(64 days)
StatNet is intended for the storage, distribution to any of several work stations, viewing, interpretation and annotation of X-ray of coronary anatomy that have been obtained in coronary catheterization laboratories and written on DICOM-3 CD-ROM media.
StatNet is a network of image display, processing, and archiving modules composed of general purpose, personal computer level, digital hardware; commercial, general purpose digital communication hardware; general purpose operating systems and communications software; medical image analysis and processing software developed by others; and proprietary software modules developed by GORCA that integrate the preceding components into a complete system. Images enter the network on DICOM-3 CD-ROM media.
The provided text describes a PACS system called StatNet and compares its features to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria for device performance, nor a study proving it meets such criteria. The document is a 510(k) summary, which focuses on device description and comparison to predicates for regulatory clearance, not performance validation studies against specific acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance, as this information is not present in the provided text.
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K 970525 GORCA MEDICAL TECHNOLOGIES
510(k) Summary for GORCA Medical Technologies StatNet Prepared February 6, 1997
APR 1 6 1997
GORCA Medical Technologies Submitted by: 300 West Route 38 Moorestown, NJ 08057
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Donald G. Herzog Contact Person: Vice President, Medical Technologies
Device Trade Name: StatNet. -
Picture Archiving and Communication System (PACS) Common name: for cardiology departments.
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Accessory to angiographic X-ray system (892.1600) or PACS, product code Classification: LLZ, consisting of a combination of medical image storage devices, product code LMB, and medical image communication devices, product code LMD, to which image processing and display functions have been added.
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Predicate Device: Camtronics Archium manufactured by Camtronics Ltd., 900 Walnut Ridge Drive, Hartland, WI (K934496).
Description of Device:
StatNet is a network of image display, processing, and archiving modules composed of general purpose, personal computer level, digital hardware; commercial, general purpose digital communication hardware; general purpose operating systems and communications software; medical image analysis and processing software developed by others; and proprietary software modules developed by GORCA that integrate the preceding components into a complete system. Images enter the network on DICOM-3 CD-ROM media.
Intended Use of Device:
StatNet is intended for the storage, distribution to any of several work stations, viewing, interpretation and annotation of X-ray of coronary anatomy that have been obtained in coronary catheterization laboratories and written on DICOM-3 CD-ROM media.
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Statement of Substantial Equivalence
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| Function or Variable | STATnet | Predicate | |||
|---|---|---|---|---|---|
| IMACS | EIGEN | Camtronics | |||
| 1 | Electronic Equivalent ofCine Review | Yes | Yes | Yes | Yes |
| 2 | Cine-like ControlTechniques | Pan and Zoom, Frame RateControl, Window and LevelAdjustments, Image Inversion | Pan and Zoom, Frame RateControl, Window and LevelAdjustments, Image Inversion | Pan and Zoom, Frame RateControl, Window and LevelAdjustments, Image Inversion | Pan and Zoom, Frame RateControl, Window and LevelAdjustments, Image Inversion |
| 3 | Vessel Measurements | Yes, Using NIH Image Software | Yes, Under Proprietary Method | Yes, Under Proprietary Method | Yes, Under Proprietary Method |
| 4 | Display Resolution | 512x512, 512x1024, and1024x1024 Pixels | 512x512 and 512x1024 Pixels | 512x512, 512x1024, and1024x1024 Pixels | 512x512, 512x1024, and1024x1024 Pixels |
| 5 | Image Enhancement | Real-Time Digital EdgeEnhancement While Displaying | Real-Time Digital EdgeEnhancement While Displaying | Real-Time Digital EdgeEnhancement While Displaying | Real-Time Digital EdgeEnhancement While Displaying |
| 6 | Case Storage Technique | As a Single Patient Record | As a Single Patient Record | As a Single Patient Record | As a Single Patient Record |
| 7 | Interchange of CardiacAngiographic Studies | CDR DICOM 3.0 FormattedDisk | CDR DICOM 3.0 FormattedDisk | CDR DICOM 3.0 FormattedDisk | CDR DICOM 3.0 FormattedDisk |
| 8 | Network Link | Digital Fiber | Digital Fiber | None (Dual-Path Digital OpticalDisk as Input to all ReviewStations and Archives) | Digital Fiber |
| 9 | Image Acquisition intoSystem | DICOM 3 Formatted CDR Disk | CDR DICOM 3.0 FormattedDisk and Analog AcquisitionFrom Cath Lab Camera | Analog Acquisition From CathLab Camera | CDR DICOM 3.0 FormattedDisk and Analog AcquisitionFrom Cath Lab Camera |
| 10 | Demographics-BasedCase Selection Menu | Yes | Yes | Yes | Yes |
| 11 | Archive Storage Format | Digital | Digital | Digital | Digital |
| 12 | Selected FramesSeparately Stored for Usein Report Generation | Yes | Yes | Yes | Yes |
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§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.