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The OEC 3D mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal.endoscopic, urologic, neurologic, vascular, cardiac, critical care, and emergency procedures.

The OEC 3D 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 and volumetric reconstructions 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 system is composed of two major components, a C-Arm and a tethered Workstation. The C-Arm is a stable mobile platform capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral) 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 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. Its functionality is controlled by software on the Workstation and on the OEC Touch, a digital flat panel controller mounted on the cross-arm. 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. The Workstation is the primary user interface to the system and can be located at a convenient location in the room independent of where the C-Arm is located.

The provided text describes modifications to the OEC 3D mobile fluoroscopy system, specifically introducing a "3D Spine Centerline Tool with Manual Labeling of the Vertebrae," a "3D Screw Evaluation Tool," and "Augmented Fluoroscopy." The document indicates that these modifications do not require clinical data to establish safety or efficacy and that the device meets acceptance criteria through non-clinical performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The text states that "cadaveric volume datasets of the spine representing different imaging conditions" were used for the 3D Spine Centerline Tool and 3D Screw Evaluation Tool, and a "rigid phantom" was used for Augmented Fluoroscopy. Specific numbers for the cadaveric datasets or phantom instances are not provided.
• Data Provenance:
  • Cadaveric datasets: Implies human cadavers. Country of origin is not specified.
  • Rigid phantom: Artificial, not human data.
  • Retrospective or Prospective: Not specified, but given the nature of cadaver and phantom studies, they are typically considered controlled experimental setups rather than retrospective or prospective clinical studies.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not report a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the performance of the device's new features with respect to established metrics (e.g., accuracy for Augmented Fluoroscopy) and demonstrating substantial equivalence to the predicate device through non-clinical testing. It also explicitly states, "The new performance claims did not require clinical data in order to establish safety or efficacy."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The testing described for the "3D Spine Centerline Tool with Labeling" and "3D Screw Evaluation Tool" on cadaveric data, and the "Augmented Fluoroscopy" error quantification with a rigid phantom, suggests standalone performance evaluation of these features. The documentation does not describe a human-in-the-loop study for these features, rather it focuses on the intrinsic performance of the algorithms.

7. Type of Ground Truth Used

• 3D Spine Centerline Tool and 3D Screw Evaluation Tool: The ground truth for these tools was likely established through precise measurements or expert annotations on the cadaveric volume datasets, though the exact method is not detailed.
• Augmented Fluoroscopy: The ground truth for accuracy was established by the known true positions within the rigid phantom, against which the projected 3D points were compared.

8. Sample Size for the Training Set

The document does not specify a sample size for any training set. It primarily discusses validation and verification testing of modifications, which implies the features were developed and potentially trained using internal datasets not detailed in this submission summary.

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

The document does not provide information on how the ground truth for any training set (if applicable) was established.

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The OEC 3D mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediativ populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, neurologic, vascular, cardiac, citical care and emergency procedures.

The OEC 3D 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 and volumetric reconstructions 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 system is composed of two primary physical components. The first is referred to as the "C -Arm" because of its "C" shaped image gantry; the second is referred to as the "Workstation", and this is the primary user interface for the user to interact with the system. The C-arm has an interface tablet allowing a technician to interact with the system.

The C-arm is a stable mobile platform capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral) 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 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,

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.

On the C-Arm, the generator remains unchanged from the OEC Elite. This is also true for the 31 cm x 31 cm image receptor, consisting of a Thallium-doped Cesium Iodide [Cs] (TI)] solid state flat panel X-ray detector with Complementary Metal Oxide Semiconductor (CMOS) light imager. The X-ray tube housing and insert remains the same as on the predicate OEC Elite (K192819).

C-Arm functionality is managed by a digital flat tablet control panel mounted on the C-arm base. Motion is controlled by a joystick.

On the workstation, the main hardware includes a computer with integrated wireless capability and a dedicated computer for 3D reconstruction located within the storage bay. The OEC 3D employs the same software architecture and platform design that fully supports the flat panel detector as the OEC Elite and complies with IEC 60601-1. The OEC 3D includes the existing 2D imaging functionalities available on the OEC Elite including imaging and post processing applications.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. Instead, it is a 510(k) premarket notification summary from the FDA, asserting substantial equivalence to predicate devices rather than demonstrating performance against explicit acceptance criteria with clinical data.

Here's an analysis of the information available in the document, and where details are explicitly not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance testing against general standards, rather than specific acceptance criteria for performance metrics.

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

This information is not provided. The document states that "clinical data is not required to demonstrate substantial equivalence" and that the device was evaluated using "engineering bench testing" and "non-clinical performance testing." Therefore, there is no discrete "test set" of patient data in the clinical sense mentioned.

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

This information is not provided. Since clinical data was not used for the performance evaluation for substantial equivalence, no expert ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical test set with human assessments is described, no adjudication method is relevant or provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The new performance claims did not require clinical data in order to establish safety or efficacy." Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes non-clinical performance testing and engineering bench testing, which would broadly cover standalone algorithm performance in a technical sense (e.g., image quality metrics, reconstruction accuracy). However, it does not explicitly detail a "standalone performance study" in the context of clinical metrics like sensitivity, specificity, or reader performance. The focus is on demonstrating that the new 3D functionality is "substantially equivalent" to that of reference devices.

7. The Type of Ground Truth Used

The document does not describe the use of specific ground truth (expert consensus, pathology, outcomes data) in the context of clinical performance evaluation for substantial equivalence to the same extent as a traditional clinical study. The "ground truth" for the non-clinical performance testing would be derived from engineering specifications, phantom measurements, and compliance with standards (e.g., IEC 60601-1, NEMA XR-27). The 3D algorithm is stated to be "identical" to one of the reference devices (INNOVA IGS 5), implying its performance characteristics are assumed to be similar to that previously cleared device.

8. The Sample Size for the Training Set

This information is not provided. The document does not describe any machine learning or AI algorithm development that would involve a training set of data. The 3D algorithm is stated to be "identical" to one of the reference devices, suggesting it's an existing, proven algorithm rather than a newly trained one requiring a specific training set.

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

This information is not provided, as no training set is mentioned.

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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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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, vasular, 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 system is composed of two primary physical components. The first is referred to as the "C - Arm" because of its "C" shaped image gantry; the second is referred to as the "Workstation", which is the primary interface for the user to interact with the system.

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 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.

The primary purpose of the mobile fluoroscopy system is to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, cardiac, critical care and emergency procedures.

This document (K172550) is a 510(k) summary for a medical device (OEC Elite fluoroscopy system) and does not describe a study related to an AI/ML-based device.

Therefore, many of the requested details, such as "number of experts used to establish ground truth", "adjudication method", "MRMC study", "standalone performance", "training set size", and "ground truth for training set", are completely irrelevant to this document.

The document discusses the substantial equivalence of an updated version of a fluoroscopy system (OEC Elite with Cardiac option) to its predicate device. This is a hardware/software update to an imaging device, not an AI/ML diagnostic or assistive tool.

Based on the provided text, here's what can be extracted regarding acceptance criteria and performance, focusing on the device's performance rather than an AI's performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating that the updated OEC Elite with Cardiac option maintains the performance of the predicate device and meets established industry standards for X-ray imaging systems. The "reported device performance" are statements of compliance and successful testing rather than specific numerical results for all metrics.

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

The document explicitly states that no clinical images or human studies were used to demonstrate substantial equivalence for the cardiac option. The testing conducted was "engineering (non-Clinical) testing," "engineering bench testing," and "imaging performance evaluation using anthropomorphic phantoms."

Therefore, there is no "test set" in the sense of clinical patient data, nor is there data provenance (country of origin, retrospective/prospective). The "sample size" would refer to the number of phantom tests or bench tests, which are not specified in numerical terms beyond "successful verification and validation testing" and "additional engineering bench testing."

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

Not applicable. No ground truth was established by human experts for a clinical dataset because no clinical dataset was used for demonstration of substantial equivalence.

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

Not applicable. No clinical test set requiring adjudication was used.

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. This is not an AI device, and no MRMC study was performed.

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

Not applicable. This is a fluoroscopy imaging system, not an AI algorithm.

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

The "ground truth" for the device's technical performance was established by measurement against established engineering standards and phantom studies, rather than clinical ground truth (e.g., pathology). The "truth" was defined by what parameters an X-ray imaging system should meet.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set" of data. The software changes were built upon an existing architecture and followed a standard software development lifecycle.

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

Not applicable. No training set was used in the context of AI/ML.

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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, 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 system is composed of two primary physical components. The first is referred to as the "C - Arm" because of its "C" shaped image gantry; the second is referred to as the "Workstation", which is the primary interface for the user to interact with the system.

The provided document describes the OEC Elite mobile fluoroscopy system, which is a medical imaging device. The document is submitted as a 510(k) premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

However, the document specifically states: "Clinical images are not required to demonstrate the substantial equivalence to the predicate device." This means that there was no clinical study involving human patients or human readers performed to prove the device meets acceptance criteria related to clinical performance (e.g., diagnostic accuracy, reader improvement with AI assistance).

The acceptance criteria and proof of performance are based on non-clinical testing (engineering bench testing and phantom studies).

Here's a breakdown of the requested information based on the provided text, while acknowledging the absence of a clinical study:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

The acceptance criteria are implied by compliance with various industry standards and guidance documents for X-ray imaging devices. The document asserts that the device met these criteria.

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

• Test Set Sample Size: Not applicable in the context of a clinical test set. The document refers to "engineering bench testing" and "imaging performance evaluation using anthropomorphic phantoms." The specific number of phantoms or tests is not provided.
• Data Provenance: Not applicable for clinical data. The tests were performed internally by the manufacturer (GE OEC Medical Systems, Inc.) in Salt Lake City, Utah, USA. The data is from non-clinical sources (bench tests, phantom studies).

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

• Not applicable. As no clinical study was performed, there were no human experts establishing clinical ground truth for a test set. Ground truth for non-clinical performance (e.g., image quality metrics) is established through engineering and physics measurements against defined standards.

4. Adjudication Method for the Test Set:

• Not applicable, as no clinical study with human readers or AI performance evaluation was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. The document explicitly states: "Clinical images are not required to demonstrate the substantial equivalence to the predicate device." Therefore, no MRMC study to compare human readers with and without AI assistance was performed.

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

• Yes, indirectly, in a non-clinical context. The device itself is an imaging system, not explicitly an "AI algorithm" in the modern sense of a diagnostic AI. However, the performance metrics listed (DOE, spatial resolution, contrast resolution, etc., and the functioning of new software features like subtraction or roadmapping) represent the "standalone" imaging performance of the device, without human interpretation as part of the validation study. The "algorithm" here refers to the underlying image processing and control software of the fluoroscopy system.

7. The Type of Ground Truth Used:

• Engineering specifications, physical measurements, and phantom imaging results. The ground truth for the non-clinical performance was based on:
  • Design input specifications.
  • Compliance with recognized standards (e.g., IEC 60601 series, FDA's "Information for Industry: X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment, Tests and Standards", "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (SSXI)").
  • Measurements obtained from anthropomorphic phantoms that simulate human anatomy, rather than actual patient data or clinical outcomes.

8. The Sample Size for the Training Set:

• Not applicable. This device is a fluoroscopy system, not a machine learning model that undergoes "training" in the typical AI sense. The software development process mentioned (IEC 60324 compliant, design control, risk management) pertains to traditional software engineering, not AI model training with large datasets. The new vascular features were "built upon the existing robust and extensible software architecture."

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

• Not applicable, for the same reason as point 8.

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The OEC Everview 7500 is a mobile digital C-arm designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical, critical-care and emergency room procedures. Examples of clinical application may include, but are not limited to cholangiography, endoscopy, urology, vascular, orthopedic, neurology and cardiac procedures. It is anticipated that this product will be used on a daily basis by such users, as prescribed by the physician. The system may be used for other imaging applications at the physician's discretion.

The OEC Everview 7500 is an image intensified fluoroscopic mobile C-arm system. It consists of a C-arm that supports a high-voltage generator, x-ray tube, x-ray controls, image intensifier, and CRT monitors. It is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles with respect to the patient, and supports image processing and recording devices.

The provided text refers to a 510(k) Notification for the GE OEC Everview 7500, a mobile digital C-arm. This document is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study designed to establish new performance criteria. Therefore, the information requested in points 1-9, which typically relate to clinical performance studies for novel devices or significant modifications, is not fully present or directly applicable in this 510(k) summary.

Here's a breakdown of the available information in relation to your questions:

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

This document does not contain a table of acceptance criteria in the context of clinical performance or specific reported device performance metrics. Instead, it lists product standards that the device is designed in accordance with. These standards primarily cover safety, electrical, and radiation protection requirements, and not clinical performance metrics like sensitivity or specificity.

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

No information is provided regarding a test set sample size or data provenance related to clinical performance. This type of information is not typically part of a 510(k) summary for a substantial equivalence determination of a C-arm. The focus is on technical specifications and comparison to predicate devices.

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. As no clinical performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.

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

Not applicable. No test set or adjudication method 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. This device is an image-intensified fluoroscopic x-ray system, and the document does not mention any AI components or MRMC studies.

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

Not applicable. No algorithm-only performance study is mentioned for this imaging system.

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

Not applicable, as no external ground truth for clinical performance is described. The "ground truth" for this 510(k) is the substantial equivalence to the predicate devices, meaning it performs as intended and is as safe and effective as those existing devices based on technical specifications and design.

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning model or a training set.

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

Not applicable, as no machine learning model or training set is described.

In summary, the provided 510(k) notification for the GE OEC Everview 7500 focuses on demonstrating substantial equivalence to previously cleared predicate devices based on design, technical specifications, and adherence to relevant product safety and performance standards. It does not contain information about clinical performance studies, test sets, or ground truth establishment in the manner typically associated with studies for novel devices or AI-powered systems.

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The OEC Fluorostar is a mobile digital C-arm designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, stone localization, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.

The OEC Fluorostar is a mobile digital C-arm.

The provided text is a 510(k) premarket notification letter from the FDA to GE OEC Medical Systems, Inc. for their OEC Fluorostar device. It primarily focuses on the FDA's "substantial equivalence" determination and regulatory classification.

The document does not contain information about acceptance criteria for device performance, a study proving the device meets these criteria, sample sizes for test sets or training sets, data provenance, details about ground truth establishment, or any information related to multi-reader multi-case (MRMC) studies or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the given text.

The closest relevant information is the "Indications For Use Statement" which describes the intended purpose of the device: "The OEC Fluorostar is a mobile digital C-arm designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, stone localization, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion."

To answer your request, I would need a different type of document, such as a clinical study report, a performance validation report, or a detailed technical specification submitted as part of the 510(k) application itself, which would elaborate on how the device's technical performance was tested and proven.

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The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation provides the physician with fluoroscopic images during diagnostic, surgical and interventional procedures. The surgical navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may be benefit from the use of stereotactic surgery and which provides a reference to ridged anatomical structures such as sinus, cranial, long bone or vertebra visible on fluoroscopic images.

The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation is a fluoroscopic system with integrated surgical navigation capabilities.

The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the high-voltage generator, x-ray tube, x-ray controls, and image intensifier. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The OEC workstation is a mobile platform that supports image display monitors, image processing and recording devices.

The integrated surgical navigation system allows the surgeon to view reconstructed two-dimensional images of the patient's anatomy in response to an electromagnetically tracked surgical instrument. This indicates the position of the tracked surgical instrument with regard to the patient's anatomy based on preoperative medical images.

The provided text is a 510(k) summary for the GE OEC Olympus Mobile Fluoroscopy System with Integrated Navigation. This document focuses on establishing substantial equivalence to previously marketed devices and compliance with safety standards rather than presenting a performance study with acceptance criteria in the typical sense for a new diagnostic device.

Therefore, many of the requested categories (acceptance criteria table, sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth specifics for studies) are not present in this type of regulatory submission.

The document states that the device is "substantially equivalent to the OEC FluoroTrak 9800 Plus (K022069) and the OEC 9800 E/CV+ Digital Mobile System (K024012)." This statement implies that the device inherently meets the performance established by these predicate devices. The study proving this substantial equivalence would primarily involve demonstrating that its technical characteristics and indications for use are similar, and that it adheres to relevant safety and performance standards.

Here's a breakdown of what can be extracted based on the provided text:

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

This information is not explicitly provided in the 510(k) summary as a set of acceptance criteria for a new performance study. The core of this submission is demonstrating substantial equivalence to predicate devices rather than proving performance against novel performance metrics. The "performance" is implicitly considered equivalent to the predicate devices.

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

This information is not provided. There is no mention of a specific test set or data provenance in the context of a new performance study.

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)

This information is not provided.

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

This information is not provided.

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

An MRMC study was not mentioned or described. The device is a fluoroscopy system with integrated navigation, not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate reader improvement.

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

A standalone performance study was not mentioned or described. The device is a system with human-in-the-loop (surgeon using navigation aid).

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

This information is not provided.

8. The sample size for the training set

This information is not provided.

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

This information is not provided.

Summary based on the 510(k) document:

The regulatory submission for the "OEC Olympus Mobile Fluoroscopy System with Integrated Navigation" focuses on demonstrating substantial equivalence to pre-existing devices (OEC FluoroTrak 9800 Plus (K022069) and OEC 9800 E/CV+ Digital Mobile System (K024012)) and adherence to various product safety and performance standards (e.g., 21 CFR 1020.30-32, ANSI/NFPA 70 & 99, UL 60601, IEC series). It does not present a de novo performance study with explicit acceptance criteria, test sets, or ground truth establishment as would be expected for a novel diagnostic algorithm. The "study" proving the device meets criteria is implicitly the demonstration of its technical specifications aligning with predicate devices and compliance with established industry and regulatory safety standards.

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The OEC Olympus Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.

The OEC Olympus Mobile Fluoroscopy System is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the high-voltage generator, x-ray tube, x-ray controls, and image intensifier. The C-arm is designed to perform linear and rotational motions that allow the user to position the xray imaging components at various angles and distances with respect to the patient. The OEC workstation is a mobile platform that supports image display monitors, image processing and recording devices.

Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCR's. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets and DICOM 3.0. An auxiliary connection is provided for a angiographic injector system to facilitate synchronization of angiographic images during contrast media injections.

Here's an analysis of the provided text regarding the OEC Olympus Mobile Fluoroscopy System, focusing on the requested information about acceptance criteria and studies.

It's important to note that this document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance validation studies and acceptance criteria in the same way a full design validation report would. Therefore, much of the requested information about explicit acceptance criteria and a detailed study proving performance against them is not directly present in this document. The document primarily focuses on regulatory compliance and substantial equivalence to existing devices.

Nonetheless, I will extract what can be inferred and explicitly stated from the provided text.

Acceptance Criteria and Device Performance Study for OEC Olympus Mobile Fluoroscopy System

Based on the provided 510(k) Summary for the OEC Olympus Mobile Fluoroscopy System, the device's acceptance is primarily based on meeting established product standards and demonstrating substantial equivalence to predicate devices, rather than a specific, detailed performance study with explicit acceptance criteria provided in this summary.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of quantitative performance-based acceptance criteria (e.g., image resolution, contrast-to-noise ratio) and corresponding measured device performance. Instead, its "acceptance criteria" are implied through adherence to recognized safety and performance standards for medical electrical equipment and diagnostic x-ray systems.

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

The 510(k) summary does not describe a specific "test set" in the context of an algorithm or AI performance evaluation. This document pertains to a traditional medical device (an X-ray system), not an AI/ML software device. Therefore, concepts like "test set sample size" and "data provenance" for algorithm validation are not applicable or provided here.

The "testing" mentioned would typically refer to engineering verification and validation testing to ensure compliance with the listed standards and specifications, rather than a clinical performance study with a 'test set' of medical images.

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

This information is not applicable and not provided in the 510(k) summary as it is for an X-ray imaging system, not an AI/algorithm-based diagnostic tool requiring expert ground truth for image interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers with vs. without AI Assistance:

This information is not applicable and not provided. The device is an image acquisition system, not an AI-assisted diagnostic software. There is no AI component described in this summary that would involve human readers being assisted or compared with AI.

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

This information is not applicable and not provided. The device is an X-ray system, not a standalone algorithm.

7. The Type of Ground Truth Used:

This information is not applicable and not provided for an X-ray system. The "ground truth" for an imaging system usually relates to its ability to accurately visualize anatomical structures, and its performance is assessed against technical specifications (e.g., spatial resolution, contrast resolution, dose) and compliance with standards.

8. The Sample Size for the Training Set:

This information is not applicable and not provided as this is not an AI/ML device that requires a training set.

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

This information is not applicable and not provided as this is not an AI/ML device.

Summary of what's provided for acceptance/proof of performance:

The acceptance and proof of performance for the OEC Olympus Mobile Fluoroscopy System, as presented in this 510(k) summary, hinge on two primary aspects:

• Compliance with Recognized Standards: The device is designed in accordance with a comprehensive list of national and international safety and performance standards for diagnostic X-ray systems and medical electrical equipment (e.g., 21 CFR 1020.30-32, ANSI/NFPA, UL, CSA, IEC 60601 series, 93/42/EEC). The underlying assumption is that adherence to these standards ensures the device is safe and performs as intended.
• Substantial Equivalence to Predicate Devices: The submission explicitly states that the OEC Olympus Mobile Fluoroscopy System is substantially equivalent to two previously cleared GE OEC Mobile Imaging Systems (K021049 and K024012). This means that its indications for use, fundamental technology, and performance characteristics are similar enough to existing legally marketed devices that it does not raise new questions of safety and effectiveness.

The document does not delve into specific quantitative performance metrics or clinical study results to "prove" the device's acceptance against detailed diagnostic outcome criteria. Such detailed performance data, if collected, would typically be part of internal design validation documentation rather than summarized in a 510(k) for a device of this nature and era.

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