The Definium™ 5000 X-Ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Device Description

The Definium 5000 Digital Radiographic Imaging System provides state of the art image quality, image manipulation, operator control, dose reporting and system maintenance. These features make this system easy to use and reliable while providing high quality radiographic images in a digital environment. The Definium 5000 System is designed to handle radiographic applications using the digital table. The system configuration includes an elevating or non-clevating table, a floor column stand with rotating U-arm, and GE's patented Digital Detector that captures radiographic images in digital form, as well as an X-ray generator/power unit. An Acquisition and Review Workstation for image post-processing, short-term storage, and quick in-room viewing of images is included as part of the system. Images may be transferred manually or automatically via a DICOM network for printing, longterm storage archive, and detailed review.

AI/ML Overview

The provided text is a 510(k) summary for the Definium™ 5000 X-Ray System (K063283). This document aims to demonstrate substantial equivalence to previously cleared devices rather than providing a detailed study proving performance against acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert qualifications are not present in the provided text. The document focuses on comparing the new device's characteristics to its predicate devices to establish substantial equivalence.

Here's an attempt to answer the questions based only on the provided information:

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

The provided document does not explicitly state quantitative acceptance criteria for image quality or clinical performance as it would in a de novo submission or a detailed clinical study report. Instead, it attests to "state of the art image quality" and that "the new device is as safe and effective as the predicate devices" based on "bench, user, and standards testing."

The "Substantial Equivalence Chart" compares technical characteristics rather than performance metrics against acceptance criteria.

Characteristic	Acceptance Criteria (Not explicitly defined, but inferred as "equivalent to predicate")	Reported Device Performance (as presented in the "This Submission" column)
Intended Use	General purpose diagnostic X-ray unit	SAME (General purpose diagnostic X-ray unit)
Image Acquisition	Digital: CANON CXDI-50G, K031447 (from predicate K042876)	Digital: GE Tethered Portable Digital Radiographic Detector K041922
Digital Panel Size	Up to 14" x 17" active area (from predicate K042876)	16" x 16" active area
Digital Resolution	160 x 160 microns pixel pitch, with approximately 6 million pixels (from predicate K042876)	200 x 200 micron pixel pitch, approximately 4 million pixels
Maximum Output	Depends on model of generator (from predicate K042876)	64 Kw model only
User Interface	Depends on Control Console option (from predicate K042876)	Software Driven Touch Panel LCD, + remote control unit + remote console
Method of Control	Dedicated push button controls (from predicate K042876)	Software Driven Touch Panel LCD, + IR remote control unit and control room interface box
Collimator	Manual R302/A (from predicate K042876)	Automatic Collimator Hewitt 150

Note: The differences in "Digital Panel Size" and "Digital Resolution" are noted in the submission but are deemed not to raise new questions of safety or effectiveness, as the overall system is considered substantially equivalent. The performance "criteria" are implicitly met if the device is deemed substantially equivalent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench, user, and standards testing" but does not provide any details on sample sizes, whether the data was retrospective or prospective, or the country of origin.

3. 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)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

This device is an X-ray system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed. The document is about the physical X-ray system.

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

This refers to an AI algorithm's performance. As the device is an X-ray system and not an AI algorithm, this type of standalone performance study is not applicable and was not performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document refers to "bench, user, and standards testing" leading to a conclusion of safety and effectiveness, but it does not specify the type of ground truth used. For an X-ray system, ground truth for image quality might involve physical phantoms, dose measurements, or qualitative expert assessment of image clarity, but these details are not provided.

8. The sample size for the training set

This refers to AI algorithm training. As the device is an X-ray system and not an AI algorithm, a "training set" as commonly referred to in AI/ML is not applicable.

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

Not applicable, as this is not an AI/ML device.

Summary

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K063283

EXHIBIT 2 510(k) Summarv

NOW 1 7 2006

SEDECAL SA
Pelaya 9- Poligono Industrial Rio De
Janeiro 28110-Algete Madrid Spain
Tel (34) 91-628 0544/91-628 1592
Fax (34) 91-628 0574
(Foreign Manufacturer)

GE Medical Systems, LLC 3200 N. Grandview Blvd. Waukesha, WI 53188 Phone: 262-544-3012 Fax: 262-544-3863 (Digital Panel Manufacturer Contact: Ms. Martha Kamrow

September 18, 2006

1. Identification of the Device: Proprietary-Trade Name: Definium™ 5000 X-Ray System Classification Name: Stationary X-ray system, Product Codes Product Code 90 KPR and MOB Common/Usual Name: Gencral purpose diagnostic X-ray Unit.
1. Equivalent legally marketed devices: This notification is for a MODIFIED device COMBINES two 510(k) cleared devices, the SEDECAL X PIJJS LP PLUS Universal Radiographic Systems K062335 AND the GE Medical Systems Digital Radiographic Detector, K041922. This combination is functionally identical to a SEDECA1. cleared device, Sedccal URS LP X-Ray Units with Digital Detector, K042876.
1. Indications for Use (intended usc) The Definium™ 5000 X-Ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
1. Description of the Device: The Definium 5000 Digital Radiographic Imaging System provides state of the art image quality, image manipulation, operator control, dose reporting and system maintenance. These features make this system easy to use and reliable while providing high quality radiographic images in a digital environment. The Definium 5000 System is designed to handle radiographic applications using the digital table. The system configuration includes an elevating or non-clevating table, a floor column stand with rotating U-arm, and GE's patented Digital Detector that captures radiographic images in digital form, as well as an X-ray generator/power unit. An Acquisition and Review Workstation for image post-processing, short-term storage, and quick in-room viewing of images is included as part of the system. Images may be transferred manually or automatically via a DICOM network for printing, longterm storage archive, and detailed review.
1. Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.

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1. Substantial Equivalence Chart, The Definium™ 5000 X-Ray

Characteristic	Sedecal URS X-Ray Units withDigital DetectorK042876	SEDECAL XPLUS LP PLUSUniversalRadiographicSystems K062335	Definium™ 5000(This Submission):Combines twocleared devices:K062335 ANDK041922
Intended Use:	General purposediagnostic X-ray unit	SAME	SAME
User Interface	Depends on ControlConsole optionchosen. Mainlydedicated touchcontrols	Software DrivenTouch Panel LCD, +IR remote control unit	Software DrivenTouch Panel LCD. +remote control unit +remote console
Maximum output	Depends on model ofgenerator chosen.Models available from30 kW 10 64 kW	SAME as originalunits.	64 Kw model only.
Image Acquisition	Digital: CANONCXDI-50G.K031447	Film	Digital: GE TetheredPortable DigitalRadiographic DetectorK041922
Digital Panel Size	Up to 14" x 17" activearea	N/A	16" x 16" active area
Digital Resolution	160 x 160 micronspixel pitch, withapproximately 6million pixels	N/A	200 x 200 micronpixel pitch,approximately 4million pixels.
Method of Control	Dedicated push buttonControls	Software DrivenTouch Panel LCD.+IR remote controlunit	Software DrivenTouch Panel LCD.+IR remote controlunit and control roominterface box.
Collimator	Manual R302/A	Manual R302/A andAutomatic available	Automatic CollimatorHewitt 150

7. Conclusion

After analyzing bench, user, and standards testing data, it is the conclusion of Scdccal that the Definium™ 5000 Radiographic System with Digital Detector is as safe and effective as the procate devices, have few technological differences, and have no new indications for use, thus rendering then substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image contains a circular logo on the left and some text on the right. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around a symbol that resembles an abstract eagle or bird. The text on the right is not clear enough to read.

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

SEDECAL SA % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

AUG 23 2013

Re: K063283

Trade/Device Name: Definium™ 5000 X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB and KPR Dated: October 30, 2006 Received: October 30, 2006

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of November 17, 2006.

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,

Janine M. Morris

Janine M. Morr 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

510(k) Number (if known): _ | 0632 8 3

Device Name: Definium™ 5000 X-Ray System

Indications For Use:

Indications for Use: The Definium™ 5000 X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic rapisures of the skull, spinal column, chest, abdomen, cxtremities, and other hody parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 Clik 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Maureen C. Brandon
Page 1 of 1

(Division Sign-Off)0.
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K062883

Page 8 of 504

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.