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 QC Workstation with software, cassettes, and image plates. Image data is sent via a dedicated connection from the Reader to the CRystalView R200 OC 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 postprocessing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the Alara CRystalView® R200 Computed Radiography System meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, spatial resolution, contrast-to-noise ratio requirements). Instead, it relies on a qualitative assessment of "substantial equivalence" to predicate devices. The primary performance criterion appears to be:

Acceptance Criterion (Implicit)	Reported Device Performance
Diagnostic capabilities and image quality equivalent to predicate devices (specifically the Agfa ADC Compact).	"The results of these studies show that CRystal View R200 performance characteristics are comparable with those of the predicate devices. Clinically, no statistically significant difference was found in image quality ratings of CRystalView R200 and the Agfa ADC Compact when images were judged by a radiologist." The device also demonstrated compliance with electrical, mechanical, EMC, and laser safety standards (though not directly image quality performance). Images are generated for human anatomy, replacing film/screen systems in general diagnostic procedures.
Compliance with applicable FDA and international safety standards.	"CRystalView R200 complies with applicable FDA and international standards pertaining to electrical, mechanical, EMC, and laser safety of medical and/or laser devices."

Acceptance Criterion (Implicit)

Reported Device Performance

Diagnostic capabilities and image quality equivalent to predicate devices (specifically the Agfa ADC Compact).

"The results of these studies show that CRystal View R200 performance characteristics are comparable with those of the predicate devices. Clinically, no statistically significant difference was found in image quality ratings of CRystalView R200 and the Agfa ADC Compact when images were judged by a radiologist." The device also demonstrated compliance with electrical, mechanical, EMC, and laser safety standards (though not directly image quality performance). Images are generated for human anatomy, replacing film/screen systems in general diagnostic procedures.

Compliance with applicable FDA and international safety standards.

"CRystalView R200 complies with applicable FDA and international standards pertaining to electrical, mechanical, EMC, and laser safety of medical and/or laser devices."

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

Sample Size for Test Set: The document states that clinical studies were performed, including a "confirmatory clinical concurrence study." However, it does not specify the sample size (number of images or patients) used in this clinical study.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical concurrence study comparing to a predicate, it would typically be prospective, but this is not explicitly confirmed.

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

Number of Experts: The document states "images were judged by a radiologist." This implies a single radiologist was involved in the clinical concurrence study.
Qualifications of Experts: The document explicitly states the expert was a "radiologist." However, it does not provide any further details on their qualifications (e.g., years of experience, subspecialty).

4. Adjudication Method for the Test Set

The document indicates that images were "judged by a radiologist." With only one radiologist mentioned, an explicit adjudication method (like 2+1 or 3+1) is unlikely to have been used for discrepancies, as there were no multiple independent readers to adjudicate. So, the method would be "none" in the typical sense of adjudicating disagreements. The single radiologist's judgment served as the benchmark.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Yes, a comparative effectiveness study was done, though it involved a single reader. The study compared the CRystalView R200 to the Agfa ADC Compact.
Effect Size: The document states, "Clinically, no statistically significant difference was found in image quality ratings of CRystalView R200 and the Agfa ADC Compact when images were judged by a radiologist." This implies the effect size was not statistically significant in terms of improved human reader performance with the new device compared to the predicate, as their image quality ratings were comparable. The goal was equivalence, not superiority.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device being evaluated is a Computed Radiography System that generates digital X-ray images, which are then reviewed by a human. The "image quality ratings" mentioned are judgments by a radiologist, implying human-in-the-loop performance evaluation.
While the system has acquisition console software and postprocessing image enhancement software, the document does not describe any standalone algorithm-only performance evaluation independent of human interpretation for diagnostic purposes. The focus is on the human interpretation of the images produced by the system.

7. The Type of Ground Truth Used

The ground truth in this study appears to be expert consensus (from a single radiologist, acting as the expert) on "image quality ratings." It is not based on pathology, outcomes data, or a gold standard that is independent of image interpretation. The comparison is between images of the new device and the predicate, as interpreted by an expert.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This is a medical device clearance submission (510(k)), which typically focuses on demonstrating equivalence to a predicate, not necessarily on detailing the developmental process, including machine learning model training sets.

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

As no information about a training set is provided, there is no information on how its ground truth was established.

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. The word "INCORPORATED" is written in smaller letters below the logo.

Attachment D: 510(k) Summary

JUN 3 0 2006

CRystalView® R200 Computed Radiography System

Kolo 1538

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 510-315-5201 Fax:
Date Prepared: May 30, 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 Devices:	510(k)#
Alara CrystalView CR SystemAgfa ADC Compact	K032210 K974597

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 generalpurpose diagnostic procedures.

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KOL 153 8

Rationale for Substantial Equivalence:

CRystalView R200 has the same indication for use as the predicate devices. CRystal View R200 shares the same technological characteristics as the predicate devices. 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 CRystalView R200 is substantially equivalent to the predicate devices.

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 CRystalView R200 performance characteristics and diagnostic capabilities are equivalent to the predicates. The results of these studies show that CRystal View R200 performance characteristics are comparable with those of the predicate devices. Clinically, no statistically significant difference was found in image quality ratings of CRystalView R200 and the Agfa ADC Compact when images were judged by a radiologist.

Conclusion:

CRystalView R200 performance tests and clinical studies have demonstrated that CRystalView R200 is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in blue, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written in a clear, sans-serif font. To the left of the text is a symbol featuring a stylized human figure, also in blue, which is part of the department's official emblem.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

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

AUG 2 3 2013

Re: K061538

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: June 1, 2006 Received: June 2, 2006

Dear Ms. King:

This letter corrects our substantially equivalent letter of June 30, 2006.

We have reviewed vour 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 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

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 B: Indications for Use Statement

510(k) Number: K061538

Device Name:

Alara CRystalView® R200 Computed Radiography System

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.

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

'rescription Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061538

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.