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The OEC® 9900 Elite 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 OEC® 9900 Elite is a system used to assist trained physicians. The system is used to provide X-Ray images while the physician performs a 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 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 service platform to allow the user to connect to hospital intranet PACS system. The predicate product features a hard-wired connection. Verification testing confirmed that all specifications, including data security, were met.

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

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.

The provided document is a 510(k) Premarket Notification Submission for the GE OEC 9900 Elite Mobile Fluoroscopic Imaging System. This submission describes modifications to an existing device rather than a new device requiring extensive clinical trials for performance validation. Therefore, the document discusses verification activities to confirm that the modifications meet the same specifications as the predicate device, rather than a study with specific acceptance criteria related to clinical performance metrics like sensitivity, specificity, or reader improvement.

Based on the provided text, here's a breakdown of the requested information:

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

The acceptance criteria are implicitly that the proposed modifications (alternative X-Ray tube, alternative Radiological Imaging Unit (RIU), wireless service platform, combined printed circuit boards, and wireless foot/hand switch) meet the "same specifications" as the current/predicate components and demonstrate "equivalent functionality." The reported device performance is that these criteria were met through verification testing.

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

The document does not specify a "test set" in the context of clinical performance evaluation with patient data. The "verification activities" mentioned are engineering and standards compliance testing, indicating a focus on hardware and software functionality and safety rather than a clinical dataset. Therefore, information about sample size, country of origin, or retrospective/prospective nature of patient data is not provided.

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 applicable to the type of study described. The verification testing focused on engineering specifications, not expert interpretation of medical images.

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

This information is not applicable. There was no clinical test set requiring expert 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 MRMC study was done. This submission is for modifications to a fluoroscopic imaging system, not an AI-powered diagnostic tool. The focus is on hardware and software equivalence, not human reader performance with or without AI assistance.

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

No standalone algorithm performance was evaluated. The device is a "Mobile Fluoroscopic Imaging System," which is an imaging modality, not an algorithm.

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

The "ground truth" for this submission was based on engineering specifications and voluntary standards compliance. The verification activities confirmed that the modified components met the established technical requirements and safety standards, which are the "ground truth" for this type of medical device modification.

8. The sample size for the training set:

Not applicable. This submission concerns hardware and software modifications to an existing imaging system, not a machine learning model that requires a training set.

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

Not applicable, as there was no training set.

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The OEC® 9900 Elite 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, vascular, cardiac, critical care and emergency room procedures.

The OEC® 9900 Elite is a system used to assist trained physicians. The system is used to provide X-Ray images while the physician performs a 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 provided text describes the GE OEC 9900 Elite Mobile Fluoroscopic Imaging System and its 510(k) premarket notification. However, it does not contain information about specific acceptance criteria or a study proving the device meets said criteria in the way typically expected for performance-based medical device submissions (e.g., accuracy, sensitivity, specificity, etc., with detailed statistical analysis).

The submission focuses on establishing substantial equivalence to a predicate device (OEC 9900 Elite, K082781) by stating that the modified device "employs the same fundamental scientific technology" and that "engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks."

Therefore, I cannot fulfill most of your request from the provided text, as the specific details you're asking for are not present.

Here's an attempt to answer based on the available information, highlighting what is not present:

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

• Information Not Provided: The submission does not specify numerical acceptance criteria (e.g., for image quality, resolution, contrast, etc.) nor does it report specific performance metrics against such criteria. The claim is substantial equivalence to a predicate device, implying that the performance is at least as good as 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)

• Information Not Provided: The document does not describe any specific "test set" of patient data or images used for performance evaluation. The "engineering testing and standards compliance testing" mentioned would typically involve technical performance verification (e.g., calibration, image quality phantoms) rather than clinical image interpretation by humans.

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)

• Information Not Provided: Since no clinical test set is described, there's no mention of experts or ground truth establishment in this context.

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

• Information Not Provided: No clinical 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

• Information Not Provided: This device is a fluoroscopic imaging system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission and is not mentioned.

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

• Information Not Provided: This device is a direct imaging system, not an algorithm. Its performance is inherent to its imaging capabilities, with a human operator (physician or system operator) in the loop during its intended use. It does not have a "standalone algorithm" performance to report.

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

• Information Not Provided: No clinical ground truth is discussed in this submission. The "ground truth" for showing substantial equivalence relies on technical specifications and adherence to standards for the device's components and overall function, compared to the predicate.

8. The sample size for the training set

• Information Not Provided: This device is not an AI/ML algorithm that requires a "training set."

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

• Information Not Provided: This device is not an AI/ML algorithm, so there is no training set or associated ground truth establishment.

Summary based on the provided text:

The GE OEC 9900 Elite Mobile Fluoroscopic Imaging System K120613 submission relies on demonstrating substantial equivalence to a predicate device (OEC 9900 Elite, K082781) rather than presenting a de novo performance study against explicit acceptance criteria.

The key statements regarding performance and safety are:

• "The modified OEC® 9900 Elite device employs the same fundamental scientific technology as the predicate device."
• "Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks."
• "GE Healthcare considers the modified GE OEC® 9900 Elite to be safe, as effective, and performance is substantially equivalent to the predicate device OEC® 9900 Elite (K082781)."

This type of 510(k) submission typically does not include the detailed clinical performance studies, reader studies, or AI algorithm evaluation metrics you requested. The "study" referenced would be the engineering and standards compliance testing that validated the modifications did not alter the fundamental safety or effectiveness demonstrated by the predicate device.

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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, urolagic, orthopedic, neurologic, vascular, cardiac, 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.

The provided 510(k) summary for the OEC® 9900 Elite Mobile Fluoroscopic Imaging System does not include specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

The document states:

• "Performance testing included in Section 18 Performance Testing – Bench and Section 19 Performance Testing - Animal of this 510(k) demonstrates that the OEC® 9900 Elite is safe, effective and performs in an equivalent manner to the predicate device(s) and in accordance with its labeling."

However, Sections 18 and 19 are not provided in the given text. Without these sections, the detailed information about acceptance criteria, reported performance, study methodologies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and specific comparative effectiveness or standalone study results cannot be extracted.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. The submission only gives a high-level statement that such testing was performed and demonstrated equivalence to predicate devices.

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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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