(57 days)
The CRystalView T-Series is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The CRystalView T-Series is not indicated for use in mammography.
The CRystal View T-Series System is an electrostatic X-ray imaging system that employs storage phosphor plates in place of conventional X-ray film for radiographic imaging applications. The system provides image data that must then be viewed with an external computer and appropriate software. The CRystal View T-Series System is comprised of the following functional components: Reusable storage phosphor plates, multiple sizes; Plate carousels, corresponding to reusable storage phosphor plate size; The CRystal View T-Series Scanner, an image reader /digitizer. The CRystal View T-Series Scanner / Communications Interface, USB 2.0; Optional Integrated phosphor plate eraser; CRystal View T-Series control software and a user or distribution channel-supplied computer system. Image data is sent via a dedicated connection from the CRystalView T-Series Scanner to the computer system, where it is processed and displayed for review.
The provided text is a 510(k) summary for the Alara CRystalView® T-Series Computed Radiography System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance. It lacks the quantitative data and detailed methodology typically found in such a study.
Here's an analysis based only on the provided text, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria nor reported device performance metrics in a comparative format. It makes a general claim:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance characteristics equivalent to predicate device | "Alara's laboratory and V&V testing demonstrate that the CRystal View T-Series performance characteristics and diagnostic capabilities are equivalent to the predicate." |
| Diagnostic capabilities equivalent to predicate device | "Alara's laboratory and V&V testing demonstrate that the CRystal View T-Series performance characteristics and diagnostic capabilities are equivalent to the predicate." |
| Substantial equivalence to predicate(s) | "The CRystalView T-Series' performance is substantially equivalent to the DenOptix Imaging System and the FCR ClearView using the ST-VI imaging plates." |
Missing: Specific, measurable acceptance criteria (e.g., spatial resolution, DQE, contrast resolution, noise levels, etc.) and quantitative data demonstrating how the CRystalView T-Series met these criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide any information regarding the sample size used for a test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective). It only refers to "Alara's laboratory and V&V testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method
The document does not describe any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone performance study. The device itself is a Computed Radiography System, implying it produces images for human interpretation, rather than an AI algorithm for diagnosis.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any testing.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. Given that this is a CR acquisition system and not an AI-based diagnostic algorithm, a "training set" in the context of machine learning is not applicable here. The device produces images, and the "training" involved would be for the internal algorithms responsible for image processing and reconstruction, which are typically developed using engineering and physics principles rather than a labeled medical image training set.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set, the document does not describe how ground truth for a training set was established.
Summary of what is available from the text:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the CRystalView T-Series Computed Radiography System to previously cleared predicate devices (K042023: Fuji Computed Radiography (FCR) ClearView CS Image Reader and K955643; DenOptix ALARA Imaging System). The claims of equivalence are based on "Alara's laboratory and V&V testing," which are stated to show that the performance characteristics and diagnostic capabilities are equivalent. However, without the underlying test reports, the specific acceptance criteria, quantitative results, and methodological details (like sample sizes, expert involvement, and ground truth establishment) cannot be extracted from this document. This level of detail is typically found in the full 510(k) submission and supporting validation documentation, not usually in the public summary.
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KD71682
PREMARKET NOTIFICATION 510(k) CRystalView® T-Series Computed Radiography System
AUG 1 5 2007
E. 510(k) Summary Statement
CRystalView T-Series Computed Radiography System
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Alara, Inc.47505 Seabridge DriveFremont, CA 94538 |
|---|---|
| Registration Number: | 2953719 |
| Contact Person: | Robert LundbergDirector of Regulatory Affairs and Quality SystemsPhone: 510-315-5189Fax: 510-315-5201 |
| Date Prepared: | July 18, 2007 |
| Trade Name: | CRystalView® T-Series Computed Radiography System |
| Common Name: | Computed Radiography (CR) System |
| Classification Name: | Solid State X-Ray ImagerClass II, 21CFR 892.1650 |
| Product Code: | 90-MQB |
| Predicate Device: | K042023: Fuji Computed Radiography (FCR) ClearView CSImage Reader (CR-IR363)K955643; DenOptix ALARA Imaging System |
Product Description:
The CRystal View T-Series System is an electrostatic X-ray imaging system that employs storage phosphor plates in place of conventional X-ray film for radiographic imaging applications. The system provides image data that must then be viewed with an external computer and appropriate software. The CRystal View T-Series System is comprised of the following functional components: Reusable storage phosphor plates, multiple sizes; Plate carousels, corresponding to reusable storage phosphor plate size; The CRystal View T-Series Scanner, an image reader /digitizer. The CRystal View T-Series Scanner / Communications Interface, USB 2.0; Optional Integrated phosphor plate eraser;
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Image /page/1/Picture/0 description: The image shows the text "A|L|A|R|A" in a bold, sans-serif font. The letters are separated by vertical lines. Below the letters, the word "INC" is written in a smaller font size. The text appears to be a logo or brand name.
CRystal View T-Series control software and a user or distribution channel-supplied computer system. Image data is sent via a dedicated connection from the CRystalView T-Series Scanner to the computer system, where it is processed and displayed for review.
Indications for Use:
The CRystalView T-Series is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in generalpurpose diagnostic procedures.
The CRystal View T-Series is not indicated for use in mammography.
Rationale for Substantial Equivalence:
The CRystal View T-Series is the equivalent of the DenOptix Imaging System. Its "Intended Use" statement limits the DenOptix Imaging System to dental computed radiography. The Fuji Computed Radiography (FCR) ClearView CS Image Reader uses the same ST-VI Imaging Plates for general computed radiography that is the same "Intended Use" desired for the CRystalView T-Series. Differences between the FCR ClearView and the present device are in the implementation of similar technologies for computed radiography. These differences do not alter the intended diagnostic effect of a computed radiographic imaging system.
Safety and Effectiveness Information:
The CRystalView T-Series is a Class II medical device and a Class I laser product. The CRystalView T-Series complies with applicable FDA and international standards pertaining to electrical, mechanical, EMC, and laser safety of medical and/or laser devices.
Alara's laboratory and V&V testing demonstrate that the CRystal View T-Series performance characteristics and diagnostic capabilities are equivalent to the predicate.
Conclusion:
The CRystalView T-Series' performance is substantially equivalent to the DenOptix Imaging System and the FCR ClearView using the ST-VI imaging plates.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert Lundberg Director, Regulatory Affairs & Quality Systems Alara, Inc. 47505 Seabridge Drive FREMONT CA 94538
AUG 2 3 2013
Re: K071682
Trade/Device Name: CRystalView® T-Series Computed Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 18, 2007 Received: July 20, 2007
Dear Mr. Lundberg:
This letter corrects our substantially equivalent letter of August 15, 2007.
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 (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 11 you don't 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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PREMARKET NOTIFICATION 510(k) CRystalView® T-Series Computed Radiography System
A|L|A|R|A®
INC.
C. Indications for Use Statement
| 510(k) Number: | K071682 |
|---|---|
| Device Name: | CRystalView ® T-Series Computed Radiography System |
| Indications for Use: | The CRystalView T-Series is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The CRystalView T-Series is not indicated for use in mammography. |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ーーー Concurrence of CDRH, Office of Device Evaluation (ODE)
D. Whang 8/15/07
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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.