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The TTM For Windows + is used for Transtelephonic Cardiac Monitoring. It provides the ability to download, present and store the ECG signal via a phone using commercially available transtelephonic cardiac monitoring devices. It only presents the data such as one, two or twelve lead ECG and pacer spikes. There is no age or other physiological limitations using this device TTM For Windows +. It is intended that TTM For Windows + will be used only by a physician and trained technicians. It also acts as a database for patients with or without pacemakers or implantable cardioverter defibrillators.

The TTM For Windows + system is designed and manufactured by Rozinn Electronics Inc. It is a PC based computer that is used for Transtelephonic cardiac monitoring. It consists of a standard PC computer, monitor, printer and proprietary download module. It provides the ability to download, present and store the ECG signal via a phone using commercially available transtelephonic cardiac monitoring devices. TTM For Windows + does not come in contact with the patient. TTM For Windows + does not perform any diagnostic functions. It only presents the data. There is no age or other physiological limitations using this device TTM For Windows +.

The provided 510(k) summary for the TTM For Windows + device does not contain information regarding acceptance criteria or a study that proves the device meets those criteria.

The document explicitly states that the "TTM For Windows + does not perform any diagnostic functions. It only presents the data." The FDA's substantial equivalence determination is based on the device's function as a transtelephonic cardiac monitoring station for downloading, presenting, and storing ECG signals, similar to legally marketed predicate devices.

Therefore, I cannot provide the requested table or answer the questions related to performance studies, ground truth, or expert involvement because this information is not present in the provided text. The device's nature as a data presentment and storage tool means that clinical performance metrics typically associated with diagnostic or therapeutic devices (like sensitivity, specificity, or reader improvement with AI) are not applicable or detailed in this document.

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The Holter Plus ™ Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patients response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery, and/or evaluation of patients with pacemakers.

The need to record, review, edit and archive these ambulatory ECG data is most commonly encountered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.

The Holter Plus™ Ambulatory ECG Analysis System is an ambulatory ECG analysis system comprised of a standard computer display, a standard Personal Computer (PC) based system, and hardware used to acquire the ambulatory ECG data (specifically the Braemar RZ153+ data recorder - 510(k) K993618). The Holter Plus™ Ambulatory ECG Analysis System System can provide the retrospective display, storage and recording (or printing) of ambulatory ECG waveform and annotated data that is provided by the Braemar RZ153+ recorder.

The Holter Plus™ Ambulatory ECG Analysis System allows the assessment and review of a patient's recorded ambulatory ECG records, and presents an analysis for the clinician's review and editing. This product performs a high-speed analysis of the data, classify the data into appropriate ECG morphologies, and allow the results to be printed if desired. The Holter Plus TM does not perform any diagnosis of data, but only displays the ECG morphologies, and associated curves calculated form the data such as heart rate trends and RR variability in graphical form. The physician will be able to review, edit, and print the data collected. The Holter Plus™ will provide information such as when patient-activated events occurred.

The Holter Plus™ Ambulatory ECG Analysis System provides storage of patient data for archiving and printing various reports. This includes waveform and patient parameter data for the ambulatory ECG data and assessment. The waveform and parameter data that has been stored in a patient file can be retrieved and reviewed on the display or printed out on a laser printer.

The Holter Plus™ Ambulatory ECG Analysis System received 510(k) clearance based on its substantial equivalence to several predicate devices. The submission indicates that performance testing was conducted to demonstrate this equivalence. However, the provided document does not contain a detailed table of acceptance criteria or specific reported device performance metrics in numerical form.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Tests demonstrating ambulatory ECG testing equivalence with the predicate devices listed above has been performed, and these results show similar performance with these devices."

However, it does not provide a quantitative table of acceptance criteria (e.g., minimum sensitivity, specificity, accuracy for specific arrhythmia detection) or the specific numerical performance results achieved by the Holter Plus™ system. The claim is based on a general "similar performance" to the predicate devices.

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

This information is not provided in the document. There is no mention of the number of cases or patients used in any test set, nor is there any indication of 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. There is no mention of experts involved in establishing ground truth for any test set or their qualifications.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

An MRMC study was not mentioned in the document. The submission focuses on device equivalence, not on the improvement of human readers with AI assistance. The device's role is described as analysis and display for a clinician's review and editing, but not as an AI-assisted diagnostic tool in the sense of improving human reader performance directly.

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

The description implies standalone performance in terms of its analysis capabilities: "This product performs a high-speed analysis of the data, classify the data into appropriate ECG morphologies..." However, the document does not provide specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) for these classifications. The output is referred to as "analysis for the clinician's review and editing," emphasizing human oversight for diagnosis.

7. Type of Ground Truth Used:

This information is not explicitly stated in the document. Given the nature of Holter monitoring and the "review, edit, and print" functionality for clinicians, it's highly probable that expert review and adjudication (human expert consensus) of the ECG waveforms would form the basis of a "ground truth" if one were established for performance testing. However, this is an inference, not a direct statement.

8. Sample Size for the Training Set:

This information is not provided in the document. The document describes the system's capabilities but does not detail its development process in terms of machine learning training, thus no training set size is mentioned.

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

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

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The intended use of the Holter Recorder Rz153+/ Cardio ID+ is to perform ambulatory ECG and impedance recording, on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording. The data is intended to be downloaded to an analysis software package after the recording is completed.

Detection of Arrhythmia. The Rozinn 153+ 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, syncope, and the symptoms as determined by the physician. Efficacy of treatment using the 153+ 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 is also indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits. This device is to be used only by the order of a physician

The basic operation of the Holter Recorder RZ153+ is to collect and store multiple channels of ECG data along with impedance measurements. The Holter scanner software reads this data and it can be printed out in tabular form or graphical form. This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data. The Holter for Windows software reads this data and provides ability to the user to review, edit and print the data collected.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the structure you requested:

Acceptance Criteria and Device Performance Study for Holter Recorder Cardio ID+ RZ153+

The provided document describes a 510(k) summary for a new Holter Recorder, the Cardio ID+ RZ153+, seeking substantial equivalence to a predicate device, the Holter Recorder DR180 II (K001288). The acceptance criteria are implicitly defined by the technical specifications and performance characteristics of the predicate device. The study performed is a comparison of technology characteristics to demonstrate substantial equivalence, rather than a clinical performance study with specified numerical acceptance criteria for a diagnostic outcome.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the specifications of the predicate device, and the reported device performance is the specifications of the new device.

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The APB for Windows is a software package to be used by a trained physician or health care provider to load, download, review and print data from the Mobile-O-Graph blood pressure monitor. The software will store and playback systolic, diastolic pressures as well as patients heart rates to be reviewed by a trained physician.

The ABP for Windows Software is a software designed to be used in conjunction with I.E.M's Mobile-O-Graph Blood Pressure Monitor, Model ABP Control (K964235). The software will allow the user to program the Mobile-O-Graph using the software by inputting patient identification, protocols and setting recorder clock. The software will have the ability to download the data recorded from the Mobile-O-Graph to the computer to be reviewed by a trained professional. The software will allow the data to be printed and e-mailed in PDF or HTML format if desired. The ABP for Windows does not perform any diagnosis or provide any interpretation of data, it can only display and print the downloaded data such as systolic, diastolic, heart rates and mean arterial blood pressure in tabular or graphical form which was recorded by the Mobile-O-Graph. The physician will be able to review, edit and print the data collected. The ABP for Windows will provide information such as when patient events occurred , errors during recording and when day and night were marked on the Mobile-O-Graph. The software ABP for windows will be shown to be substantially equivalent to the software which is provided by I.E.M.'s Mobile-O-Graph Blood Pressure Monitor, Model ABP Control.

The provided document is a 510(k) premarket notification for the "ABP for Windows" software, which is designed to be used with the Mobile-O-Graph Blood Pressure Monitor (K964235). The submission focuses on demonstrating substantial equivalence to the predicate device's software.

Based on the provided text, the ABP for Windows software does not perform any diagnosis or provide any interpretation of data. It is purely for displaying, storing, and printing data recorded by the Mobile-O-Graph, which is then reviewed by a trained professional. Therefore, the concept of "acceptance criteria" related to diagnostic performance metrics (like sensitivity, specificity, AUC) and a "study that proves the device meets the acceptance criteria" in the traditional sense of AI/CADe devices for interpretation is not applicable here.

The "study" described is a comparison of technological characteristics to demonstrate substantial equivalence, rather than a clinical performance study.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

As the device is software for data management (displaying and printing) and not for diagnostic interpretation, the acceptance criteria are related to its functional compatibility with the predicate device's software and its ability to process and display the blood pressure data accurately.

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

Not applicable. This is not a study involving a "test set" of patient data for diagnostic performance evaluation. The "tests" mentioned are for software safety and efficacy, likely functional testing and compatibility, not based on patient data provenance.

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

Not applicable. There is no diagnostic "ground truth" establishment described, as the software does not perform diagnosis or interpretation.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is not relevant for this software's intended use, which is data management, not diagnostic assistance.

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

Yes, in a conceptual sense related to software functionality. The comparison of technological characteristics against the predicate software evaluates the "algorithm only" in terms of its ability to manage and display data, rather than interpret it. The software's performance is standalone in that it processes and presents data without human intervention in the data processing step, but human review is required for interpretation.

7. The type of ground truth used

Not applicable for diagnostic performance evaluation. For functional equivalence, the "ground truth" would be the demonstrated functionality of the predicate device's software and the specified technical requirements for the new software.

8. The sample size for the training set

Not applicable. This software does not use machine learning or AI models that require a "training set" of data.

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

Not applicable. No training set is involved.

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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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