Search Results

The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. The SmartCardia 7L Platform is intended for continuous external electrocardiogram (ECG) information to support Holter Monitoring, Extended Holter Monitoring, and Outpatient Cardiac Telemetry (OCT) commonly called Mobile Cardiac Telemetry (MCT) monitoring.

The SmartCardia 7L Platform is intended for:

1. Patients who experience transient symptoms that may suggest cardiac arrhythmia.

2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).

3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath).

4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.

5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports Measurements include: electrocardiogram (ECG signal), R-R interval, Heart Rate. Notification alerts can be set for one or more of these measures.

The SmartCardia 7L Platform is indicated for use on patients who are 18 years of age or older to provide monitoring of physiological information. It is intended for use in a physician office, outpatient facility, or in the patient's home.

SmartCardia 7L Platform contraindications:

1. The SmartCardia 7L Platform is contraindicated for use for detection of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities.

2. The SmartCardia 7L Platform is contraindicated for use during external defibrillation.

The SmartCardia 7L Platform MCT is a body worn monitoring product that is designed with a disposable adhesive 7L Patch and reusable 7L Sensor. It is designed to be worn by the patient for up to 14 days. If longer monitoring is necessary, the 7L Patch is removed from the body, the 7L Sensor is removed from the worn 7L Patch which is discarded. The 7L Sensor is inserted into a new 7L Patch and the new assembly is placed on the patient for monitoring to continue.

The 7L Sensor/7L Patch assembly communicates to the SmartCardia Phone via Bluetooth technology and shows the patient's heart rate and ECG on its display and allows the patient to input symptoms (Mark Event) which are shown in the patient record. The SmartCardia Phone has a medical grade mains powered charger and uses its cellular technology to act as a gateway to the SmartCardia Cloud Service provided by Amazon Web Services. The SmartCardia Phone is pre-configured by SmartCardia and placed in a kiosk mode. Data stored in the SmartCardia cloud can be viewed in the SmartCardia Web Browser application by a clinician or healthcare provider. The SmartCardia 7L Platform incorporates three modes of monitoring:

1. Holter Monitoring (up to 48 hours) and Extended Holter Monitoring (>48 hours and up to 14 days),
2. Event Monitoring (up to 48 hours, and >48 hours up to 14 days)
3. Cardiac Outpatient Telemetry (OCT) commonly called Mobile Cardiac Telemetry (MCT) (>48 hours up to 30 days when changing the 7L Patch)

During any of the selected modes, a clinician or healthcare provider can use the SmartCardia Web Browser to view the continuously streaming patient's ECG.
The SmartCardia 7L Platform provides alarm notifications for heart rate and atrial fibrillation. As stated in the Intended Use statement, the system is contraindicated for use in a critical care setting where an immediate response to life threatening conditions such as lethal arrhythmias is required. There are no alarm signals presented to the clinician for conditions other than heart rate and atrial fibrillation. The SmartCardia 7L Platform performs retrospective analysis and identifies events which it shows the clinician when they are reviewing historical data. The clinician must then review these events and determine if they are indeed valid and should be included in a physician's report. These events are things like "Ventricular Bigeminy', 'Supraventricular Couplet', etc. A full list is included in the Clinician Instructions for Use.

The provided text describes the SmartCardia 7L Platform, an ECG monitoring device, and its evaluation for FDA 510(k) clearance. However, the document does not contain specific details regarding acceptance criteria for the algorithm's performance, nor does it provide a full study report with detailed performance metrics (like sensitivity, specificity for various arrhythmias), sample sizes, ground truth establishment methods, or expert qualifications for the algorithm testing.

The document primarily focuses on:

• General device description and intended use.
• Comparison to predicate devices for substantial equivalence.
• Non-clinical bench performance testing for electrical safety, EMC, wireless coexistence, and general ECG monitoring standards (IEC 60601-1, IEC 60601-2, IEC 60601-2-47, ANSI/AAMI EC12).
• Mention of testing the ECG detection algorithm per ANSI/AAMI EC57, but explicitly states it does not claim ST analysis and developed its own protocol and database for evaluating the algorithm.

Therefore, many of the requested details about the algorithm's performance study and acceptance criteria are NOT present in the provided text.

Here's a summary of what can be extracted and what is explicitly missing:

Acceptance Criteria and Reported Device Performance

The document states: "The ECG detection algorithm was tested per ANSI/AAMI EC57 standard for testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms. The SmartCardia 7L Platform does not claim ST analysis or measurements. Therefore, the sections of the EC57 standard relating to ST measurement is not applicable. Because of the nature of the SmartCardia 7L Platform as a body worn sensor and patch device with the electrodes in close proximity to each other, and not utilizing ECG lead wires such as a traditional ECG device, SmartCardia developed a protocol and database for evaluating the analysis algorithm. The results show that the SmartCardia 7L Platform algorithm detection and reported results for the stated output arrhythmia were satisfactory and met industry norms."

This statement vaguely indicates that the algorithm's performance met "industry norms" and was "satisfactory." However, a specific table of acceptance criteria with numerical targets and the device's reported performance against those targets is NOT provided in this document.

Details of the Study Proving Device Meets Criteria

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

   • Test set sample size: NOT provided. The document mentions that SmartCardia "developed a protocol and database for evaluating the analysis algorithm" but does not give the size or composition of this test set.
   • Data provenance: NOT provided. The country of origin and whether the data was retrospective or prospective are not mentioned.

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

   • NOT provided. The document does not mention the number or qualifications of experts involved in establishing ground truth for any test set for the algorithm. It only notes that the clinician "must then review these events and determine if they are indeed valid and should be included in a physician's report." This refers to clinical use, not the validation study methodology.

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

   • NOT provided. No information on an adjudication method for establishing ground truth is given.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • NO. There is no mention of an MRMC study or any comparison of human readers with vs. without AI assistance. The device description mentions a "clinician or qualified cardiac technician" can view continuous ECG streams and the device performs "retrospective analysis" to identify events which the clinician "must then review... and determine if they are indeed valid." This implies the AI is assisting but a formal comparative effectiveness study like an MRMC is not described.

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

   • YES, implied. The statement "The ECG detection algorithm was tested per ANSI/AAMI EC57 standard... The results show that the SmartCardia 7L Platform algorithm detection and reported results for the stated output arrhythmia were satisfactory and met industry norms" indicates that the algorithm itself was evaluated in a standalone manner against a "protocol and database." However, specific performance metrics are not given.

6. The type of ground truth used:

   • Implied Expert Consensus/Annotation for algorithm training/testing. The text mentions "SmartCardia developed a protocol and database for evaluating the analysis algorithm" and that the algorithm identifies "events" that clinicians later review. While not explicitly stated for the validation test set, it implies that the "ground truth" for the algorithm's performance evaluation would stem from expert annotation of ECG data. It is not pathology or direct outcomes data.

7. The sample size for the training set:

   • NOT provided. The document does not specify the size of the training set used for the algorithm. It only refers to a "protocol and database."

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

   • NOT provided explicitly. It is implied that for any "database" used, ground truth would be established through expert interpretation or annotation of ECG recordings, but the exact methodology (e.g., number of experts, adjudication) is not detailed for the training set.

Ask a specific question about this device

The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. It is not intended for use on critical care patients.

The Zio AT® Electrocardiogram (ECG) Monitoring System is intended for continuous, long-term monitoring of a patient's ECG data with the ability to provide symptomatic and asymptomatic transmissions of potential arrhythmias during wear time. The Zio AT ECG Monitoring System enables ambulatory Mobile Cardiac Telemetry (MCT) services for non-critical care patients by providing the following devices for use. The Zio AT device consists of the Zio AT patch and Zio AT wireless gateway. The Zio AT patch is a single-use ECG monitor applied to the patient's chest, in-clinic or at home, and worn for up to 14 days without any required patient interaction for maintenance, such as replacing or charging a battery. The patch continuously records ECG data and transmits symptomatic and asymptomatic cardiac events through the Zio AT wireless gateway during the wear period. After the wear period concludes, the patient removes and returns the patch to the monitoring center, an Independent Diagnostic Testing Facility (IDTF), for analysis and end-of-wear reporting. The Zio AT wireless gateway securely receives ECG data from the Zio AT patch using Bluetooth technology. The gateway securely transmits ECG data through cellular technology for subsequent processing.

The provided document, a 510(k) Summary for the Zio AT® device (K240029), states that no clinical testing was performed in support of this premarket notification. The submission relies solely on nonclinical testing to demonstrate substantial equivalence to the predicate device (Zio® AT ECG Monitoring Device [K163512]).

Therefore, based on the provided text, I cannot provide details regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance that would typically be associated with clinical studies.

The document indicates that the device's acceptance criteria were based on its conformance to established performance specifications and FDA-recognized consensus standards. The study that proves the device meets these acceptance criteria is the nonclinical testing described.

Here's an overview of the information available:

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

The document does not provide a specific table of quantitative acceptance criteria and reported device performance metrics in the format typically seen with clinical study results (e.g., sensitivity, specificity, accuracy for arrhythmia detection). Instead, it states that "All necessary performance testing was conducted on the Zio AT device to ensure performance as intended per specifications and to support a determination of substantial equivalence to the predicate device."

The acceptance criteria implicitly relate to the successful completion of the following nonclinical tests and their conformance to specified standards:

• System performance testing: This would ensure the device functions as designed in various operational aspects.
• Biocompatibility testing: This confirms the materials used in the device are safe for contact with the human body.
• Firmware verification testing: This validates the software operating the device.
• Electrical safety and EMC testing: This ensures the device is electrically safe and does not interfere with other electronic devices, and vice versa.

The reported device performance, in this context, is that the device "meets the requirements of established conformance standards and performance specifications necessary for its intended use."

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

Not applicable, as no clinical testing was performed. The nonclinical testing would use various test samples and equipment as dictated by the specific standards and internal protocols, but these are not disclosed in terms of number or provenance in the provided summary.

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, as no clinical testing with expert ground truth establishment was performed.

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

Not applicable, as no clinical testing requiring adjudication was performed.

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, as no clinical testing or MRMC study was performed. The Zio AT device itself functions as a monitoring and transmission system, not an AI-powered diagnostic aid that assists human readers in real-time interpretation.

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

The device is described as "intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data." While it transmits events, the overall system for diagnosis involves a monitoring center for analysis and end-of-wear reporting, which would typically involve human oversight. The provided text does not suggest a standalone algorithm-only diagnostic performance evaluation in a clinical setting. The nonclinical testing focused on the device's functional performance and compliance with relevant standards.

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

Not applicable, as no clinical testing that would require such ground truth for diagnostic accuracy was performed. For nonclinical tests, the "ground truth" would be the specified parameters and expected outputs defined by the relevant engineering and safety standards.

8. The sample size for the training set

Not applicable, as no clinical testing or development of an AI algorithm based clinical data was detailed as part of this submission for demonstrating substantial equivalence. The device is an updated version of a previously cleared device, focusing on hardware and firmware changes.

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

Not applicable for the same reasons as #8.

Ask a specific question about this device

The RhythmStar system is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers all recorded cardiac activity to the cloud server where it is presented and can be retrospectively reviewed by a medical professional at a monitoring center. The RhythmStar system is not intended for real-time monitoring.

The data received from the RhythmStar device can be used for retrospective review, arrhythmia analysis, and further evaluation, reporting and signal measurements using RhythmStar system or a compatible arrhythmia analysis software that has been FDA cleared for Lead II analysis using nontraditional wet electrode placement. The RhythmStar system is not intended to sound any alarms.

The device does not deliver any therapy, administer any drugs, or provide for life support. The RhythmStar system does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibility of a physician. RhythmStar is for prescription use only.

The RhythmStar system consists of the RhythmStar device and the server. The RhythmStar device is a portable, battery-powered, wireless cardiac monitor which may be worn by a patient to record ECG and activity level data for up to 30 consecutive days. The device can capture patient activated and autotriggered events such as Bradycardia, Tachycardia, and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is capable of automatically delivering the collected ECG data to the server using a built-in 4G LTE wireless data modem, or the data can be transferred from the device using a USB connection. The data transmitted by the RhythmStar device can be stored, evaluated, and presented for review, analysis and reporting by a medical professional using a server, such as the RhvthmStar Svstem server.

The provided document, an FDA 510(k) summary for the RhythmStar System (K233584), describes the device and its indications for use, but it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (RhythmStar System K141813 and Zio AT ECG Monitoring System K163512) by comparing intended use, indications for use, and technological characteristics. While it mentions various types of testing performed (Biocompatibility, Electrical Safety, EMC, Software V&V, Performance Testing, Cybersecurity), it does not present the acceptance criteria for these tests or the quantitative results of the device's performance against those criteria.

Specifically, the following information, crucial for addressing your request, is not available in the provided text:

• A table of acceptance criteria and reported device performance: This is the most significant missing piece. The document states that performance testing was done in accordance with ANSI/AAMI EC57 and that bench testing confirmed certain functionalities, but it does not quantify the performance (e.g., sensitivity, specificity, accuracy for arrhythmia detection) or list the specific target acceptance values.
• Sample size used for the test set and data provenance: No information on the actual test dataset size, age group, or whether the data was retrospective or prospective.
• Number of experts used to establish ground truth and their qualifications: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device's primary function is to record and transmit data for retrospective review by a medical professional; it is not presented as an AI-assisted diagnostic tool for human readers itself.
• Standalone (algorithm only) performance: While an embedded arrhythmia detection algorithm is mentioned, its standalone performance metrics (e.g., accuracy for AFib detection) are not provided. The document states: "The RhythmStar system does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibility of a physician." This suggests the algorithm's output is raw data or simple event flags, not a diagnostic interpretation.
• Type of ground truth used: Not specified, as no detailed performance study results are provided.
• Sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

Conclusion based on the provided text:

The document serves as a 510(k) summary, demonstrating the substantial equivalence of the RhythmStar System to existing legally marketed devices, primarily the RhythmStar RS-10002 (K141813). It asserts that the device is safe and effective based on various conformance tests to recognized standards (IEC, ANSI/AAMI, ISO) and bench testing, but it does not disclose the specific quantitative acceptance criteria or the numerical performance results that would fulfill your request for detailed proof of meeting acceptance criteria for its core functions (like arrhythmia detection accuracy).

To obtain the information you requested about device performance against acceptance criteria, one would typically need access to the full 510(k) submission, which contains the detailed testing reports and results.

Ask a specific question about this device

The Now Cardio™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified healthcare professional for out-patient individuals with known non-lethal arrhythmias such as:

• · Atrial Fibrillation
• · Bradycardia
• Tachycardia
• · Pause

It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the Now Cardio™ will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG data are available to HealthCare Providers for analysis and reporting.

Now Cardio™ is intended to be used with adult patients 22 years and older, but not designed for pediatric patients.

The NowCardio™ System is a wearable, wireless arrhythmia detection system that provides continuous cardiac monitoring functionality for an extended period of up to 32 days. The NowCardio System is prescribed by healthcare providers to monitor, record, and report on a patient's electrocardiographic (ECG) data. The NowCardio™ system consists of: (1) a wearable electronic component that collects and monitors a patient's ECG data referred to as a NowCardio™ Sensor; (2) a custom cradle, referred to as the NowCardio™ Cradle, that is used to configure/charge the NowCardio™ Sensor in addition to providing ECG data download capability; and (3) a Remote Data Management System (RDMS) which is a remote server with software that will allow qualified healthcare providers to receive, analyze, interpret, and report on the results of the ECG test. The NowCardio™ System can be equipped with an optional Transmitter. The NowCardio™ Transmitter is used to transmit data acquired from the NowCardio™ Sensor to the RDMS as cardiac events are detected or patient triggered.

The provided document, K162956, is a 510(k) premarket notification letter for the NowCardio™ System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a detailed clinical or performance study with a test set. This type of submission relies heavily on non-clinical testing and comparison to legally marketed predicate devices.

Therefore, the document does not contain the specific information required to complete a table of acceptance criteria and reported device performance based on a test set, nor does it detail a study proving the device meets such criteria in terms of algorithm-specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection) as would be derived from a clinical validation study.

The document states:

• "Similar performance testing has been conducted on the NowCardio™ System and its predicates. There are no substantial differences in performance testing of the devices. Therefore, the NowCardio™ System is determined to be substantially equivalent to the predicate devices." (Page 5, Section VI)
• Under "VII. PERFORMANCE DATA", it lists various nonclinical tests, primarily focusing on general device safety, electrical performance, software validation, and compliance with standards like IEC 60601-1, IEC 60601-2-47, ISO 14971, and IEC 62304. These are engineering and regulatory compliance tests, not performance studies of the arrhythmia detection algorithm.

Given this, I cannot extract the requested information regarding algorithm performance, acceptance criteria for those metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, or training set details from this 510(k) summary.

In summary, the provided document does not contain the information necessary to fulfill the request as it describes a 510(k) submission based on substantial equivalence and non-clinical testing, not a detailed clinical performance study proving specific algorithm-driven acceptance criteria.

Ask a specific question about this device

The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center provides the ECG data to the medical practitioner for evaluation.

The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended to be prescribed for patients who have demonstrated a need for cardiac monitoring and are at low risk of developing life-threatening arrhythmias. Conditions where the system should not be used include patients likely to experience primary Ventricular Fibrillation or Ventricular Tachycardia and patients who have other co-morbid cardiovascular conditions where an arrhythmia could be potentially life threatening.

The device has been validated for use on patients 6 years of age and older.

The MCT 3L Continuous ECG Monitor and Arrhythmia Detector is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center.

The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 4 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a patient alert buzzer.
The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell phone. It has sufficient memory and processing capability to run the proprietary application.
When an arrhythmia event is detected, the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center for professional analysis. When cellular service is unavailable the patient has an option to transmit via a landline telephone.

The MCT 3L does contain software. The device is not supplied sterile or intended to be sterilized by the operator prior to use, and is not intended for single use.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria. Instead, it is a 510(k) summary for the LifeWatch Mobile Cardiac Telemetry 3 Lead (MCT 3L), which focuses on demonstrating substantial equivalence to a predicate device (K143359 CG-6108 ACT 3L).

Here's what can be extracted and what is not available based on your request:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing specific performance metrics against pre-defined acceptance criteria for the new device's arrhythmia detection algorithm.

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 explicitly states: "No clinical data was necessary to support substantial equivalence of the proposed device compared to the predicate." Therefore, no test set for clinical performance is detailed. The only "testing" mentioned is bench testing for engineering standards and human factors for pediatric use.

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 mentioned, there is no discussion of ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No test set is detailed.

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 device is an "Arrhythmia Detector and Alarm" that automatically generates alerts and transmits data to a monitoring center for "professional analysis." While it uses an "arrhythmia detection algorithm," the document does not describe it as an "AI" in the context of improving human reader performance. It functions more as an automated detection system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone algorithm for detection: "The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm..." However, the performance metrics of this standalone algorithm (e.g., sensitivity, specificity for various arrhythmias) are not detailed in the document. The alert then transmits data to a monitoring center, implying a subsequent human review.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. Without a detailed clinical performance study, the type of ground truth used for evaluating the arrhythmia detection algorithm is not specified.

8. The sample size for the training set
This information is not provided. The document makes no mention of training data for the device's algorithms.

9. How the ground truth for the training set was established
This information is not provided. As no training set is mentioned, how its ground truth was established is also not discussed.

Summary of Device Performance/Validation provided:

The submission focuses on demonstrating substantial equivalence to a predicate device (K143359 CG-6108 ACT 3L). The key statements related to performance and validation are:

• "The Indications for Use for the proposed MCT 3L device are identical to those of the predicate device with the exception that use for pediatrics age 6 and older is not excluded in the MCT 3L labeling."
• "Bench testing of the proposed MCT 3L was conducted to demonstrate substantial equivalence to the predicate device."
• "Insignificant historical changes are listed within the device description. No changes have been made to the user interface, device algorithms, or applications software compared to the predicate device."
• "The proposed device has the same intended use and employs the same fundamental scientific technology."
• Non-Clinical Testing:
  • IEC 62366-1:2015 (human factors validation testing for pediatric use age 6-21 with adult caregivers)
  • ISO 14971:2012 (evaluation of use-related risks)
  • ANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02 (Electromagnetic Compatibility)
  • Wireless Coexistence Testing (in accordance with FDA guidance)
• Clinical Testing: "No clinical data was necessary to support substantial equivalence of the proposed device compared to the predicate."

Essentially, the FDA clearance for K170565 relies on the demonstrated substantial equivalence to a previously cleared device (K143359), with specific non-clinical tests conducted to address a labeling change for pediatric use and ensure compliance with relevant engineering standards. The performance of the arrhythmia detection algorithm itself is presumed to be equivalent to the predicate device, given "no changes have been made to the user interface, device algorithms, or applications software compared to the predicate device."

Ask a specific question about this device

The Zio QX ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) information for long-term monitoring. While continuously recording patient ECG, both patient-triggered and automatically detected arrhythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on beat-to-beat information from the entire ECG recording. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.

The Zio® QX ECG Monitoring System consists of three key device components: (1) Zio QX Patch Recorder with Bluetooth technology, (2) Zio QX Wireless Gateway with both Bluetooth and cellular technology, and (3) the Zio ECG Utilization Service (ZEUS) System for data analysis and reporting.

The Zio® QX Patch is a non-sterile, single-patient-use ECG monitor that provides a continuous, single-channel recording in addition to asymptomatic and symptomatic data transmission for up to 14 days. The Zio® QX Patch is applied and activated by the patient. Once activated, the Patch records ECG without patient interaction, with the goal of improving patient compliance via simplicity of operation. The Zio® QX Patch, in conjunction with the Wireless Gateway and the ZEUS System, has arrhythmia auto-detection capabilities. Additionally, patients have the option of pressing a convenient trigger button which marks the continuous record and initiates the wireless transfer of a 90-second ECG strip. The wireless transfer of data is enabled by the Zio® QX Gateway, which requires Bluetooth proximity to the Patch and cellular network reception but no patient interaction to transmit to the monitoring center. The patient is encouraged to document symptomatic events in either the provided booklet, mobile medical app (iOS 9+, Android 4.4+) or via a patient website, which will support symptom-rhythm correlation in the Zio QX Report.

At the conclusion of the wear period (up to 14 days), the patient removes the Zio® QX Patch and returns it by mail to an iRhythm data processing center.

Upon receipt of both symptomatic/asymptomatic transmissions (during wear) and downloaded continuous ECG data (post wear) at iRhythm's Clinical Center (iCC), the data is processed through the ZEUS detection algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm's Certified Cardiographic Technicians (CCTs) for accuracy. iRhythm employed and trained Patch in-take and CCT personnel follow internal procedures for processing and are made aware of performance limitations and anomalies with both the detection algorithms and software workflow tools. All anomalies are visible to and, where appropriate, are manually corrected by iRhythm Technologies CCTs during the QA review and/or Patch Report edits. The CCT generates a final report (Zio QX Report) of the ECG findings contained within the data, thereby providing a complete ECG processing and analysis service.

Upon explicit request from a clinician responsible for the patient's healthcare, longer segments of ECG data from the continuous recording on the Patch can also be wirelessly retrieved during the wear period. Alternatively, such periods are also available for inclusion in the final report, where the entire ECG recording is available for review and selective inclusion based on clinical relevance.

The provided FDA 510(k) summary for the Zio® QX ECG Monitoring System (K163512) describes the device's acceptance criteria and the study conducted to prove it meets them.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements."

However, the specific quantitative acceptance criteria (e.g., minimum sensitivity of X%, minimum PPV of Y% for specific arrhythmia types) and the actual reported performance metrics (e.g., Sensitivity = A%, PPV = B%) are NOT explicitly provided in the excerpt. The document only makes a general statement that the device satisfies requirements.

Without the actual numbers, a precise table cannot be constructed.

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

The document states: "No clinical testing was performed in support of this premarket notification." and "All necessary performance testing was conducted on the Zio® QX ECG Monitoring System to ensure performance as intended per specifications and to support a determination of substantial equivalence to the predicate devices."

This indicates that the primary performance evaluation for the automated ECG analysis was done as part of non-clinical testing. This likely means simulated or pre-recorded ECG datasets were used.

• Test Set Sample Size: Not explicitly provided.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given "nonclinical testing," it's likely a retrospective analysis of existing datasets or simulated data.

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

The document describes the role of human experts in the data processing workflow:

• "...the data is processed through the ZEUS detection algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm's Certified Cardiographic Technicians (CCTs) for accuracy."
• "All anomalies are visible to and, where appropriate, are manually corrected by iRhythm Technologies CCTs during the QA review and/or Patch Report edits."
• "The CCT generates a final report (Zio QX Report) of the ECG findings contained within the data, thereby providing a complete ECG processing and analysis service."

From this, we can infer:

• Number of Experts: Not explicitly stated as a fixed number for establishing a ground truth dataset for the purpose of the regulatory submission's performance study. However, it implies that multiple CCTs are involved in the standard operational workflow for quality assurance and report generation. For the study proving acceptance criteria, the number of experts used to establish the "ground truth" for the test set is not specified.
• Qualifications of Experts: "iRhythm's Certified Cardiographic Technicians (CCTs)" are mentioned. Their specific experience (e.g., 10 years) is not provided. It also doesn't specify if a higher level of expertise (e.g., cardiologists) was involved in establishing the ground truth for the performance claim.

4. Adjudication Method for the Test Set

The document states that CCTs review and adjust the algorithm's results. This implies a human-in-the-loop system where the CCTs serve as a final arbiter. However, for the non-clinical performance testing used for the regulatory submission, the specific adjudication method to build the "ground truth" dataset is not described. General methods like "2+1" or "3+1" are not mentioned. It's possible that a single CCT or a panel of CCTs established the ground truth in the datasets used for testing.

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

The document explicitly states: "No clinical testing was performed in support of this premarket notification."

Therefore, a MRMC comparative effectiveness study involving human readers improving with AI vs. without AI assistance was NOT done for this submission. The device is a "monitoring system" with an automated analysis component that produces a report for human review; the study focuses on the algorithm's performance and the general process, not on human-AI collaboration effectiveness.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation of the algorithm was conducted. The document states:

• "Automated ECG analysis performance was quantified for any claimed analysis metrics."
• This falls under "Nonclinical testing."

The device description also clarifies the algorithm's role: "...the data is processed through the ZEUS detection algorithm...". This "ZEUS detection algorithm" is the standalone component whose performance was quantified.

7. Type of Ground Truth Used

The document indicates that CCTs review and "adjust" results to ensure "accuracy" and manually "correct" anomalies. This suggests the ground truth for the performance evaluation (or at least the operational ground truth for report generation) is established by expert consensus/adjudication by Certified Cardiographic Technicians (CCTs). It's not explicitly stated whether a higher level of ground truth (e.g., pathology, clinical outcomes, or adjudication by cardiologists) was used for the non-clinical test set.

8. Sample Size for the Training Set

The document does NOT provide any information regarding the training set's sample size. The focus of the 510(k) summary is on the testing that demonstrates substantial equivalence, not on the details of algorithm development (training, validation).

9. How Ground Truth for the Training Set Was Established

The document does NOT provide any information on how the ground truth for the training set was established. This is typical for a 510(k) submission, which focuses on the validation of the final product.

Ask a specific question about this device

MoMe® Kardia is intended to be used for:

1. Patients who experience transient symptoms that may suggest cardiac arrhythmia.

2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)

3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)

4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.

5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.

MoMe® Kardia is contraindicated for:

1. MoMe® Kardia is contraindicated for those patients requiring attended, in-hospital monitoring for life threatening arrhythmias.

Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.

MoMe® Kardia includes the wearable MoMe® Kardia Device that acquires and stores ECG and motion (accelerometer) data and transmits that data via cellular technology to the MoMe® Software System (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe® Device Communications Protocol. MoMe® Software System analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. MoMe® Kardia requires no patient intervention to capture or analyze data however does provide a patient event trigger.

MoMe® Kardia supports three cardiac monitoring modes:

1 Holter
2 Event Monitoring
3 Mobile Cardiac Telemetry (MCT)

MoMe® Kardia:

• Is non-invasive and poses no significant safety issues ●
• Uses existing electrode and ECG technology ●
• ls used in an adjunctive fashion, where physicians also use patient ● symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias.

MoMe Kardia is not an emergency service. If the patient is experiencing symptoms that he/she is concerned about, the patient needs to seek immediate medical attention.

This document is a 510(k) summary for the MoMe® Kardia Wireless Ambulatory ECG Monitoring and Detection System, comparing it to a predicate device (TruVue™ Wireless Ambulatory ECG Monitoring System). It does not contain a detailed study proving the device meets specific acceptance criteria with reported performance metrics.

However, based on the information provided, we can infer some aspects relevant to your request.

Missing Information:

• Specific acceptance criteria with numerical targets for device performance (e.g., sensitivity, specificity, accuracy for arrhythmia detection).
• Reported device performance against these numerical acceptance criteria.
• Details of the study that proves the device meets specific acceptance criteria. The document states "The test reports in the submission demonstrate the MoMe® Kardia meets its intended use and design requirements," but does not elaborate on these test reports or their results.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study details.
• Standalone (algorithm-only) performance details.
• Sample size for the training set.
• How ground truth for the training set was established.

Information that can be extracted or inferred:

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

This information is not explicitly provided in the document. The document states that "The MoMe® Kardia submission was written according to and in conformance with FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" released on October 2003. The test reports in the submission demonstrate the MoMe® Kardia meets its intended use and design requirements." However, the specific acceptance criteria and the reported performance values that demonstrate this conformance are not listed.

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 explicitly 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 explicitly provided in the document.

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

This information is not explicitly 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

This information is not explicitly provided in the document. The device "flags for physician review" but there's no mention of a comparative effectiveness study with human readers.

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

The document mentions "proprietary algorithms for analysis" that flag data for physician review, suggesting a standalone algorithmic component. However, specific standalone performance metrics are not provided.

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

The document states, "Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician." This implies that the ultimate "ground truth" for clinical diagnosis would be physician interpretation. However, how the ground truth for the performance testing of the device's arrhythmia detection algorithm was established is not explicitly stated. It can be inferred that it would be based on expert review of ECG data, but the specifics are absent.

8. The sample size for the training set

This information is not explicitly provided in the document. The document mentions "proprietary algorithms for analysis" but does not detail their development or training.

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

This information is not explicitly provided in the document.

Ask a specific question about this device

The MoMe™ Continuous ECG Monitor and Arrhythmia Detector System (MoMe™ System) is indicated for:

1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.
2. Patients with dizziness or lightheadedness.
3. Patients with palpitations.
4. Patients with syncope of unknown etiology.
5. Patients who require monitoring for non-life threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block.
6. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias.
7. Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease.
8. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias.
9. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation.

The MoMeTM Continuous ECG Monitor and Arrhythmia Detector System (abbreviated to MoMe System in this section) is a remote physiologic monitoring system that detects non-life threatening arrhythmias. The MoMeTM System incorporates a front end device worn by the patient that collects and streams ECG, heart rate and motion (activity) to a dedicated smartphone that continuously transmits the data to remote server. The system then uses proprietary algorithms to continually analyze data and provide reports of detected events. These reports can be accessed anytime, anywhere by a physician using a standard browser or a MoMe iPad App.

The provided text includes a 510(k) Summary for the MoMe™ Continuous ECG Monitor and Arrhythmia Detector System, which details its performance data and the studies conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" (October 2003) for the acceptance criteria, and states that the device was tested using "standard industry practices and in accordance" with this guidance. However, the specific acceptance criteria (e.g., minimum sensitivity, specificity for certain arrhythmia types) and corresponding reported device performance values are not explicitly detailed in the provided text. The document broadly states: "The MoMe Arrhythmia detection algorithm has been tested using standard industry practices and in accordance with the FDA Guidance 'Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm', released October 2003. The Software Verification and Validation reports, MoMe System Verification and Validation report, Algorithm validation report, Transceiver Verification and Validation report, Usability test reports all demonstrate that the MoMe System meets its intended use and design input requirements."

Without the specific performance targets from the FDA Guidance and the numeric results from the MoMe system's validation reports, a detailed table cannot be created.

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

The document mentions "Algorithm validation report" but does not specify the sample size of the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

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

This information is not provided in the given text.

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

This information is not provided in the given text.

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 in the given text. The study mentioned is a "standalone" algorithm validation, not a comparative effectiveness study involving human readers with and without AI assistance.

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

Yes, a standalone algorithm validation was done. The document states: "The MoMe Arrhythmia detection algorithm has been tested..." and refers to an "Algorithm validation report." This implies testing the algorithm's performance independent of human intervention.

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 the algorithm validation. For arrhythmia detection algorithms, ground truth is typically established by expert cardiologists reviewing the ECG tracings.

8. The sample size for the training set:

The document does not specify the sample size for the training set.

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

The document does not specify how the ground truth for the training set was established.

Summary of available information regarding the study:

• Study Type: Algorithm validation, software verification and validation, system verification and validation, transceiver verification and validation, usability testing.
• Standards Followed: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, ANSI/AAMI/ISO EC 57:1998/R(2008), ANSI/AAMI EC53:1995/(R)2008, ISO 10993 (various parts for biological evaluation).
• Compliance: The MoMe System complies with applicable clauses of IEC 60601 and was tested in accordance with the FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" (October 2003).

Missing Information (not found in the provided text):

• Specific quantitative acceptance criteria for arrhythmia detection (e.g., sensitivity, specificity, accuracy for different arrhythmia types).
• Specific quantitative reported performance metrics of the MoMe system against these criteria.
• Sample size of the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for ground truth.
• Details of any MRMC comparative effectiveness study or human reader improvement data.
• Type of ground truth explicitly defined (though likely expert review for ECGs).
• Sample size of the training set.
• Method for establishing ground truth for the training set.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device