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This device is intended for use as a patient monitor for any patient undergoing ECG S-T Segment Analysis and/or ECG stress analysis during rest or exercise. Exercise can be performed treadmill or bicycle ergometer use. The intended use locations are either in a physician's office, hospital or rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in a hospital environment, physician's office, or similar settings. This device is not intended for home use.

The QRS CARD™ S-T Segment Analysis Patient Monitoring System converts a commercially available personal computer (PC) into an ECG monitor with ST segment measurement capability. Physicians can initiate ST evaluations on patients and the data are transmitted, using Bluetooth wireless technology, to a computer screen. Test results can also be printed at any time during the testing, or saved in computer memory for future review or additional report generation. The QRS CARD™ S-T Segment Analysis Patient Monitoring System consists of the following components: The QRS CARD™ Office ECG Device, ECG Patient Cable and Lead Wires, Product Software on CD, User Manual.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets these criteria. The document is a 510(k) Summary for a "Special 510(k)" modification, stating that the technological characteristics of the device are "safe and effective and substantially equivalent to the legally marketed predicate devices." This type of submission generally relies on demonstrating equivalence to existing devices rather than presenting new clinical study data against defined performance metrics.

However, based on the information provided, here's what can be extracted and what is missing:

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

This information is not provided in the document. The document primarily focuses on the device description, intended use, and substantial equivalence claim to predicate devices. It does not list specific numerical acceptance criteria or present performance data from a study.

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

This information is not provided. As no specific performance study is detailed, there is no mention of a test set, sample size, or data provenance.

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. There is no mention of experts or ground truth establishment for a test set.

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

This information is not provided.

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

There is no indication that an MRMC comparative effectiveness study was done. The device is described as converting a PC into an ECG monitor with ST segment measurement capability, implying it's a diagnostic tool, not an AI-assisted reading system for human improvement.

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

The document does not detail any standalone algorithm performance study.

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

This information is not provided.

8. The sample size for the training set

This information is not provided. If the device uses algorithms that require training data, there is no mention of such a training set or its size.

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

This information is not provided.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance data from a new study against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the given text.

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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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This device is intended for use as a patient monitor for any patient undergoing ECG ST Segment Analysis and/or ECG Stress Analysis during resting or exercise. Exercise can be performed during treadmill or bicycle ergometer use.

This device is capable of performing automatic computerized ECG Interpretation during resting condition. This device does not support automatic ECG Interpretation for neonatal use.

The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use.

Not Found

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) clearance letter from the FDA for the QRS Card™ S-T Segment Analysis Patient Monitoring System III.

This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. However, it does not include the detailed performance data, study design, or acceptance criteria that would typically be part of a submission's technical documentation.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device