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VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data. VERICIS is intended to allow users to review diagnostic and non-diagnostic quality images, annotate studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physician-generated clinical reports (via structure reporting and template based tools), and to store this information in a database.

· VERICIS is software comprised of modules that perform under standard "offthe-shelf" personal computers and servers running the Microsoft Windows 2000/2003/XP operating systems.

• VERICIS is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) image data files from multiple modalities. It accepts text data using other standards-based formats including but not limited to HL7 and XML.

• VERICIS is an Internet/Intranet network system that is designed for small and large, multi-user environments. The VERICIS network structure (including server and workstations) provides for the system's database management, storage, printing, and all DICOM/HL-7 interface services.

The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system. The VERICIS is a modification of the Camtronics Analytical Review Station (K955519) and the Echocardiography System (K992259) to accept multiple modalities. The VERICIS combines modular software applications and third party "off-the-shell" software on standard computer workstations and servers running the specified Microsoft Windows operating systems.

The provided text is a 510(k) premarket notification for the "VERICIS Cardiovascular Image and Information System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a detailed clinical study with acceptance criteria and performance metrics against a ground truth.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the submission states:

"Camtronics Medical Systems has demonstrated through its comparison of performance with the predicate devices that the VERICIS is equivalent to the Horizon Medical Imaging system."

This indicates that the "study" proving the device meets its "acceptance criteria" (which in this context would be the requirement of substantial equivalence) was a comparison to a predicate device (McKesson Horizon Medical Imaging, K043146) based on technological characteristics and intended use, rather than a clinical performance study with predefined metrics. The submission asserts that the VERICIS "employs the same fundamental scientific technology" and will "act and perform similar" to the predicate.

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