge or dismiss events.

The communication between the PiiX and the zLink is enabled via the BlueTooth™ Technology. The zLink transmits the data to the Server via cellular technology, where healthcare professionals can access with standard browsers.

This document describes the NUVANT™ Cardiac Event Monitor (CEM) System and the NUVANT™ Mobile Cardiac Telemetry (MCT) System, but it is a regulatory filing (510(k) summary) focused on demonstrating substantial equivalence to predicate devices, not on presenting a standalone study with detailed acceptance criteria and performance data.

Therefore, much of the requested information regarding specific acceptance criteria, study details, and performance metrics is not explicitly present in the provided text. The document primarily focuses on comparing the new device's intended use and technological characteristics to established predicate devices to argue for substantial equivalence.

Here's an attempt to answer based on the available information, with specific notes on what is not found:

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

This information is not provided in the document. The filing states that the NUVANT systems "have the same intended use, similar operating principles and technological characteristics as their predicate devices" and that "design verification tests" were conducted, but it does not specify the acceptance criteria for these tests or report their numerical performance.

2. Sample size 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. The document makes no mention of a clinical test set, its sample size, or data provenance.

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 test set is described, there's no mention of experts establishing ground truth for such a set.

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

This information is not provided. Again, no clinical test set is described.

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

This information is not provided. The document describes a device for continuously measuring, recording, and transmitting physiological data for cardiac arrhythmia detection. It does not mention any AI component in the context of improving human reader performance, nor does it detail a comparative effectiveness study involving human readers.

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

The document mentions that the PiiX device has "detection algorithms residing in the Adherent Device" which trigger data collection. While this implies an algorithm operating in a standalone fashion to detect events, the document does not provide any performance metrics for these algorithms in a standalone study. The primary focus is on the device's overall functionality and equivalence to predicate devices.

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

This information is not provided. Given the absence of detailed study results, the method for establishing ground truth for any internal validation is not described.

8. The sample size for the training set

This information is not provided. There is no mention of a training set or its size in the document.

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

This information is not provided. No training set is described.

Summary of what's largely missing:

The provided document is a 510(k) summary, which aims to demonstrate that a new device is "substantially equivalent" to legally marketed predicate devices. This typically involves showing similar indications for use, technological characteristics, and safety and effectiveness, often through engineering and performance testing that is compared to the predicate device's known characteristics, rather than extensive, detailed clinical trials with specific acceptance criteria and performance reporting as might be found in a primary clinical study publication.

The "Conclusions" section states: "As supported by the descriptive information and the design verification tests, it is concluded that the NUVANT™ Cardiac Event Monitor (CEM) System and the NUVANT™ Mobile Cardiac Telemetry (MCT) System are as safe and effective as the predicate devices." This implies that the 'design verification tests' served as the basis for proving equivalence, but the specifics of these tests are not publicly detailed in this document.

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The AVIVO™ Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO™ Mobile Patient Management System also monitors, derives and displays:
• ECG

• · Heart Rate (including Heart Rate Variability)
• · Activity
• Posture
• · Body Temperature
• · Respiration rate (including Respiratory Rate Variability)
• Body fluid status

The AVIVIO Mobile Patient Management System includes the following components:

• Adherent Device .
• Gateway .
• Server .
  The Adherent Device is a patient-worn device. It collects, stores and transmits user physiological parameters. The Adherent Device, when applied to the user's torso, will automatically activate and measure the above mentioned physiological parameters. Data collected by the sensors are transmitted to the Server for derivation and display via the Gateway periodically. ECG signals recorded by the Adherent Device will be transmitted on a heart rate trigger basis with predetermined thresholds that are not user adjustable. The ECG signals are also transmitted periodically and will be displayed via the Server.
  The Gateway receives information from the Adherent Device and transmits them to the Corventis Server. It also interacts with the Corventis Server to receive configuration updates and other relevant hardware diagnostic information.
  The Server receives information from the Adherent Device via the Gateway. The secure server performs the following functions:
• Derive physiological parameters using the raw data collected by the Adherent . Device.
• Display the physiological parameters in trend graphs format. .
• Display ECG waveform when the heart rates are beyond the specified threshold. t
• Provide visual notifications when healthcare professionals need to be aware of . heart rates that are beyond the specified threshold.
• Provide patient summary reports. .
  The communication between the Adherent Device and the Gateway is enabled via the BlueTooth™ Technology. The Gateway transmits the data to the Server via cellular technology, where healthcare professionals can access with standard browsers.

The provided text from K083287 does not contain any information regarding acceptance criteria, device performance metrics, or details of a study proving the device meets acceptance criteria.

The document is a 510(k) Summary of Safety & Effectiveness, which primarily focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics. It lists the components of the AVIVO Mobile Patient Management System and its functions, and identifies predicate devices for various aspects of the system.

The "Conclusions" section briefly states: "Performance testing conducted on the AVIVO Patient Management System demonstrates that the product performs as it is intended to." However, no specifics about this performance testing (e.g., methodology, results, acceptance criteria, sample sizes, ground truth) are provided.

Therefore, I cannot extract the requested information.

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