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The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all "off-the-shelf" standard computer components and may be purchased independently by the end user or supplied by NIT. The NIT InSight™ software receives image files from medical scanning devices, such as CT or MRI and performs real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving.

The InSight™ Diagnostic Imaging Workstation receives image files from medical scanning devices, such as CT or MRI and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving. All of the functions are supported on standard personal computer platform for ease of cost and maintenance. The use of Microsoft Windows NT™ operating system makes the InSight™ Diagnostic Imaging Workstation easy to use and capable of being integrated with your other computer needs.

This document primarily focuses on the 510(k) submission for the Neo Imagery Technologies Inc., InSight™ Diagnostic Imaging Workstation, asserting its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a dedicated study proving the device meets specific performance criteria.

The device is being cleared based on its equivalence to existing PACS systems, which implies it operates under similar performance expectations but doesn't detail new, specific performance metrics or studies to validate them for this particular submission.

Therefore, requested information, such as specific acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set information (items 1, 2, 3, 4, 5, 6, 7, 8, 9), is not available within the provided text.

The document states:

• Device Description and Intended Use: The InSight™ Diagnostic Imaging Workstation receives image files from medical scanning devices, performs real-time viewing, image manipulation, three and four-dimensional visualization, communication, and archiving.
• Substantial Equivalence: The submission argues that the InSight™ device is substantially equivalent to K965179 (Neo Imagery Technologies Inc., InSight™ Diagnostic Imaging Workstation) and K961023 (AccuImage, AIDP).
• Software Certification: Neo Imagery Technologies Inc. certifies that the InSight™ software is designed, developed, tested, and validated according to written procedures.
• Hazard Analysis: The potential hazards are deemed "no different than those of other PACS components" and are primarily related to computer system component failure, not expected to "materially contribute to patient death or injury." The "Level of Concern" is "Minor."

In essence, the document confirms the device's regulatory pathway (510(k)) and its intended use, but it doesn't offer the detailed study information regarding acceptance criteria for device performance that you requested.

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The InSight™ Diagnostic Imaging Workstation must be used by or on the order of a physician. The system receives digital information from scanning devices and manipulates image data for the purpose of image characterization, enhancement, communication, archiving, and real-time 3D visualization. The system is designed as an aide to trained medical practitioners in the diagnostic process. Only qualified personnel should service system hardware and software.

The InSight™ Diagnostic Imaging Workstation provides real-time 3-D visualization, communication, archiving, characterization, and image enhancement with digital information received from medical scanning devices. System utilizes IBM compatible PC with Intel "X"86 family microprocessors and Microsoft Windows NT™ operating system for ease of maintenance and cost.

The provided text is a 510(k) Summary for the InSight™ Diagnostic Imaging Workstation (K965179). It focuses heavily on describing the device and establishing its substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

Based on the provided text, there is NO acceptance criteria or study that proves device performance against specific metrics.

The document explicitly states:

• "Although there are no performance standards established by the Special Controls: FDA on image processing workstations, Neo Imagery Technologies, Inc. has developed the InSight™ Diagnostic Imaging Workstation in compliance with the guidance issued by the FDA, CDRH, ODE such as the August 29, 1991 Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review."

This indicates that the device was cleared based on its substantial equivalence to predicate devices and adherence to general guidance, not on a specific performance study against defined acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. No performance study involving a test set is described.
• Data Provenance: Not applicable. No performance study is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No performance study involving ground truth establishment is described.

4. Adjudication method for the test set

• Not applicable. No performance study involving a test set is described.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

• Was an MRMC study done? No. The document does not describe any MRMC comparative effectiveness study. The clearance is based on substantial equivalence to predicate devices, not on a study demonstrating improved human reader performance with AI assistance.
• Effect size of human readers improve with AI vs without AI assistance: Not applicable. No such study was described.

6. Standalone (i.e. algorithm only without human-in-the loop performance) study

• No. The document does not describe any standalone performance study of the algorithm. The device is referred to as a "workstation" for medical practitioners, implying human-in-the-loop operation.

7. Type of ground truth used

• Not applicable. No performance study requiring ground truth is described.

8. Sample size for the training set

• Not applicable. No machine learning training process is described, nor is a training set referenced.

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

• Not applicable. No machine learning training process or training set ground truth establishment is described.

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