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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 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications.

InnovaSpin is a software option that permits fast spin rotational angiography. It is not intended for mammography applications.

The Innova 3D is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under K031637), Innova 2100''' (2100-IQ) aiready cleared under K050489), Innova 4100''' and Innova 3100'''.

The InnovaSpin is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under K031637), Innova 4100'0 and Innova 3100'9.

The Digital Fluoroscopic Imaging Systems Innova 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 positioner, a vascular or cardiac table, an X-RAY system and a digital detector.

The provided text describes a 510(k) summary for GE Healthcare's Digital Fluoroscopic Imaging Systems (Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ) with optional Innova 3D or InnovaSpin. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a new device's accuracy or effectiveness.

Therefore, the document does not contain detailed acceptance criteria or a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement with AI assistance.

However, it does describe the basis for substantial equivalence, which serves as a form of "acceptance criteria" in a regulatory context, and the "study" (or rather, the data referenced) used to support this claim.

Here's a breakdown of the requested information based on the provided text, with explicit notes where the information is not present:

Acceptance Criteria and Device Performance Study for GE Innova Digital Fluoroscopic Imaging Systems

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size:
  • For Innova 3D option: Clinical data was "submitted in the Advantage 3D XR 510K (K954355)." The sample size for this prior submission is not specified in the provided document.
  • For InnovaSpin option: Clinical data was "submitted in the LCV+ Version 2 system 510K (K993037)." The sample size for this prior submission is not specified in the provided document.
  • For Innova 2000 "Fast Spin Rotational Angiography" option (previous clearance to establish equivalence for InnovaSpin): Cleared without clinical data "based on the fact that this mode of acquisition does not address different anatomies versus LCV+ Version 2 system (K993037)."
• Data Provenance: The document states "previously submitted clinical data are applicable for this submission." The original provenance (e.g., country of origin, retrospective/prospective) of these referenced clinical datasets (K954355 and K993037) is not specified in the provided text.

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 as no new clinical study analyzing expert performance or ground truth establishment is described for this specific 510(k) submission. The submission relies on prior clearances.

4. Adjudication method for the test set:

• This information is not provided in the document, as no new clinical study with expert adjudication 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:

• A MRMC comparative effectiveness study is not mentioned or described in the document. The submission is focused on demonstrating substantial equivalence to existing devices and software options through technical comparison and referencing prior clinical data, not explicitly on AI assistance or reader improvement.

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

• A standalone algorithm performance study is not described in the document. The Innova 3D and InnovaSpin are described as "software options" that "assist the physician" or "permit fast spin rotational angiography," implying they are tools used by a human, rather than standalone diagnostic algorithms.

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

• The document references prior "clinical data" but does not specify the type of ground truth used in those original studies that supported the predicate devices.

8. The sample size for the training set:

• This information is not provided in the document. Since the submission relies on demonstrating substantial equivalence to already marketed devices and software, and not on developing a new AI algorithm from scratch, the concept of a "training set" in the context of machine learning is not discussed.

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

• This information is not provided in the document, as no training set is described for this submission.

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The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET, SPECT scans and X-Ray of the human body including any organ. The volume, linear and angular measurement functions are intended for the evaluation and quantification of turnor or selected organ volume/linear measurements, angular location/ displacement, study/ analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp, lesion, mass, implants, fracture, aneurysms, stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning and/or X-Ray. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM compliant specified organ image studies, utilizing PC hardware.

The V-3D Explorer is a software device for evaluating CT/MRI scanned and X-Ray images of selected human organ. It is an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780, dated November 17, 2000. It is a general software module, designed for use as a part of our V-3D visualization system core technology. The system consists of a V-3D processor and a V-3D viewer in two computer configuration or V-3D processor and V3D viewer in a stand alone one computer configuration. Upon receipt of a multi-slice CT / MR scan image or X-Ray image for any selected organ in a DICOM format, the V-3D processor converts the DICOM image data into an internally recognized volume data format using our core software technology. The V-3D viewer provides interactive orthogonal and multiplanar reformatted 2D and 3D images from the V-3D processor and user can evaluate these images for any abnormality or malformation in specified organs obtained from scanned images or X-Ray images. The volume, linear and angular measurement features provided in the software for the evaluation and quantification of organ volume, linear measurements, angular location/displacement for hard and soft tissues as well as internal organ structures for polyp, lesion, mass, tumor, implants, fracture, aneurysms, stenoses etc. The software also supports interactive segmentation of any organ from removing certain structure from display for critical evaluation of selected part of organ. The intended user can use the software device to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant images of any organ, utilizing PC hardware.

Here's a breakdown of the acceptance criteria and the study details for the Viatronix V3D Explorer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on substantial equivalence rather than explicit quantitative acceptance criteria for device performance. The primary "criterion" is that the V3D Explorer performs similarly to the predicate devices.

• Display and 2D/3D visualization of medical image data (CT, MRI, PET, SPECT, X-Ray)
• Evaluation and quantification of tumor/organ volume, linear measurements, angular location/displacement
• Study/analysis of hard/soft tissues, internal organ structures (polyp, lesion, mass, implants, fracture, aneurysms, stenoses)
• Evaluation of abnormalities/malformations
• Interactive segmentation of organs
• Acquisition, processing, rendering, evaluation, archiving, printing, distribution of DICOM compliant images | - V3D Explorer provided interactive orthogonal and multiplanar reformatted 2D and 3D images from datasets to detect and evaluate known abnormalities or status of organs.
• Volume, linear and angular measurement features were used to evaluate and quantify abnormalities or status of internal organ structures.
• Evaluation results of both predicate device and V3D Explorer device were same, and no significant differences were detected in the results of evaluation.
• DICOM compliant X-Ray images were correctly processed and converted, allowing for accurate display and evaluation.
• Phantom data showed measurements are accurate.
• Concluded the V3D Explorer is substantially equivalent to predicate devices in its ability to review, analyze, and evaluate images. |
  | Accuracy of Measurements:
• Volume, linear, and angular measurements | - Phantom data showed that the measurements are accurate and the V3D Explorer is evaluated to be safe and effective. |
  | Reliability and Ease of Use:
• Consistent operation and user-friendliness | - The product has shown itself to be reliable, easy to use and capable of evaluating DICOM 3.0 compliant scanned images or X-Ray images of any human organs. |
  | Software Development Standards:
• Developed in accordance with accepted standards | - The V3D Explorer Module has been developed in a manner consistent with accepted standards for software development, including both unit and system integration testing protocols. |

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

• Sample Size: "Scanned image or X-Ray datasets of various patients organs" and "Patients' various organs" were used. The exact number of patients or cases is not specified.
• Data Provenance: The data came from "various patients organs with known abnormalities or status." It is not explicitly stated whether the data was retrospective or prospective, or the country of origin. However, the use of "known abnormalities or status" suggests that these were existing clinical cases, implying a retrospective nature.

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

The document does not explicitly state the number of experts or their qualifications involved in establishing the ground truth for the test set. It mentions "known abnormalities or status," which implies that a previous clinical assessment (likely by medical professionals) already determined these conditions.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth from multiple experts. The ground truth appears to be based on pre-existing "known abnormalities or status".

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study directly compared the V3D Explorer's output against predicate devices and pre-calculated phantom values, not against human reader performance with or without the device. The V3D Explorer is presented as an image processing and visualization tool to be used by radiologists, clinicians, and referring physicians, not as an AI-assisted diagnostic aid that directly improves human reader performance in a quantitative sense as might be assessed in an MRMC study.

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

Yes, a standalone evaluation was implicitly done. The software's functionalities, measurements, and processing capabilities were tested independently (or in comparison to predicate devices) to verify its performance. The phrase "Evaluation results of both predicate device and V3D Explorer device were same and no significant differences were detected" suggests a direct comparison of the software outputs.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• "Known abnormalities or status": For patient data, the ground truth was based on pre-existing clinical knowledge of the patient's condition. The specific method (e.g., pathology reports, follow-up, expert consensus) is not detailed.
• "Pre-calculated values": For phantom datasets, the ground truth was established by known, pre-calculated values for the phantom's characteristics.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is described as a software tool for image processing and visualization, not an AI/ML diagnostic algorithm that typically requires a dedicated training set. The software development included "unit and system integration testing protocols," which would involve software validation on various datasets, but these are not referred to as a "training set" in the modern AI sense.

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

As no training set (in the AI/ML sense) is mentioned, there is no information on how its ground truth was established. The testing described is more akin to software validation against known outcomes or established standards.

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The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET and SPECT scans of the human body including any organ. The volume , linear and angular measurement functions are intended for the evaluation and quantification of turnor or selected organ volume/linear measurements, angular location/ displacement, study/ analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp, lesion, mass, implants, fracture, aneurysms, stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant specified organ image studies, utilizing PC hardware.

The V-3D Explorer is a software device for evaluating scanned images of selected human organ. It is an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780, dated November 17, 2000. It is a general software module, designed for use as a part of our V-3D visualization system core technology. The system consists of a V-3D processor and a V-3D viewer in two computer configuration or V-3D processor and V3D viewer in a stand alone one computer configuration. Upon receipt of a multi-slice CT or MR scan image for any selected organ in a DICOM format, the V-3D processor converts the DICOM image data into an internally recognized volume data format using our core software. technology. The V-3D viewer provides interactive orthogonal and multiplanar reformatted 2D and 3D images from the V-3D processor and user can evaluate these images for any abnormality or malformation in specified organs obtained from scanned images. The volume, linear and angular measurement features provided in the software for the evaluation and quantification of organ volume, linear measurements, angular location/displacement for hard and soft tissues as well as internal organ structures for polyp, lesion, mass, tumor, implants, fracture, aneurysms, stenoses etc. The software also supports interactive segmentation of any organ from removing certain structure from display for critical evaluation of selected part of organ. The intended user can use the software device to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant images of any organ, utilizing PC hardware.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Viatronix V3D Explorer:

Summary of Acceptance Criteria and Reported Device Performance

Study Information:

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

   • Sample Size: Not explicitly stated as a number of cases or patients. The document vaguely mentions "various patients organs with known abnormalities or status" for non-clinical tests and "Patients' various organs" for clinical tests.
   • Data Provenance: The data used for testing was "Scanned image datasets of various patients organs" and "Patients' scanned organs images." The country of origin is not specified, but it implies retrospective use of existing patient data.

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

   • Not specified. The document indicates that "known abnormalities or status" were used, implying a pre-established understanding of the pathologies in the patient data. It doesn't detail how this "known status" was determined for the purpose of the study, nor does it mention a specific number or qualification of experts establishing this ground truth for the test set itself.

3. Adjudication Method for the Test Set:

   • Not explicitly described. The study compares the V3D Explorer against predicate devices, stating that "evaluation results of both predicate device and V3D Explorer device were same and no significant differences were detected." This implies a direct comparison rather than an adjudication process typically used to reconcile expert discrepancies for ground truth.

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

   • No, a formal MRMC comparative effectiveness study is not described. The study performed was a comparison of the device's functionality and output against predicate devices, not an evaluation of human reader performance with and without AI assistance.
   • Effect Size: Not applicable, as no MRMC study was performed.

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

   • Yes, the non-clinical and clinical tests described appear to be primarily standalone evaluations of the software's ability to process images and provide measurements and visualizations comparable to predicate devices. While the software is intended for use by radiologists and clinicians, the evaluation itself focuses on the software's output, not on how human users integrate the software's output into their diagnostic process or how their performance changes. The phrasing "evaluated various organs using the predicate device and recorded the results" and "evaluated all Patients' various organs using V3D Explorer application, and recorded the results" suggests an assessment of the device's output rather than human performance.

6. Type of Ground Truth Used:

   • The ground truth referenced for the test set is "known abnormalities or status" within patient organ images. For phantom datasets, the ground truth was "pre-calculated values." This implies a combination of expert consensus/clinical diagnosis (for patient data) and empirical measurements (for phantom data). Pathology or outcomes data are not explicitly mentioned as ground truth sources.

7. Sample Size for the Training Set:

   • Not specified. The document describes the V3D Explorer as "an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780." It mentions "core software technology" developed in a manner consistent with accepted software development standards and unit/system integration testing. It does not provide details on a specific "training set" in the context of machine learning, as this predates widespread deep learning applications for medical image analysis. The "training" likely refers to standard software development and testing practices rather than machine learning model training.

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

   • Given that the document describes software developed under standard engineering practices rather than a machine learning model, the concept of a "training set" with ground truth (as understood for AI/ML) is not directly applicable or discussed in the text. The "ground truth" for the software's development likely refers to functional requirements specifications, expected outputs, and successful execution of unit and integration tests against these specifications. For phantom data, "pre-calculated values" would serve as the ground truth.

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Smart Vessel Analysis (SmartVA) is a software post-processing option for the Advantage Workstation (AW) platform which can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.

SmartVA is a software post-processing package for the Advantage Workstation (AW) platform. It is an additional tool for the analysis of 3D angiography data providing a number of display, measurement and batch filming/archive features to study user-selected vessels which include but are not limited to stenosis analysis, pre/post stent planning procedures and directional vessel tortuosity visualization.

The provided document is a 510(k) summary for the GE Smart Vessel Analysis (Smart VA) Option. This type of document is typically submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to present a full clinical study proving specific performance criteria.

Therefore, the document does not contain the detailed information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Analysis of the document:

The document focuses on establishing substantial equivalence to existing devices (Advantage Windows 3D with Navigator Option and DLX) based on similar functionalities for 3D angiography data analysis. It highlights features like:

• Display, measurement, and batch filming/archive features.
• Assistance in studying user-selected vessels for stenosis analysis, pre/post stent planning, and directional vessel tortuosity visualization.

Instead of presenting performance metrics, the submission relies on:

• Comparison with Predicate: Stating that "The vessel measurements are similar to DLX and the visualization views of the vessel provided are similar to Advantage Windows 3D with Navigator option."
• Risk Management: Mentioning a risk management plan, software development and validation process, and software verification plan to control potential hazards.
• Image Comparability: Concluding that "This product provides images comparable to the predicate devices."

Conclusion:

Based on the provided text, a comprehensive answer to the request regarding acceptance criteria and a study proving those criteria cannot be formulated because the document does not contain this specific information. The 510(k) summary is designed to demonstrate substantial equivalence, not to detail the clinical validation or performance studies that would typically include the requested data points.

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The Advantage 3D XR is an X-ray imaging software option that offers the ability to construct a 3D model from images taken during a single DSA rotational angiography. The product is optimized for neuro-angiographic cases.

The Advantage 3D XR is an X-ray imaging software option that allows the interactive display of a structure from any point of view. This is accomplished by constructing a 3D model from images taken during a single Digital Subtracted Angiography (DSA) rotation (200 degrees). A spin acquisition is performed with an LC gantry system using a specific mode (predefined start and stop positions). The data is available for diagnosis on the acquisition system and may be sent to the Advantage Windows workstation. Within 10 minutes, a 3D construction of the vasculature is available and the Navigator software package (K954355) is used to interactively create views of this object. The software allows the ability to make measurements ( length and volume) on the 3D structure. The gantry angles for each view are displayed and the physician may use them to make a DSA acquisition on the patient to get an optimized 2d image of the desired viewpoint.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds). Instead, the performance is described through the successful validation and clinical use, implying that the device generates "3D information from an X-ray spin sequence" and that "the 3D construction of the vasculature is available" for diagnosis and measurement. The primary acceptance criterion seems to be the successful demonstration of the device's ability to perform its stated function and the absence of identified hazards that are not controlled by a risk management plan.

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

The document mentions two types of clinical sites and examinations:

• Morphometer Sites: More than 200 examinations were done using a morphometer device at Hopital Ponchaillou, Rennes, France and HCL, Lyon, France.
• LC Angiographic System Gantry Sites: 250 examinations were performed at Hopital Pontchaillou, Rennes, France and CHU Saint-Julien, France.

Combining these, a total of over 450 examinations were performed for the clinical validation.

• Data Provenance: The data is prospective clinical data collected from two countries: France (Hopital Ponchaillou, Rennes; HCL, Lyon; CHU Saint-Julien).

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

The document states "external validations of the algorithms by different research hospitals to assess the validity of the 3D information." It also mentions "A publication from Pr Picard, CHU Saint-Julien, France is available." and "medical publications on the obtained results are available in Attachment #9."

However, the document does not specify the exact number of experts used to establish ground truth for the test set, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). It only implies involvement of medical professionals at the research hospitals.

4. Adjudication Method for the Test Set:

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). It only refers to "external validations" and "medical publications."

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The focus is on the standalone performance and capabilities of the 3D reconstruction software itself.

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

Yes, the studies described are essentially standalone performance evaluations of the algorithm. The "successful validation" using morphometer and LC angiographic system gantry, producing 3D constructions and measurements, describes the algorithm's direct output. The statement "Within 10 minutes, a 3D construction of the vasculature is available" and the ability to make measurements directly reflect the algorithm's standalone capability.

7. The Type of Ground Truth Used:

The document implies a form of expert consensus and clinical assessment as the ground truth. The "external validations of the algorithms by different research hospitals to assess the validity of the 3D information" and the "medical publications on the obtained results" suggest that the output of the 3D reconstruction was clinically reviewed and found to be valid and useful by medical experts in determining patient anatomy. It's not explicitly stated as pathology or outcomes data in this summary.

8. The Sample Size for the Training Set:

The document does not specify the sample size used for the training set. The described studies focus on the validation of the device.

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

The document does not provide information on how the ground truth for the training set was established. This detail is typically part of development and internal validation, which is not detailed in this summary of safety and effectiveness.

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