Search Results

The device is designated as Rx only. Its indications for use are as follows:

1. Patients who have a demonstrated need for cardiac Monitoring. These may include but are not limited to patients who require Monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmas associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.

2. 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; c) dyspnea (shortness of breath).

3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.

4. Patients who require outpatient monitoring of antiarrhythmic therapy: a) Monitoring of therapeutic and potential proarrhythmic effects of membrane active drugs, b) Monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).

5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia Monitoring

6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias

7. Patients requiring arthythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter.

8. Patients requiring measurement, analysis and reporting of QT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter

9. Patients who require monitoring for potential arrhythmias based on risk factors (e.g. atrial fibrillation).

10. Patients requiring measurement of ST segment changes. The device is not intended to sound any alarms for ST segment changes.

The Braemar Telemetry Patch System BTPS-1000 is an ambulatory ECG monitor with capability to detect cardiac arrhythmias and transmit ECG data to a customerstaffed monitoring center (referred to as "Remote Site").

The subject device is comprised of two (2) main components: 1) a patient-worn Sensor and 2) a Monitor.

The Sensor functions as the data acquisition element in the Braemar BTPS-1000 system. It collects ECG data and transmits it with appropriate Sensor status updates to the Monitor. The Sensor software also manages Leads Off detection and Pacemaker Pulse detection, monitors battery voltage, motion information, and controls a sounder (beeper) for notifications or warnings. The Sensor software manages battery charging and data retrieval from the Monitor via Bluetooth®. The user interacts with the Sensor software only by connecting the Sensor to the Patch / Electrodes providing a usable battery at which time the Sensor automatically starts. There are four integrated Electrodes built into the Patch, and these adhere to the user. The Electrodes are hardwired to the Sensor within the Patch. There are no Sensor software functions that are controlled or modified by the user.

The Monitor will perform data/arrhythmia detection analysis and transmit the data to the customer Remote Site via cell modem for further post-processing and reporting.

The Monitor software is responsible for managing patient ECG data for the purpose of storage, analysis, and transmission. The Monitor software also performs system integrity checks on itself. The Monitor software provides all visual indications for itself and its associated Sensor. The Monitor also contains software that enables transmission of ECG data via cellular. The user interacts with the software via an On/Off physical button and by touching buttons drawn on the Monitor LCD touch screen. All other physical buttons are disabled and on lock-down by the Monitor, which prevents use of camera and other functions. The user can start/stop the Monitor, declare a symptomatic event, change the screen and speaker intensity levels, and enable/disable the built-in cellular communications. The user can also acknowledge alerts and warnings such as Leads Off or Low Battery, and request help for notices or system messages. The user is not otherwise provided with any means to control or modify software functions

The data is received by trained technicians at the Remote Site who make use of Medical Device Data System (MDDS) software to review the ECG waveforms and determine if they concur with the analysis made by the algorithm in the Monitor.

The Sensor-Monitor network is designed to be operational in a home environment, able to co-exist with other Bluetooth. WiFi, and other protocols operating in the 2.4GHz ISM band. Robustness of Bluetooth networks to interferences from other documented players in this band is in literature (www.bluetooth.com/Pages/Basics.aspx ). In addition, attached summary test reports (Attachments T and U) regarding testing specified in IEC60601-1-2 confirm that the device is fully capable of the standard's required safe and effective communication across the cellular (WWAN) and Bluetooth protocols.

The subject device provides continuous ECG recording and automated analysis through operation in MCOT mode (Mobile Cardiac Outpatient Telemetry). Some documentation (including the System Risk Analysis in Attachment G), refers to the subject device as BTPS-1000 MCOT or version 1. The subject device continuously collects ECG data from the patient. The Sensor acquires the ECG data and transmits the data to the Monitor wirelessly. In MCOT mode, the Monitor continuously and automatically analyzes the ECG data using the same proprietary algorithm found in predicate K093288. The data is algorithmically processed and transmitted to customer Remote Site using cellphone.

The provided text describes the Braemar Telemetry Patch System Model BTPS-1000 and its substantial equivalence to a predicate device (CardioNet Ambulatory ECG Monitor with Arrhythmia Detection Model CN1006). The document is a 510(k) summary submitted to the FDA. While it discusses performance data, it primarily focuses on demonstrating substantial equivalence rather than explicitly outlining "acceptance criteria" for an AI algorithm's performance and a study proving it meets those criteria, as one might find for a novel AI device submission.

However, the document does mention an "in-house clinical study" to demonstrate substantial equivalence, particularly concerning the ECG analysis algorithm. It also references "Beat by Beat comparison between C5 and BTPS-1000 beat detection and classification as well as heart rate measurement performances." This suggests that the core algorithm is being evaluated for its performance characteristics.

Based on the provided text, here's an attempt to extract and infer the requested information, acknowledging that some details, particularly specific acceptance criteria for a new algorithm, are not explicitly stated for this 510(k) given its focus on substantial equivalence to an existing, similar algorithm:

Acceptance Criteria and Performance Study for Braemar Telemetry Patch System Model BTPS-1000 ECG Analysis

The device, Braemar Telemetry Patch System Model BTPS-1000, utilizes the same proprietary algorithm for ECG data analysis as its predicate device (CardioNet Ambulatory ECG Monitor with Arrhythmia Detection Model CN1006). Therefore, the "acceptance criteria" and "study proving the device meets the acceptance criteria" in this context are interpreted as demonstrating substantial equivalence in performance of this existing algorithm when integrated into the new device's hardware (Sensor/Monitor), particularly concerning beat detection, classification, and heart rate measurement.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) demonstrating substantial equivalence with an existing algorithm, explicit quantitative acceptance criteria for algorithm performance (e.g., a specific sensitivity/specificity target) are not detailed within this document as they might be for a completely novel AI system. Instead, the "acceptance" is based on the new device's ECG analysis being "substantially equivalent" to the predicate device's, which itself implies a level of established performance.

The reported device performance is qualitative, stating that the subject device's performance is comparable to the predicate.

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

• Sample Size for Test Set: Twelve (12) volunteers (eight males and four females).
• Data Provenance: The study was an "in-house clinical study." The country of origin is not explicitly stated but is implicitly the USA, given the FDA submission. The study appears to be prospective as it involved generating new ECG waveforms from volunteers using both devices.

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

The document does not explicitly state the number or qualifications of experts used to establish a ground truth for the "Beat by Beat comparison" of detection and classification. Given the context of a medical device company and the nature of ECG analysis, it is implied that internal experts (e.g., cardiologists, cardiac technicians, or clinical researchers) would have performed or overseen this comparison, likely using established ECG interpretation guidelines. However, no specific details are provided. The remote site where data is processed is staffed by "trained technicians," but this refers to the ongoing operational use, not necessarily the ground truth establishment for this specific study.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the test set. The comparison is described as "Beat by Beat comparison between C5 and BTPS-1000 beat detection and classification," suggesting a direct comparison of the outputs of the two devices, rather than an independent expert adjudication against a separate ground truth.

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

No, an MRMC comparative effectiveness study was not done. The study described focuses on the substantial equivalence of the device's algorithmic output to a predicate device, not on how human readers' performance improves with or without AI assistance. The "trained technicians" at the remote site "review the ECG waveforms and determine if they concur with the analysis made by the algorithm," which describes a human-in-the-loop process, but no comparative effectiveness study of this human-AI interaction is reported in this document.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance assessment of the (integrated) algorithm was effectively done. The "Beat by Beat comparison" of the subject device (BTPS-1000) against the predicate device (K093288, referred to as C5) in terms of "beat detection and classification as well as heart rate measurement performances" represents an evaluation of the algorithm's performance independent of live human interpretation beyond what's inherent in comparing it to the performance of another algorithmic system. Since the subject device uses the same proprietary algorithm as the predicate, this study validates the algorithm's performance within the new hardware.

7. Type of Ground Truth Used

The "ground truth" for this study is the output of the predicate device's algorithm (K093288) rather than an independent expert consensus, pathology, or outcomes data. The study's goal was to show that the subject device's algorithm performs equivalently to the predicate's algorithm.

8. Sample Size for the Training Set

The document states that the subject device's algorithm is the "same proprietary algorithm found in predicate K093288." This implies that the algorithm was trained and validated prior to its incorporation into the predicate device. This document does not provide information on the training set size for the algorithm itself.

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

Since the algorithm is inherited from the predicate device, this document does not provide details on how the ground truth for the training set of the original algorithm (used in K093288) was established. This information would typically be detailed in the original 510(k) submission for K093288 or internal development documents for that device.

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