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.

AI/ML Overview

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., < 33 msec).
Image Enhancement (AVG or LIT modes)	Produces enhanced image contrast and reduced image noise. (This is a qualitative claim, not quantified with specific thresholds in the document.)
Safety - Interaction with Fluoroscope	The device is passive; its operation depends only on the video output of the fluoroscope. No control signals or images move from 3DFIS to the fluoroscope. It serves only as an image display in addition to the fluoroscope's standard display.
Safety - Electrical Components Compliance	Apple Corp. PowerMac computer and Scion Corp. CG7 frame grabber: Complies with Class B digital device limits (Part 15 of FCC rules). PowerMac is U.S. EPA ENERGY STAR compliant and TCO95 approved. 3DFIS Monitor: Agency approvals including FCC Part 15 Class B, EN55022 Class B, EN55024, VCCI Class 2B, AS/NZS 3548 Class B, CNS 13438 Class B, ICES-003 Class B, MPR II, EC 950, UL 1950, CSA 950, EN60950, U.S. EPA ENERGY STAR, TCO 95.

2. Sample Size for Test Set and Data Provenance

Sample Size (Test Set): Not specified. The document does not describe a clinical or performance "test set" in the context of image analysis. The "performance" section refers to technical specifications (frame rate, delay) and qualitative claims of image enhancement, without detailing a specific dataset used for evaluation.
Data Provenance: Not applicable, as no specific image dataset or clinical study is described for evaluation of the enhancement features. The compliance testing for the electronic components would have been performed by their respective manufacturers.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The document does not describe the establishment of a ground truth for image interpretation by experts. Its claims about "enhanced image contrast and reduced image noise" are qualitative statements within the regulatory filing, not supported by a reader study or expert consensus on a specific dataset.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring expert adjudication is described.

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

No MRMC comparative effectiveness study is mentioned or implied. The document focuses on the technical functionality and safety of the image processing system, not on its impact on human reader performance or diagnostic accuracy.

6. Standalone (Algorithm Only) Performance

Yes, in a sense, the document describes the standalone technical performance of the algorithm and system. The "Performance" section directly addresses the system's capabilities (processing speed, delay, image enhancement modes: RAW, AVG, LIT). However, this is machine performance (e.g., speed of processing, qualitative statement about contrast/noise), not a standalone diagnostic performance (e.g., sensitivity/specificity for a particular condition) which would require a specific ground truth and evaluation methodology. The device is purely an image display and enhancement system, not a diagnostic algorithm in itself.

7. Type of Ground Truth Used

Not applicable for the image enhancement claims. The "ground truth" for the electronic components is their compliance with specified industry and regulatory standards (e.g., FCC, TCO). For the image enhancement claims (contrast/noise), no objective ground truth (e.g., expert consensus, pathology, outcomes data) is described to quantify its efficacy. It's presented as a functional capability.

8. Sample Size for the Training Set

Not applicable. The 3DFIS appears to use fixed image manipulation methods (averaging, or the "3DSharp image enhancement method"), rather than a machine learning model that would require a "training set."

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

Not applicable, as no machine learning training set is described.

Summary of Device Nature and Regulatory Pathway:

The 3DSharp Fluoroscope Image System (3DFIS) is classified as an "Image Processing System." Its 510(k) clearance (K013841) is based on substantial equivalence to an existing predicate device (not explicitly named in the provided text but implied by the regulatory letter). The device functions as a "retrofit" that enhances standard fluoroscope video output by providing contrast/brightness enhancement and noise reduction. Crucially, it's described as a passive image display device that does not interact bi-directionally with the fluoroscope and does not introduce new safety or effectiveness issues. Its performance claims are primarily functional and technical (e.g., processing speed, display delay, qualitative image enhancement effects) and its safety is primarily demonstrated through compliance of its electronic components with established industry standards.

Summary

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K013841

JAN 1 7 2002

3DSharp Inc. 6425 Forward Ave. Pittsburgh, PA 15217

(412)648-9211

510(k) Summary

Description

The 3DSharp Fluoroscope Image System (3DFIS - Model IES-FL-101) is a stand-alone computer The SUSHarp Finderscope through a video cable. The images produced by the display system interraced to a norolocopy and ough a frame capture board in the computer where the nuoroscope are transimited through the computer's monitor. Each image is displayed on the mages are emailed and the 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 The SDSHalp Pruchoscope image by seconnection. 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.

Intended Use

The 3DFIS is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of desease.

Technological Characteristics

The 3DSharp Fluoroscope Image System (3DFIS) is designed as a "retrofit" for an existing fivoro-The obsides interescope mage enhancement capabilities in addition to those provided by the fluoroscope. The 3DFIS is connected to the fluoroscope by a video cable.

The 3DFIS is comprised of three elements. The input element to which the video images from the The SDF Is comprised of three capture interface. The computational element, the central component of the system, is a computer. The computer includes several expansion bus central component of the syestaal e 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 mage display of the observal, hand control or 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.

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Performance

The 3DFIS processes images at any user selectable rate up to full frame rate (30 frames/sec). The delay between frame acquisition and frame display is less than the time between frames, i.e. 33 msee. Utilization of the 3DFIS in the AVG or LIT modes produces enhanced image contrast and reduced image noise.

Safety and Effectiveness

The device serves only as an image display which is in addition to the fluoroscope's standard image display device. Both are viewable at all times. Furthermore, the device is passive, i.e. its operation depends only on the video output of the fluoroscope. Neither control signals or images move in the other direction from the 3DFIS to the fluoroscope. It herefore has no adverse safety or effectiveness issues and its use poses no risk of injury or death to patient or medical personnel.

The electronic components of the 3DFIS, i.e. the Apple Corp. PowerMac computer and the Scion Corp. CG7 frame grabber, have been tested by their manufacturers and have been found to comply with the limits for a Class B digital device in accordance with the specification in Part 15 of FCC rules. In addition, the PowerMac computer is U.S. EPA ENERGY STAR compliant and is TCO95 approved and labelled. The TCO standard covers environmental issues, ergonomics, usability, reduction of electric and magnetic fields, energy consumption, and energy safety. The 3DFIS monitor has the following agency approvals: FCC Part 15 Class B, EN55022 Class B, EN55024, VCCI Class 2B, AS/NZS 3548 Class B, CNS 13438 Class B, ICES-003 Class B, MPR II, EC 950, UL 1950, CSA 950, EN60950, U.S. EPA ENERGY STAR, TCO 95.

Classification

The 3DFIS is classified as "System, Image Processing." It is equivalent in safety and performance to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles an abstract caduceus, with three lines representing the staff and a stylized representation of a serpent winding around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Don Krieger, Ph.D. 3DSharp, Inc. 6425 Forward Ave. PITTSBURG PA 15217 Re: K013841

Trade/Device Name: 3DSharp Fluoroscope Image System Model IES-FL-101 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 19, 2001 Received: November 20, 2001

Dear Dr. Krieger:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave revious your so determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you debto of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on 03 reserved to primaries act may be obtained from the Division of Small Manufacturers, 5 carresponsible in Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page __ of

510(k) Number (if known): KO13841

Device Name: 3DSharp Fluoroscope Image System (3DFIS) Model IES-FL-101

Indications For Use:

is intended for use SPF15 The any a fiftoroscope is where లాగ ા and iagnosis a A chisease

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Formal 1-2-96)

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Numb

Regulation Number and Section

§ 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).