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The Insight Agile DRF is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during routine fluoroscopic and image-guided procedures. The device is to be used in professional healthcare facilities, in a variety of image-guided procedures such as feeding tube and catheter insertion on pediatric patients and neonates (birth to one month). This device is not indicated for large/obese patients or interventional use. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (Rx Only)

The Insight Agile DRF Digital Imaging System is a modification of Insight Enhanced DRF, a previously cleared (K200396) fluoroscopic imaging chain employing a flatpanel digital detector (Vieworks 1212G) to replace the image intensifier and video camera on GE R&F systems (P500, Legacy and Advantx). This system has now been modified in the following manner: 1) the digital interface board (DIB) that provides communications with the GE systems has been replaced with a software program that utilizes virtual serial ports. 2) Another software program has been added to allow the system to communicate with and control a Source-Ray x-ray generator. The generator interface provides for Automatic Brightness Stabilization (ABS) control and optional manual control through a graphical user interface on the Insight Aqile image acquisition screen. 3) A second dynamic flat-panel detector (Rayence 1212FCA, K202722) has been integrated to provide an alternate digital detector. 4) the software risk assessment has been changed from minor to moderate. 5) the Indications for Use has been changed to that of the predicate device.

With these modifications, Insight Agile DRF is a fluoroscopic imaging chain that can acquire, process, and display fluoroscopic images when installed on any suitable positioning system in a fixed room, on a mobile or portable stand. Another purpose of this application is to expand the indications for use.

The Insight Agile DRF is an X-ray system, and the provided text does not define acceptance criteria typical for AI/ML-driven diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on bench testing and qualitative expert assessment for its substantial equivalence to a predicate device.

However, based on the provided text, I can extract information related to the device's performance, testing, and evaluation:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: The text mentions a "series of fluoroscopic patient exam images" evaluated by a radiologist. However, a specific number for this series is not provided.
• Data Provenance: The provenance of the patient exam images is not explicitly stated (e.g., country of origin, retrospective or prospective). It is likely from a clinical setting where the OEC mobile c-arms are used for comparison.

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

• Number of Experts: One radiologist was used.
• Qualifications: The text identifies the expert simply as "A radiologist." No further details on their years of experience or sub-specialty are provided.

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

• The text describes a single radiologist's evaluation. There is no mention of an adjudication method involving multiple experts.

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, an MRMC comparative effectiveness study was not done. The study described is a qualitative assessment by a single radiologist comparing fluoroscopic images from the subject device to predicate devices (OEC 9800 and 9900). There is no AI assistance mentioned, and therefore, no effect size of human readers improving with AI vs without AI assistance is reported.

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

• The device described is an X-ray imaging system, not an AI/ML algorithm. The evaluation focuses on the image quality and performance of the hardware and integrated software. Therefore, the concept of a "standalone (algorithm only)" performance does not directly apply in this context. The bench testing and phantom image comparisons represent the device's inherent imaging capabilities.

7. The type of ground truth used:

• For the image quality assessment, the "ground truth" was the expert opinion/consensus of a single radiologist, who deemed the images "clinically acceptable for the intended use and fully comparable" to existing systems. For bench testing, the ground truth was based on established technical standards and predicate device performance (e.g., image quality characteristics from phantom images).

8. The sample size for the training set:

• The provided text does not describe an AI/ML training set. Therefore, there is no information on a training set sample size.

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

• As there is no mention of a training set for an AI/ML component, this information is not applicable and not provided in the text.

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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.

The Insight Enhanced™ DRF Digital Imaging System is designed to provide an additional imaging acquisition device to the existing image intensifier, camera and user interface with a dynamic flat-panel detector (dFPD) on the following FDA approved R&F fluoroscopic imaging systems employing an image intensifier: GE Advantx, GE Legacy, GE P500 and Shimadzu YSF300. The subject fluoro system Insight Enhanced is based on the predicate Insight Essentials. The following dynamic digital detectors are added to the predicate system: Vivix-D 1212G and Vivix-D 1717G. The x-ray generator, beam-limiting device and patient positioner, necessary for a full fluoroscopy system are not part of the subject device software stays unchanged from the predicate Insight Essentials DRF.

The Insight Enhanced™ DRF Digital Imaging System allows the operator to view and enhance high-definition fluoroscopy images. High resolution digital spot images may also be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for short term storage. The Insight Enhanced™ DRF Digital Imaging System enables the operator to produce hardcopy images with a laser printer or send images over a network for longer-term storage. The major system components include: a fluoroscopic video camera, monitors, and an image processor PC.

The provided text is a 510(k) summary for the Insight Enhanced™ DRF Digital Imaging System. It describes a device that adds dynamic flat-panel detectors (dFPD) to an existing, already cleared fluoroscopic imaging system. The submission argues for substantial equivalence to a predicate device, the Insight Essentials™ DRF Digital Imaging System (K191310).

Based on the provided text, the device does not have acceptance criteria related to its performance in terms of diagnostic effectiveness that would be proven by a clinical study. Instead, the "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing.

Here's a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in terms of patient images. The "test set" described consists of phantom images. The document mentions that "Phantom images were acquired with the subject device and compared to the predicate device, also installed on the same GE Legacy R&F system." The number of phantom images acquired or the specifics of the phantom used are not provided.
• Data Provenance: The data is from non-clinical bench testing rather than human subjects. No country of origin is specified for these bench tests, but they were conducted to support a U.S. FDA submission.

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

• This information is not applicable as the test involved non-clinical bench testing with phantoms and direct comparison to a predicate device, not diagnostic performance with human readers against a human-established ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable as the test involved non-clinical bench testing with phantoms. The comparison was based on analysis of the acquired phantom images and doses, not expert adjudication of diagnostic outcomes.

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

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• The device described is an imaging system component (dynamic flat-panel detectors added to a fluoroscopic imaging system), not an AI algorithm. Its performance is evaluated as part of the overall imaging system's ability to acquire images comparable to a predicate device. Therefore, the concept of a "standalone algorithm" performance study is not applicable in the context of this submission. The "algorithm" if any, is likely for image processing, which is stated to be "unchanged from the predicate Insight Essentials DRF."

7. The Type of Ground Truth Used

• For the non-clinical bench testing, the "ground truth" was effectively the performance of the legally marketed predicate device (Insight Essentials™ DRF Digital Imaging System) and its ability to produce comparable phantom images and use similar doses.

8. The Sample Size for the Training Set

• This information is not applicable. The device is an imaging system component, not an AI model that requires a training set. The software for image processing and workflow functions is stated to be "unchanged from the predicate Insight Essentials DRF."

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

• This information is not applicable as there is no mention of an AI model with a training set.

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Intended for use by a qualified/trained doctor on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.

The Insight Essentials™ DRF Digital Imaging System is designed to replace the video camera and user interface on the following FDA cleared R&F fluoroscopic imaging systems employing an image intensifier: GE Advantx, GE Legacy, GE P500 and Shimadzu YSF300. The x-ray generator, beam-limiting device and patient positioner. necessary for a full fluoroscopy system are not part of the subject device.

The Insight Essentials™ DRF Digital Imaging System allows the operator to view and enhance high-definition fluoroscopy images. High resolution digital spot images may also be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for short term storage. The Insight Essentials™ DRF Digital Imaging System enables the operator to produce hardcopy images with a laser printer or send images over a network for longer-term storage. The major system components include: a fluoroscopic video camera, monitors, and an image processor PC.

This document describes a 510(k) submission for the Insight Essentials™ DRF Digital Imaging System, comparing it to a predicate device, the FluoroPRO RF Digital Imaging System (K070390). The submission focuses on demonstrating substantial equivalence rather than proving clinical performance against specific acceptance criteria for an AI algorithm.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI device is not directly applicable to this submission, as it is a device modification submission for digital imaging system components, not an AI/ML medical device.

However, I can extract information regarding non-clinical tests performed to demonstrate substantial equivalence, which serves as the "study" for compliance in this context.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission for hardware/software components, the "acceptance criteria" are implied by the comparison to the predicate device. The goal is to show the new device is "as safe and effective as" the predicate. Performance is assessed through non-clinical bench testing.

The Study:

The study conducted to demonstrate the device meets these (implied) criteria is a non-clinical bench testing study.

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

• Sample Size: Not explicitly stated as a number of distinct "cases" or "images" in the way an AI study would define a test set. The document mentions "phantom images" were acquired. The quantity of phantom images is not specified.
• Data Provenance: The images were acquired from a "GE Legacy R&F system" with the subject device installed and compared to images from a "GE Advantx 1 R&F system" with the predicate device installed. This indicates prospective acquisition for the purpose of the comparison. The country of origin is not specified but implicitly within the context of the submitter's (Imaging Engineering, LLC in Florida, USA) operations.

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

• Not applicable in the context of this submission. The "ground truth" for this engineering bench test is objective measurement and comparison of technical parameters and image quality, not expert clinical interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. This was a technical comparison, not a clinical interpretation study requiring adjudication. The analysis was based on direct comparison of acquired images and doses.

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. This is not an AI-assisted device, nor is it a clinical efficacy study involving human readers.

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

• Not applicable. This device is a digital imaging system component, not an autonomous algorithm.

7. The Type of Ground Truth Used:

• The ground truth in this context is objective technical performance measurements (e.g., image output characteristics, resolution, doses, adherence to safety standards) derived from the phantom images acquired during bench testing, compared against the known specifications and performance of the predicate device.

8. The Sample Size for the Training Set:

• Not applicable. This is a hardware/software upgrade to an existing imaging system, not a machine learning model that requires a training set.

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

• Not applicable, as there is no training set for an AI/ML model.

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