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The OEC Elite mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, vascular, cardiac, critical care, and emergency procedures.

The OEC Elite is a Mobile Fluoroscopic C-arm Imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic X-Ray images during diagnostic, interventional, and surgical procedures. These images help the physician visualize the patient's anatomy and interventional tools. This visualization helps to localize clinical regions of interest and pathology. The images provide real-time visualization and records of pre-procedure anatomy, in vivo-clinical activity and post-procedure outcomes.

The C-arm is a stable mobile platform capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allow the user to position the X-Ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C - arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock. The C-Arm is comprised of the high voltage generator, software. X-ray control, and a "C" shaped image gantry, which supports an X-ray tube and a Flat Panel Detector or Image Intensifier, depending on the choice of detector configuration desired.

The workstation is a stable mobile platform with an articulating arm supporting a color image, high resolution, LCD display monitor. It also includes image processing equipment/software, recording devices, data input/output devices and power control systems.

GE is submitting this pre-market notification for proposed labeling changes (quantitative performance claims) related to a previously-released feature, Enhanced Noise Reduction.

The provided text describes a 510(k) premarket notification for the GE OEC Elite mobile fluoroscopy system with "Enhanced Noise Reduction" claims. However, it does not contain the specific acceptance criteria or an explicit study proving the device meets those criteria in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and engineering bench testing, rather than reporting on a clinical study against predefined performance metrics.

Therefore, I cannot populate the table and answer all questions directly from the provided input. However, I can extract the information related to the non-clinical testing and the claims being made for the Enhanced Noise Reduction feature.

Here's a breakdown of what can be extracted and what information is missing:

Information that can be extracted or inferred:

• Device Name: OEC Elite with Enhanced Noise Reduction
• Purpose of the Submission: Proposed labeling changes (quantitative performance claims) related to the Enhanced Noise Reduction feature, demonstrating substantial equivalence to the predicate device.
• Nature of Enhanced Noise Reduction: It's a user-selectable, augmented image processing pathway for Cardiac and Vascular acquisition profiles. It "reduces image noise in a manner characteristic of the reduction in noise resulting from an increase in photon flux" while maintaining "spatial and temporal resolution." It does not change the tube output (dose).
• Claim: "Claims for equivalence to a higher power system without an increase in radiation dose for both cardiac and vascular applications."
• Testing Conducted: Non-clinical testing, engineering bench testing, risk analysis, required reviews, design reviews, integration testing, performance testing, safety testing, simulated use testing. Specific mention of "image quality and dose performance using standard IQ metrics and QA phantoms" and "a wide variety of anthropomorphic phantoms."
• Conclusion: The scientific engineering bench testing methods "demonstrate substantial equivalence." Clinical data was not required.

Missing Information (Crucial for the requested table and questions):

• Specific Acceptance Criteria: The document mentions "quantitative performance claims" but does not detail what these exact criteria are (e.g., specific SNR improvement percentages, resolution metrics, dose reduction targets).
• Reported Device Performance: Without explicit acceptance criteria, the "reported performance" cannot be formally assessed against them. The claim itself implies performance ("equivalence to a higher power system without an increase in radiation dose"), but specific metrics are absent.
• Sample Size (Test Set): Not specified for any performance testing. Phantoms are mentioned.
• Data Provenance (Test Set): Phantoms are artificial, so no country of origin or retrospective/prospective status.
• Number of Experts for Ground Truth (Test Set): Not applicable as no human interpretation of test set images is mentioned as part of performance evaluation.
• Qualifications of Experts for Ground Truth: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Explicitly stated that "clinical data is not required to demonstrate substantial equivalence." Therefore, no MRMC study with human readers comparing AI vs. without AI assistance was performed or reported.
• Standalone Performance: The testing described is for the algorithm (Enhanced Noise Reduction) as part of the device (OEC Elite C-arm) but without human-in-the-loop performance reported.
• Type of Ground Truth: For the "quantitative performance claims," the ground truth would typically be objective physical measurements of image quality parameters derived from phantoms.
• Sample Size (Training Set): Not mentioned.
• Ground Truth for Training Set: Not mentioned.

Based on the available information, here's what can be provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. Testing involved "standard IQ metrics and QA phantoms" and "a wide variety of anthropomorphic phantoms."
• Data provenance: Not applicable in the traditional sense, as testing was performed using phantoms and engineering bench tests. This is non-clinical, in-house testing by the manufacturer.

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

• Not applicable. The claims are based on objective, quantifiable physical measurements using phantoms, not on expert human interpretation of images for ground truth.

4. Adjudication method for the test set

• Not applicable, as ground truth was established through physical measurements rather than human consensus or adjudication.

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. The document explicitly states: "The new performance claims and the accumulated changes did not require clinical data in order to establish safety or efficacy." And "clinical data is not required to demonstrate substantial equivalence." Therefore, no MRMC study was performed or reported.

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

• Yes, implicitly. The "Enhanced Noise Reduction" is an algorithm (an "augmented image processing pathway"). The "additional engineering bench testing was performed to substantiate the quantitative performance claims related to Enhanced Noise Reduction" and to demonstrate "overall imaging performance... using a wide variety of anthropomorphic phantoms." This describes testing the algorithm's effect on image quality metrics without human interpretation as part of the core evaluation for these particular claims.

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

• For the non-clinical performance claims, the ground truth was established through objective physical measurements using "standard IQ metrics and QA phantoms" and "anthropomorphic phantoms." This involves measuring parameters like signal-to-noise ratio, spatial resolution, and potentially dose, against expected or ideal values from the phantoms.

8. The sample size for the training set

• Not specified in the provided text.

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

• Not specified in the provided text, as details on the training set or its ground truth are absent.

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