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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 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The OEC® 9800 Plus is a system used to assist trained Surgeons. The system is used to provide X-Ray images while the Surgeon performs a medical procedure. Images from the system help the Surgeon to visualize the patients' anatomy. This visualization helps to localize surgical regions of interest and pathology. The images provide real-time visualization and records of pre-surgical anatomy, in vivo-surgical activity and post surgical outcomes.

The proposed device will add an alternative supplier for the X-Ray Tube. The current tube and the proposed tube have the same specifications and will be interchangeable. Verification activities confirmed that the proposed tube meets the same specification as the current supplier's tube.

The proposed device will add an alternative supplier for the Radiological Imaging Unit (RIU) or Image Intensifier. The current RIU and the proposed RIU have the same specifications and will be interchangeable. Verification activities confirmed that the alternate RIU meets the same specification as the current supplier's RIU.

The proposed device will provide an optional wireless foot switch and hand switch. The new option is equivalent to the predicate in that functionality is identical. The wireless option provides placement flexibility and reduced cable clutter.

Two printed circuit board assemblies have been combined into a single board in the proposed device due to parts obsolescence. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.

The proposed device will include a LCD monitor which replaces the obsolete CRT monitor. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.

The proposed device includes an alternative solid state drive. This drive provides a faster write speed. Both drives meet their specifications.

The proposed device will include a different model of an OEM injector system. Both the proposed and predicate OEM injector systems share common specifications as confirmed through verification testing.

Here's an analysis of the provided text regarding the acceptance criteria and study for the OEC® 9800 Plus, structured according to your request:

Acceptance Criteria and Device Performance

This 510(k) summary primarily describes modifications to an existing fluoroscopic imaging system (OEC® 9800 Plus) rather than a novel device. The core acceptance criteria revolve around demonstrating that the modified components (X-Ray tube, RIU/Image Intensifier, wireless switches, PCBs, LCD monitor, solid state drive, OEM injector system) perform equivalently to the original components and that the overall system maintains its safety, effectiveness, and intended use as the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify numerical sample sizes for test sets (e.g., number of images, number of patients, number of devices tested).
   • The testing described is primarily retrospective in the sense that the device is a modification to an already cleared product. The testing involved verification and validation of component changes and system performance against established specifications.
   • Data provenance: Not explicitly stated as "country of origin for data" in the context of clinical data, as no clinical studies on human patients were performed. The testing seems to be internal to GE Healthcare Surgery, likely performed at their facilities or those of their component suppliers.

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

   • The document states "testing performed by users with relevant clinical experience" for the "Product Simulated Use Testing."
   • It does not specify the number of experts, nor their specific qualifications (e.g., "Radiologist with 10 years of experience"). It's a general statement about "users with relevant clinical experience."

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

   • No formal adjudication method (like 2+1 or 3+1 consensus for image interpretation) is mentioned. This is typical for a 510(k) submission for modifications where the focus is on engineering verification and validation rather than new clinical claims requiring extensive reader studies.

4. 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 MRMC study was done. This submission is for modifications to an existing fluoroscopic imaging system, not an AI-powered diagnostic tool. The purpose was to demonstrate equivalence of new components and maintain overall system performance, not to evaluate human reader performance with or without AI.

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

   • This question is not applicable. The device is an image-intensified fluoroscopic X-ray system, a hardware and software system for image acquisition and display, not a standalone AI algorithm. The performance evaluated was the system's ability to produce images and function correctly.

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

   • For component-level changes, the "ground truth" was the specifications of the predicate device's components. The new components had to match or exceed these specifications.
   • For system-level functionality and performance (like image quality, electrical/mechanical tests), the "ground truth" was established engineering design input requirements and established standards (e.g., IEC 60601 series, 21 CFR 1020.30-32).
   • For "Product Simulated Use Testing," the "ground truth" for meeting user needs was likely based on the assessment/feedback of "users with relevant clinical experience" against the intended use and established functional requirements.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This is not an AI/machine learning device that requires a training set.

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

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

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The OEC 9800 Plus is designed to provide fluoroscopic and spotfilm imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The Series OEC® 9800 is a System used to assist trained Physicians. The system is used to provide X-Ray images while the Physician performs medical procedure. Images from the system help the Physician to visualize the patients' anatomy. This visualization helps to localize surgical regions of interest and pathology. The images provide real-time visualization and records of pre-surgical anatomy, in vivo-surgical activity and post surgical outcomes.

The system is composed of two primary physical elements. The first is referred to as the "C-Arm" because of its "C" shaped image gantry; the second referred to as the "Workstation" because this is the primary user interface to the system.

The system is used in different surgical procedures. Orthopedic Physicians may use the system to help perform hip replacements and reconstructions of badly fractured bones. Vascular Physicians may use the system to perform blood flow studies. Cardiologists may use the system to help see if there are blockages in some of the key arteries supplying blood to the heart. The procedures that these physicians perform are broadly referred to as "Clinical Applications". The system is controlled and run in a clinical environment.

The system employs X-Rays as its imaging technology. An X-Ray Generator located in the base of the C-Arm creates high voltage. High voltage is carried to the X-Ray tube across a set of cables. The X-Ray tube emits X-Rays that are directed toward the patient under the control of the operator. The Physician defines the desired view for the specific clinical procedure and directs the operator. The X-Rays pass through the patient and are captured by the image intensifier (II). Image intensifier images are captured by a camera and displayed on the image monitor located on the Workstation. The system operator and/or Physician view the images as they are displayed and they may choose to store the images for later review.

In order to perform these procedures different views of the human anatomy are required, so the system is designed with the ability to rotate and translate the C-Arm's image gantry to obtain different viewing angles. In addition since there is variation in thickness and density of the anatomy the operator has the ability to adjust the X-Ray Generator technique, image size and orientation to account for the anatomical differences.

This document, K111551, describes the GE Healthcare Surgery OEC® 9800 / OEC® 9800 Plus, which is a mobile fluoroscopic imaging system. The submission focuses on demonstrating substantial equivalence to a predicate device (K082781 OEC® 9900 Elite) rather than proving performance against specific acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested details, such as those related to AI algorithm performance testing, ground truth establishment, expert adjudication, and MRMC studies, are not applicable or not provided in this specific 510(k) summary. This is a conventional medical imaging device, not an AI/ML-driven one.

Here's a breakdown of the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present performance in terms of specific, quantifiable acceptance criteria or reported device performance metrics in the way one would for an AI algorithm (e.g., sensitivity, specificity, AUC). Instead, it states:

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

• Test Set Size: Not specified for any specific "test set" in the context of an algorithm. The submission mentions "non-clinical performance data" and "bench testing."
• Data Provenance: Not specified. The data would likely be from laboratory bench tests or phantom studies, as this is a hardware device.

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

• Not Applicable. This is a hardware imaging device, not an AI algorithm requiring expert ground truth for classification or detection.

4. Adjudication Method for the Test Set

• Not Applicable. No human-interpreted test set requiring adjudication is described.

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

• No. An MRMC study is not mentioned. This type of study is typically done for AI-assisted diagnostic devices to measure human reader performance improvement.

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

• Not Applicable. This is a hardware device, not a standalone algorithm.

7. The Type of Ground Truth Used

• Not Applicable in the context of ground truth for an AI algorithm. The "ground truth" for a fluoroscopic system would relate to its physical performance characteristics (e.g., image quality metrics, dose output, spatial resolution, contrast resolution), typically measured through bench testing with phantoms and calibrated instruments, rather than expert consensus or pathology.

8. The Sample Size for the Training Set

• Not Applicable. There is no AI algorithm being described, so there is no training set in this context.

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

• Not Applicable. As there is no training set, there's no ground truth establishment for it.

Summary of what IS in the document:

• Device Type: Mobile Fluoroscopic Imaging System (OEC® 9800 / OEC® 9800 Plus).
• Intended Use: "to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures."
• Technology: Employs X-Rays and image intensifiers.
• Substantial Equivalence: Claimed based on comparison of features to predicate device (K082781 OEC® 9900 Elite) and assessment of non-clinical performance data (bench testing).
• Conclusion: "Performance testing... demonstrates that the OEC® 9800 / OEC® 9800 Plus is safe, effective and performs in an equivalent manner to the predicate device and in accordance with its labeling."

This document is a standard 510(k) submission for a conventional medical imaging device, demonstrating safety and effectiveness through substantial equivalence, not through AI/ML performance testing protocols.

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The OEC® 9900 Elite 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, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

The OEC® 9900 Elite Mobile Fluoroscopy System is an image intensified fluoroscopic system consisting of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and an image intensifier. The Mainframe 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 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 instant film printers.

Since the input pertains to a medical device's 510(k) summary, specific acceptance criteria and detailed study results like sample sizes, ground truth establishment, and MRMC studies are typically not explicitly detailed in the summary itself. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial report.

However, I can extract the information that is present and indicate where details are not provided in this specific document.

Here's an analysis based on the provided text:

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

The provided 510(k) summary for the OEC® 9900 Elite Mobile Fluoroscopy System does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen in a clinical study report. Instead, the demonstration of substantial equivalence is based on a comparison of features to a predicate device and an assessment of non-clinical performance data.

The conclusion states: "Performance testing included within this 510(k) demonstrates that the OEC® 9900 Elite is safe, effective and performs in an equivalent manner to the predicate device, with improved reliability and in accordance with its labeling."

Without specific numerical criteria or performance results in this document, a table cannot be accurately constructed. The "performance" here refers to the device meeting the essential safety and effectiveness requirements by being equivalent to the predicate.

2. Sample size 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 in the 510(k) summary. The summary mentions "non-clinical performance data" without specifying the nature or origin of the test sets used. Given it's a fluoroscopy system, testing would likely involve technical performance characteristics rather than patient data in the context of substantial equivalence to a predicate.

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 in the 510(k) summary. As noted above, the testing appears to be non-clinical performance data for the device itself, rather than diagnostic interpretation requiring expert ground truth establishment for a test set of images.

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

This information is not provided in the 510(k) summary. Given the non-clinical nature of the described performance testing, an adjudication method for a test set (which typically refers to human interpretation of images) would not be applicable here.

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 conducted (or at least not mentioned) in this context. The OEC® 9900 Elite Mobile Fluoroscopy System is an imaging device, not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device. The 510(k) is for the imaging system itself.

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

This is not applicable as the device is a mobile fluoroscopic imaging system, not a standalone algorithm.

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

Given that the device is a fluoroscopic imaging system and the testing reported is "non-clinical performance data" for demonstrating substantial equivalence, the "ground truth" would likely relate to objective measurements of the system's technical specifications and imaging capabilities (e.g., image resolution, dose, contrast, noise, geometric accuracy) against established industry standards or the predicate device's performance, rather than clinical ground truth like pathology or outcomes data. However, the specific type of "ground truth" used is not detailed in the summary.

8. The sample size for the training set

This is not applicable as the device is a hardware imaging system, not a machine learning model that requires a training set.

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

This is not applicable as the device is a hardware imaging system, not a machine learning model.

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The 9900 Plus Mobile Fluoroscopy System is designed to provide fluoroscopic images of human anatomy 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 digital fluoroscopic imaging systems are intended to replace fluoroscopic system images obtained through image intensifier technology.

The 9900 Plus 3D option is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. 9900 Pins 3D is intended for imaging bone and soft tissues as well as other internal body structures. 9900 Plus 3D is not intended for mammography applications.

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 benefit from through of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images. The system may be used for other imaging applications at the physicians discretion.

The GE OEC 9900 Plus is a digital 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, flatpanel digital detector, and LCD monitors. 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 GE OEC Workstation is a mobile platform that provides image display screens, image processing, recording, and problem devices.

Interfaces are provided for optional peripheral devices such as thermal or laser printer, video recording devices, and display monitors. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DIC WM . An auxillary connection is provided for an angiographic injector system to facilitate synchronization of angiographic images during contrast media injections.

This document is a 510(k) summary for the GE OEC 9900 Plus Mobile Digital C-Arm. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document outlines:

• Submitter Information: GE OEC Medical Systems, Inc.
• Device Proprietary Name: GE OEC 9900 Plus
• Classification Name: Image Intensified Fluoroscopic X-ray System with Image Processing System / Mobile X-ray system.
• Common/Usual Names: Fluoroscopic Imaging System or Mobile C-arm.
• Substantial Equivalence: To the GE OEC 9900 Elite Mobile C-Arm (K041932) and GE OEC 9900 Elite™ Mobile C-Arm (K041931).
• Indications for Use: Provides fluoroscopic images of human anatomy during diagnostic, surgical, and interventional procedures. Specific applications listed include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care, and emergency room procedures. It also mentions a 3D option for reconstructing 3D volumes from Rotational Fluoroscopy and a surgical navigation feature to aid in locating anatomical structures.
• General Description: A digital image intensified fluoroscopic mobile C-arm system with a C-arm, high-voltage generator, X-ray tube, X-ray controls, flat-panel digital detector, LCD monitors, and a mobile workstation for image display, processing, and recording.

The FDA's letter (K061953) acknowledges the substantial equivalence determination but does not include details on performance criteria or validation studies beyond the general statement of substantial equivalence to predicate devices.

Therefore, I cannot provide the requested table or information regarding acceptance criteria and studies, as this specific document does not contain that level of detail. The FDA's 510(k) clearance process is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies against specific acceptance criteria for every new submission, especially for established device types like C-arms.

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GE OEC Altitude is a Fluoroscopic Imaging System designed to provide fluoroscopic images of the patient during diagnostic, surgical and interventional angiography and cardiology procedures.

GE OEC Altitude is an image intensified fluoroscopic fixed C-arm system. It consists of a C-arm that supports a high-voltage generator, x-ray controls, image intensifier and flat panel display monitors. The system consists of a Ceiling suspended C-arm support (MH-200S), digital substraction system (DAR-9000) and a High Voltage generator (UD150B-40). It 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, and supports image processing and recording devices. This system can be used in conjunction with a mobile or fixed surgical table.

The provided text describes a 510(k) summary for the GE OEC Altitude, a fluoroscopic imaging system. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria directly met by the device's algorithmic performance.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria for algorithmic performance or specific metrics for the GE OEC Altitude itself. Instead, it aims to prove substantial equivalence to a predicate device based on regulatory and safety standards.

The "reported device performance" is implicitly that the device performs comparably to the predicate and meets relevant safety and performance standards.

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

No information is provided about a specific test set for evaluating the GE OEC Altitude's image quality or diagnostic performance against a ground truth. The summary mentions evaluation to "appropriate performance standards" and "IEC 60601-1 International Medical Equipment Safety standard, IEC 60601-2-28 Particular Requirements of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis and IEC 60601-2-32 Particular Requirements of Associated Equipment for X-Ray Equipment for Safety." These are safety and general performance standards, not diagnostic efficacy studies with patient data.

Therefore, there is no information on:

• Sample size for a test set.
• Data provenance (country of origin, retrospective/prospective).

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

This information is not applicable to the provided document. The submission does not describe a study involving expert-established ground truth for image interpretation or diagnostic accuracy.

4. Adjudication Method for the Test Set:

This information is not applicable. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC comparative effectiveness study is not mentioned or described. The GE OEC Altitude is a fluoroscopic imaging system, not an AI-powered diagnostic tool. The document focuses on the hardware and its general imaging capabilities, establishing equivalence to another fluoroscopic system.

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

No standalone algorithmic performance study is mentioned or described, as this device is not an AI algorithm.

7. The Type of Ground Truth Used:

No specific ground truth (expert consensus, pathology, outcomes data) is mentioned because the document does not describe a study evaluating the diagnostic accuracy of the GE OEC Altitude's images against such truths. The "ground truth" for the submission is regulatory compliance and functional equivalence to the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. The GE OEC Altitude is a hardware imaging system, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no training set described.

Summary of the Study Mentioned in the Document:

The "Summary of Studies" section indicates that the GE OEC Altitude was evaluated for compliance with various performance and safety standards, specifically:

• IEC 60601-1 International Medical Equipment Safety standard
• IEC 60601-2-28 Particular Requirements of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis
• IEC 60601-2-32 Particular Requirements of Associated Equipment for X-Ray Equipment for Safety

The core of the submission is to demonstrate that the GE OEC Altitude is substantially equivalent to the predicate device, the AngioSpeed VC (consisting of MH-200S (K943545) and DAR-2400-15B/30B (K955395)). The conclusion states that "Usage of GE OEC Altitude does not result in any new potential hazards," implying that it meets the safety and performance profile established by the predicate device and the relevant standards. The "study" here is a regulatory comparison and compliance assessment, not a clinical trial or AI performance evaluation.

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