Search Results

Horizon Cardiology ECG™ is a system for importing, storing, displaying and reviewing ECG procedures. Horizon Cardiology ECG is intended for use in the hospital environment by medical professionals.

HC ECG™ is a software application designed for use in various hospital departments, to import, display, store, analyze, distribute and process ECG procedures from resting ECG devices.

The HC ECG™ is intended to provide analysis or reanalysis of resting ECG's and to provide preliminary data for editing and confirmation by an over-reading physician. The HC ECG™ may provide a serial comparison of ECG data to facilitate the review of the patient's current ECG with previous ECG's of the same patient.

HC ECG™ is a comprehensive ECG management system for importing ECG waveform data, reviewing and performing measurements, diagnosis and comparison of ECG procedures and storing the data for future review and management.

HC ECG™ functions as a non-real time system. It receives ECG procedure files after the cessation of the ECG procedure, which can originate from any one of a variety of manufacturer's cardiographs. HC ECG™ acquires the ECG waveforms through a network connection or via a diskette, and normalizes them to a common format. If the ECG cart has made an ECG procedure analysis, HC ECG™ presents it and utilizes the Glasgow University Interpretive Algorithm to perform its own measurements, diagnosis and serial comparison without changing the raw waveform data.

The HC ECG™ graphic user interface provides tools that enable the physician to:

• edit measurements. .
• edit procedure diagnoses. .
• review numerous ECG procedures concurrently. .
• confirm ECG procedures. .
• distribute and print ECG procedure reports.

HC ECG™ complies with HL7 standards for export of reports to the Hospital Information System. HC ECG™ supports final ECG report distribution by printing, faxing, e-mailing and automatic export to other systems. The Horizon Cardiology ECG™ database complies with the requirements of HIPAA through robust password security, record access security and file allocation in a secure and managed server.

Horizon Cardiology ECG ™ allows access to ECG records from web-enabled PCs throughout a network and enables authorized clinical users to access the system from remote locations.

The provided documentation is a 510(k) summary for the Horizon Cardiology ECG™ system. It describes the device, its intended use, and indicates that it has been found substantially equivalent to predicate devices. However, the document does NOT contain information about specific acceptance criteria or a study that proves the device meets those criteria. Such detailed performance data and study results are typically found in the full 510(k) submission, which is not publicly available in this summary format.

Therefore, I cannot provide the requested information based solely on the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical performance study with acceptance criteria.

To answer your request, if the information were available, here's how it would be structured and what details would be needed:

Acceptance Criteria and Device Performance Study (Information Not Found in Provided Text)

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The Windsurfer is a system for acquiring, digitizing, storing, displaying and reviewing hemodynamic data (vital signs). The Windsurfer is intended for use in hospital cardiac catheterization laboratories.

Windsurfer is a standard hemodynamic monitoring system for monitoring vital signs before, during and after catheterization procedures. Windsurfer is intended to acquire, display, store, analyze and process vital signs and log all cath lab activity. There are tools for entering measurements, calculations and procedure notes. Windsurfer also acquires patient information from other hospital information systems and makes hemodynamic information available to them. Windsurfer is connected to a patient in the cath lab via: - ECG leads . - Invasive Blood Pressure transducers . - . SpO2 finger clip - NIBP cuff . Windsurfer uses an intuitive interface that clearly displays patient data, procedure data, waveforms and numeric values. The performing physician views the monitor in the cath lab and conveys instructions and procedure notes to the certified technician, who operates the application using a touch screen, keyboard and mouse, for maximum convenience.

Here's an analysis of the provided text regarding the Windsurfer device, focusing on the acceptance criteria and study information.

It is important to note that the provided text is a Summary of Safety and Effectiveness for a 510(k) submission. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and typically does not contain detailed information about performance studies, acceptance criteria, sample sizes for training/test sets, ground truth establishment, or multi-reader studies. These details are usually found in the full 510(k) submission, particularly in sections related to performance testing.

Based on the provided text, many of your requested items cannot be fully answered.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state any quantitative acceptance criteria or detailed performance metrics from a specific study for the Windsurfer device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (VERICIS Physiolog, K013032). The "performance" mentioned is implicitly that it performs as intended as a hemodynamic monitoring system.

2. Sample size used for the test set and the data provenance

The document does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance study. The 510(k) summary relies on comparison to a predicate device rather than presenting results from a de novo clinical trial with a defined test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not describe any process for establishing ground truth using experts, as it does not report on a specific performance study that required such an evaluation.

4. Adjudication method for the test set

The document does not describe any adjudication method as it does not report on a specific performance study where expert consensus or adjudication would be required.

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

The document does not mention any MRMC comparative effectiveness study and does not refer to AI assistance. The Windsurfer is described as a "standard hemodynamic monitoring system," not an AI-powered diagnostic tool that assists human readers.

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

The document does not mention any standalone algorithm performance testing. The device is described as a monitoring system operated by a certified technician with a physician viewing the monitor.

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

The document does not specify any type of ground truth, as it does not present data from a performance study that would require such a determination.

8. The sample size for the training set

The document does not mention a training set sample size. This device, as described, is a data acquisition and display system, not a machine learning or AI algorithm that typically requires a training set.

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

The document does not mention a training set or how ground truth for it would be established, as it's not a machine learning device.

In summary: The provided 510(k) Notification for Windsurfer is a high-level summary that establishes substantial equivalence to a predicate device. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in full regulatory submissions for devices requiring extensive clinical performance testing. This type of device (a hemodynamic monitoring system) typically demonstrates performance through verification and validation activities (e.g., electrical safety, EMC, software validation) and comparison to the predicate, rather than large-scale clinical trials with extensive ground truth establishment by experts.

Ask a specific question about this device

The TCS is a software device intended to acquire, print, archive and communicate catheterization laboratory image studies, and to view these images on a PC in real-time mode. In addition, the TCS is intended to provide image enhancement and filtering tools for the viewing of selected images, to import and generate DICOM CDs, to prepare reports in Microsoft® Word format and to export DICOM images into commercial file formats.

The TCS provides a complete software tool for the convenient and efficient recording, storage, review, and communication of heart catheterization and other angiographic studies In the catheterization lab environment. The TCS also creates DICOM 3.0 CDs from the cath lab procedures. The TCS operates on a WindowsNT® PC. The TCS automatically acquires the x-ray video signal and places each video inside the patient's file. The patient file may also contain single images from a video, and reports (which automatically include the full patient details and selected images from the procedure) in Microsoft® Word format. During the review of videos and single images, image enhancement tools, such as zooming, magnification, full screen view, playback loop and brightness, contrast and gamma controls may be applied. As well as creating DICOM CDs, the TCS can also import data from DICOM CDs into its database, where they are written as patient files. Data may also be introduced to the TCS via telecardiology over an ISDN line, enabling professional consultation and referral of patients from level to level of the cardiac health care system. The patient files sent and received via telecardiology may also have vocal and graphic annotations attached to them. All new patient files, whether acquired from x-ray, imported from a DICOM CD, or received via telecardiology, are logged so that their source and ownership may easily be determined.

The provided text describes a medical device, the TCS - Medcon's Telecardiology System, and its submission for 510(k) clearance. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The text is a summary of safety and effectiveness, indicating that the device is substantially equivalent to a predicate device (ComView's WriteStar and ViewStar System K964274). It describes the device's functions, such as acquiring, storing, reviewing, and communicating heart catheterization and angiographic studies, creating DICOM 3.0 CDs, and providing image enhancement tools.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details because it is not present in the provided input.

Ask a specific question about this device

The MOVIEW is a software device vicently , print and save cardia. In the same income studio refrieve refrieve, display, profit and into in a mage studio cathelerization faboration and to view these real-Time mode PC images on Cu

The MDVIEW is a software device intended to retrieve, display, print and save cardiac catheterization laboratory image studies from CD-R media, and to view these images on a PC computer in real time mode. Digital imaging from the cardiac catheterization laboratory is recorded on the CD-R in conformance with the DICOM standard. These loss free images provide physicians with a valuable tool for diagnostic review and analysis.

The provided document is a 510(k) premarket notification for a medical image communication and storage device (MDVIEW-MEDCON's DICOM Viewer). It does not contain typical acceptance criteria or a detailed study proving device performance in the way modern AI/ML medical devices would.

This document is from 1997, a time before the widespread use of AI/ML in medical devices, and it concerns a Picture Archiving and Communication System (PACS) device. For such devices, "performance" relates to their ability to accurately display, store, and retrieve medical images, ensuring image integrity and compatibility with standards like DICOM. The review process for such devices would focus on demonstrating technical functionality and equivalence to existing devices rather than a detailed clinical performance study with statistical endpoints.

Therefore, many of the requested sections about acceptance criteria, study details, human reader performance, and ground truth establishment, as they apply to clinical performance of an AI/ML algorithm, are not applicable or available in this document.

However, I can extract the relevant information that is present:

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

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided. This document does not describe a clinical performance study with a test set of patient data to evaluate diagnostic accuracy. The assessment focuses on technical and functional equivalence to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided. No ground truth establishment for a test set is mentioned, as there was no clinical performance study in the context of an AI/ML diagnostic aid.

4. Adjudication method for the test set

• Not Applicable / Not Provided. No test set or adjudication method is 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

• No. This device is a PACS viewer, not an AI diagnostic aid. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant to this submission.

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

• Not Applicable / Not Provided. This is a PACS viewer, not an algorithm. Standalone performance as understood for AI/ML algorithms is not relevant to this device's regulatory review.

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

• Not Applicable / Not Provided. The concept of "ground truth" for a diagnostic outcome is not relevant to a PACS device's functional equivalence review. The "truth" in this context refers to the accurate display and storage of the original, unadulterated medical images.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no mention of a training set as this is not an AI/ML device.

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

• Not Applicable / Not Provided. No training set or ground truth establishment is described.

Ask a specific question about this device