(22 days)
The KODAK DirectView CR 800 System and the KODAK Direct View CR 900 System are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications.
The KODAK DirectView CR 800 is a single cassette computed radiography (CR) system while the KODAK DirectView CR 900 is an autoloading CR system. Each CR system contains a storage phosphor reader, CR cassette, HeNe laser, QA workstation with image processing software, and a DICOM network connection. These CR systems are capable of reading the latent image formed on a storage phosphor imaging plate in a CR cassette and producing a digital image. The system scans the phosphor plate, communicates the image data to a host (e.g. soft copy review workstation or laser printer) and erases the residual image on the plate. An internal imaging plate eraser removes the residual image. The plate is then returned to the cassette, ready for the next exposure.
The provided text describes a software modification to the KODAK DirectView CR 800 and CR 900 Systems to reduce grid artifacts in radiographic images. The study conducted aimed to demonstrate that this software modification, specifically the grid detection and suppression algorithm, does not negatively impact diagnostic image quality.
Here's a breakdown of the acceptance criteria and study details based on the provided information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Diagnostic Image Quality | Radiologists rate images as "acceptable for interpretation" or better (defined as 7 or higher on a 1-9 scale). | Average scores ranged from 7.2 (with no grid suppression) to 7.7 (with maximum grid suppression applied). The differences were deemed "not clinically significant." |
| Grid Artifact Reduction | The algorithm should be effective at reducing grid-induced artifacts. | The algorithm was effective at reducing grid induced artifacts for a wide variety of grids. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated how many images/cases were included in the evaluation. It mentions "a variety of radiographic exams (e.g. chest, abdomen, spine, shoulder, pelvis)"
- Data Provenance: The study used "hard copy CR images." The country of origin and whether the data was retrospective or prospective are not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Ten radiologists.
- Qualifications: "Radiologists" is the only qualification given; no specific experience level is mentioned.
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Adjudication method for the test set:
- The radiologists rated the exams individually, and average scores were presented. There is no mention of a formal adjudication method (e.g., 2+1, 3+1).
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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:
- This was not an MRMC comparative effectiveness study in the typical sense of measuring human reader improvement with AI assistance. Instead, it was an evaluation of the impact of grid suppression on diagnostic image quality. It compared images with and without the grid suppression algorithm applied, and the outcome measured was the radiologists' acceptability rating of the images.
- Effect Size: The average scores shifted from 7.2 (no suppression) to 7.7 (maximum suppression). This suggests a slight improvement in perceived quality with suppression, but the text states these differences were "not clinically significant" in relation to maintaining diagnostic acceptability.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, an initial analytical evaluation of the algorithm's performance was done: "The analytical characteristics of the grid detection and suppression algorithm were evaluated for a wide variety of grids commonly in use in the medical community. The algorithm was effective at reducing grid induced artifacts." This indicates a standalone assessment of the algorithm's technical function prior to human evaluation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Expert Opinion/Rating: The ground truth for image quality was established by the subjective ratings of ten radiologists regarding the "acceptability for interpretation" of the images. There is no mention of a true diagnosis based on pathology or outcomes data.
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The sample size for the training set:
- Not provided. The text only mentions the evaluation of the algorithm, not its training data.
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How the ground truth for the training set was established:
- Not provided. As training set details are absent, so is the method for establishing its ground truth.
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MAR 2 1 2002
510(k) Summarv
1. Company Identification
Eastman Kodak Company 343 State Street Rochester, NY 14650
Establishment Registration: 1317267
2. Contact Person
Susan Pate Regulatory Affairs Associate (716)-781-6314
3. 510(k) Summary Preparation Date
2/26/2002
4. Device Name
Trade Name: KODAK Direct View CR 800 System KODAK DirectView CR 900 System
Common Name: Storage phosphor reader with software modification
5. Device Classification
Class II
6. Indications for Use
The KODAK DirectView CR 800 System and the KODAK DirectView CR 900 System are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiology applications.
7. Description of Device
The KODAK DirectView CR 800 is a single cassette computed radiography (CR) system while the KODAK DirectView CR 900 is an autoloading CR system. Each CR system contains a storage phosphor reader, CR cassette, HeNe laser, QA workstation with image processing software, and a DICOM network connection.
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These CR systems are capable of reading the latent image formed on a storage phosphor imaging plate in a CR cassette and producing a digital image. The system scans the phosphor plate, communicates the image data to a host (e.g. soft copy review workstation or laser printer) and erases the residual image on the plate. An internal imaging plate eraser removes the residual image. The plate is then returned to the cassette, ready for the next exposure.
Software Modification
Anti-scatter grids are commonly used in radiography to reduce scattered x-rays and improve image contrast and signal-to-noise ratio. The new software modification uses a grid detection and suppression algorithm to reduce line artifacts caused by the use of anti-scatter grids. These grid artifacts, when present, can be distracting to radiologists when reviewing CR images, particularly in soft copy. The user may select the amount of grid suppression to be applied within a range of 0-15 through preference settings at the operator console of the CR system.
All other features and capabilities of the CR 800 and the CR 900 system remain unchanged by this software modification.
8. Substantial Equivalence
The analytical characteristics of the grid detection and suppression algorithm were evaluated for a wide variety of grids commonly in use in the medical community. The algorithm was effective at reducing grid induced artifacts.
An evaluation was performed, with hard copy CR images, to study the impact of grid suppression on diagnostic image quality. The effect of grid suppression on images with and without grids was assessed across several grid frequencies, orientations and a variety of radiographic exams (e.g. chest, abdomen, spine, shoulder, pelvis). On a scale of 1 to 9 with 7 being acceptable for interpretation, ten radiologists rated the exams as acceptable for interpretation or better when grid suppression was applied. Average scores ranged from 7.2 with no grid suppression to 7.7 with maximum grid suppression applied. The differences in rating for with and without grid suppression were not clinically significant.
The KODAK DirectView CR 800 and KODAK DirectView CR 900 with grid suppression are substantially equivalent to the previously cleared device [K923544].
KODAK DirectView CR 800 and CR 900 Systems 510(k) Submission
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a bold, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Susan Pate Regulatory Affairs Associate Eastman Kodak Company 343 State Street ROCHESTER NY 14650
AUG 23 2013
Re: K020635
Trade/Device Name: Kodak DirectView CR 800 and CR 900 Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: February 26, 2002 Received: February 27, 2002
Dear Ms. Pate:
This letter corrects our substantially equivalent letter of March 21, 2002.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Attachment 9 - Indications for Use
K020635 510(k) Number (if known): 幽绘丝
Device Name: KODAK DirectView CR 800 and KODAK DirectView CR 900 Systems
Indications of Use: The KODAK DirectView CR 800 System and the KODAK Direct View CR 900 System are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter
David A. Segerson
KODAK DirectView CR 800 and CR 900 Systems 510(k) Submission
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.