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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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