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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 generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications.

The Digital Fluoroscopic Imaging System is 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. This device is not intended for mammography applications.

The Digital Fluoroscopic Imaging System 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. Digital Fluoroscopic Imaging System consists of an angiographic monoplane positioner, a vascular table, an X-RAY system and a digital detector.

The GE Medical Systems Digital Fluoroscopic Imaging System (Innova 4100) was studied for its diagnostic capabilities compared to a predicate device, the Innova 2000. The primary goal was to demonstrate equivalent image diagnostic capability.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 11 pairs of patient sequences. This relatively small number suggests a comparative efficacy study.
• Data Provenance: The study was conducted at three hospitals:
  • Saint-Luke's Hospital (Bethlehem, Pennsylvania - US)
  • Saint-Francis Hospital (Peoria, Illinois - US)
  • Centre Paris Nord (Sarcelles - France)
    This indicates a mix of retrospective and prospective data, given the comparison of existing Innova 2000 images with new Innova 4100 images. The involvement of different hospitals across different countries suggests a more diverse dataset than if it were confined to a single institution or country.

3. Number of Experts and Qualifications

• Number of Experts: 6 radiologists.
• Qualifications: Not explicitly stated beyond "radiologists." It's implied they are qualified to interpret angiographic images for diagnostic purposes.

4. Adjudication Method

• The document describes the radiologists "compared digital images" and "found that the digital images from the Innova 4100 had equivalent image diagnostic capability." This phrasing suggests a consensus or majority opinion among the radiologists, but a specific adjudication method (e.g., 2+1, 3+1) is not detailed.

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

• Yes, a clinical comparison study was done with 6 radiologists evaluating images.
• Effect Size of Human Readers with vs. without AI: Not applicable. This study does not involve AI assistance to human readers. It's a comparison of two different fluoroscopic imaging systems (Innova 2000 vs. Innova 4100) and their inherent diagnostic image quality.

6. Standalone Performance (Algorithm Only)

• Not applicable. This is a medical device clearance for an imaging system, not an artificial intelligence algorithm. The device itself is the entire system outputting images.

7. Type of Ground Truth Used

• Expert Consensus/Clinical Agreement: The "gold standard" for determining equivalent diagnostic capability was the collective evaluation and agreement of the 6 radiologists. There's no mention of pathology or long-term outcomes data being used as ground truth for this particular comparison.

8. Sample Size for the Training Set

• Not applicable. This device is a digital fluoroscopic imaging system, not an AI algorithm that requires a distinct training set. The "training" for the device would be its engineering and design, informed by established medical imaging principles and prior device iterations (like the Innova 2000).

9. How Ground Truth for the Training Set was Established

• Not applicable, as there is no specific "training set" in the context of an AI algorithm. The device's fundamental design is based on known physics, engineering principles, and clinical requirements for fluoroscopic imaging.

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