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The PetaVision is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to Image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic applications.

PetaVision™ is PACS (Picture Archiving and Communication System) software for radlologist and physician doctor. By use of PetaVision™ enables images such as xray and scans to be stored electronically and viewed on screens. Doctors and other health professional can access and compare images at the touch of a button Also, PetaVision™ is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices.

The provided text is a 510(k) summary for the PetaVision PACS device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not available in this document.

Here's an analysis of the provided information concerning the acceptance criteria and study, with clear indication of what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific, measurable acceptance criteria (e.g., image display accuracy, processing speed, data transfer rates, system uptime, error rates). Quantitative performance results against such criteria.

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

Not provided. The document does not describe any specific test set of medical images or patient data used for evaluating the PetaVision device.

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

Not applicable/Not provided. Since no specific test set or clinical evaluation is described, there's no mention of experts establishing ground truth for such a test. The device is a Picture Archiving and Communication System (PACS) and its primary function is display and management, not diagnostic interpretation in itself.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As no test set is detailed, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This document does not describe an MRMC comparative effectiveness study. PACS systems typically do not undergo MRMC studies in the same way diagnostic AI algorithms do, as their primary function is infrastructure (display, storage, transfer) rather than direct diagnostic interpretation assistance. The efficacy claim is based on substantial equivalence to an existing PACS.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The device itself, PetaVision, is a standalone software system. Its function is to perform operations related to image manipulation, enhancement, compression, transfer, display, and storage without direct human intervention in the execution of these underlying software functions. However, its overall utility is in supporting human radiologists and physicians. No performance study of the algorithm in isolation (e.g., measuring its success rate in image acquisition or display) is detailed in this summary. Instead, the focus is on the functions it provides.

7. The Type of Ground Truth Used

Not applicable/Not provided. As no specific evaluation of diagnostic performance against objective ground truth (e.g., pathology, outcomes data) is presented, the concept of "ground truth" as it pertains to diagnostic accuracy is not relevant here. The device's "ground truth" would be its ability to correctly perform its stated functions (e.g., display an image accurately as originally acquired), but this is not explicitly detailed as a ground truth in the context of a performance study in this summary.

8. The Sample Size for the Training Set

Not applicable/Not provided. PetaVision is described as a Picture Archiving and Communication System (PACS) software. It is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns or making diagnostic predictions. Its functionality is based on established DICOM standards and imaging processing techniques.

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

Not applicable/Not provided. As stated above, this device is not an AI/ML algorithm requiring a training set with established ground truth.

Summary of Device and Study as Per Provided Text:

The PetaVision is a Picture Archiving and Communication System (PACS) software designed to acquire, transfer, display, store, and digitally process medical images from various modalities (CR, CT, MR, etc.). It facilitates image manipulation, enhancement, compression, and quantification. It is not intended for mammographic applications.

The study described here is a 510(k) premarket notification aiming to demonstrate substantial equivalence to a predicate device, the MEDIFACE PACS (K010259). The document concludes that PetaVision is safe and effective and substantially equivalent to the predicate device based on the information provided in the premarket notification. This type of submission relies on comparing design, indications for use, technological characteristics, and performance data (if available) to an already cleared device, rather than conducting a de novo clinical performance study against specific acceptance criteria.

The submission does not provide details on specific performance metrics, sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, or results of MRMC or standalone performance studies against defined acceptance criteria. It primarily focuses on defining the device's functions and claiming equivalence to a predicate PACS system.

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