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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 CT is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.

Innova CT is intended for imaging bone and soft tissues as well as other internal body structures.

Innova CT is not intended for mammography applications

The Innova CT imaging is offered as an option for Innova 4100 Innova 3100, Innova 2100 IQ (2100-IQ), 4100 IQ and Innova 3100 IQ. The 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 a monoplane positioner, a vascular or cardiac table, an X-RAY system and a digital detector.

The provided text is a 510(k) summary for the GE Healthcare Innova CT option. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on specific acceptance criteria and performance metrics for the Innova CT option itself. Therefore, many of the requested details about acceptance criteria and study design are not explicitly present in the document.

However, based on the information provided, here's what can be extracted and what remains unknown:

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

This information is not explicitly provided in the document. The document focuses on demonstrating substantial equivalence to a predicate device (Siemens DynaCT) based on similar indications for use, design, materials, and energy sources. It does not list quantitative acceptance criteria or performance metrics for the Innova CT option.

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

• Sample size for the test set: "Sample clinical data for the Innova CT option are included in this submission." The exact sample size is not specified.
• Data provenance: The country of origin and whether the data is retrospective or prospective are 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)

This information is not provided. The document mentions "Sample clinical data" but does not describe the process of establishing ground truth or the involvement of experts for this data.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The focus is on substantial equivalence to an existing device, not on comparing human reader performance with and without AI assistance. The Innova CT is described as a software option that reconstructs 3D volumes, not an AI for interpretation.

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

The Innova CT is described as a "software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up." This implies it's an algorithm-only function (reconstruction of 3D volumes), designed to provide images for physician use, rather than an AI for diagnostic interpretation that would typically have a "human-in-the-loop" performance study. Therefore, in the context of its function, its performance would inherently be "standalone" for its image reconstruction task. However, a formal "standalone performance study" with specific metrics for image quality or diagnostic accuracy based on the reconstructed images is not detailed in this summary.

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

This information is not explicitly stated. The document mentions "Sample clinical data," but the method for establishing the ground truth for this data is not described.

8. The sample size for the training set

The document does not mention a training set. As this is a 510(k) submission for a device that reconstructs 3D volumes from fluoroscopic acquisitions, it may not involve machine learning in the conventional sense that requires a "training set" for model development. The design validation mentions "Failures Modes Effects Analysis (FMEA) process," which is a risk management tool, not a method for training a machine learning algorithm.

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

Since a training set is not mentioned, this information is not available.

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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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