(106 days)
The KDS FD is designed to allow operators and physicians greater access to images by transmitting them electronically over networks instead of physically sending films. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KDS FD is a DICOM conformant digitization product designed for use within a Picture Archiving and Communication System (PACS).
Kodak's Film Digitizer (KODAK DIGITAL SCIENCE Film Digitizer or KDS FD) is a system designed to convert X-ray films into digital images for display, transmission, and/or archiving. The KDS FD is designed to accomplish its interface over the American College of Radiology-National Electrical Manufacturers Association (ACR-NEMA) standard known as DICOM (Digital Imaging and Communications in Medicine) which gives direct access to imaging devices, Local Area Networks (LANs), and Wide Area Networks (WANs).
This document, a 510(k) summary for the KODAK Digital Science Film Digitizer L7501/L7506, primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not contain information about acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, expert involvement, or sample sizes typically found in performance studies for diagnostic algorithms.
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, expert involvement, ground truth, and sample sizes based solely on the provided text.
The document discusses:
- Device Name: KODAK Digital Science Film Digitizer L7501 / L7506
- Intended Use: Converting X-ray films into digital images for display, transmission, and/or archiving within a PACS, facilitating remote consultations and faster image recall.
- Predicate Device: KODAK Film Digitizer ("FD")
- Substantial Equivalence: Claimed based on similar purpose, functionality, and image clarity/definition compared to the predicate device (Vortech (Kodak) FD system K915362). The main difference mentioned is hardware choice and some updates in patient information entry and networking standards (DICOM for KDS FD vs. ACR-NEMA 2.0 for FD).
To fulfill the request, a different type of document (e.g., a detailed performance study report or clinical validation report) would be needed.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENE
I. DATE PREPARED: May 3, 1996
SUBMITTER: II.
Eastman Kodak Company Health Imaging Division 18325 Waterview Parkway Dallas, Texas 75252-8026
CONTACT PERSON: III.
Edward A. Weaver Regulatory Affairs (214) 454-1506
IV DEVICE NAME:
| Trade Name | KODAK Digital Science Film Digitizer L7501KODAK Digital Science Film Digitizer L7506 (with Film Autofeeder) |
|---|---|
| Common Name | Picture Archiving and Communications Systems (PACS) Component |
V DEVICE CLASSIFICATION
FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750.
VI. PREDICATE DEVICE:
KODAK Film Digitizer ("FD')
VII. DESCRIPTION OF DEVICE:
Kodak's Film Digitizer (KODAK DIGITAL SCIENCE Film Digitizer or KDS FD) is a system designed to convert X-ray films into digital images for display, transmission, and/or archiving. The KDS FD is designed to accomplish its interface over the American College of Radiology-National Electrical Manufacturers Association (ACR-NEMA) standard known as DICOM (Digital Imaging and Communications in Medicine) which gives direct access to imaging devices, Local Area Networks (LANs), and Wide Area Networks (WANs).
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VIII. INDICATIONS FOR USE:
The KDS FD is designed to allow operators and physicians greater access to images by transmitting them electronically over networks instead of physically sending films. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KDS FD is a DICOM conformant digitization product designed for use within a Picture Archiving and Communication System (PACS).
IX. Substantial Equivalence
The purpose and functionality of the KDS FD is substantially similar to the Vortech (Kodak) FD system (K915362, November 27, 1991), as well as numerous other x-ray digitizers currently on the market. The basis for the equivalence is that both systems consist of a Lumisys laser film digitizer with image preview software with similar functionality.
Each system performs high definition scanning of images on film for display on monitors. The level of clarity and definition is similar. The ability to input and tie in patient information to complete records is similar -- the FD allowed for manual data entry only whereas the KDS FD allows for manual data entry or an interface into a HIS/RIS to capture patient demographic data.
The transmission of the images across networks is also supported by both systems. Kodak used ACR-NEMA 2.0 for the FD and will use DICOM for the KDS FD. The function of image routing is supported by both systems.
The only real difference in the systems is the choice of hardware. Both systems use reliable, mature components. The software and system functionalities are comparable with few minor exceptions in patient information fields and networking options.
Based on the similarity of the purpose and functionalities of these two systems. Kodak concludes that the KODAK DIGITAL SCIENCE Film Digitizer is substantially equivalent to the Kodak Film Digitizer.
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.