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The Omega Medical Imaging, LLC CS-series-FP (SSXI) systems with optional accessory device CA-100S as a modification device to provide an automated Region of interest that manages exposure to the patient and operator. The system is intended for use in Radiographic applications including cardiac, vascular, general radiographic/ fluoroscopic diagnostic, and interventional x-ray imaging for General Populations.

At no time will the CA-100S be considered as a replacement for the primary collimator shall always be used, in accordance with good medical practice, to define a Region of Interest

This 510(k) submission is for the addition of an optional secondary fast collimator system (Model: CA-100S). The CA-100S will only be used with the following FDA cleared device: Omega's CSseries-FP ( K121293). The-CA-100S system is composed of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor, two ROI Control Panels and a Monitor.

Omega's (CA-100S) allows for auto collimation while maintaining a perspective of surrounding anatomy. The blended image incorporates a lower frequency refresh of the peripheral image area. This combined image (live fluoroscopy of ROI + background refreshed at a rate of once or twice per second) increases the quality of information presented during interventional procedures.

The CA-100S secondary collimator may be used to additionally shield anatomy that is not the primary focus of the physician but is required to maintain peripheral imaging. The CA-100S ROI image processing combines the live ROI with the legacy image of the full field of view (defined by the primary collimator). This allows for the collimation of the ROI without impacting the doctors normal work flow, visualisation, orientation and navigation.

The Product is permanently incorporated in the host fluoroscopy system (Omega's CS-series-FP) and its clinical environment. The system is intended to be installed by trained technicians and operated by professionals trained in its use and the associated medical interventional procedures. The CA-100S Product functions in ON Mode, OFF Mode or Bypass Mode.

The Product consists of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor with Status / Reduction Monitor and two ROI Control Panels.

The Omega Medical Imaging, LLC CS-series-FP with Optional Accessory Device CA-100S, a secondary fast collimator system, was designed to reduce patient and operator exposure to X-ray radiation during fluoroscopic procedures by dynamically defining a Region of Interest (ROI).

Here's an analysis of its acceptance criteria and the study that demonstrates compliance:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in a tabular format with corresponding reported device performance values. Instead, it describes the device's functional aims and summarizes the regulatory and safety compliance. The primary 'acceptance criterion' implicitly defined is the reduction in Dose Area Product (DAP) to patients and medical staff by reducing the area of exposure, while maintaining or improving image quality and clinical utility.

Since no specific quantitative acceptance criteria and reported performance with numerical values are given in the provided text, a table can be constructed based on the stated benefits and intended function.

2. Sample Size and Data Provenance for the Test Set

The document mentions "Bench performance testing" and "detailed data comparing performance with the existing Omega Medical Imaging CS-series-FP system utilizing the CA-100S integrated into an existing system." It further states that "The tests that were performed utilized commercially available Phantoms such as the Phillips Phantom, and including a fabricated Moving Catheter to exercise the auto ROI functionality."

• Sample Size for Test Set: Not explicitly stated, but implies multiple tests on phantoms. No human subject data (patients or operators) appears to have been used for this specific phase of testing as described.
• Data Provenance: The testing was conducted in a laboratory/bench setting, likely at Omega Medical Imaging, LLC. The data is thus prospective in terms of being generated specifically for this regulatory submission via bench tests. No country of origin for clinical data is mentioned as clinical data is not explicitly described for this testing.

3. Number of Experts and Qualifications for Ground Truth

The document does not detail the use of human experts to establish ground truth for the bench testing described beyond the general statement that the system is intended for use by "professionals trained in its use and the associated medical interventional procedures." The "fabricated Moving Catheter" and "Phillips Phantom" test the physical and automated tracking performance, implying objective, measurable outcomes rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

Not applicable, as the testing described is primarily technical performance evaluation using phantoms, rather than subjective clinical interpretation requiring expert adjudication.

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

No MRMC comparative effectiveness study is mentioned in the provided text regarding the effect size of human readers' improvement with AI vs. without AI assistance. The CA-100S is a hardware and image processing modification to an existing fluoroscopy system, focusing on dose reduction and maintaining visualization through dynamic collimation, not on AI-assisted diagnostic reads or interpretations.

6. Standalone Performance Study

The document describes the device's standalone operation modes (ON, OFF, BYPASS) and its functionality in managing exposure and image blending. The "Bench performance testing" utilizing phantoms focuses on the device's intrinsic capabilities, which can be considered a standalone (algorithm only without human-in-the-loop) performance evaluation in terms of its technical function (e.g., ROI tracking, dose reduction effectiveness with phantoms, image blending). The results of these tests (e.g., dose reduction, image quality improvement, auto-tracking of the moving catheter) represent the device's performance when operating independently as intended.

7. Type of Ground Truth Used

The ground truth for the described bench testing appears to be objective physical measurements and simulated scenarios using phantoms. For instance, the "fabricated Moving Catheter to exercise the auto ROI functionality" implies a known, controlled movement that the device's auto-ROI feature is expected to track. Dose reduction would be verified against dosimetric measurements.

8. Sample Size for the Training Set

The document does not provide information on a training set sample size. The CA-100S is described as a "secondary fast collimator system" that implements "image processing software" and an "Auto-ROI Processor." While this implies algorithms, the text focuses on its physical and operational integration rather than a machine learning model that would require a distinct training set. If machine learning is involved in the "Auto-ROI Processor," details about its training are not provided.

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

As no training set is explicitly mentioned or detailed for a machine learning component, information on how its ground truth was established is not available in the provided text. The "Auto-ROI Processor" is described as calculating "the ROI settings that provide the most useful image," suggesting rule-based or conventional image processing algorithms rather than deep learning that heavily relies on labeled training data and ground truth.

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Optional movable gantry base unit for use with an Aquilion ONE (TSX-301C) system to support longitudinal movement and allow acquisition of images in the z-direction (Z-axis).

Note: When installed with the movable gantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room.

The Aquilion ONE Vision Self-Propelled Scan Base Kit for IVR-CT, CGBA-033A is an optional kit intended to be used in conjunction with an Aquilion ONE Vision / INFX-8000C based IVR-CT system. The subject device is attached to the CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is selected, the standard CT patient couch is replaced with the patient handling system utilized by the interventional x-ray system, Toshiba INFX-8000C. The intended uses and technological characteristics of the Aquilion ONE Vision CT System and INFX-8000C Interventional X-Ray System with which this device is used, remain the same.

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them in the format you requested.

The document is a 510(k) premarket notification for an accessory to a Computed Tomography (CT) system (an optional movable gantry base unit). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with acceptance criteria for device performance in detecting or diagnosing conditions, which is typically what your request implies.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• Acceptance Criteria Table and Device Performance: The document describes the device's function (supporting longitudinal movement and allowing image acquisition in the z-direction) and notes modifications from a predicate device. It does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy, resolution) with numerical targets that would constitute acceptance criteria, nor does it present "reported device performance" in that context.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These items are relevant for studies evaluating diagnostic or prognostic accuracy, often involving image interpretation by human readers or an algorithm. This document describes a hardware accessory for a CT system, and the "testing" mentioned is primarily engineering verification and validation (bench testing) to ensure that the modifications function as intended and meet safety standards. There's no indication of a clinical study involving patients, image interpretation, or ground truth establishment in the manner your questions suggest.
• Type of Ground Truth: Since there's no clinical study described, there's no ground truth (pathology, expert consensus, outcomes data) discussed.
• Training Set Sample Size and Ground Truth Establishment (for training set): These questions are relevant for AI/ML-based devices. The device described here is a hardware accessory for a CT system, not an AI/ML algorithm.

What the document does provide regarding "testing" (which is more about engineering validation than clinical performance):

• Non-Clinical Tests: "This submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met. Evaluation of the modified device included, but was not limited to, confirmation that base movement speed, scanogram and axial/helical scan functions, and interlocks including contact detection, performed according to specifications."
• Software Documentation: "Software Documentation for a Moderate Level of Concern, per the FDA guidance document, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document' issued on May 11, 2005, is also included as part of this submission."
• Standards Compliance: "Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Clectrotechnical Commission (IEC) for Medical Devices and CT Systems."

In summary, the provided text describes a regulatory submission for a hardware component where the "evidence" is primarily engineering verification and validation against design specifications and international safety standards, not a clinical study assessing diagnostic performance against specific acceptance criteria.

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