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The ePatch® is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety.

The ePatch® is intended for use by adolescents 18-21 and adults.

The ePatch® ECG Recorder is intended for continuous recording of heart action potentials (ECG). While in use, the sensor is connected to a compatible ECG electrode and placed on the patient.

The ePatch® ECG Recorder is a small digital Holter recorder intended for use by professionals to acquire continuous ambulatory recording of heart action potentials (ECG) from a patient through a compatible ECG patch electrode. The ePatch® is intended for use in a clinical, point of care or at a patient setting. The recording time of the ECG recorder is dependent on the set configuration of the recorder (sample rate and channel selection). The patient's ECG is recorded to the ePatch® ECG Recorder and then transferred via the ePatch® USB cable to a Holter analysis system for review by physician or other qualified personnel.

The ePatch® ambulatory electrocardiograph (ECG) recorder is a small, lightweight monitor that records ECG continuously. The unit records 1, 2 or 3 channels of ECG up to 9 days. The device is composed of a large ECG electrode and an ECG recorder. The ECG recorder snaps onto the electrode and records until the recorder is removed from the electrode. At the end of the recording, the recorder can be plugged into a PC via a USB cable. The ECG recording can be transferred in an available file format at can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. The ePatch® can be worn continuously up to 5 days in homes, healthcare facilities, hospitals, and wherever the patient may go. The components that are part of the ePatch® recorder are a lead wire, USB cable and the ePatch® electrode.

During the recording the patient wears the ePatch® connected to an electrode on the upper sternum or an alternative placement on the upper torso. The ePatch® consists of a microprocessor, measuring circuit, memory, data storage, lightemitting diode (trans-illuminates the plastic casing), and contract to the electrode. In addition to that, ePatch® contains firmware to control the collection of the ECG data and software to transfer to the processing software.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics for the ePatch® device. The document is a 510(k) premarket notification letter and summary, which focuses on establishing substantial equivalence to predicate devices rather than providing a standalone performance study.

However, based on the information available, here's what can be extracted and inferred:

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

The document lists performance standards and categories of testing but does not provide quantitative acceptance criteria or corresponding reported performance values for the ePatch® device itself. Instead, it states that "The technological characteristics of the proposed ePatch® are very similar to the predicate devices." and broadly mentions "Design Verification" as a performance standard.

A table format would look like this, but the "Acceptance Criteria" and "Reported Performance" columns cannot be filled with specific numbers from this document:

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 mentions "Validation of patch adhesion and signal quality data were conducted to support substantial equivalence" and "Non-clinical testing summary," which includes biocompatibility, electrical safety, EMC, software, and usability testing. However, it does not provide any specific sample sizes for these tests, nor does it detail the data provenance (country of origin, retrospective/prospective).

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. The document describes a medical device for ECG recording, not an AI or diagnostic interpretation system that would typically require expert-established ground truth in the way a diagnostic algorithm would. The "ground truth" for an ECG recorder would be the accurate capture of electrical heart signals, which is validated through technical performance standards rather than expert consensus on diagnostic images or reports.

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

This information is not provided and is generally not applicable to the technical validation of an ECG recording device. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments, which are not the primary focus of validating an ECG recorder's hardware and software functionality.

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 and is not relevant to the ePatch® device as described. The ePatch® is an ECG recorder, not an AI-powered diagnostic interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be performed for this type of device.

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

This information is not provided and not directly applicable. The ePatch® is a physical device that records ECG data, which is then transferred to a Holter analysis system for review by qualified personnel. While it has firmware and software, it's not described as an "algorithm only" device in the context of standalone diagnostic performance. Its performance is tied to its ability to accurately record physiological signals.

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

For the technical performance of the ECG recorder, the "ground truth" is established by conformance to recognized standards (e.g., IEC 60601-2-47 for ambulatory electrocardiographic systems) and the accurate capture of electrical heart activity. This is not typically based on expert consensus, pathology, or outcomes data in the same way a diagnostic algorithm's output would be. The "ground truth" for signal quality means the device faithfully reproduces the biological signal within specified technical tolerances.

8. The sample size for the training set:

This information is not provided. As the ePatch® is an ECG recorder focused on hardware and embedded software for data acquisition and storage, it typically does not involve a "training set" in the machine learning sense. The firmware and software are likely developed and validated through traditional software engineering and testing processes against specifications derived from regulatory standards, rather than being "trained" on a dataset.

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

This information is not provided and is not applicable for the reasons stated in point 8.

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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.

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The CK100 CardioKey Holter Recorder is intended for patients requiring ambulatory (Holter) Monitoring. The following is a listing of the most frequent indications for use:

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
3. Evaluation of patients for ST segment changes.
4. Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
5. Clinical and epidemiological research studies.
6. Reporting of time and frequency domain heart rate variability.
7. Reporting of QT Interval.

The CardioKey Hotter Recorder, Model CK100, is an ambulatory ECG recorder which is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Lead wire and 3) a host application.
The Sensor is a USB dongle that acquires ECG data and stores the data in nonvolatile memory. The Sensor is worn for up to 14 days and operates on one coin cell battery for the duration of the recording period. This Sensor can plug directly into a host computer's USB port for data transfer.
The female end of the lead wire cable assembly plugs onto the Sensor. The lead wire cabling on the other end of the assembly is connected to the User via two electrodes
The host application extracts user data from the Sensor and translates it to processing by a 510(k) cleared third party analysis software.

The provided text describes the CardioKey Holter Recorder, Model CK100, a medical device for ambulatory ECG monitoring. However, it does not contain a detailed study proving the device meets specific acceptance criteria with reported performance metrics, ground truth establishment, or sample sizes for test and training sets.

The document states that the device "meets the requirements of following performance standards" and lists:

• ANSI/AAMI EC 38:2007 - Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
• IEC60601-1:1988+A1:1991+A2:1995 - Medical Electrical Equipment - Part 1: General Requirements for Safety
• IEC60601-1-2:2007 Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

These are general safety and performance standards for medical electrical equipment, not specific, quantitative acceptance criteria with corresponding device performance metrics. The document does not provide any specific "reported device performance" against quantitative acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text.

Based on the provided information, I can answer some of the other requested points:

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

• Not provided in the text. The document states compliance with general medical device standards (ANSI/AAMI EC 38:2007, IEC60601-1:1988, IEC60601-1-2:2007) but does not list specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular arrhythmia detection) or corresponding reported device performance for these criteria.

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

• Not provided in the text. No information on a specific test set, its size, or data provenance is mentioned. The "Summary of Performance Testing" refers to compliance with safety and performance standards generally, not a specific clinical or performance evaluation study.

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/Not provided. Since no specific test set and ground truth establishment are detailed, this information is not available.

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

• Not applicable/Not provided. No adjudication method is mentioned as there's no detailed test set described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a Holter recorder, a data acquisition device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function as described.

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

• Not provided/Not fully applicable. The device records ECG data and stores it for processing by a "510(k) cleared third party analysis software." The document does not describe the performance of this third-party analysis software or any standalone algorithm performance testing of the recorder itself beyond its ability to record and store data according to general standards.

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

• Not applicable/Not provided. No specific ground truth type is mentioned as there is no detailed performance study described.

8. The sample size for the training set

• Not applicable/Not provided. This device is a hardware recorder, not a machine learning algorithm that requires a training set.

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

• Not applicable/Not provided. (See point 8).

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