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Intended as a medical diagnostic imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as preoperative software for simulating surgical treatment options. The True 3D Viewer is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

The True 3D Viewer system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system. The t3D-Viewer software application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The t3D-Viewer software application enables HCPs to visualize and interact with image data and depictions of tissue and organs as if they were real physical objects.

The provided text is a 510(k) Summary for the EchoPixel True 3D Viewer device. It outlines the device's description, intended use, and the basis for its substantial equivalence to predicate devices. However, the document does not contain the detailed information required to describe acceptance criteria and the specifics of a study proving the device meets those criteria, especially regarding clinical performance with quantitative metrics like sensitivity, specificity, or reader performance improvement with AI assistance.

The document primarily focuses on:

• Regulatory Classification: Identifying the device as Class II, product code LLZ (Picture archiving and communications system, 21 CFR 892.2050).
• Substantial Equivalence: Comparing the EchoPixel True 3D Viewer to existing predicate devices (Surgical Theater Surgery Rehearsal Platform and Vital Images Vitrea 2) based on intended use and technological characteristics.
• Performance Data: This section broadly states that the device was validated according to the company's documented development and test procedures, including testing against applicable standards (IEC EN, ANSI 60601-1, IEC60601-1-2, NEMA PS 3.1 3.18 (DICOM), ISO 14971, and FDA Guidance on Software Contained in Medical Devices). It mentions "testing that fulfills the requirements" and "verification and validation was performed on qualified phantoms as well as in simulated use conditions."

Crucially, the document does not provide:

• A table of specific acceptance criteria (e.g., minimum sensitivity, specificity, or performance metrics).
• Reported device performance data against those criteria.
• Details about a clinical study involving human readers or a standalone AI performance evaluation.
• Information on sample size for test or training sets, data provenance, number/qualifications of experts, or ground truth establishment methods for clinical performance.
• Any mention of MRMC studies or an effect size for human reader improvement.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text, as the necessary details are not present.

What can be inferred from the document regarding "performance data," though it doesn't meet the detailed request:

The "Performance Data" section indicates that the validation was focused on technical and regulatory compliance standards rather than a clinical performance study with human readers or AI metrics. The "acceptance criteria" referred to here are likely related to:

• Safety and Essential Performance: Meeting standards like IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility).
• Risk Management: Compliance with ISO 14971.
• DICOM Conformance: Adherence to NEMA PS 3.1 3.18 (DICOM).
• Software Design Control: Meeting 21 CFR Part 820.30 requirements and FDA Guidance on Software.
• Rendering and Interaction Fidelity: The statement "verification and validation was performed on qualified phantoms as well as in simulated use conditions" suggests testing of the 3D rendering accuracy, interactive manipulation, and display of image data.

In summary, based on the provided text, the device's "performance" was evaluated for substantial equivalence through:

• Compliance with general medical device safety and quality system standards.
• Demonstration of its ability to process, review, and display multi-dimensional digital images, as stated in its intended use, likely via phantom studies and simulated use cases to confirm functionality and accuracy of rendering/interaction features.

The document does NOT describe:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy, reader improvement, or AI standalone performance.
2. Sample size for test set or data provenance for a clinical performance study.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used for a clinical performance study.
8. Sample size for a training set.
9. How ground truth for training set was established.

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Vitrea2 is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea2 Version 3.8.1 adds the following previously FDA-cleared software applications to the currently marketed Vitrea2 system: Fusion7D, RTist, ImageChecker CT Lung v2.0 System, AutoPoint Temporal Comparison Tool, and the Pulmonary Artery PE (Patency Exam).

The Vitrea2 system is a medical diagnostic device that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The Vitrea2 system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea2 user interface follows typical clinical workflow patterns to process, review, and analyze digital images.

The provided text describes the Vitrea2®, Version 3.8.1 Medical Image Processing Software and its substantial equivalence to predicate devices, but it does not contain the specific details about acceptance criteria or a dedicated study proving the device meets those criteria for the Vitrea2 system itself.

Instead, the document primarily focuses on:

• Device Description: What the Vitrea2 system does.
• Intended Use: The purpose of the Vitrea2 system and its added functionalities (Fusion7D, RTist, ImageChecker CT Lung v2.0 System, AutoPoint Temporal Comparison Tool, Pulmonary Artery PE).
• Predicate Device Comparison: How Vitrea2 compares to other legally marketed devices.
• Summary of Studies: A general statement about design, development, testing, and validation according to written procedures, integration testing, Beta testing, and risk management.
• Conclusion: The device is substantially equivalent to predicate devices.
• FDA Clearance Letter: Formal FDA clearance.

The "Summary of Studies" section provides a high-level overview of their development and testing process, but it does not detail performance metrics or studies using specific acceptance criteria, sample sizes, or ground truth methodologies that would typically be presented for a detailed performance study. It mentions internal testing and "Beta validation" but does not provide results from these.

Therefore, for your request, I can only provide what can be inferred or directly stated from the text, and will explicitly state what information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

• "The software utilized was designed, developed, tested, and validated according to written procedures."
• "The Vitrea2, Version 3.8.1 system will successfully complete integration testing prior to Beta validation."
• "Software Beta testing/validation will be successfully completed prior to release."
• "Potential hazards have been studied and controlled by a Risk Management Plan."
• It concludes the device is "substantially equivalent" to predicates. |

Missing Information: Specific quantitative or qualitative acceptance criteria (e.g., accuracy thresholds, precision values, specific clinical endpoints) are not provided. The document does not report performance metrics against any defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Missing Information: The document states that "integration testing" and "Beta testing/validation" were successfully completed, but it does not specify the sample size of cases or images used for these tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Missing Information: The document does not mention the use of external experts for establishing ground truth for any test set, nor does it specify their number or qualifications.

4. Adjudication Method for the Test Set

Missing Information: As no specific test set or expert ground truth establishment is detailed, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Missing Information: The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated, nor does it provide an effect size for such a study.

6. Standalone (Algorithm Only) Performance Study

Missing Information: While the device has functionalities for image processing and analysis, the document does not describe a standalone performance study specifically for an algorithm without human-in-the-loop performance measurement. The descriptions for some of the added functionalities (like ImageChecker CT Lung) sound like CAD systems, which often have standalone performance studies, but no such details are provided for the Vitrea2 system or its components in this document.

7. Type of Ground Truth Used

Missing Information: The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for any of its internal testing or validation.

8. Sample Size for the Training Set

Missing Information: The document does not provide any details about a training set, its size, or its composition. This suggests the Vitrea2 system (or at least the core system described here) may not rely on a machine learning model that requires a dedicated training set in the way a modern AI/CAD system would. It appears to be more of an image processing and visualization platform.

9. How Ground Truth for the Training Set Was Established

Missing Information: As no training set is mentioned, naturally, the method for establishing its ground truth is also not provided.

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