(233 days)
The device is designated as Rx only. Its indications for use are as follows:
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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.
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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).
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Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
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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).
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Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia Monitoring
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Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias
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Patients requiring arthythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter.
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Patients requiring measurement, analysis and reporting of QT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter
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Patients who require monitoring for potential arrhythmias based on risk factors (e.g. atrial fibrillation).
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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.
| Performance Metric | Acceptance Criteria (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Beat Detection | Demonstrated statistical equivalence to predicate device (K093288). | "Beat by Beat comparison...demonstrate that the detection...of the 3-lead ECG system (K093288 predicate) and the BTPS-1000 system (subject device) are substantially equivalent." |
| Beat Classification | Demonstrated statistical equivalence to predicate device (K093288). | "Beat by Beat comparison...demonstrate that the...classification of the 3-lead ECG system (K093288 predicate) and the BTPS-1000 system (subject device) are substantially equivalent." |
| Heart Rate Measurement | Demonstrated statistical equivalence to predicate device (K093288). | "Beat by Beat comparison...heart rate measurement performances were generated...More details are provided in Section 9 of the Premarket Notification," indicating positive results supporting substantial equivalence. |
| ECG Waveform Key Features (P, QRS, T) | Clear representation of key ECG features. | "The ECG waveforms from both products showed all the key features in rhythm analysis, including the depolarization of the atria (P wave), depolarization of the ventricles (QRS complex), and the repolarization of the ventricles (T wave)." |
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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.