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TigerView Professional is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, TigerView Professional enables the storage of clinical notes, audio recordings, and clinical exam data.

It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

TigerView Professional is an image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card.

This 510(k) summary for Televere Systems TigerView Professional describes a Picture Archiving and Communication System (PACS) software. As such, the information provided focuses on its functional equivalence to predicate devices rather than clinical performance metrics typical of AI/ML-driven diagnostic devices.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the way one would expect for a diagnostic algorithm. Instead, the "performance" is implicitly tied to demonstrating functional equivalence to predicate devices.

Study Details

Given the nature of this submission for a PACS system, a "study" in the clinical trial sense (with a test set, ground truth, and expert readers) is not described. The evaluation relies on demonstrating functional equivalence.

1. Sample size used for the test set and the data provenance: Not applicable/not specified. The "testing" mentioned is functional demonstration, not a clinical performance study with a test set of images.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified. There is no mention of a ground truth established by experts for a test set.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not specified.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a PACS system, not an AI-driven diagnostic aid.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a software platform, not a standalone diagnostic algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is the functional performance of predicate devices, which the new device is compared against for substantial equivalence.
7. The sample size for the training set: Not applicable. As a PACS system, it doesn't involve machine learning model training in the conventional sense.
8. How the ground truth for the training set was established: Not applicable.

Conclusion based on the provided text:

The submission for Televere Systems TigerView Professional is a 510(k) for a Picture Archiving and Communication System (PACS). The "study" referenced in the document is a demonstration of functional equivalence to predicate PACS devices (EagleSoft ChairSide Software Application and TigerScan/TigerView), rather than a clinical performance study with defined acceptance criteria, test sets, or ground truth for diagnostic accuracy, which would be typical for an AI/ML-driven diagnostic device. The manufacturer states that "TigerView Professional has been demonstrated to perform as intended" and is "substantially equivalent to legally marketed Image Processing Systems (i.e. PACS)."

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