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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.

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The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. 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:
6. The SmartCardia 7L Platform is contraindicated for use in a critical care setting where an immediate response to life threatening conditions such as lethal arrhythmias is required.
7. The SmartCardia 7L Platform is contraindicated for use during external defibrillation.

The SmartCardia 7L Platform is a body worn Holter 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 two modes of Holter 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)
   During any of the selected modes of Holter monitoring, a clinician or healthcare provider can use the SmartCardia Web Browser and continuously monitor the patient.
   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, like most Holter monitoring systems 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.

This document describes the device's technical characteristics and bench testing summary but does not provide complete details on a clinical study that proves the device meets the acceptance criteria, particularly for AI/algorithm performance. The information provided is primarily focused on hardware and basic signal acquisition validation against regulatory standards.

Here's an attempt to answer your questions based on the provided text, with explicit notes where information is missing or unclear for a comprehensive AI/algorithm study:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Pass criteria is compliance with the claimed range and precision provided in the labeling for the SmartCardia 7L Platform" and that the device "met the pass/fail criteria established by the appropriate standards." However, it does not explicitly list specific numerical acceptance criteria or performance metrics for arrhythmia detection beyond stating that "the SmartCardia 7L Platform algorithm detection and reported results for the stated output arrhythmia were satisfactory and met industry norms."

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

The document states, "SmartCardia developed a protocol and database for evaluating the analysis algorithm" for the EC57 testing. However, it does not specify the sample size of this database (test set). It also does not mention the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. For an algorithm evaluation, expert review is crucial for establishing ground truth, but no details are given.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

The document does not indicate that a MRMC comparative effectiveness study was done. The testing described is primarily focused on the device's technical performance and algorithm's standalone detection capabilities, not the improvement in human reader performance with AI assistance.

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

Yes, a standalone performance evaluation of the algorithm was conducted. The document states: "The ECG detection algorithm was tested per ANSI/AAMI EC57 standard for testing and reporting performance results of cardiac rhythm... 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."

7. Type of Ground Truth Used

The document mentions "SmartCardia developed a protocol and database for evaluating the analysis algorithm" per the ANSI/AAMI EC57 standard. This standard provides guidelines for performance reporting of cardiac rhythm algorithms, which typically implies comparison against known, validated arrhythmia events within the ECG recordings. The source of this ground truth (e.g., expert consensus, independent adjudication, or a pre-validated dataset) is not explicitly stated, but for EC57, it's generally based on highly accurate reference annotations.

8. Sample Size for the Training Set

The document does not mention any details about a training set or its sample size. The focus of this submission is on the testing and validation of the device, not its development or algorithm training.

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

Since no training set details are provided, information on how its ground truth was established is not available in this document.

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