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uWS-Angio Basic is intended to display and process XA (X-Ray Angiographic), CT (Computed Tomography), and MR (Magnetic Resonance) images that comply with the DICOM3.0 protocol.

uWS-Angio Basic is an image processing software that matches the use of medical vascular angiography X-ray machines. It contains the following functions:

• Patient Administration
• Review 2D: This application can be used to load 2D images and perform related processing. The function provides Basic processing tools for
  1. 2D image viewing,
  2. 2D image processing,
  3. 2D DSA image viewing and processing,
  4. Calibration and Measurement.
• Review 3D: This application can be used for loading and processing 3D data. The function provides Basic processing tools for
  1. 3D image viewing;
  2. 3D image processing;
  3. CTA bone removal.
• Saving
• Filming

uWS-Angio Basic can be deployed on independent hardware such as a stand-alone diagnostic review and post processing workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, it can be deployed on systems of the United-imaging Angiography system family.

The provided FDA 510(k) clearance letter for the uWS-Angio Basic device does not contain the detailed performance data, acceptance criteria, or study design information typically found in a clinical study report or a more comprehensive technical and clinical assessment. The letter is a regulatory document affirming substantial equivalence to predicate devices, and while it mentions "Performance Testing" for certain algorithms, it only provides very high-level summaries and no specific quantitative acceptance criteria or detailed study results.

Therefore, I cannot extract the full information requested for acceptance criteria and the study proving the device meets them from this document. However, I can infer and state what is present and what is absent.

Here's an analysis based on the provided text, highlighting the limitations:

Information NOT available in the provided document:

• Detailed acceptance criteria with specific thresholds (e.g., AUPRC > 0.95, sensitivity > X%, specificity > Y%).
• Specific reported device performance metrics against those criteria.
• Sample size used for the test set.
• Country of origin of data, or whether it was retrospective/prospective.
• Number of experts used for ground truth, or their specific qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers.
• Specific details on standalone algorithm performance (beyond a general statement that one performs "as well as" and another has "high accuracy").
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set.
• How the ground truth for the training set was established.

Information that can be inferred or is explicitly mentioned (though not in the requested format):

The document states:
"Testing was conducted between uWS-Angio Basic and the predicate device to evaluate the performance of the algorithms mentioned above. It is shown that catheter calibration of uWS-Angio Basic has high accuracy with average error rates consistently lower than those of the predicate device. CTA Removing Bone of the uWS-Angio Basic perform as well as the predicate devices."

This indicates that comparative performance against predicate devices was the primary method of demonstrating "safety and effectiveness," rather than meeting pre-defined quantitative performance metrics against a clinical ground truth.

Attempted Fulfilling of Request (with significant caveats due to missing information):

Given the limitations of the provided text, most of the requested table and details cannot be populated. The performance data section is extremely brief and qualitative.

1. Table of acceptance criteria and reported device performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.
• Note: It's unclear if expert consensus was even the ground truth method, or if it was comparative to predicate output. This document does not suggest an independent ground truth for "accuracy" other than comparison to the predicate.

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

• Not specified.

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 MRMC study is mentioned. The study described focuses on algorithm-to-algorithm comparison (uWS-Angio Basic vs. predicate device algorithms), not human-in-the-loop performance.

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

• Yes, implicitly. The "Performance Testing" section describes evaluation of the "Catheter Calibration Algorithm for Review 2D" and "CTA Removing Bone Algorithm for Review 3D." This refers to the performance of these algorithms themselves, likely in a "standalone" fashion, by comparing their output to that of predicate device algorithms.

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

• Not explicitly stated. The document implies a "ground truth" derived from the performance or output of the predicate devices. For example, "average error rates consistently lower than those of the predicate device" for catheter calibration suggests a definition of "accuracy" relative to the predicate's output. It's not stated that an independent, gold-standard clinical ground truth (e.g., pathology, clinical outcomes, or expertconsensus on the true measurement/absence/presence of bone) was established for the performance testing of these algorithms.

8. The sample size for the training set:

• Not specified. The document does not discuss the training of the algorithms.

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

• Not specified, as training set details are not provided.

Summary of what can be gleaned vs. what is missing:

This 510(k) clearance letter primarily focuses on demonstrating "substantial equivalence" based on similar intended use, technological characteristics, and a basic comparative performance assessment against already cleared predicate devices. It does not provide the detailed breakdown of quantitative acceptance criteria, robust clinical study design, or comprehensive ground truth establishment methods that would be seen for higher-risk devices or novel AI functions requiring extensive clinical validation. The "Performance Testing" described is rudimentary comparative testing without specified quantitative metrics or detailed study populations.

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