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TRON is a mobile X-Ray imaging system with fluoroscopy and tomography capability that is intended to be used for anatomy that can safely fit within the device gantry and positioned within the imaging aperture (such as the head, neck, chest, abdomen, and extremities: arm, wrist, hand, leg, knee, ankle, and foot).

The TRON is a mobile fluoroscopy and cone-beam CT x-ray system for point-of-care (POC) imaging. The TRON system consists of a high voltage x-ray generator, 360-degree rotational open-bore gantry, x-ray tube assembly, x-ray controller, detector panel, and x-ray controls containing a power distribution unit, onboard PC and operator PC (user interface).

The provided text describes the regulatory clearance of Xoran Technologies LLC's TRON device, but it does not contain information about specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), or a study that evaluates such performance using a test set with ground truth established by experts.

The document focuses on demonstrating substantial equivalence to a predicate device (Medtronic O-arm™ 02 Imaging System) and a reference device (Xoran Technologies xCAT) based on technological characteristics and Indications for Use.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document states that "TRON meets all the evaluation criteria for Bench Testing, SW Validation, and Product Validation tests," but it does not specify what those criteria are or report quantitative performance metrics against them.

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

Not provided. The document states "N/A - No clinical testing was conducted for the TRON" and discusses "Bench Testing, SW Validation, and Product Validation testing" but offers no details about sample sizes or data provenance for these internal tests.

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

Not applicable/Not provided. Since no clinical testing was conducted and no test set with ground truth established by experts is mentioned for performance evaluation, this information is not available.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No test set requiring adjudication is described.

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

Not applicable/Not provided. The TRON device is an X-Ray imaging system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable/Not provided. The TRON is a hardware imaging system; the document does not describe an "algorithm only" component with standalone performance being evaluated independently of the system's operation. Its performance is inherent to its image acquisition capabilities.

7. The Type of Ground Truth Used

Not applicable/Not provided. As no clinical or performance study evaluating diagnostic accuracy against a ground truth is described, this information is not available. The testing performed focused on safety, effectiveness, and conformance to user needs, likely through engineering and design verification/validation rather than clinical diagnostic ground truth.

8. The Sample Size for the Training Set

Not applicable/Not provided. The TRON is an X-ray imaging system, not a device relying on machine learning or AI models that require a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. Similar to point 8, this is not relevant for the type of device described.

In summary, the provided FDA clearance letter and its associated documents (510(k) summary) do not detail performance acceptance criteria in terms of diagnostic accuracy or a study proving such criteria are met through evaluation against a ground truth. The submission primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and indications for use, as is common for many 510(k) submissions for imaging devices.

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Xoran Workstation is an image processing and viewing software. The Xoran Workstation software provides tools for patient data management, image processing, viewing, interpretation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.

Xoran Workstation is an image processing and viewing software for use with imported Xoran MiniCAT IQ, MiniCAT 2020, xCAT XL, and xCAT IQ patient image data. The Xoran Workstation runs on a Windows OS based PC with the following Minimum requirements:

• Laptop or desktop computer
• Windows 10 64-bit Professional or Enterprise
• 4GB of RAM or more
• Intel i5 or better
• USB Type A port

This document describes the Xoran Workstation, Model 10050, an image processing and viewing software. This submission focuses on its substantial equivalence to the predicate device, the MiniCAT. The provided text, however, does not describe specific acceptance criteria and detailed study results to prove that the device meets those criteria.

Based on the provided text, here is a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Xoran Workstation underwent "Verification. Software Validation and Product Validation testing to demonstrate its safety, effectiveness, and conformance to its user needs intended use, as required by 21 CFR 820.30 Design controls - (f) Design Verification, and (g) Design Validation." It also states, "Xoran Workstation meets all the evaluation criteria for Verification, Software Validation and Product Validation tests."

However, specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or image quality metrics) and the reported device performance against these criteria are not provided in the document. The document refers to these details being laid out in "Test Protocol and Test Cases" documents and results captured in "Test Results" documents, which are not included in the provided text.

The closest to "performance" comparison is the "Comparable Properties" table which outlines functional equivalence to the predicate device:

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

The document states that "test sample sizes" were "established" in the Test Protocol and Test Cases documents. However, the specific sample size used for the test set is not provided in the given text.

The data provenance (e.g., country of origin, retrospective or prospective) for any clinical data used in validation is not specified. The Xoran Workstation is intended to import data from Xoran MiniCAT IQ, MiniCAT 2020, xCAT XL, and xCAT IQ devices.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

The document states that "Product validation evaluations were performed by qualified physicians, who have anatomical and/or surgical expertise related to Xoran Workstation's intended use."

However, the exact number of experts used to establish ground truth or for product validation, and their specific qualifications (e.g., years of experience, specialty) are not provided.

4. Adjudication Method

The adjudication method used for the test set is not specified in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
   The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers improving with AI vs. without AI assistance. The study described focuses on the substantial equivalence of the software's functionality to existing software, not on the impact of AI assistance on human performance.

6. Standalone Performance Study
   A standalone performance study (algorithm only without human-in-the-loop performance) was implicitly performed in the sense that the software's functionalities (image processing, viewing, reconstruction algorithms, annotation tools, etc.) were verified and validated on their own. The document states: "Xoran Workstation has undergone Verification. Software Validation and Product Validation testing to demonstrate its safety, effectiveness, and conformance to its user needs intended use." The comparison table primarily highlights the standalone software features. However, specific performance metrics (e.g., accuracy of reconstruction, precision of measurements) from such a standalone study are not quantified in the provided text.

7. Type of Ground Truth Used
   The type of ground truth used is not explicitly stated. Given that "Product validation evaluations were performed by qualified physicians," it implies the ground truth might have been based on expert consensus or clinical interpretation by these physicians. There is no mention of pathology or outcomes data.

8. Sample Size for the Training Set
   The document does not mention a training set sample size. The Xoran Workstation is described as an "image processing and viewing software" that uses "reconstruction software algorithms." If the software relies on models that were trained (e.g., for image processing features), the details of such a training set are not included in this document. The focus of the submission is on functional equivalence and verification/validation processes, not on the development of AI/ML models.

9. How the Ground Truth for the Training Set Was Established
   As no training set is mentioned, the method for establishing its ground truth is not provided.

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The MiniCAT 2D is a diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.

The MiniCAT 2D is a dedicated X-ray imaging device that acquires a 360° rotational X-ray sequence and produces two dimensional views. MiniCAT 2D provide immediate access to images at the patient's point-of-care resulting in faster diagnosis and treatment. The MiniCAT 2D system consists of a high voltage x-ray generator, 360-degree rotational overhead gantry, x-ray tube assembly, x-ray controller, fixed detector panel, and x-ray controls containing a "power distribution unit and operator PC (user interface)."

This document does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria for a new AI/algorithm feature. Instead, it is a 510(k) summary for a general X-ray system (MiniCAT 2D) seeking substantial equivalence to a predicate device (Carestream DRX-Evolution).

The document details the device description, indications for use, and a comparison of technological characteristics to the predicate device to demonstrate substantial equivalence, rather than providing performance data for a specific algorithm or AI component.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

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