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The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode.

Holter Mode

Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation.

Event Recorder

The Telaheart event recorder module is a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain). Once data is recorded, the data is transmitted via telephone for evaluation.

An ambulatory monitor, sometimes called a Holter, is a painless method to monitor the heart for a period of time (such as 24 hours, or 72 hours). The Holter is a small recording device that records the heart beat while being worn by the patient.

The physician or technician places electrodes and wires on the patient. The wires are connected to the Holter or digital recorder.

The Telaheart Digital Recorder has two modes that allow it to be used either as a standard Holter monitor or a looping Event recorder. The device is designed to facilitate ambulatory cardiac monitoring on the order of a physician, of those patients (including infants weighing less than 10 kg) who may herefit from such monitoring.

The data obtained during monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring Holtec or Event analysis system (TelePro Software) to be analyzed. The Holter Analysis Software was cleared by FDA under K930564.

The device is not intended to replace real time telemetry monitoring for patient suspected of having life threatening arrhythmias.

The Telaheart Digital Recorder package includes:

• . Telaheart Digital Recorder
• . Operation Manual
• SD Card .
• Patient Cable

The Telaheart digital recorder is powered by one 1.5 volt AA alkaline battery (MN1500 or the equivalent), one AA rechargeable NiMH (nickel metal hydride) battery, or one AA Eveready Lithium Lqurbattery. Batteries should not be re-used for a second patient. The batteries are not included, users are instructed to purchase 2 AA batteries.

The device is compatible with standard silver / silver chloride ECG electrodes are not provided with the subject device. The user is instructed to purchase standard silver / silver chloride ECG electrodes.

The Telaheart digital recorder uses NorthEast Monitoring Telaheart patient cables with either 2, 5, or 7 patient leads. The patient cable connects to the recorder via a connector on the recorder. A patient cable is provided with the Telaheart Digital Recorder.

The Telaheart has an LCD that is used to display the time of day (during the recording), prompts and error messages (during the hookup procedure or during recording), or lead quality (during the hookup procedure).

The data collected by the Telaheart digital recorder is stored on a removable SD Card.

The Telaheart is packaged in a plastic bag in a cardboard shipping carton. The shipping carton will also include a patient cable and an SD Card.

This 510(k) submission (K061293) for the Telaheart Digital Recorder does not contain a study that establishes performance against acceptance criteria in the way a typical clinical performance study would.

This submission is for a medical device (an ambulatory ECG recorder, also known as a Holter or Event Recorder) that does not perform automated analysis. Its primary function is to record physiological data (ECG signals) for later analysis by compatible software (TelePro Software, cleared under K930564). Therefore, the "performance data" and "acceptance criteria" presented here relate to the device's functional and safety aspects, not its ability to diagnose conditions or assist human readers.

Here's the breakdown of the information based on your request, focusing on what is available in the provided text:

Acceptance Criteria and Reported Device Performance (Table)

Since the device's function is data acquisition and not analysis, the "acceptance criteria" are related to its physical and electrical specifications and compliance with safety standards rather than diagnostic performance metrics.

Study Details for Performance Evaluation:

As mentioned, this 510(k) does not describe a clinical performance study in the traditional sense (e.g., comparing diagnostic accuracy). Instead, it focuses on the device's engineering, safety, and software validation.

2. Sample Size for Test Set and Data Provenance:
* N/A. The document does not describe a clinical test set with patient data for diagnostic performance evaluation. The "tests" mentioned are for electrical safety, EMC, and software validation, which typically use engineering samples, test signals, and software testing methodologies rather than a clinical test set of patients.

3. Number of Experts and Qualifications for Ground Truth:
* N/A. There is no mention of experts establishing a ground truth for a clinical test set, as no such study is presented.

4. Adjudication Method:
* N/A. Not applicable, as there is no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No. This type of study would compare human readers with and without AI assistance to assess diagnostic improvement. The Telaheart Digital Recorder is a data acquisition device, not an AI-powered diagnostic tool, and it does not perform automated analysis. Therefore, an MRMC study is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study:
* No. The device itself does not contain an algorithm for standalone diagnostic performance. It records raw ECG data. The separate "TelePro Software" (cleared under K930564) is responsible for analysis, but its standalone performance is not detailed in this 510(k) for the recorder.

7. Type of Ground Truth Used:
* N/A. For the device itself, "ground truth" would relate to accurate signal acquisition and storage (e.g., comparing recorded waveforms to known input signals for electrical performance, or verifying software functionality against specifications). It does not involve "expert consensus," "pathology," or "outcomes data" for diagnostic purposes.

8. Sample Size for Training Set:
* N/A. There is no mention of a training set for an AI algorithm, as this device does not utilize AI for diagnostic analysis.

9. How Ground Truth for Training Set was Established:
* N/A. Not applicable, as there is no training set mentioned.

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• Detection of Arrhythmias: The NorthEast Monitoring, Inc. SD360 Digital Recorder is indicated for use in continuous monitoring of cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks (TIAs), syncope (fainting), or other such symptoms as determined by the physician.
• Efficacy of Treatment: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for use to determine whether current pharmacological treatment(s) of known arrhythmia is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment.
• Pacemaker Evaluation: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits.
• The NorthEast Monitoring SD360 Digital Recorder is to be used by or on the order of a physician.

An ambulatory monitor, sometimes called a Holter, is a painless method to monitor the heart beat for a period of time (usually 24, 48, or 72 hours). The Holter is a small recording device that records the heart beat while being worn by the patient.

The physician or technician places electrodes and wires on the patient. The wires are connected to the recorder. The patient is asked to write down a diary of daily activity including the time and character of any symptoms.

The patient can push a patient event button to mark an event. The patient must write down details about the event in their diary so that physician or technician can relate the event to specific symptoms or activities.

The NorthEast Monitoring SD360 Digital Recorder is a holter monitor designed to facilitate the ambulatory cardiac monitoring, on the order of a physician, of those patients who may benefit from such monitoring including but not limited to those with complaints of palpitations, syncope, chest pains, shortness of breath, or those who need to be monitored to judge their current cardiac function, such as patients who have recently received pacemakers.

The SD360 Digital Recorder package includes:

• SD360 Digital Recorder
• Operation Manual
• SD Card
• Patient Cable
• Pouch

The data obtained by monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring holter analysis system to be analyzed. The Holter Analysis Software was cleared by FDA under K930564.

The SD360 is not intended to replace real time telemetry monitoring for patients suspected of having life-threatening arrhythmias.

The SD360 digital recorder is powered by one 1.5 volt AA alkaline battery (MN1500 or the equivalent), one AA rechargeable NiMH (nickel metal hydride) battery, or one AA Eveready Lithium L91 battery. Batteries should not be re-used for a second patient. The batteries are not included; users are instructed to purchase 2 AA batteries.

The device is compatible with standard silver / silver chloride ECG electrodes. Electrodes are not provided with the subject device. The user is instructed to purchase standard silver / silver chloride ECG electrodes.

The SD360 digital recorder uses NorthEast Monitoring SD360 patient cables with either seven leads or five leads for a 3-channel holter recording. The patient cable connects to the recorder via a 9-pin female connector on the recorder. A patient cable is provided with the SD360 Digital Recorder.

The SD360 has a small LCD that is used to display either time of day (during the recording), error messages (during the hookup procedure or during recording), or lead quality (during the hookup procedure).

The data collected by the SD360 digital recorder is stored on a removable SD Card. To store 24 hours in normal mode, the minimum capacity of the SD Card should be 28 megabytes; 56 megabytes are required for 24 hours in high resolution mode. To store 24 hours in 360 samples/sec mode, 112 megabytes are required. To stored 24 hours in 720 samples/sec, 224 megabytes are required. Double all storage requirements for 48 hour recordings, and triple them for 72 hour recordings. The SD360 is provided with an SD memory card with at least 32 megabytes.

The SD360 is packaged in a plastic bag in a cardboard shipping carton. The shipping carton will also include a patient cable and a pouch. The pouch is used by the patient to hold the digital recorder while in use.

The physician or technician can optionally use a PC as an interface to key in patient information. If a PC were used, the patient information would be keyed into the SD card using the NorthEast Monitoring Holter Analysis software (cleared under a separate 510k).

Another option for entering patient information is through the use of a PDA (i.e. Palm Pilot). Patient information such as patient name, sex, date of birth, identification number, scan number, hookup tech name or initials, physician name, indications, and medications.

The provided text describes a 510(k) submission for the NorthEast Monitoring SD360 Digital Recorder, an ambulatory ECG recorder (Holter monitor). The document focuses on demonstrating substantial equivalence to a predicate device and outlines the device's characteristics and intended use. However, it does not contain information about a study proving the device meets specific acceptance criteria based on its performance metrics.

The "Performance Data" section merely states: "The subject device has been subjected to and passed electrical safety and EMC testing requirements." This indicates compliance with general safety and electromagnetic compatibility standards, but not clinical performance or accuracy in detecting arrhythmias, evaluating treatment efficacy, or pacemaker function.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This is because the provided submission asserts substantial equivalence based on technological characteristics and functional identity with a predicate device, rather than a clinical performance study with defined acceptance criteria for diagnostic accuracy or similar metrics. The focus is on physical specifications, battery life, memory, and connectivity, alongside basic electrical safety.

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The Netlink/Netscan is a transmission software which will transmit ECG, ambulatory blood pressure, EKG, spirometry, and any other data files from a remote site to a central station for analysis using a modem, cable modem, ISDN line, T1 lines, DSL, Internet or Intranet and send the analyzed data back to the remote site from the central site using the same transmission media.

Netlink/Netscan is an accessory to Northeast Monitoring's Holter for Windows Holter Scanner (K930564) that sends recorded cardiac ECG data from remote sites to a central site using standard TCP/IP transfer protocols and where the central site is equipped with Northeast Monitoring's Holter for Windows Holter Scanner for analysis. equipped Monitoring's Holter for Windows Holter Scanner software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data which is analyzed and provides reports on eforms and patterns of consecutive waveforms. The analysis is then returned to the remote site and interpreted by trained medical personnel to diagnose patients with cardiac rhythm patterns.

Netlink/Netscan is an accessory that provides a means to transmit data to and from Northeast Monitoring's Holter for Windows Holter Scanning System . Data can be transferred via modem, cable modems, ISDN lines, T1 lines, DSL, Internet or Intranet. All transferred data is encrypted and is only accessed through a password controlled by the remote and central sites. Netlink/Netscan software contains data checks to prevent the loss or corruption of data during transmission. Nelink/Netscan will resend data if transmission is interrupted.

The provided document is a 510(k) summary for the Netlink/Netscan device, an ECG Transmission System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use. The document does not contain information about specific acceptance criteria, comprehensive device performance studies, sample sizes for testing, expert adjudication, or MRMC studies. It mainly compares the technical specifications and transmission methods of the new device with a predicate device.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document states, "In summary the performance between the two systems were nearly identical and supports the claim that they are substantially equivalent," but does not provide specific performance metrics or acceptance criteria that were met. The comparison focuses on hardware specifications and transmission modalities.

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

Not available. The document does not describe any specific test set or data provenance for a performance study.

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

Not available. The document does not describe the establishment of ground truth by experts for a test set.

4. Adjudication Method for the Test Set

Not available. The document does not describe any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention an MRMC study or any comparison of human reader performance with or without AI assistance. This device is a data transmission system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. The device is a transmission system, not an algorithm providing diagnostic outputs. The "analysis" of ECG data is performed by "Northeast Monitoring's Holter for Windows Holter Scanner software," and then "interpreted by trained medical personnel." The Netlink/Netscan facilitates the transmission of this data.

7. The Type of Ground Truth Used

Not applicable in the context of a diagnostic algorithm. The "ground truth" implicitly refers to the accuracy and integrity of data transmission, not diagnostic accuracy based on expert consensus, pathology, or outcomes data, as this device does not perform diagnosis. The document states that the software "contains data checks to prevent the loss or corruption of data during transmission," implying that the "ground truth" for its function would be successful, uncorrupted data transfer.

8. The Sample Size for the Training Set

Not applicable. The device is a data transmission system, not a machine learning model that requires a training set.

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

Not applicable. As noted above, the device is not an AI/ML model requiring a training set.

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