Search Results

The Heartlab HeartStation™ ECG Management System is a comprehensive data management solution which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.

The Ascentia HeartStation™ ECG Management System ("HeartStation™") is a comprehensive data management solution, which automates the processing, storage and display of electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation™ accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ("serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.

HeartStation™ allows access to ECG records from web-enabled PCs throughout a network. Authorized clinical users may also access HeartStation™ from remote locations, including a home office. The type of access that is permitted depends on the clinical user within the healthcare enterprise, and can include the ability to produce confirmed, signed diagnostic reports

Comprehensive workflow management software enables HeartStation™ to be tailored to the needs of the enterprise, resulting in the highest possible level of automation for routine tasks. The processing of an ECG can be adjusted depending on a patient's stage within the care process, from an emergency event to a routine follow-up test. Final ECG reports are distributed by printing, faxing, e-mailing and automatic exporting to other systems, including an electronic medical record.

A patient's confirmed ECGs become a part of his or her cardiology information and image record within the Heartlab Ascentia™ database. Authorized clinicians may review patients' integrated ECG, X-ray Angiography, Echocardiography and other cardiology tests through a web-enabled Ascentia PortalTM.

This document does not contain information about acceptance criteria or a study proving the device meets those criteria. It is a 510(k) summary for the Heartlab Ascentia HeartStation™ ECG Management System, outlining its description, intended use, substantial equivalence to predicate devices, and regulatory compliance.

Specifically, it includes:

• Identification of the product: Ascentia HeartStation™ ECG Management System.
• Device Description / Intended Use: Automates processing, storage, and display of ECGs, normalizes 12-lead ECGs, measures, interprets, performs serial comparisons, stores with preliminary diagnoses, allows physician review and modification, electronic signature, and distribution of reports.
• Substantial Equivalence Information: Compares the device to several predicate devices (Dräger-Siemens Infinity MegaCare, Burdick Eclipse ECG, Philips Tracemaster ECG Management System, Quinton Pyramis ECG Management System), highlighting similarities in function, user interface, operating systems, record export, web software, and the use of the Glasgow Interpretive ECG Program or Philips 12-lead algorithm for measurement.
• Standards: Lists various safety and performance standards the device is designed to meet.
• Summary of Design Control Activities: Describes the quality assurance design control measures applied during development, including risk analysis, requirement reviews, design reviews, and various levels of testing.
• FDA 510(k) Clearance Letter: Confirms the substantial equivalence of the device to legally marketed predicate devices.
• Indications for Use: Reiteration of the device's function as a comprehensive ECG data management solution.

The document does not provide:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets or data provenance.
3. Information on experts used for ground truth or their qualifications.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

Ascentia ™ (formally Encompass™) is a picture archiving and communications system intended to be used as a networked cardiovascular information and image data storage and display system. Ascentia™ is comprised of modular software programs that run on standard "off-the-shelf" personal computers and servers running the Windows 2000/2007/XP operating system. Ascentia™ accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging equipment from multiple OEM vendors. The system provides the capability to, consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative analysis on cath images, generate and review patient reports with additional measurement capabilities and provides accessible digital image archive. Ascentia™ is a scalable network solution that can be used in small areas and departments (with 2 or 3 users) to large hospital networks (with tens of users).

Ascentia is a picture archiving and communications system intended to be used as a networked cardiovascular information and image data storage and display system. Ascentia is comprised of modular software programs that run on standard "off-the-shelf" personal computers and servers running the Windows 2000/2007/XP operating system. Ascentia accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging equipment from multiple OEM vendors. The system provides the capability to, consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative analysis on cath images, generate and review patient reports with additional measurement capabilities and provides accessible digital image archive. Ascentia is a scalable network solution that can be used in small areas and departments (with 2 or 3 users) to large hospital networks (with tens of users).

The provided document is a 510(k) summary for the Ascentia™ (formerly Encompass™) device, which is an Image Processing System classified as a Picture Archiving and Communications System (PACS). This submission primarily focuses on establishing substantial equivalence to predicate devices rather than proving a pre-defined set of acceptance criteria through a specific study.

Therefore, the document does not contain information related to specific acceptance criteria, a study designed to prove the device meets these criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. The provided text is a regulatory filing, not a scientific publication detailing performance testing against specific metrics.

The "Substantial Equivalence Information" section details the comparison of features between the Ascentia device and its predicate devices, Agfa Corp. Impax and Philips Inturis Suite. This comparison serves as the "study" for substantial equivalence, rather than a clinical performance study with predefined acceptance criteria.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

No explicit acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are defined or reported in the document. The "performance" is demonstrated through feature comparison for substantial equivalence.

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

• Sample Size: Not applicable/Not mentioned. The comparison is based on features of the predicate devices and the new device, not on a test set of data.
• Data Provenance: Not applicable/Not mentioned.

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

• Number of Experts: Not applicable/Not mentioned. Ground truth as typically understood for clinical performance studies is not established here.
• Qualifications of Experts: Not applicable/Not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/Not mentioned.

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

• MRMC Study: No, an MRMC study was not done or reported in this document.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:

• Standalone Study: Not applicable. Ascentia is described as an "Image Processing System" and "picture archiving and communications system" that assists with viewing, analysis, and reporting, implying a human-in-the-loop interaction rather than a standalone algorithmic performance. No standalone performance metrics are provided.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not applicable. The submission is based on a functional comparison of features against existing legally marketed predicate devices, not against a clinical "ground truth" like pathology or outcome data.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable/Not mentioned. This document does not describe a machine learning algorithm that requires a training set.

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

• Ground Truth Establishment: Not applicable/Not mentioned.

Summary of what the document explains regarding "proof of meeting acceptance criteria":

The document establishes "substantial equivalence" by comparing the technical characteristics and functionality of the Ascentia™ device to two legally marketed predicate devices (Agfa Corp. Impax and Philips Inturis Suite). The "proof" is the demonstration that Ascentia™ offers similar techniques and the same functionality for DICOM compliant image distribution over a network as the predicate devices, and in some aspects, like display rate, it even exceeds them. This comparison fulfills the regulatory requirement for a 510(k) submission seeking market clearance for a device that is substantially equivalent to a predicate.

Ask a specific question about this device

The Ultrasound Capture System™ (UCS) system captures analog video and audio from any ultrasound with a composite or S-video output and converts the captured video to DICOM image and audio files. UCS software runs on a standard "off-the-shelf" personal computer running the Windows XP operating system and a high-resolution video acquisition interface.

The Ultrasound Capture System™ (UCS) system captures analog video and audio from any ultrasound with a composite or S-video output and converts the captured video to DICOM image and audio files. UCS software runs on a standard "off-the-shelf" personal computer running the Windows XP operating system and a high-resolution video acquisition interface.

1. Allows demographic (Patient Name, ID etc.) input consistent with the DICOM standard for image storage.
2. Performs automatic image acquisition triggered by the cine-pedal.
3. Performs network transmission of images in DICOM format to a DICOM compatible storage system.

The provided text describes the Heartlab Inc. Ultrasound Capture System (UCS), a device for capturing analog ultrasound video and audio and converting it to DICOM files.

Here's an analysis of the acceptance criteria and the study (or lack thereof) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the design control activities that were performed to ensure the device met its specifications. However, it does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., image quality, conversion speed, accuracy of DICOM conversion) and their corresponding reported device performance values in a direct comparison.

Instead, the document states:
"All verification and validation activities were performed by the designated individual(s), and the results demonstrated that the predetermined acceptance criteria were met."

This implies that acceptance criteria were established internally as part of the design control process, but the specific details and the performance against them are not disclosed in this 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices based on functional characteristics and adherence to industry standards.

The closest to "acceptance criteria" are the mentioned design control measures and adherence to standards:

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

The document does not specify a sample size for a test set in the context of clinical performance or diagnostic accuracy. The testing described (unit, integration, acceptance, performance) likely refers to software and system functionality testing, not a clinical study involving a dataset of patient images. Therefore, details like country of origin or retrospective/prospective nature are not applicable for this submission.

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

Since there's no mention of a clinical or image-based test set requiring ground truth established by experts, this information is not provided. The device converts analog signals to DICOM; it does not perform diagnostic interpretation.

4. Adjudication method for the test set:

Not applicable, as no clinical or image-based test set requiring expert adjudication 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 MRMC study was conducted or mentioned. This device is an image capture and conversion system, not an AI-powered diagnostic or assistive tool for human readers.

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

The device itself is a standalone system in terms of its function (capturing and converting). The performance testing mentioned ("Performance testing" under Design Control) would assess its ability to perform these functions independently. However, this is not an "algorithm only" in the sense of an AI algorithm performing a diagnostic task. The document implies that the system's performance (e.g., successful capture, correct DICOM conversion, maintaining specified compression ratios) was verified, but specific quantitative results are not provided in this public summary.

7. The type of ground truth used:

Given the nature of the device (capture and conversion), the "ground truth" for its verification and validation would likely involve:

• Known input signals: Using standardized analog video/audio signals (e.g., test patterns, known cine loops from an ultrasound machine) to verify correct capture.
• DICOM standard conformance: Verifying that the output files adhere strictly to the DICOM 3.0 standard.
• Data integrity: Comparing captured digital images/audio with the original analog source to ensure no loss or degradation beyond expected compression.
• Metadata accuracy: Verifying that demographic and study information is correctly embedded in the DICOM headers.

No clinical "ground truth" (e.g., pathology, outcomes data, expert consensus on disease presence) is relevant for this type of device.

8. The sample size for the training set:

Not applicable. This device is an image capture and conversion system, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

Encompass™ is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. Encompass™ is software comprised of modular software programs that run on standard "off-the-shel?' personal coonyters and servers running the Windows 2000/XP operating system. Encompass™ is image data surage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging transfer. The system provides the capability to; consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative measurements on both cath and ultrasound images, perform quantitative analysis on cath images, generate and on voview patient reports with additional measurement and report writer capabilities and provides accessible digital image archive. Encompass™ is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).

Encompass™ is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. Encompass™ is software comprised of modular software programs that run on standard "off-the-shelf" personal computers and servers running the Windows 2000/XP operating system. Encompass™ is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging transfer. The system provides the capability to; consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative measurements on both cath and ultrasound images, perform quantitative analysis on cath images, generate and review patient reports with additional measurement and report writer capabilities and provides accessible digital image archive. Encompass™ is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users). The original core functionality is detailed below:

1. Review of x-ray angiography, ultrasound, intravascular ultrasound, computed tomography (CT), nuclear medicine, and magnetic resonance imaging (MRI) images.
2. Compare images from different studies on one or two monitors, regardless of modality.
3. Perform report data entry and view the report.
4. Print, save as mpeg/avi, save as bitmap, and copy to clipboard any image(s).
5. Perform standard image processing such as brightness, contrast, gamma, sharpen, window/level, invert, pan, zoom, and digital subtraction.
6. Perform standard stop, start, single frame advance and reverse, previous/next image playback, and various standard clinical presentations.
7. Control the speed of playback.
8. Use a supported jog wheel to control playback.
9. Play/repeat a subset of a loop with user defined begin and endpoints.
10. Search sources for studies based on demographic information.
11. Copy any study or subset of study from any supported source to any supported destination.
12. Write DICOM study to CD/DVD for interchange.
13. Calibrate the monitor to a SMPTE pattern.

The provided text does not contain detailed information about acceptance criteria and a specific study proving that the device meets these criteria in the format requested. The document is a 510(k) summary for the Encompass™ Cardiac Network Image Processing System, which describes the device, its intended use, and substantial equivalence to predicate devices, along with design control activities.

However, based on the Summary of Design Control Activities section, the document states:

"All verification and validation activities were performed by the designated individual(s), and the results demonstrated that the predetermined acceptance criteria were met."

This indicates that some form of testing was done to verify the device met pre-defined criteria, but the specifics of these criteria, the study design, and the reported performance are not detailed for most of the requested points.

Here's a breakdown of what can be inferred or directly stated from the text, and where information is missing:

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

The document broadly mentions "predetermined acceptance criteria were met" but does not provide a table specifying what these criteria were or the quantitative performance metrics achieved by the device. The listed standards (DICOM, 21 CFR 1020.10, SMPTE, etc.) imply compliance, but actual performance against these is not detailed.

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 in the document. The text mentions "Integration testing (System verification)" and "Final acceptance testing (Validation)" but does not specify the dataset used for these tests, its size, or its 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 in the document. The device is for "diagnostic quality image review" and "aid in diagnosis," implying expert involvement, but details on how ground truth was established for testing are absent.

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

This information is not provided in the document.

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

This information is not provided in the document. The device offers "analysis and measurement capabilities" and "graphical representation," but there's no mention of a comparative effectiveness study with human readers or AI assistance effect sizes.

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

The document describes the device as "image data storage and display software" with capabilities for "quantitative measurements" and "quantitative analysis." While it performs these functions, it's considered a system for medical professionals to use. The text does not explicitly detail a standalone algorithm-only performance study without human-in-the-loop interaction. Its design implies it's an assistive tool.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. The document primarily focuses on a modification to existing software and its compliance with standards and design control. It does not describe a machine learning model's training process.

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

This information is not provided in the document.

Ask a specific question about this device

Ask a specific question about this device