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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.

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