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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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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 two Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. These devices are not intended for mammography applications. The Bolus Chasing option submitted here is intended to perform subtracted angiography in real time of the lower limbs for diagnostic purpose.

The new Bolus Chasing is offered as an option for Innova 4100 and 3100, already cleared under K033244 and K031637.

The provided text contains information about a 510(k) submission for a Digital Fluoroscopic Imaging System with an optional Bolus Chasing feature. However, it does not include specific details about acceptance criteria, a dedicated study proving performance against defined criteria, sample sizes for test or training sets, data provenance, expert qualifications, or adjudication methods for establishing ground truth.

The document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing a detailed performance study against a set of acceptance criteria.

Therefore, many parts of your request cannot be answered from the provided text.

Here's what can be extracted based on the document:

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

• Acceptance Criteria: Not explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific quantifiable performance metrics.
• Reported Device Performance: Not explicitly stated as quantifiable performance metrics. The equivalence is based on the device's design, materials, and intended use being similar to the predicate.

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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)

• Not applicable as no specific test set or ground truth establishment process is described in the context of a performance study.

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

• Not applicable.

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 is mentioned. This device is an imaging system, not an AI-assisted diagnostic tool for interpretation by human readers.

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

• Not applicable. This is an imaging system, not an algorithm being evaluated in a standalone capacity. The "Bolus Chasing option" is a feature of the imaging system itself, controlling image acquisition.

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

• Not applicable as no specific performance study with ground truth is described. The basis for approval is substantial equivalence to a predicate device for its intended use.

8. The sample size for the training set

• Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable.

Summary of available information regarding the "study" (equivalence demonstration):

The "study" presented here is a Substantial Equivalence (SE) demonstration for the GE Healthcare Innova 4100 and Innova 3100 (with the new Bolus Chasing option).

• Predicate Device: GE Advantx LCV+ Bolus Chasing (K960575)
• Basis of Equivalence: Comparison table and product data sheets (details not provided in the text). The opinion is based on technical and functional similarity to the predicate device.
• Risk Management: The manufacturer states that potential hazards related to the new Bolus Chasing option are controlled by a risk management plan, including:
  • Hazard identification
  • Risk evaluation
  • Software Development and Validation Process
• Testing: Materials are compliant with UL 2601 and IEC 60601-1 standards. Design controls prevent useless X-ray/contrast agent exposure during a Bolus Chasing sequence in case of failure. This implies some form of engineering testing and verification, but not a clinical performance study as typically understood for diagnostic accuracy.

In essence, the document serves as a 510(k) summary demonstrating that the new device is as safe and effective as a previously cleared device, rather than providing a new clinical performance study with defined acceptance criteria.

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The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiography procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional angiography procedures. This device is not intended for mammography applications.

The Innova 3100 is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition equipment then to network (in using DICOM) for applications such as post-processing, printing, viewing and archiving. The Innova 3100 consists of an angiographic monoplane positioner, a table, an X-RAY system and a digital detector. The SuperFast Gantry (InnovaTrace) includes capacitive sensor technology and optimized collision avoidance software that permits an increase of pivot and C-arm speed of up to 20°/sec.

The provided document for the GE Innova 3100 Digital Fluoroscopic Imaging System is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a novel algorithm.

Therefore, the requested information, particularly regarding specific acceptance criteria, a standalone study with defined performance thresholds, and details on ground truth establishment and expert adjudication for a new AI-based device, is not present in this document.

Instead, the document states:

• "Summary of Studies: Not applicable as Innova 3100 is considered substantially equivalent to Innova 4100 in terms of image quality and diagnostic capabilities."

This indicates that extensive new clinical performance studies to establish specific acceptance criteria for a novel device, as might be done for an AI algorithm, were not conducted or deemed necessary for this 510(k) clearance due to direct comparison and equivalence to existing, already cleared devices.

However, I can extract information related to the device and its comparison to predicates.

Here's a breakdown of what can be inferred or is directly stated, with explicit mention of what is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable thresholds for a novel device's performance. The "acceptance criteria" here is met by demonstrating substantial equivalence to predicate devices.
• Reported Device Performance: The primary "performance" reported is its equivalence to the predicate in "image quality and diagnostic capabilities." No specific metrics (e.g., sensitivity, specificity, AUC) are provided.

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

• Not applicable/Not provided. No separate "test set" from a performance study is mentioned because the submission relies on substantial equivalence.

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

• Not applicable/Not provided. Ground truth establishment for a test set is not mentioned as part of this equivalence submission.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:

• Not applicable/Not provided. This is not an AI device, and no MRMC study is mentioned.

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

• Not applicable/Not provided. This is an imaging system, not an AI algorithm.

7. The Type of Ground Truth Used:

• Not applicable/Not provided. For substantial equivalence, the "ground truth" is that the predicate device is safe and effective.

8. The Sample Size for the Training Set:

• Not applicable/Not provided. This is an imaging system, not an AI algorithm that requires a "training set."

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

• Not applicable/Not provided.

Summary based on the provided document:

The GE Innova 3100 Digital Fluoroscopic Imaging System sought 510(k) clearance by demonstrating substantial equivalence to previously cleared predicate devices:

• Innova 4100 (K023178) for the overall system and image quality/diagnostic capabilities.
• Innova 2000/Innova 2000S (K022322) for the SuperFast Gantry (InnovaTrace) with capacitive sensor feature.

The rationale provided for not needing new clinical performance studies (which would typically define acceptance criteria and collect performance data) is: "Not applicable as Innova 3100 is considered substantially equivalent to Innova 4100 in terms of image quality and diagnostic capabilities."

The acceptance criteria are therefore implicitly met by:

• The device being designed for the same intended use (fluoroscopic images for vascular/rotational angiography, replacing image intensifier technology).
• The device having similar technological characteristics (amorphous silicon detector with cesium iodide scintillator).
• The manufacturer's conclusion that the system provides fluoroscopic images "equivalent to the diagnostic capabilities of the predicate images."
• Control of potential hazards through a risk management process, including hazard identification, risk evaluation, and a Software Development and Validation Process.

The FDA's clearance letter confirms their review and determination that the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market.

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