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The OEC 902 C-Arm frame, X-Ray Generator, X-Ray Control, Control Panel, Electrical Systems remain the same. Imaging Services, Inc. takes an OEC 902 and repaints it. We repair all mechanical brakes, replace the wheels with the new wheels rated for a greater weight, repair or replace motor drive assemblies with original or comparable replacement parts, repair all electronic systems, then calibrate the X-Ray generator to manufacture specifications using the OEC 902 Service Manual. Then we add a new 9/6 Image Intensifier and CCD Camera system. The CCD Camera System is calibrated to North American Imaging and Imaging Services Specifications. The ABS system utilizes original manufacturer's specifications, wiring and its electronic path remains the same. The wiring of the CCD Camera system uses original wires provided by the original camera system which was deinstalled. The interface between the C-Arm and monitor cart. also utilizes existing wiring as well as spares provided by OEC when the unit was originally manufactured.

This document is a Premarket Notification 510(k) Summary for the Nasa II C-arm, a refurbished mobile X-ray system. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, specifically the OEC 901 and 902 model C-arms.

It does not contain acceptance criteria for device performance in the typical sense of a clinical or technical study with specific metrics (e.g., sensitivity, specificity, resolution in lp/mm, signal-to-noise ratio). Instead, the "acceptance criteria" are implied by the process of demonstrating substantial equivalence to pre-existing, legally marketed devices.

The "study" demonstrating this involves:

1. Direct comparison and assertion of equivalence: The core argument is an assertion by the manufacturer that the Nasa II C-arm is mechanically and electrically as safe and effective as the OEC models 901 and 902. The primary difference is an upgrade of the imaging chain (CCD Camera and Camera Control Unit).
2. Adherence to existing specifications and standards: The manufacturer states they use the original OEC 902 Service Manual for calibration, follow North American Imaging and Imaging Services Specifications for the CCD Camera system, and test the system to comply with all Federal, State, and BRH standards.
3. Claim of improved performance without specific quantified metrics for acceptance: The document claims "improved image quality," "decreased patient dose," and increased "dynamic range and contrast/resolution" due to the CCD Camera upgrade, but it doesn't provide specific quantitative targets or measurements to "prove" these improvements against an acceptance criterion.

Therefore, the requested table and detailed information about a "study" with specific acceptance criteria as you've outlined for typical AI/diagnostic device submissions cannot be directly extracted from this document, as it describes a different type of regulatory submission (substantial equivalence for a refurbished/modified device).

However, I can extract the relevant information related to the claims made and the process described:

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable or Not Provided in the Document:

This document describes a "substantially equivalent" regulatory submission for a refurbished and upgraded C-arm, not a de novo AI/software device. Therefore, the following points are not directly addressed or are inapplicable:

2. Sample size used for the test set and data provenance: No specific "test set" in the context of clinical images or patient data is mentioned for performance evaluation. The "testing" refers to mechanical, electrical, and radiation compliance.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. No expert review of a "test set" is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for demonstrating clinical utility often involving AI.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This is a hardware device with an upgraded imaging component.
7. Type of ground truth used: Not applicable in the context of a diagnostic algorithm. Performance is assessed against technical specifications and regulatory standards.
8. Sample size for the training set: Not applicable. There is no AI model or algorithm being "trained."
9. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" and Proof of Meeting Criteria:

The "study" referred to in this 510(k) summary is the process of refurbishing, upgrading, and testing the Nasa II C-arm to demonstrate its substantial equivalence to the predicate OEC 901 and 902 models.

• Proof: The primary proof offered is the manufacturer's assertion that the device is as safe and effective, coupled with the description of the refurbishment process that meticulously reuses, repairs, or replaces components while adhering to the original manufacturer's specifications (OEC) for the core C-arm functionality, and using specified standards for new components (North American Imaging and Imaging Services Specifications for the CCD camera).
• Compliance Testing: The manufacturer states that the system is "tested...to comply with all Federal, State and BRH standards" which serves as the direct evidence for regulatory compliance.
• Calibration: Calibration procedures for both the X-ray generator (using OEC 902 Service Manual) and the imaging chain (using North American Imaging and Imaging Services, Inc. standards) are detailed, with traceability to the National Bureau of Standards, implying a robust and verifiable technical performance.
• Performance Claims: Improved image quality, decreased patient dose, and increased dynamic range/contrast/resolution are claimed as benefits of the upgrade, positioning the device as "state of the art" and "superior image quality as with a new C-Arm," thereby inherently satisfying (or exceeding) the imaging performance of the predicate device. However, these are general claims without specific quantitative data presented in this summary document.

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