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The QRS-Card Cardiology Suite 4.0™ 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 exercise/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 associations and medical professional, and not intended for any home use applications.

The Cardiology Suite 4.0™ 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 DXP1000 data recorder - 510(k) K993618). The Cardiology Suite 4.0TM 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 XP 1000 recorder.

The Cardiology Suite 4.0™ 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 Cardiology Suite 4.0™ does not perform any diagnosis of data, but only displays the ECG morphologies, and associated curves calculated form the data but only displays the LCG morphologics, and graphical form. The physician will be able such as heart rate trends and RR variability in graphical form. A PM will provide such as nearl Tate trends and ICC variability in grapped on will provide io roviow, och, as when patient-activated events occurred.

The Cardiology Suite 4.0™ Ambulatory ECG Analysis System provides storage of The Cardionogy Sunte 4.0 - Finouiing various reports. This includes waveform and patient data for atchiving and priming furtous i dpata 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 provided text describes the "Cardiology Suite 4.0™ Ambulatory ECG Analysis System" and outlines its intended use and comparison to predicate devices, but lacks detailed information about specific acceptance criteria and a structured study proving those criteria are met. 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."

And, "Conformance to the product development procedures and plans have been assured by the application of the system tests, design reviews, and product verification and validation testing performed prior to product release."

However, it does not provide the quantitative data, detailed methodology, or specific acceptance criteria that would typically be found in a study report. Therefore, I cannot fully complete the requested table and study description as much of the information is not present in the provided text.

Based on the available text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that tests demonstrating equivalence were performed and showed similar performance, but it does not quantify specific acceptance criteria (e.g., sensitivity, specificity, accuracy for arrhythmia detection) or provide exact performance metrics for the Cardiology Suite 4.0™ or its predicate devices. The table below represents the implied acceptance criteria based on intended use and comparison to predicate devices, but the specific numerical targets and results are absent.

Study Proving Device Meets Acceptance Criteria

The provided text only briefly mentions "Summary of Performance Testing" without detailing a specific study.

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

• Not explicitly stated. The document mentions "tests demonstrating ambulatory ECG testing equivalence," but does not provide details on the sample size of the test set, number of recordings, patient demographics, or data provenance (e.g., country of origin, retrospective/prospective nature).

2. 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 explicitly stated. The document refers to analysis for "clinician's review and editing" and intended use by "medical professionals" and "trained physician or health care professional," but does not specify the number or qualifications of experts involved in establishing ground truth for any testing.

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

• Not explicitly stated. The document does not describe any specific adjudication methods used for the test set.

4. 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 explicitly stated. The document discusses the device as an "Ambulatory ECG Analysis System" that aids clinicians in reviewing and editing data. It doesn't present itself as an "AI assistance" device in the modern sense or detail an MRMC study comparing human performance with and without its aid. The focus is on its function as an analysis and display system for existing ECG data.

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

• Not explicitly stated. The device is described as providing "an analysis for the clinician's review and editing," indicating a human-in-the-loop design. A standalone performance evaluation is not mentioned.

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

• Not explicitly stated. Given the nature of ECG analysis, ground truth for arrhythmias would typically be established by expert cardiologists reviewing the raw ECG tracings manually, possibly through expert consensus, but the document does not specify this.

7. The sample size for the training set:

• Not applicable / Not explicitly stated. The document does not describe a machine learning or AI model that would require a distinct "training set." It refers to "software" for data analysis, which might involve rule-based systems or traditional signal processing algorithms rather than trainable models with specific training data.

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

• Not applicable / Not explicitly stated. As there's no mention of a training set, the method for establishing its ground truth is also not mentioned.

Summary of Device and its Claimed Performance:

The Cardiology Suite 4.0™ Ambulatory ECG Analysis System is a software and hardware system designed for the retrospective display, storage, and analysis of ambulatory ECG data acquired from a Braemar DXP1000 recorder. It performs high-speed analysis, classifies ECG morphologies, and displays trends like heart rate and RR variability. The system's purpose is to assist medical professionals in the review and editing of patient ECG records, enabling evaluation of arrhythmias, ischemic attacks, and other cardiac conditions.

The manufacturer claims that "Tests demonstrating ambulatory ECG testing equivalence with the predicate devices listed above has been performed, and these results show similar performance with these devices." The FDA's 510(k) clearance indicates that the device was found "substantially equivalent" to predicate devices, implying that its performance is considered acceptable for its intended use, although the specific metrics and study details are not provided in this summary.

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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 VX3 digital Holter recorder is intended for the recording of ECG data collected from ambulatory patients. The recorder can collect data in the presence of implanted pacemaker pulses, and can detect and record the occurrence of signals characteristic of pacemaker pulses. The recorder is used under the order of a physician, who reviews the data after downloading and processing by a Holter playback system. The physician determines the presence of normal and abnormal ECG data as well as pacemaker pulses during the events of the patient's daily activity.

The VX3 is a lightweight, compact, digital Holter recorder designed for the recording of ECG data collected from ambulatory patients. A derivative of the Datrix DR512 digital Holter recorder, the VX3 has enhanced features, including an LCD to verify leadwire hookup and display recorder status and error messages, optional keypad for selection of various options, and optional pacemaker pulse detection. Various channel and lead configurations are accommodated by using the appropriate leadwire set without additional recorder reconfiguration. Data are recorded on industry standard compact flashcards for subsequent download and to a Holter playback system. Sampling rates are factory programmable to accommodate compatibility with various OEM Holter playback systems.

The provided document is a 510(k) Premarket Notification Summary for the Datrix VX3 Series Digital Holter Recorder. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a new performance study with detailed acceptance criteria and expert reviews of an AI/algorithm-based device.

Therefore, the document does not contain the information requested in the prompt, such as detailed acceptance criteria for an AI device, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, type of ground truth used, or details about the training set for an algorithm.

The document primarily focuses on:

• Device Description: The VX3 is a digital Holter recorder for ECG data collection from ambulatory patients, with features like an LCD, optional keypad, and optional pacemaker pulse detection.
• Intended Use: Recording ECG data and pacemaker pulses for physician review after processing by a Holter playback system.
• Predicate Device Comparison: A table comparing the Datrix VX3 to the Datrix DR512 and Braemar DXP1000 across functional, physical, environmental, and electrical specifications. This comparison is used to establish substantial equivalence, meaning the safety and effectiveness of the new device are similar to legally marketed devices.

Conclusion: The provided text describes a medical device's technical specifications and its comparison to predicate devices for regulatory clearance, but it does not detail acceptance criteria or a study proving device performance in the context of an AI/algorithm-based system as requested.

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