CRystalView 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™ is a Desktop Computed Radiography (CR) System designed to generate digital x-ray images by scanning photo-stimulable storage phosphor imaging plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a OC workstation with software, cassettes, and imaging plates. Image data is sent via a dedicated connection from the Reader to the CRystalView 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 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.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state quantitative acceptance criteria in a table format. However, it implicitly defines the acceptance criteria as demonstrating substantial equivalence to predicate devices. The performance is reported in terms of comparability.

Acceptance Criteria Category	Reported Device Performance
Overall Equivalence	"demonstrate that CRystalView is substantially equivalent to the predicate devices."
Image Quality	"Clinically, no statistically significant difference was found in image quality ratings of CRystalView and the Agfa ADC Compact when images were judged by a radiologist."
Functional Characteristics	"CRystalView performance characteristics are comparable with those of the predicate devices."
Indications for Use	"CRystalView has the same or similar indications for use as the predicate devices."
Technological Characteristics	"CRystalView shares the same technological characteristics as the predicate devices."
Safety and Standards	"CRystalView complies with applicable FDA and international standards pertaining to electrical, mechanical. EMC, and laser safety of medical and/or laser devices." (This is a design requirement, but also implies performance in meeting safety standards)

Notes on Acceptance Criteria:

The primary acceptance criterion is substantial equivalence to the predicate devices (PhorMax Eagle Scanner (K001499) and Agfa ADC Compact (K974597)).
For clinical performance, the key metric for image quality was "no statistically significant difference" compared to a predicate device.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document does not specify the exact number of images or cases used in the clinical concurrence study. It only states that "a clinical concurrence study" was carried out, where "images were judged by a radiologist."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: "a radiologist" (singular, implying one radiologist).
Qualifications of Experts: The specific qualifications (e.g., years of experience, subspecialty) of the radiologist are not provided.

4. Adjudication method for the test set

Adjudication Method: Not explicitly stated. Given that only "a radiologist" was mentioned, it suggests a single-reader assessment rather than a multi-reader adjudication method (like 2+1, 3+1).

5. 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?

MRMC Study Conducted: No, an MRMC study was not conducted. The study described is a "clinical concurrence study" where images from the CRystalView and a predicate device (Agfa ADC Compact) were judged by a single radiologist for image quality.
Effect Size: Not applicable, as this was not an MRMC study nor an AI-assisted study. The device itself (CRystalView) is a Computed Radiography (CR) system, not an AI-based diagnostic tool for assisting human readers.

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

Standalone Performance: Yes, implicitly. The performance of the CRystalView system itself (the algorithm and hardware) was evaluated through laboratory and clinical studies. The "image quality ratings" of the CRystalView were compared to those of the predicate. This is a standalone evaluation of the device's output quality.

7. The type of ground truth used

Type of Ground Truth: "Image quality ratings... judged by a radiologist." This implies expert consensus (or in this case, expert judgment by a single radiologist) was used to establish the "ground truth" for image quality comparison. It's not pathology or outcomes data.

8. The sample size for the training set

Sample Size for Training Set: Not mentioned or applicable. This documentation focuses on the validation of the device and does not describe the development or training of any machine learning component. The CRystalView system described here is a Computed Radiography system for image generation, not an AI diagnostic algorithm that requires a "training set" in the conventional machine learning sense.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as this device does not describe an AI/ML algorithm requiring a training set with established ground truth.

Summary

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032210

Premarket Notification, 510(k) for the CRystalView CR System

Image /page/0/Picture/2 description: The image shows the logo for ALARA Incorporated. The logo consists of the word "ALARA" in large, bold, sans-serif font, with vertical lines separating each letter. Below the word "ALARA" is the word "INCORPORATED" in a smaller, sans-serif font. There is a thick black line above the word "ALARA".

510(k) Summary F.

CrystalView™ Computed Radiography System

OCT = 2 2003

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

Submitter:	Alara, Inc.2545 Barrington CourtHayward, CA 94545
Contact Person:	Diane M. KingVP Regulatory AffairsPhone: 510-265-6224Fax: 510-723-0111
Date Prepared:	July 18, 2003
Trade Name:	CRystalView Computed Radiography System
Common Name:	Computed Radiography (CR) System
Classification Name:	Solid State X-Ray Imager (per 21 CFR 892.1650)
Predicate Device:	PhorMax Eagle ScannerAgfa ADC Compact	510(k) #	K001499 K974597

Product Description:

Indications for Use:

CRystalView 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 has the same or similar indications for use as the predicate devices. CRystalView 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 validation and image quality performance testing, including a clinical concurrence study. The results of this testing demonstrate that CRystalView is substantially equivalent to the predicate devices.

Safety and Effectiveness Information:

CRystalView is a Class II medical device, and a Class I laser product. CRystalView 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 CRystalView performance characteristics and equivalent diagnostic capabilities as the predicate. The results of these studies show that CRystal View performance characteristics are comparable with those of the predicate devices. Clinically, no statistically significant difference was found in image quality ratings of CRystalView and the Agfa ADC Compact when images were judged by a radiologist.

Conclusion:

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three lines forming its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2003

Ms. Diane M. King VP, Regulatory Affairs Alara, Inc. 2545 Barrington Court HAYWARD CA 64545 Re: K032210

Trade/Device Name: Alara CRystalView™ Computed Radiograph System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified Fluoroscopic x-ray system Regulatory Class: II Product Code: 90 MQB Dated: July 18, 2003 Received: July 21, 2003

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 (PMA), it may be subject to 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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

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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Premarket Notification, 510(k) for the CRystalView CR System

Statement of Indications for Use E.

510(k) Number (if known):	K032210
Device Name:	Alara CRystalView TM Computed Radiography System
Indications for Use:	CRystalView is indicated for use in generatingradiographic images of human anatomy. It is intended toreplace radiographic film/screen systems in all general-purpose diagnostic procedures.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

・・

Daniel R. Symons

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

(Optional Format 3-10-98)

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.