(58 days)
The 3DFIS is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of desease.
The 3DSharp Fluoroscope Image System (3DFIS - Model IES-FL-101) is a stand-alone computer system interfaced to a fluoroscopy and display system through a video cable. The images produced by the fluoroscope are transmitted through a frame capture board in the computer where the images are enhanced and then displayed on the computer's monitor. Each enhanced image is displayed on the 3DFIS monitor as the corresponding original image is displayed on the fluoroscope monitor(s). The 3DSharp Fluoroscope Image System 3DFIS is designed for use in conjunction with any fluoroscope by simple connection. The use of the device enables contrast and brightness enhancement with simultaneous reduction of random noise. The enclosure for the 3DFIS is metal (aluminum). The other components are commercially available hardware and electronic components. The 3DFIS is comprised of three elements. The input element to which the video images from the fluoroscope are connected is a frame capture interface. The computational element, the central component of the system, is a computer. The computer includes several expansion bus slots for the frame capture card and the display interface. The third element is the 3DFIS display. The 3DFIS software controls the frame capture, intermediate image manipulation, and subsequent image display on the 3DFIS monitor. Three image manipulation modes are provided. These are selectable by the user via the computer keyboard. These modes are: RAW: The images are unmodified. AVG: A contiguous sequence of images is averaged together. LIT: These images are modified using the 3DSharp image enhancement method.
Here's an analysis of the provided text regarding the 3DSharp Fluoroscope Image System (3DFIS) Model IES-FL-101, structured to address your specific questions.
Important Note: The provided document is a 510(k) summary and FDA clearance letter. It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a detailed clinical study proving specific performance metrics in the way a new, innovative device might require. Therefore, much of the requested information (like detailed acceptance criteria and a study design with sample sizes, expert ground truth, MRMC studies, etc.) is not present in this type of regulatory document.
Acceptance Criteria and Study Details for 3DSharp Fluoroscope Image System (3DFIS)
The provided 510(k) document (K013841) for the 3DSharp Fluoroscope Image System (3DFIS) Model IES-FL-101 is primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study with specific acceptance criteria and performance metrics in the same way a novel, high-risk device might.
As such, detailed quantitative technical and clinical performance acceptance criteria and a study explicitly designed to prove these are not explicitly stated in the provided document. The acceptance for this device hinges on its functional characteristics and safety profile being equivalent to a legally marketed predicate device.
However, based on the text, we can infer some performance characteristics and how they were tested or vouched for.
1. Table of Acceptance Criteria and Reported Device Performance
As per the introductory note, explicit acceptance criteria are not detailed in this 510(k) summary. Instead, the document describes the device's functional performance and its safety/effectiveness claims, which are assumed to be equivalent to the predicate.
| Characteristic / Claim | Reported Device Performance |
|---|---|
| Image Processing Rate | Processes images at any user-selectable rate up to full frame rate (30 frames/sec). |
| Delay (Acquisition to Display) | Less than the time between frames (i.e., |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).