The CR-Pro is a free standing, laser driven, image digitizer intended to produce digital copies of phosphor plate recorded images in 16 levels of gray scale. The digital copies are transmitted to an internal Intel Pentium 4 based personal computer (PC) where they may be displayed, processed, or compressed for archiving or transmission via computer networks to other medical facility sites.

This device is not to be used for primary imaging diagnosis in mammography.

Device Description

The eRadlink CR-Pro is a digitizing scanner that converts radiographic film transparency images to digital format. This is accomplished by utilizing a laser beam light source and a proprietary sealed path of fiber optics. The new technology provides superior image quality, requires no internal optics cleaning, no optical alignment and is inherently highly accurate and reliable.

Phosphor plates from a minimum of 10 inches to a maximum of 14 inches in width, is driven past the digitizing laser beam by a clocked, stepping motor. Scanned data is electronically converted from analog to 16 bit digital gray scale and transmitted to the internal computer for processing.

AI/ML Overview

Here's an analysis of the provided text regarding the eRadlink CR-Pro's acceptance criteria and studies:

Summary of Device Performance and Acceptance Criteria

The provided 510(k) summary for the eRadlink CR-Pro does not explicitly define "acceptance criteria" in terms of specific performance thresholds for image quality metrics (e.g., SNR, spatial resolution, contrast resolution) that the device must meet. Instead, the "Effectiveness" section states:

"Program testing and calibration using Beryllium gray-scale wedge, body part phantoms and typical x-ray plate samples has demonstrated the CR-Pro’s conformance to its defined specifications."

This implies that the acceptance criteria are tied to the device's defined specifications and successful demonstration of conformance through specific tests. While the specifications for various hardware components (like dynamic range, pixel/mm, gray scale) are listed in comparison to a predicate device, specific acceptance thresholds for image quality when tested with phantoms are not detailed.

Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria for image quality from phantom studies are not explicitly stated as performance thresholds, I will present the relevant specifications from the comparison tables which implicitly represent the device's targeted performance based on the predicate device.

Acceptance Criterion (Implicit from Predicate & Device Spec)	Reported Device Performance (eRadlink CR-Pro)
Dynamic Range	0.0 - 3.5 OD (Similar to Predicate's 0.5 - 3.8 OD)
Gray Scale Depth	16 (bits Transmitted) (Superior to Predicate's 8 or 12 bits)
Spot Size	100 µm (Matches Predicate)
Pixel/mm	8.0 (Comparable to Predicate's 10.09)
Digitizing Rate	100 lines/sec (Comparable to Predicate's 115 lines/sec)
Image Quality Conformance	Demonstrated conformance to defined specifications through program testing and calibration using Beryllium gray-scale wedge, body part phantoms, and typical x-ray plate samples.
Compliance with Safety Standards	IEC 60601-1, 2; 21CFR1040.10, DICOM 3:2004, EN55022:1998, EN55024:1998, EN61000-3-2:2000, EN61000-3-3:1995, SMPTE RP 215-2001, SMPTE 349M-2001

Study Information

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify a numerical sample size for a clinical test set.
- The effectiveness was demonstrated through "program testing and calibration using Beryllium gray-scale wedge, body part phantoms and typical x-ray plate samples." These are laboratory-based tests using inanimate objects, not a clinical trial withpatient data.
- Data provenance: Not applicable as it's not clinical data. The tests would have been performed by the manufacturer, eRadlink Inc., presumably in Torrance, California, USA, where they are based. The study is prospective in the sense that the device was tested to demonstrate current functionality.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. As the testing involved phantoms and calibration, there was no need for expert clinicians to establish "ground truth" in the diagnostic sense. The ground truth would be based on the known physical properties and measurements from the test objects and the expected output of the device as per its design specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as there was no clinical test set requiring adjudication.
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
- No MRMC comparative effectiveness study was done. This device is a digitizing scanner, not an AI-powered diagnostic tool. The submission focuses on demonstrating substantial equivalence to a predicate device for its core function of converting radiographic film to digital format.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The "effectiveness" testing described is inherently standalone in the sense that the device performs its digitizing function, and its output is assessed against its specifications using physical test objects. There is no "human-in-the-loop" performance being evaluated in this context, nor is there an "algorithm only" performance reported in the way it might for an AI diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the "effectiveness" testing consisted of the known physical properties of the Beryllium gray-scale wedge and body part phantoms, and the defined specifications of the CR-Pro device. It's a technical ground truth related to image capture and conversion accuracy, not a clinical ground truth.
The sample size for the training set
- Not applicable. This device is a hardware digitizer with associated software for processing and transmission. It does not appear to involve machine learning or AI models that would require a "training set" in the conventional sense. The software functions (e.g., image rotation, DICOM send/receive) are standard functionalities, not learned from data.
How the ground truth for the training set was established
- Not applicable, as there was no training set.

Summary

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1052938

NOV 1 7 2005

Per Title 21 CFR 807. 92, the following is the 510(k) Summary for the Solid State X-ray Imager manufactured and marketed by eRadlink Inc. under the trade-name eRadlink CR-Pro:

eRadlink Inc. SUBMITTER: (1) 22760 Hawthorne Blvd. Torrance, California 90505-3664 Phone: 310-373-5673 310-373-9763 Fax:
Albert Kouba CONTACT: Manager, Regulatory Affairs 22760 Hawthorne Blvd. Torrance, California 90505-3664 Phone: 310-373-5673 310-373-9763 Fax:

30 September 2005 SUBMISSION DATE:

DEVICE NAME: (2)

ﺴ

TRADE NAME:	eRadlink CR-Pro
COMMON NAME:	Storage Phosphor Reader with Software Modification
CLASSIFICATION NAME:	Solid State X-ray Imager (per regulation 21 CFR 892.1650)(Class II device)
PRODUCT CODE:	MQB
(3) PREDICATE DEVICE:	OREX PcCR (K003256)49 Plain St.Attleboro, MA 02760

DEVICE DESCRIPTION: (4)

INTENDED USE OF DEVICE (5)

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processed, or compressed for archiving or transmission via computer networks to other medical facility sites.

This device is not to be used for primary imaging diagnosis in mammography.

SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE - HARDWARE (6)

Table -- A illustrates the comparative equivalence of the CR-Pro to the Predicate device Hardware.

Feature	eRadlink	OREX
Product Name	CR-Pro	PcCR
510(k) Number	Not Issued	K003256
Dimensions	40in (h) x 24in(w) x 18in(d)	16"(h) x 21"(w) x 29"(d)
Weight	98lbs (44.5kg)	90 lbs. (40.9 kg)
Power	90-227vac 10A 47-63Hz	110-120vac 1A 50/60 Hz
Scan Size	8" x 10" (min) 14"x 17" (max)	7" x 7" (min), 14" x 36"
Spot Size	100μm	100 μm
Dynamic Range	0.0 - 3.5 OD	0.5 - 3.8 OD
Gray Scale	16 (Transmitted)	8 or 12 bits
Digitizing Rate	100 lines/sec	115 lines/sec
Laser	35 mw Solid State	He-Ne Laser
Beam Scan	Fiber Optics	Galvanometer
Pixel/mm	8.0	10.09
Plate Size	14" x 17"	14" x 17"
	14" x 14"	14" x 14"
	10" x 12"	10" x 12"
	8" x 10"	8" x 10"
Interface	USB 2 (Diagnostic), Ethernet	USB 1.1
Computer	Pentium 4 2.8 GHz	Pentium 4 1.8 GHz
Ram	512 MB	512 MB
Hard Drive	80GB	20 GB
Video Card	2 MB 1024 X 760 Resolution	1024 X 760 Resolution
Monitor	1024 x 760	1024 x 760
Operating System	Windows XP Pro	Windows 2000
Electrical Safety	IEC 60601-1, 2	IEC 60601-1, 2

Table A – Hardware Comparison of CR-Pro to Predicate Devices

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US 2938

SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE - SOFTWARE (7)

Table B illustrates the comparative equivalence of the CR-Pro to the Predicate device Software.

Features	eRadlink	OREX	eRadlink²
Product Name	CR-Pro	PcCR	LS-16
510(k) Number	-	K003256	K020243
Patient Information - Add/Modify/Delete	Y	Y	Y
Fax Report	Y	Y	Y
Print Dicom Image	Y	Y	Y
Image Rotate and Flip	Y	Y	Y
Black/White Inversion	Y	Y	Y
Multiple Image Display	Y	Y	Y
Dicom Send/Receive/Echo	Y	Y	Y
Dicom Query User/Provider	Y	Y	Y
Dicom Retrieve User/Provider	Y	Y	Y
Dicom Print	Y	Y	Y
JPEG Compression lossy/lossless	Y	Y	Y
iJPEG Compression	Y	Y	Y
Wavelet Compression	Y	Y	Y
Industry Standard Digital CommunicationSupport	Y	Y	Y
Color Images	N	Y	N
Cine Loop Viewing	N	Y	N
Dicom Removable Media Support	Y	Y	Y
Measurement Tools	Y	Y	Y
Communication protocols	Y¹	Y¹	Y¹

Table B - Software Comparison of CR-Pro to Predicate Devices

1 ADSL, Cable and Analog Modems and Phone Lines, ATM, ISDN, FDDL, Ethernet, Token Ring

2 The LaserPro 16 (an earlier product of eRadlink) is cited as a Predicate Device as the application software utilized in that device is the same software used in the CR-Pro with minor start-up; phosphor plate handling and erasing modifications.

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K052938

Color Images	N	Y	N
Cine Loop Viewing	N	Y	N
Dicom Removable Media Support	Y	Y	Y
Measurement Tools	Y	Y	Y
Communication protocols	Y1	Y1	Y1

ADSL, Cable and Analog Modems and Phone Lines, ATM, ISDN, FDDL, Ethernet, Token Ring

EFFECTIVENESS (8)

Program testing and calibration using Beryllium gray-scale wedge, body part phantoms and typical x-ray plate samples has demonstrated the CR-Pro's conformance to its defined specifications.

SAFETY (9)

The CR-Pro complies with the following standards:

Standard:year	Name
21CFR1040.10	PERFORMANCE STANDARDS FOR LIGHT-EMITTING PROD-UCTS: Laser products
DICOM 3:2004	Digital Imaging and Communications in Medicine (including JPEGcoding per section 3.6)
EN55022:1998 includ-ing A1:2000	Information technology equipment — Radio disturbance characteris-tics — Limits and methods of measurement
EN55024:1998 includ-ing A1:2001 andA2:2003	Information technology equipment — Immunity characteristics —Limits and methods of measurement
EN61000-3-2:2000	Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limitsfor harmonic current emissions (equipment input current up to and in-cluding 16 A per phase)
EN61000-3-3:1995 in-cluding A1:2001	Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limita-tion of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A perphase and not subject to conditional connection
IEC 60601-1:1988 in-cluding am1:1991 andam2:1995	Medical electrical equipment - Part 1: General requirements for safety
IEC 60601-1-2 (2001-09)	Medical electrical equipment - Part 1-2: General requirements forsafety - Collateral standard: Electromagnetic compatibility - Require-ments and tests
SMPTE RP 215-2001	Encoding Film Transfer Information into Vertical Ancillary Data forSMPTE 292M Bit-Serial Interface
SMPTE 349M-2001	Television - Transport of Alternate Source Image Formats throughSMPTE 292M

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or bird-like figure with three stylized lines representing its wings or body. The emblem is black, and the text around the perimeter is also in black.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

eRadlink, Inc. % Mr. Ned Devine Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K052938

NOV 1 7 2005

Trade/Device Name: eRadlink CR-Pro Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB

Dated: November 3, 2005 Received: November 4, 2005

Dear Mr. Devine:

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.

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.

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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 this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly 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

: 上一篇:

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Indications for Use 510(k) Number (if known):

Device Name: eRadlink CR-Pro

Indications for Use:

This device is not to be used for primary imaging diagnosis in mammography.

Prescription Use (Part 21 CFR 801 Subpart D)

ADIOR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segarra

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

Software Certification Statement

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.