Search Results

Visix Imaging 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). Visix Imaging is intended to acquire, display, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Visix Imaging is currently intended for dental use. It is not intended for mammography use.

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

The provided text is a 510(k) Summary for the Visix Imaging system, which is a Picture Archiving and Communication System (PACS). This document serves to demonstrate substantial equivalence to predicate devices, not to present a de novo study with acceptance criteria and a detailed performance evaluation of a new algorithm.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

• Nature of the Submission: This is a 510(k) premarket notification. For devices like PACS, substantial equivalence is often established through technological comparison to legally marketed predicate devices, rather than extensive clinical efficacy studies with predefined acceptance criteria for AI algorithms. The "Testing" section explicitly states: "Visix Imaging has been demonstrated to perform as intended," which implies verification and validation activities (e.g., software testing, compatibility testing) against design specifications, but not a clinical performance study with statistical endpoints.
• Device Type: Visix Imaging is an image management system (PACS), designed to acquire, display, edit, review, store, print, and distribute medical images. It is not an AI diagnostic algorithm or a CAD (Computer-Aided Detection/Diagnosis) system that would typically require performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement for an AI performance study is not available in this document because such a study was not conducted or required for this type of 510(k) submission.

However, I can extract the following information pertinent to the submission context:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The document does not explicitly list quantitative acceptance criteria in terms of clinical performance metrics for an AI algorithm. The implicit acceptance criterion for this 510(k) submission is that the device is "substantially equivalent" to predicate devices, meaning it performs as intended as a PACS system with similar indications for use and technological characteristics.
• Reported Device Performance: "Visix Imaging has been demonstrated to perform as intended." This statement refers to the successful completion of verification and validation activities to ensure the software functions correctly as an image management system. No specific performance metrics (e.g., accuracy, sensitivity, specificity) against a clinical gold standard are provided for an AI component because it's not an AI diagnostic device in this context.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable / Not Provided: As this is a PACS system and not an AI diagnostic algorithm requiring a test set for performance evaluation against a ground truth, no such sample size or data provenance details are given. The "Testing" mentioned would have been internal software validation and verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable / Not Provided: Ground truth establishment by experts is not described, as there was no clinical performance study of an AI algorithm in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable / Not Provided: No adjudication method is mentioned as there was no test set requiring expert adjudication for AI performance evaluation.

5. 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:

• No: An MRMC comparative effectiveness study was not conducted or reported. The device is a PACS system, not an AI-assisted diagnostic tool for which such a study would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable / Not Provided: This device is a PACS system; it's not presented as a standalone diagnostic algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not Applicable / Not Provided: No ground truth in the context of clinical disease status is mentioned, as there was no clinical validation study of an AI algorithm. For a PACS system, the "ground truth" would relate to its functionality, such as accurately displaying images or correctly performing edits, which are verified through software testing rather than clinical endpoints.

8. The sample size for the training set:

• NotApplicable / Not Provided: This document does not describe the development or training of an AI algorithm; therefore, no training set size is mentioned.

9. How the ground truth for the training set was established:

• Not Applicable / Not Provided: Not applicable for the reasons stated above.

Summary of Device and its Purpose based on the text:

• Device Name: Visix Imaging
• Classification Name: System, Image Processing, Radiological, 21 CFR 892.2050
• Intended Use: Acquire, display, edit (e.g., resize, adjust contrast, annotate), review, store, print, and distribute medical images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Intended for dental use, not mammography.
• Technological Comparison (for substantial equivalence): Compared to Televere Systems' TigerView Professional (K061035), EagleSoft ChairSide Software Application (K982422), and Tau Corp.'s TigerScan/TigerView (K955237). All are software applications with similar indications for use and functions as PACS systems.
• Conclusion of 510(k) Notice: Visix Imaging is substantially equivalent to legally marketed Picture Archiving and Communications Systems.

Ask a specific question about this device