(52 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to legally marketed PACS systems | "TigerView Professional has been demonstrated to perform as intended." |
| "Tiger View Professional is substantially equivalent to legally marketed Image Processing Systems (i.e. PACS)." | |
| Ability to acquire medical images from various sources | Receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). |
| Ability to display, edit, review, store, print, and distribute images | Acquires, displays, edits (e.g., resize, adjust contrast, crop, annotate, etc.), reviews, stores, prints, and distributes images using standard PC hardware. |
| Compatibility with standard PC hardware | Runs on standard PC-compatible computers; compatible with various capture devices connecting via Network Adaptor, USB, PCI, parallel port, memory card, S-video, or SCSI. |
| Ability to store clinical notes, audio, and exam data | Enables the storage of clinical notes, audio recordings, and clinical exam data. |
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.
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not specified.
- 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.
- 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.
- 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.
- 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.
- 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)."
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).