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The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

The Innova 4100 IQ, 3100 IQ, 2100 IQ Systems are modified with an optional software feature called StentViz. The StentViz feature enhances the visibility of stents in the x-ray images produced by the Innova systems. Specifically, StentViz provides an enhanced static image of the stent that is derived from the video image sequence as recorded during fluoroscopic guidance. It does not provide real-time guidance.

The information provided focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria and detailed performance studies for the StentViz feature itself. Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not explicitly stated in the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it relies on a qualitative comparison to predicate devices and general statements about image enhancement.

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

• Sample Size: "Bench tests were performed based on a library of clinical images." The exact number of images in this "library" is not specified.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "clinical images."

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

• This information is not provided in the document. The evaluation of "enhancement of stent visibility" appears to have been part of bench testing, but who performed these assessments and their qualifications are not mentioned.

4. Adjudication method for the test set:

• This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• A MRMC comparative effectiveness study is not explicitly mentioned. The evaluation described is "bench tests" to assess enhancement and perform comparisons. The document does not discuss human reader performance or improvement with AI assistance (StentViz).

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

• The evaluation was a "bench test" comparing the StentViz feature to the Innova without StentViz and to a predicate device's feature (StentOp). While human eyes would ultimately interpret the enhanced images, the description of "bench tests... to assess the enhancement of stent visibility" and compare performance suggests an evaluation of the algorithm's output (the enhanced image) itself, making it akin to a standalone performance assessment of the image enhancement capability. However, it's not explicitly stated as "algorithm only without human-in-the-loop performance" in the strict sense of a diagnostic task.

7. The type of ground truth used:

• The document mentions "a library of clinical images" being used for bench tests to assess "enhancement of stent visibility." The "ground truth" for assessing this enhancement is not explicitly defined. It likely relied on a subjective or objective assessment of image clarity and stent outline on the enhanced images compared to unenhanced images or images from predicate devices. There is no mention of pathology, or outcomes data being used as ground truth for this enhancement feature.

8. The sample size for the training set:

• The document does not provide information about a specific training set. The StentViz is described as an "optional software feature" that "enhances the visibility of stents." The development process mentioned includes "Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final acceptance testing (Validation), Performance testing (Verification), Safety testing (Verification)." This suggests a standard software development and testing cycle rather than a machine learning model that would typically have a distinct "training set."

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

• As no specific training set for a machine learning model is mentioned, this information is not applicable/provided. The feature development would have followed established engineering principles for image processing, not a typical machine learning training paradigm with a labeled ground truth dataset.

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The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

The Innova series digital fluoroscopy systems labeling is modified to allow the use of this device in an Operating Room environment that is suitable for this device. The device is suitable for Interventional XRAY procedures (catheter, needle, Minimally Invasive Surgery ) and can be used either in an Interventional Room (i.e. Cath Lab) or in an Operating Room Environment. The device is not suitable to do surgical procedures (ie. open surgery).

1. Table of Acceptance Criteria and Reported Device Performance:

   The submission does not provide a table of acceptance criteria or quantitative performance metrics for the device itself. Instead, it focuses on the device's substantial equivalence to predicate devices based on a labeling change.

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

   • Sample Size: Not applicable. The submission explicitly states, "There is no clinical testing for this modification since the intended use, indications for use and other product specifications do not change."
   • Data Provenance: Not applicable. No new clinical or performance data was generated for this specific modification.

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

   Not applicable. No new test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set:

   Not applicable. No new test set was adjudicated.

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

   No. The submission explicitly states, "The subject of this Premarket submission, Innova in Operating room environment, did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study:

   No. This submission is for a medical device (digital fluoroscopy system) whose labeling was modified, not a standalone algorithm. The device's performance is considered substantially equivalent to its predicate devices, which were previously cleared.

7. Type of Ground Truth Used:

   Not applicable. No new ground truth was established for this submission. The ground truth for the predicate devices' initial clearance would have been established, but this information is not part of this specific submission.

8. Sample Size for the Training Set:

   Not applicable. This submission is for a labeling modification to an existing device, not for the development of a new algorithm or system requiring a training set.

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

   Not applicable. No training set was used.

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The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova IVUS option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface. (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system.

The Innova IVUS is offered as an option for Innova 2121 IQ, Innova 3131 IQ (cleared under K060259), Innova 4100 (cleared under K033244), Innova 3100 (cleared under K031637), Innova 2100 IQ (cleared under K050489), Innova 4100 IQ and Innova 3100 IQ (cleared under K052412). The Innova Digital Fluoroscopic Imaging Systems are designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodine scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition system then to network (in using DICOM) for applications such as post-processing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of an a monoplane or biplane positioner, a vascular or cardiac table, an X-RAY system and one or two digital detectors. The Innova IVUS option provides enhanced connectivity with third party intravascular ultrasound devices.

The provided text is a 510(k) summary for the GE Healthcare Innova Digital Fluoroscopic Imaging System with the Innova IVUS option. This document primarily describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices. It does not contain the specific information required to complete the detailed breakdown of acceptance criteria and a study to prove they are met.

Here's why and what's missing:

• Substantial Equivalence: The core of this 510(k) is to demonstrate that the new device (Innova IVUS option) is substantially equivalent to existing marketed devices. This means it doesn't generally require new performance studies against predefined acceptance criteria in the same way a novel device might. Instead, it relies on demonstrating that its technological characteristics, intended use, and safety/effectiveness are comparable to the predicate devices.
• Lack of Performance Data: The document explicitly states: "GE Healthcare considers that Innova IVUS option for Digital Conclusions: Fluoroscopic Imaging Systems... to be equivalent with the predicate devices. The potential hazards, related to the introduction of Innova IVUS options are controlled by a risk management plan including: - A hazard identification (Attachment 8) - A risk evaluation (Attachment 8) - Software Development and Validation Process A (Attachment 7)". This suggests that the primary validation strategy focused on risk management and demonstrating equivalence, rather than conducting new performance studies with specific statistical acceptance criteria for imaging performance or diagnostic accuracy.
• Focus on Workflow and Connectivity: The "Innova IVUS option" itself, as described, primarily "simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing patient demographic information... (2) providing a remote access to commonly used IVUS functions... (3) displaying the IVUS Images on the multi-monitor display...". These are functional enhancements, not direct improvements in image quality or diagnostic accuracy of the fluoroscopic system itself. Therefore, the "acceptance criteria" for these features would likely be about proper function and display, not statistical performance metrics against a clinical ground truth.

Therefore, it is not possible to fill out the requested table and answer the questions based on the provided text. The document describes why the device is considered safe and effective (by being substantially equivalent to existing devices) but does not provide details of a study with acceptance criteria and reported performance metrics as if it were a new, de novo device.

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