CRystalView R200 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.

Device Description

The Alara CRystalView® R200 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor image plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a OC Workstation with software, cassettes, and image plates. Image data is sent via a dedicated connection from the Reader to the CRystalView R200 QC Workstation, where it is processed and displayed for review. The system outputs images and patient information to a PACS using the standard DICOM 3.0 protocol. The fully configured CRystalView R200 System includes acquisition console software and post-processing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware. The modification reported in this submission replaces the integrated third-party image enhancement software with image enhancement software developed by Alara.

AI/ML Overview

The provided text describes a 510(k) submission for the Alara CRystalView® R200 Computed Radiography System. The submission focuses on demonstrating substantial equivalence to a predicate device after modifying the integrated image enhancement software.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Equivalence to Predicate Device: The modified CRystalView R200 with Alara image enhancement software must demonstrate performance characteristics and diagnostic capabilities equivalent to the predicate CRystalView with integrated third-party image enhancement software.	Clinically, no statistically significant difference was found in image quality ratings from CRystalView images processed with the predicate third-party image enhancement software and with Alara image enhancement software when images were judged by a radiologist.
Substantial Equivalence: The modified device must be substantially equivalent to the predicate device.	The results of the studies show that the modified CRystalView R200 performance characteristics are comparable with those of the predicate device. CRystal View performance tests and clinical studies have demonstrated that the modified 'CRystalView R200 incorporating Alara image enhancement software is substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The text does not explicitly state the specific number of images or cases used in the "confirmatory clinical concurrence study" or "clinical studies." It mentions "images" were judged by a radiologist, but not the quantity.
Data Provenance: The text does not specify the country of origin of the data. It indicates the study was a "clinical concurrence study," implying prospective data collection for the purpose of comparing the two software versions, but does not explicitly state it was prospective. The context suggests it was to compare the newly implemented software against the previous, implying a comparison on clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: The text states "a radiologist" was used to judge the images. This implies a single radiologist.
Qualifications of Experts: The text identifies the expert as "a radiologist." No further details on their experience (e.g., years of experience) are provided.

4. Adjudication Method for the Test Set:

Adjudication Method: The text indicates that images were "judged by a radiologist." It does not describe any specific adjudication method like 2+1 or 3+1, which are typically used when multiple readers are involved and their opinions differ. Given that only "a radiologist" is mentioned, no complex adjudication method seems to have been applied, or at least it is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No, a multi-reader, multi-case comparative effectiveness study was not explicitly stated. The study described involved "a radiologist" judging images, suggesting a single-reader assessment rather than a multi-reader setup.
Effect Size of AI Assistance: This study is not evaluating the improvement of human readers with AI assistance. It is comparing the performance of a new image enhancement software (developed by Alara) against an older, third-party image enhancement software, both integrated into a Computed Radiography (CR) system. The core of the study is about the equivalence of image processing software, not AI assistance for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: The text does not explicitly describe a standalone (algorithm only) performance study of the image enhancement software. The clinical study involved a radiologist judging images, indicating a human-in-the-loop evaluation of the output of the system (which includes the image enhancement software). The "performance tests" mentioned alongside clinical studies could encompass some standalone technical evaluations (e.g., image quality metrics like spatial resolution, contrast-to-noise ratio), but the text focuses on diagnostic capabilities as judged by a human.

7. The Type of Ground Truth Used:

Type of Ground Truth: The ground truth for the clinical study was based on expert consensus/opinion (specifically, the judgment of "a radiologist" regarding image quality ratings). There is no mention of pathology, outcomes data, or other objective measures being used for ground truth. The study aimed to assess the equivalence of perceived image quality.

8. The Sample Size for the Training Set:

Sample Size for Training Set: The text does not provide any information regarding a training set size. The study described is a comparison of image enhancement software versions, not the development or training of a new algorithm requiring a distinct training dataset.

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

Ground Truth for Training Set: As no training set is mentioned or implied, the method for establishing its ground truth is not applicable or provided in the text.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for ALARA Incorporated. The logo consists of the letters A, L, A, R, and A, each separated by a vertical line. Below the letters is the word "INCORPORATED" in a smaller font size.

Attachment D: 510(k) Summary

1062390

CRystalView® R200 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 Drive Fremont, CA 94538
Contact Person: Diane King VP Regulatory Affairs Phone: 510-315-5173 Fax: 510-315-5201
Date Prepared: August 15, 2006

Trade Name: CRystalView® R200 Computed Radiography System

Common Name: Computed Radiography (CR) System
Classification Name: Solid State X-Ray Imager (per 21 CFR 892.1650)

Predicate Device: Alara CRystalView CR System 510(k)# K061538

Product Description:

Indications for Use:

CRystalView R200 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.

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Rationale for Substantial Equivalence:

CRystalView R200 with the Alara image enhancement software has the same indication for use as the unmodified predicate device. The Alara image enhancement software shares the same technological characteristics as the previously integrated third-party image enhancement software. However, the descriptive characteristics are not sufficiently precise to assure substantial equivalence. Therefore, Alara has carried out verification and image quality performance testing, including a confirmatory clinical concurrence study. The results of this testing demonstrate that the modified CRystal View with integrated Alara image enhancement software is substantially equivalent to the predicate CRystalView with integrated third-party image enhancement software.

Safety and Effectiveness Information:

CRystalView R200 is a Class II medical device and a Class I laser product. CRystalView R200 complies with applicable FDA and international standards pertaining to electrical, mechanical, EMC, and laser safety of medical and/or laser devices.

Alara has performed laboratory and clinical studies to demonstrate that the modified CRystalView R200 performance characteristics and diagnostic capabilities are equivalent to the predicate. The results of these studies show that the modified CRystal View R200 performance characteristics are comparable with those of the predicate device. Clinically, no statistically significant difference was found in image quality ratings from CRystalView images processed with the predicate third-party image enhancement software and with Alara image enhancement software when images were judged by a radiologist.

Conclusion:

CRystal View performance tests and clinical studies have demonstrated that the modified 'CRystalView R200 incorporating Alara image enhancement software is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 1 8 2006

Ms. Diane King Vice President Regulatory Affairs Alara, Inc. 47505 Seabridge Drive FREMONT CA 94538

Re: K062390

Trade/Device Name: Alara CrystalView® R200 Computed Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 15, 2006 Received: August 22, 2006

Dear Ms. King:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

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Protecting and Promoting Public Health

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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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy 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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Attachment B: Indications for Use Statement

510(k) Number:

KD62390

Device Name:

Alara CRystal View® R200 Computed Radiography System

CRystalView R200 is indicated for use in Indications for Use: generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number	K062390

Regulation Number and Section

§ 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.