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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 reduces exposure to the patient and operator. The system is intended for use in Radiographic/fluoroscopic 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 / FluoroShield™ K182834 cleared 02/18/19). The CA-100S/ FluoroShield™ will be used with the following FDA cleared device: Omega's CS-series-FP ( K100102) which utilizes a Varex 2020 Flat Panel Detector. (Note: the only difference between this submission and the predicate is the size of the FPD. The predicate device utilizes a Varex 3030 Flat Panel Detector)

The-CA-100S/ FluoroShield™ system is composed of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor, two ROI Control Panels and a Monitor.

The CA-100S / FluoroShield™ is a secondary collimator that can only be used in conjunction with the primary collimator. When using the CA-100S / FluoroShield™, the primary collimator shall be used to manually define a region of interest. Once this ROI has been established by the primary collimator, the CA-100S / FluoroShield™ can be used to further reduce the size of the ROI beyond the ROI initially established with the primary collimator.

I am sorry, but based on the provided text, there is no information about specific acceptance criteria and detailed study that proves the device meets those criteria for the CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ mentioned in the document.

The document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's description, function, and safety compliance. While it mentions that "Additional testing for this submission was performed utilizing a DAP meter to demonstrate the dose reduction results utilizing the CA-100S / FluoroShield™ accessory" and "A clinical study was conducted sampling 100 patients as well to demonstrate the dose reduction to patients and staff," it does not provide the specific acceptance criteria for these tests or detailed results in a table format.

Here's what can be extracted regarding some of your questions, but it's not a complete answer to all:

• Study Objective: The clinical study aimed to compare and measure radiation exposure to patients using Dose Area Product (DAP) and scatter radiation to endoscopy personnel using Landauer Luxel personal dosimetry badges.
• Performance Claim (from clinical study conclusion): "When using FluoroShield, unnecessary radiation can be reduced up to 61.8% in patients and 59.4% to the staff."
• Sample size for test set: 100 patients for the clinical study.
• Data provenance: The clinical study was a "prospective study of 100 consecutive patients who underwent fluoroscopy-guided endoscopic procedure." It doesn't specify the country of origin.
• Training set: No information available about a training set. The descriptions of "segmentation model" and "motion detection module" being updated or based on trained images from the 2020 system imply a training process, but details on sample size or ground truth establishment for this training are not provided.
• Ground truth: For the clinical study, the ground truth appears to be measured radiation exposure (DAP for patients, dosimetry badges for staff).
• Other details: Questions 1 (table of acceptance criteria), 3 (experts), 4 (adjudication), 5 (MRMC study), and 6 (standalone performance) are not addressed in the provided text.

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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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The Omega Medical Imaging, LLC CS-series-FP (SSXI) Systems are intended for use in Radiographic/fluroscopic applications including cardiac, vascular, general radiographic/fluroscopic diagnostic, and Interventional x-ray imaging.

The Omega Medical Imaging, LLC, CS-series-FP systems currently incorporate a 19.8cm x 19.8cm or 29.8cm x 29.8cm solid-state flat-panel detector (FPD). This 510(k) submission adds a slightly larger 21.7cm x 21.7cm and 30.3cm x 30.3cm solid-state CMOS flat-panel detector as an additional option. The CS-series-FP fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted c-arm and patient table. The dual plane systems incorporate a ceiling suspended C-arm into the system. The MX CFP 3131 flat-panel image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The captured digital image is processed by the acquisition system (separate from the Flat Panel Detector) which includes image processing, viewing functions, local storage, and DICOM compatibility. The Image Processor does not have the capability to connect to the internet as there is no browser.

Subject Device Flat Panel Detectors MX CFP 2222 / 3131 are to be used only with the Omega CSseries-FP Fluoroscopic Systems

The document provided is a 510(k) premarket notification for a medical imaging device, specifically an X-ray system. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific clinical performance acceptance criteria against a ground truth in the way a diagnostic algorithm would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an X-ray system, specifically an optional detector component), the "acceptance criteria" are related to technical performance benchmarks and compliance with safety standards, rather than clinical diagnostic accuracy. The reported "performance" is the technical testing done to show equivalence.

• 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32 (Parts related to electronic product radiation control).
• IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, and IEC 60601-2-43 (International safety standards).
• UL 60601-1 and CAN/USA C22.2 No.601.1-M90 (Specific safety standards). |
  | Equivalence in Technology | The MX CFP 2222 and 3131 option utilizes the same technology (Cesium Iodide scintillator coupled to a CMOS-light sensitive imaging component) as the predicate device. |
  | No new indications for use | The modified device does not introduce any new indications for use. |
  | No new potential hazards | The modified device does not result in any new potential hazards. |

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

• Sample Size: Not applicable. The "test set" in this context refers to commercially available test objects designed to evaluate technical imaging characteristics, not a clinical dataset of patient images.
• Data Provenance: Not applicable, as it's technical bench testing, not clinical data.

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

• Not applicable. Ground truth for technical performance tests is established by the specifications of the test objects themselves and physical measurements, not by expert consensus on clinical images.

4. Adjudication method for the test set:

• Not applicable. Technical measurements do not typically involve adjudication in the way clinical diagnostic performance studies do.

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. This is an X-ray system (hardware component), not an AI algorithm. Therefore, an MRMC study and AI-related effectiveness are not relevant.

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

• Not applicable. This is an X-ray system (hardware component), not a standalone algorithm.

7. The type of ground truth used:

• Technical performance benchmarks established by the design of commercially available test objects (e.g., phantoms for low-contrast, spatial resolution, temporal resolution, dynamic range) and compliance with international and national safety standards.

8. The sample size for the training set:

• Not applicable. This is an X-ray system; there is no "training set" in the context of machine learning.

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

• Not applicable.

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The Omega Medical Imaging, LLC CS-series-FP with 3030+ Option systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

The Omega Medical Imaging, LLC. CS-series-FP systems currently incorporate a 19.8cm x 19.8cm solid-state flat-panel detector (FPD) as an option. This 510(k) submission adds a larger format (29.8cm x 29.8cm) flat-panel detector as an additional option. The CS-series-FP fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-arm and a patient table. The dual plane systems incorporate a ceiling suspended C-arm into the system. The flat-panel image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The captured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.

The provided text is a 510(k) summary for the Omega Medical Imaging, LLC CS-series-FP with 3030+ Option radiographic/fluoroscopy system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and performance metrics against a gold standard in the way an AI/ML device might.

Therefore, the requested information elements related to acceptance criteria, ground truth, expert review, and statistical analyses of clinical performance are largely not applicable in this context. The "study" described is a non-clinical performance testing to show the new device meets the same performance standards as its predicate.

Here's an attempt to interpret and answer your questions based on the provided text, highlighting where the information is not available or not relevant for this type of submission:

1. A table of acceptance criteria and the reported device performance

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the primary acceptance criterion is substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device. The "acceptance criteria" here are therefore the performance characteristics of the predicate device, which the new device aims to match or exceed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the traditional sense of patient data. The "test set" consisted of "commercially available Test Objects" (phantoms). The number and specific types of these test objects are not detailed, but they are not human or animal subjects.
• Data Provenance: Not applicable. The "data" comes from non-clinical performance testing using phantoms, not patient data from a specific country or collected retrospectively/prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth as typically understood for clinical studies involving expert interpretation of images or diagnoses is not relevant here. The "ground truth" for non-clinical performance testing is inherent in the design specifications of the test objects themselves (e.g., a known number of low-contrast objects, a specific spatial resolution pattern). Performance is measured objectively by the system.

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

• Not applicable. There was no human adjudication of results for the non-clinical performance tests. Measurements are objective and quantitative (e.g., measuring line pairs per millimeter, contrast-to-noise ratio).

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. An MRMC study was not performed. This submission is for an imaging system (hardware), not an AI/ML diagnostic tool. There is no AI component or human-in-the-loop performance measurement described.

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

• No. This is an imaging system, not an algorithm, so "standalone (algorithm only)" is not applicable. The performance tests evaluate the physical and technical capabilities of the X-ray system and its detector.

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

• The "ground truth" for the non-clinical testing was based on the known characteristics and specifications of the commercially available test objects (phantoms). These phantoms are designed to have specific, measurable properties (e.g., specific sizes of low-contrast objects, known spatial frequencies).

8. The sample size for the training set

• Not applicable. As this is not an AI/ML device, there is no "training set" in the machine learning sense. The device is a conventional X-ray imaging system.

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

• Not applicable, as there is no training set for an AI/ML algorithm.

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The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems incorporates a solid-state flat-panel detector (FPD) as an option to the cleared Omega Medical Imaging, Inc. CS-series fluoroscopy systems (K070834) in lieu of an image intensifier/CCD based imaging detector. The CS-series fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-am and a patient table. The dual plane systems incorporate a ceiling suspended C-arm. The image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The caplured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.

The Omega Medical Imaging, Inc. CS-series-FP (SSXI) fluoroscopy system aims to provide imaging performance comparable to existing fluoroscopy systems by incorporating a solid-state flat-panel detector (FPD).

1. A table of acceptance criteria and the reported device performance:

The document provides detailed technical specifications for the CS-series-FP (SSXI) system, which serve as its performance criteria. The device is reported to meet these specifications directly by listing them as characteristics of the system.

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