Search Results

The OEC® Brivo® Mobile C-Arm X-Ray Products are designed to provide digital spot-film imaging and fluoroscopic image quidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localization/s or needle positions for aspirations, injections or biopsy. The OEC® Brivo® is not indicated for interventional use.

The OEC® Brivo® 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 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.

This document describes the 510(k) Premarket Notification Submission for the GE Healthcare OEC® Brivo® Mobile Fluoroscopic Imaging System. This is a medical imaging device, not an AI/ML algorithm, so many of the requested criteria for AI/ML studies are not applicable.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a fluoroscopic imaging system and not an AI algorithm performing a specific task like classification or detection, the "acceptance criteria" are related to compliance with medical device standards and the generation of clinically useful images. Device performance is demonstrated through various non-clinical tests.

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

• Test Set Sample Size:
  • External Image Quality Evaluation: Implied to be images from "human cadavers." No specific number is provided.
  • Product Simulated Testing Performance Use: Uses "anthropomorphic phantoms." No specific number of phantoms or images is provided.
  • Functional Product Simulated Use Testing: Uses "simulated clinical workflow" with no specific numbers of cases or procedures given.
• Data Provenance:
  • The "External Image Quality Evaluation" used human cadavers, implying pre-collected or specifically prepared cadaveric data.
  • The "Product Simulated Testing Performance Use" used anthropomorphic phantoms.
  • The document does not mention specific countries of origin for the cadaver or phantom data.
  • The testing described is prospective in nature, as it involves active testing of the device.

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

• Number of Experts:
  • Functional Product Simulated Use Testing: "an orthopedic surgeon and trained clinical technicians." This suggests at least one orthopedic surgeon and an unspecified number of technicians.
  • External Image Quality Evaluation: "orthopedic surgeons and clinical representatives." This suggests at least two types of evaluators, with an unspecified number for each.
• Qualifications of Experts:
  • "orthopedic surgeon"
  • "trained clinical technicians"
  • "clinical representatives"
  • No specific years of experience or board certifications are provided in the document.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1 consensus). The evaluations appear to be direct assessments by the stated experts and technicians. For "External Image Quality Evaluation," where multiple types of evaluators are mentioned, it states "Evaluation of the images by orthopedic surgeons and clinical representatives demonstrated OEC® Brivo® produces useful images," which might imply a collaborative or individual assessment without a formalized adjudication process for discrepancies.

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 device is a fluoroscopic imaging system, not an AI-powered diagnostic or assistive tool for image interpretation by clinicians. The study aims to demonstrate the device's ability to produce useful images and comply with standards, not to measure reader performance improvement with AI assistance.

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

• N/A. This is a hardware imaging system, not an algorithm. Its performance is its standalone performance in generating images. The evaluations of image quality and functional use are assessments of the system's output.

7. The Type of Ground Truth Used

• For image quality and clinical utility:
  • Expert assessment/consensus: Orthopedic surgeons and clinical representatives evaluated the "usefulness" of images produced from cadavers and phantoms.
  • Functional verification: The "Product Simulated Use Testing" confirmed the system conforms to user needs and intended uses by an orthopedic surgeon and technicians.
  • Compliance with standards: Verification against established regulatory and international standards (e.g., 21 CFR, IEC 60601 series).

8. The Sample Size for the Training Set

• N/A. This document describes a traditional medical device (fluoroscopic imager), not an AI/ML algorithm that requires a training set. The "design inputs" and "user needs" for its functions would have guided its development, rather than a data-driven training process.

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

• N/A. As no training set is applicable for this type of device, no ground truth for a training set was established.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device