Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be used.

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

Device Description

The device is a direct radiography imaging system of similar design and construction to the predicate. Agfa's DX-D Imaging Package uses the company's familiar NX workstation with MUSICA2 TM image processing and flat panel detectors of the scintillator-photodetector type. Flat panel detectors with scintillators of both Cesium lodide (Csl) and Gadolinium Oxysulfide (GOS) are available. The device is used to capture and directly digitize x-ray images without a separate digitizer common to computed radiography systems. This new version uses a previously cleared detector with wireless communication capability.

The device uses a direct conversion process to convert x-rays into a digital signal. X-rays incident on the scintillator layer of the detector generate light that is absorbed by photo-detectors, converted to a digital signal and sent to the workstation the data is processed by Agfa's MUSICA image processing software. The acronym MUSICA stands for Multi-Stage-Image-Contrast-Amplification. MUSICA-acts on the acquired images to preferentially enhance the diagnostically relevant, moderate and subtle contrasts.

AI/ML Overview

The provided 510(k) summary does not contain specific acceptance criteria for device performance, nor does it detail a study proving the device meets particular quantitative metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not specify quantitative acceptance criteria or performance metrics in the way your request implies (e.g., sensitivity, specificity, accuracy). The evaluation is based on comparison to a predicate device and adherence to industry standards for safety and image quality.

Acceptance Criteria	Reported Device Performance	Comments
Substantial Equivalence (General)	"Descriptive characteristics and performance data are adequate to ensure equivalence."	The primary 'acceptance criterion' is demonstrating equivalence to the predicate device (K092669) in terms of intended use, technological characteristics, and safety.
Image Quality	"Image quality measurements have been completed. Image quality comparisons between the new and predicate devices have been performed as well. Sample images have been provided."	No specific quantitative metrics (e.g., CNR, MTF, DQE) are provided in this summary, but the general statement indicates evaluation was done.
System Performance Validation	"Performance of the complete system has been validated."	Broad statement indicating functional validation, but no specific performance targets are given.
Conformance to Product Standards	Conforms to IEC 60601-1, IEC 60601-1-2, ACR/NEMA PS3.1-3.18 (DICOM).	Device adheres to relevant industry standards for medical electrical equipment safety, EMC, and digital imaging communication.
Conformance to Management Standards	Conforms to ISO 14971, ISO 13485.	Device development and manufacturing processes conform to risk management and quality management system standards.

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

Sample Size: Not specified. The document mentions "Image quality measurements have been completed" and "Image quality comparisons between the new and predicate devices have been performed as well. Sample images have been provided." This implies a set of images was used for comparison, but the size is not disclosed.
Data Provenance: Not specified. Given the nature of a 510(k) demonstrating substantial equivalence for an imaging system, these would likely be technical image quality test images (e.g., phantoms) rather than clinical patient data. The summary states, "No clinical testing was performed in the development of the DX-D Imaging Package."

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

This information is not provided in the 510(k) summary. Since "No clinical testing was performed," it is unlikely that human experts were involved in establishing ground truth for a clinical test set from patient data. The "ground truth" for technical image quality assessments would be derived from the known properties of the phantoms used and objective image quality metrics.

4. Adjudication Method for the Test Set

This information is not provided. Given the lack of clinical testing and expert involvement, an adjudication method for a clinical test set is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed in the development of the DX-D Imaging Package." Therefore, no effect size of AI assistance could be reported.

6. If a Standalone (algorithm only without human-in-the-loop performance) Study was Done

The device is an imaging system (hardware and software for image acquisition and processing), not an AI algorithm intended for diagnostic interpretation. Therefore, a "standalone algorithm only" performance study in the context of interpretation accuracy (e.g., sensitivity/specificity for disease detection) is not applicable as it's outside the scope of this device's intended use or claim. The "performance" assessment focuses on image quality and system functionality.

7. The Type of Ground Truth Used

Based on "No clinical testing was performed," the ground truth for any image quality measurements would likely be based on physical phantom measurements and objective image quality metrics (e.g., spatial resolution, contrast-to-noise ratio, modulation transfer function, detective quantum efficiency) rather than expert consensus, pathology, or outcomes data from human subjects.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is an X-ray imaging system with image processing (MUSICA2). While MUSICA2 is an image processing algorithm, the document describes it as enhancing contrast rather than performing diagnostic interpretation based on a trained model in the current AI sense. There is no mention of a "training set" for a machine learning model. The focus is on the physics of image acquisition and standard image processing.

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

This information is not applicable/not provided for the same reasons as #8. If MUSICA2 involves learned parameters, their derivation is not disclosed, but it's unlikely to involve a "ground truth" in the diagnostic context.

Summary

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(12) 095

AUG 1 6 2012

5.510(K) Summary

510(K) SUMMARY: AGFA DX-D Imaging Package

Regulation Name: Image Intensified fluoroscopic x-ray system (21 CFR 892.1650) Classification Name: Solid state x-ray imager (flat panel/digital imager) (product code MQB) Common Name: Direct radiography system Proprietary Name: DX-D Imaging Package Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Phil Cuscuna. Prepared: January 15, 2012 Telephone: (416) 240-7317 Facsimile: (416) 240-7359

LEGALLY MARKETED PREDICATE DEVICES A.

This is a 510(k) for the latest version of Agfa's DX-D Imaging Package, a solid state, flat-panel x-ray imaging system.

B. DEVICE DESCRIPTION

Principles of operation and technological characteristics of the new and predicate devices are the same.

ﺰ INTENDED USE

Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The

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DX-D Imaging Package may be used wherever conventional screen-film systems may be used.

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

SUBSTANTIAL EQUIVALENCE SUMMARY D.

Agfa's DX-D Imaging Package has an Indications For Use statement similar to the statements for the predicate device, K092669. Intended uses are the same. The devices have the same technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence.

The device does not have therapeutic effects. Differences in new device and the predicate do not alter the intended diagnostic effect.

PRODUCT COMPARISON TABLE
	DX-D Imaging Package(New Device)	AGFA DX-D Imaging Package(PREDICATE-K092669)
Communications	DICOM	DICOM
Flat PanelManufacturer	Varian Medical Systems (wired detectors)Canon (wireless detector)	Varian Medical Systems
Detector Material	Varian: Gadolinium Oxysulfide (GOS), orVarian & Canon: Cesium Iodide (CSI)	Gadolinium Oxysulfide (GOS) orCesium Iodide (CSI) scintillator
Detector Sizes	17x17 in.14x17 in.	17x17 in.14x17 in.
Active Matrix(14x17 in.)	2560x3072 (Varian)2800x3408 (Canon)	2560x3072
Pixel size	139 um (Varian), or125 um (Canon)	139 um
Dynamic Range	14 bit	14 bit
Maximum ImageAcquisitions/hr.	150	1 20
Power Supply	47-63 Hz90-264V auto ranging	47-63 Hz90-264V auto ranging
OperatorWorkstation	Agfa NX	Agfa NX
Image processing	MUSICA2	MUSICA-
Operating system	Windows 7	Windows XP Pro
Display System	Standard PC display or separately clearedmedical display (e.g. K051901)	Standard PC display or separatelycleared medical display (e.g. K051901)

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TECHNOLOGICAL CHARACTERISTICS E.

Agfa's DX-D Imaging Package is a scintillator-photodetector type solid state x-ray imaging system. The device provides the user with a choice of three wired or wireless flat panel detectors to capture and digitized the image. A computer workstation allows users view and process images, and forward them to other devices (e.g. a PACS or printer).

The DX-D Imaging Package is integrated with compatible x-ray systems.

TESTING F.

Image quality measurements have been completed. Image quality comparisons between the new and predicate devices have been performed as well. Sample images have been provided.

Performance of the complete system has been validated.

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

The product, manufacturing and development processes have been shown to conform to product safety, radiology, and imaging standards including:

PRODUCT STANDARDS

IEC 60601-1: 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) .

MANAGEMENT STANDARDS

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

CONCLUSIONS G.

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.

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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 an abstract symbol resembling an eagle or bird-like figure with three stylized wing or feather shapes.

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

AUG 16 2012

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

Re: K121095

Trade/Device Name: DX-D Imaging Package . Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: April 24, 2012 Received: April 25, 2012

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becally of 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 coninered phor to 112) 20, 2017 11:11 accordance with the provisions of the Federal Food, DNIg, devices that have occh recuired in accee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, thanks 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 If your device is classified (boo aco regulations affecting your device can be found in Title 21, additional controls. Existing mayor regulation, 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 Ficase oe advised that I Dri 3 issuated CP a sevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that I DA has made a determination administered by other Federal agencies. You must of ally Federal Statutes and regulations and 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 Incuration as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter requirents as as set forth in the quality of wice as described in your Section 510(k) premarket wilf anow you to oogin finding of substantial equivalence of your device to a legally marketed nothleation. The FDT imanig of baseian 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 II you desire specific acritor for your con Diagnostic Device Evaluation and Safety at (301) 796-007), produce venuev are the regulation entitled, "Misbranding by reference to premarket 5456. Thise, promotions and 107.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDA regulation (21 CFFF at 003), promo goblem/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 Tour may other other general encreational 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

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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510(k) Number (if known):

Device Name: DX-D Imaging Package

Indications for Use:

Agfa's DX-D Imaging Package 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)

Michael D'Amico

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

510(k) K121095

Page 1 of

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.