Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.

Agfa's DX-D 300 is not indicated for use in mammography.

Device Description

The device is a combination of a conventional x-ray system with digital image capture equipment. The new device is a simple combination of the two predicate devices with minor modifications. The DX-D 300 uses Agfa's familiar NX workstation with MUSICA-TM image processing and flat panel detectors of the scintillator-photodetector type (Cesium lodide or Gadolinium Oxysulfide),

With the new device, users have the ability to control patient exposure settings from the NX workstation. Principles of operation and technological characteristics of the new and predicate devices are the same.

Agfa's DX-D 300 includes both a traditional U-Arm x-ray system for patient exposure and digital image capture equipment.

The x-ray system includes one of four 50-80 kW generators and one of three Toshiba x-ray tubes. U-arm rotation, height, source-to-image distance and detector rotation are controlled by dual speed motors at the unit or by a remote control. Sensors on the equipment ensure patient safety at all times. An optional rolling patient table is available.

A Cesium Iodide or Gadolinium Oxysulfide flat panel detector is used to capture the image. Previews are available to the operator in as little as one second after exposure. MUSICA"1M image processing provides consistent image quality. DICOM connectivity allows images to be directed to the user's PACS system, archive or hard copy printer. The workstation can also be connected other Agfa computed radiography systems at the facility.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the AGFA DX-D 300, based on the provided text:

Summary of Device and Acceptance:

The AGFA DX-D 300 is a stationary digital x-ray system, combining a conventional x-ray system with digital image capture. Its intended use is to provide diagnostic quality images for a physician's diagnosis across various body parts (skeleton, chest, abdomen, etc.), excluding mammography.

The acceptance of this device for market clearance was based on demonstrating substantial equivalence to two legally marketed predicate devices: Agfa's DX-D Imaging Package (K092669) and Sedecal's X Plus LP Plus x-ray system (K062335). The core argument for acceptance is that the DX-D 300 is a simple combination of these two proven technologies with only minor modifications.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Equivalence to Predicates)	Reported DX-D 300 Performance
Intended Use Statement (Nearly identical to predicates)	Same as predicates
Technological Characteristics	Same as predicates
DICOM Communications	Same as predicate
Detector Material (GOS or CsI scintillator)	Same as predicate
Detector Sizes (14x17 in. & 17x17 in)	Same as predicate
Active Matrix (3056x3056, 3072x2560)	Same as predicate
Pixel Size (139 µm)	Same as predicate
Fill Factor (100%)	Same as predicate
Dynamic Range (14 bit DR, 12 bit CR)	Same as predicate
Maximum Image Acquisitions/hr. (150)	Same as predicate
Image Processing (MUSICA2)	Same as predicate
Operating System (Windows XP Pro)	Same as predicate
Display System (Standard PC or cleared medical display)	Same as predicate
Operator Workstation (Agfa NX with Soft Console Software)	Agfa NX with Soft Console Software
Power Supply (47-63 Hz, 90-264V auto ranging)	Same as predicate
Electrical Safety (IEC-60601)	Same as predicate
Performance Standard (N/A for Agfa predicates)	N/A (referencing 21CFR1020.30 for Sedecal predicate)
Generators (N/A for Agfa predicates)	Same as predicate (Choice of four models, 50-80 KW)
Tubes (N/A for Agfa predicates)	Same as predicate (Choice of three Toshiba models)
Safety and Performance Standards Conformance	Conforms to listed IEC, ACR/NEMA, ISO standards (see below)
IEC 60601-1-1	Conforms
IEC 60601-1-2	Conforms
ACR/NEMA PS3.1-3.18	Conforms
IEC 60601-1-3	Conforms
IEC 60601-1-4	Conforms
IEC 60601-2-7	Conforms
IEC 60601-2-28	Conforms
IEC 60601-2-32	Conforms
ISO 14971	Conforms
ISO 13485	Conforms

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

Test Set Sample Size: "Sample images have been provided." The document does not specify an exact number of images or patients used for performance validation.
Data Provenance: Not explicitly stated whether the sample images were retrospective or prospective, or their country of origin. Given the nature of the submission (demonstrating substantial equivalence through technical specifications and conformance to standards rather than clinical performance), these images likely served as illustrative examples rather than part of a formal clinical test set designed to establish diagnostic accuracy endpoints.

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

This information is not provided. The submission states, "No clinical testing was performed in the development of the DX-D 300." Therefore, there was no expert review process described for establishing ground truth from images or cases in a clinical trial context.

4. Adjudication method for the test set

None specified. As no clinical testing with expert review was described, there was no adjudication method.

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

No such study was done. The DX-D 300 is a digital x-ray imaging system, not an AI-powered diagnostic device designed to assist human readers. The submission explicitly states, "No clinical testing was performed."

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

Not applicable. The DX-D 300 is a hardware and software system for image acquisition and processing (MUSICA2), not a standalone algorithm performing diagnostic interpretations. Its performance is related to image quality and technical specifications, not automated diagnosis.

7. The type of ground truth used

Not applicable in a diagnostic accuracy sense. The "ground truth" for this submission was primarily established by demonstrating technical conformance to standards (e.g., IEC, ACR/NEMA, ISO) and equivalency of technical specifications to the predicate devices. The "performance of the complete system has been validated" likely refers to engineering verification and validation testing against these technical standards, rather than clinical ground truth (e.g., pathology, outcomes).

8. The sample size for the training set

Not Applicable. The DX-D 300 is not an AI/machine learning device that requires a training set in the conventional sense. The MUSICA2 image processing is a predefined algorithm rather than one that "learns" from data.

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

Not Applicable. As there is no training set for an AI algorithm for this device, there is no corresponding ground truth establishment.

Summary

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510(K) SUMMARY: AGFA DX-D 300

Common/Classification Name: Stationary System, 21 CFR 892.1680 Proprietary Name: DX-D 300 Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Phil Cuscuna, Prepared: September 24, 2010 Telephone: (416) 240-7317 Facsimile: (416) 240-7359

QCT 2 9 2010

LEGALLY MARKETED PREDICATE DEVICES A.

This is a 510(k) for Agfa's DX-D 300, which is a combination of the two predicate devices: Agfa's DX-D Imaging Package (K092669) and Sedecal's X Plus LP Plus x-ray system (K062335).

DEVICE DESCRIPTION B.

C. INTENDED USE

Agfa's DX-D 300 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis.

Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.

Agfa's DX-D 300 is not indicated for use in mammography.

SUBSTANTIAL EQUIVALENCE SUMMARY D.

Agfa's DX-D 300 has an Indications For Use statement nearly identical to the statements for the two predicate devices (Agfa DX-D Imaging Package and the Sedecal X Plus LP Plus). Intended uses are the same. The devices have the same technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence.

Differences in devices do not alter the intended therapeutic/diagnostic effect.

: : ::

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PRODUCT COMPARISON TABLE
	AGFA DX-D 300(NEW DEVICE)	AGFA DX-D ImagingPackage (PREDICATE-K092669)	Sedecal X-Plus LP Plus(PREDICATE-K062335)
Communications	Same as predicate	DICOM	N/A
Detector Material	Same as predicate	Gadolinium Oxysulfide(GOS) or Cesium Iodide(CSI) scintillator	N/A
Detector Sizes	Same as predicate	14x17 in. & 17x17 in	N/A
Active Matrix	Same as predicate	3056x3056 (17x17 in.)3072x2560 (17x14 in.)	N/A
Pixel size	Same as predicate	139 µm	N/A
Fill factor	Same as predicate	100%	N/A
Dynamic Range	Same as predicate	14 bit DR, 12 bit CR	N/A
Maximum ImageAcquisitions/hr.	Same as predicate	150	N/A
Image processing	Same as predicate	MUSICA2	N/A
Operating system	Same as predicate	Windows XP Pro	N/A
Display System	Same as predicate	Standard PC display orseparately cleared medicaldisplay (e.g. K051901)	N/A
OperatorWorkstation	Agfa NX with SoftConsole Software	Agfa NX	N/A
Power Supply	Same as predicate	47-63 Hz90-264V auto ranging	U Arm - Single phase,50/60 Hz 230/240v ±10%
Electrical Safety	Same as predicate	IEC-60601	IEC-60601
PerformanceStandard	Same as predicate	N/A	21CFR1020.30
Generators	Same as predicate	N/A	Choice of four models, 50-80 KW 400-480v AC, 3phase, 50/60 Hz
Tubes	Same as predicate	N/A	Choice of three Toshibamodels: E7254FX,E7869X and E7884X.Automatic or manualcollimation, integratedDose Area Product (DAP)meter and automaticexposure control.

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TECHNOLOGICAL CHARACTERISTICS E.

Agfa's DX-D 300 includes both a traditional U-Arm x-ray system for patient exposure and digital image capture equipment.

F. TESTING

The new device combines proven technology from both predicates which have been combined to create the new device. The new device includes minor modifications that have been fully tested.

The device has been tested and shown to conform to electronic medical product safety, radiology, and medical imaging standards including:

PRODUCT STANDARDS

IEC 60601-1-1: Medical electrical equipment Part 1: General requirements for basic safety and essential . performance, plus collateral standard: Electromagnetic compatibility - requirements and tests.
IEC 60601-1-2: Medical electrical equipment Part 1-2: General Requirements For Safety Collateral . Standard: Electromagnetic Compatibility - Requirements And Tests
ACR/NEMA PS3.1-3.18: Digital Imaging and Communications in Medicine (DICOM) .
IEC 60601-1-3: Medical electrical equipment Part 1: General requirements for safety 3. Collateral standard: � General requirements for radiation protection in diagnostic X-ray equipment
. IEC 60601-1-4 Programmable Electrical Medical Systems
IEC 60601-2-7 (1998-02) Medical electrical equipment Part 2-7: Particular requirements for the safety of . high-voltage generators of diagnostic X-ray generators
IEC 60601-2-28 Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies t for medical diagnosis
IEC 60601-2-32 Particular Requirements For The Safety Of Associated Equipment Of X-Ray Equipment .

MANAGEMENT STANDARDS

ISO 14971 Application of Risk Management to Medical Devices .
ISO 13485 Medical Devices Quality Management Systems Requirements For Regulatory purposes .

Performance of the complete system has been validated. Sample images have been provided.

No clinical testing was performed in the development of the DX-D 300.

G. CONCLUSIONS

This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

ﺎﺕ : :

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, abstract design. The bird appears to be in flight or soaring, and it is positioned above three wavy lines, which may represent water or movement.

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

Agfa HealthCare N.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K103050

Trade/Device Name: DX-D 300 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 14, 2010 Received: October 15, 2010

0CT 2 9 2010

Dear Mr. Job:

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. Iisting 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.

Dan

David G. Brown, Ph.D. 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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Indications for Use Form

OCT 2 9 2010

KI03050 510(k) Number (if known):

Device Name: DX-D 300

Indications for Use:

Agfa's DX-D 300 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis.

Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.

Agfa's DX-D 300 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) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103050

Page 1 of _

Page 29

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.