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A nuclear medicine image display and processing application suite that provides software applications used to process, analyze and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structure. The data processed may be derived from any nuclear medicine gamma camera. JETPack 2.0 should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

JETPack 2.0 is a Windows®-based Nuclear Medicine suite of image display and processing applications for the Nuclear Medicine market segment. The software package is deployable on hardware platforms, which meet the minimum requirements needed to run the software. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report . generation and contains the utilities necessary to support the workflow and data management between those activities.

This 510(k) summary does not contain the information requested for acceptance criteria or specific study details to prove the device meets acceptance criteria.

The document is a premarket notification for a new version of a Picture Archiving and Communication System (PACS) software, JETPack 2.0. It primarily focuses on establishing substantial equivalence to a predicate device (Philips Medical Systems NM Application Suite, K080961).

Here's why the requested information is not present:

• Acceptance Criteria and Reported Device Performance: This document states that JETPack 2.0 and the predicate device "perform in a similar manner with respect to, display, review and processing applications." It concludes that JETPack 2.0 is "substantially equivalent based on similar intended use, technological comparison, and system performance." However, it does not define specific acceptance criteria (e.g., quantitative metrics, thresholds) or present a table of reported device performance against such criteria. The "system performance" is described in a general, rather than a quantifiable, manner.
• Sample Size for Test Set and Data Provenance: This information is not provided. No specific test set or clinical study data is referenced.
• Number of Experts and Qualifications: This information is not provided. There's no mention of experts establishing ground truth for a test set.
• Adjudication Method: Not applicable, as no test set requiring adjudication is mentioned.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned. The document relies on substantial equivalence to a previous device rather than a new comparative effectiveness study.
• Standalone Performance: While the description focuses on the software's functionality, there's no standalone performance study in the context of diagnostic accuracy or clinical impact presented here.
• Type of Ground Truth Used: Not applicable, as no specific ground truth for a performance study is described.
• Sample Size for Training Set: This information is not provided. The development process of the software, including any training data for AI/ML components (if present, which is not explicitly stated for this 2011 submission), is not detailed.
• How Ground Truth for Training Set Was Established: Not applicable, as no training set or its ground truth establishment is described.

In summary, this 510(k) filing demonstrates substantial equivalence by comparing the device's intended use and general technological characteristics to a legally marketed predicate device. It does not present detailed performance studies with specific acceptance criteria, test sets, or ground truth establishment that would be required for innovative devices making new claims or for devices undergoing more rigorous evaluation pathways.

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