The DDR Digital 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 DDR MAK-800 is the digital panel available alone for upgrading current systems. The DDR MAK-1000 FS is a complete system with a straight tube stand/detector combination. The DDR MAK-1100FA is a complete system with a "C-arm" shaped tube stand/detector combination which permits lateral positioning. These systems have been designed as a direct digital imaging system for use in hospital emergency rooms, imaging centers and all general radiology applications. The C-arm design maintains constant alignment between the x-ray tube and image receptor, regardless of C-arm tilt positions or image receptor angle. Its extraordinary flexibility makes the system ideal for all patients in standing, sitting or laying position, including those who are disabled or physically restricted. The DDR MAK-1100 digital flat panel detector provides advanced technology to capture radiographic images in a digital format almost instantly. The nearly 17 x 17 inch imaging area allows for the capture of chest and abdominal images without having to rotate the detector unit.

AI/ML Overview

The provided text describes a 510(k) submission for a new X-ray system (DDR MAK-800, MAK-1000 FS, and MAK-1100 FA) that combines two previously cleared devices. The submission asserts "substantial equivalence" to predicate devices, focusing on the system's technical specifications and intended use rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a clinical or analytical performance study.

Therefore, many of the requested sections regarding acceptance criteria, specific performance metrics, sample sizes, expert ground truth, adjudication methods, and MRMC studies are not explicitly addressed or applicable in the provided document, as the FDA cleared the device based on substantial equivalence, which primarily relies on technical comparison to predicate devices, and bench, user, and standards testing.

Here's a breakdown of the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as quantitative thresholds for performance metrics. Instead, the acceptance criterion for the submission appears to be demonstrating substantial equivalence to predicate devices in terms of technical characteristics and safety/effectiveness. The "reported device performance" is essentially a comparison of its technical specifications to those of the predicate devices.

Characteristic	Predicate Devices (K042876 & K062335)	DDR MAK-800/1000 FS/1100 FA (This Submission)	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	General purpose diagnostic X-ray unit	SAME	Same intended use as predicate devices	General purpose diagnostic X-ray unit for skull, spine, chest, abdomen, extremities, and other body parts; adult and pediatric.
Image Acquisition	Digital (CANON CXDI-50G, K031447) OR Film	Digital (DRTech Portable Digital Radiographic Detector, K080064)	Digital acquisition equivalent to or better than predicate	Digital acquisition using DRTech Portable Digital Radiographic Detector K080064.
Digital Panel Size	Up to 14" x 17" active area (for digital predicate)	17" x 17" or 14" x 17"	Panel size comparable or larger than predicate	Larger option (17"x17") available, allowing capture of chest and abdominal images without rotating.
Digital Resolution	160 x 160 microns pixel pitch, with approximately 6 million pixels (for digital predicate)	139 x 139 OR 160 x 160 micron pixel pitch, either 6.8 or 7.8 million pixels.	Resolution comparable or better than predicate	Improved resolution (139x139 micron pixel pitch) and higher pixel count (6.8 or 7.8 million pixels) available.
Safety & Effectiveness	As safe and effective as other marketed devices	As safe and effective as predicate devices (based on bench, user, and standards testing)	Demonstrates equivalent safety and effectiveness to predicate	Bench, user, and standards testing indicates the new device is as safe and effective as predicate devices.
Technological Differences	None or minor, not raising new safety/effectiveness questions	Few technological differences, no new indications for use	No significant technological differences that raise new safety/effectiveness questions	System combines two cleared devices (K062335 and K080064), resulting in functionally identical performance to K042876.

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

The document does not specify a "test set" in the context of a performance study with a defined sample size for image analysis or clinical outcomes. The evaluation was based on bench, user, and standards testing, which typically involves testing the physical device, its components, and its adherence to relevant technical standards (e.g., electrical safety, radiation output). Details on the number of units tested, the specific tests performed, or the number of "users" in user testing are not provided.

The data provenance is not specified in terms of country of origin or retrospective/prospective nature, as it's not a clinical study yielding patient data. It's focused on engineering and regulatory compliance testing.

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

This information is not applicable and not provided. The evaluation was not based on expert-adjudicated ground truth image sets for diagnostic accuracy.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided, as there was no test set requiring expert adjudication for ground truth.

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

An MRMC comparative effectiveness study was not done. This device is a general-purpose diagnostic X-ray unit, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is an X-ray imaging system, not an AI algorithm. Its performance is tied to image acquisition, not interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically used in diagnostic algorithm evaluation is not applicable here. The ground truth for this submission was the demonstration of the device's technical specifications, safety, and effectiveness through engineering tests and comparison to already-cleared predicate devices and applicable industry standards.

8. The Sample Size for the Training Set

This is not applicable. The device is a hardware system, not a machine learning model, so there is no "training set."

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

This is not applicable, as there is no training set.

Summary of the Study and Conclusion:

The "study" in this context refers to the comprehensive evaluation performed by Medicatech USA to demonstrate substantial equivalence for the 510(k) submission. This evaluation included:

Bench Testing: Engineering tests to verify technical specifications, safety, and performance of the hardware components.
User Testing: Likely to ensure the system's usability and interface design met expectations for operators.
Standards Testing: Verification that the device complies with relevant medical device standards (e.g., electrical safety, radiation emission).
Comparison to Predicate Devices: A detailed comparison of the new device's technical characteristics (intended use, user interface, maximum output, image acquisition method, digital panel size, digital resolution, method of control, collimator) against two existing legally marketed devices (SEDECAL X PLUS LP PLUS Universal Radiographic Systems K062335 and a version of the DRtech Digital Panel, K080064, which combined functionally result in a device equivalent to Sedecal URS LP X-Ray Units with Digital Detector, K.042876).

The conclusion of this "study" was that the DDR MAK-800/1000 FS/1100 FA Radiographic Systems with Digital Detectors are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent. The FDA concurred with this assessment.

Summary

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KO80582

EXHIBIT 2 510(k) Summary K08 MedicaTech USA 50 Maxwell Irvine , CA , 92618 Toll Free : +1 800 817 5030 Phone : +1 949 679 2881 : +1 949 679 2882 FAX February 25, 2008 Contact: Ashraf Stefan . CEO

MAY 15 2008

1. Identification of the Device: Proprietary-Trade Name: DDR MAK-800; the Model # DDR MAK-1000 FS, and the Model DDR MAK-1100 FA Classification Name: Stationary X-ray system, Product Codes Product Code 90 KPR and MQB Common/Usual Name: General purpose diagnostic X-ray Unit.
1. Equivalent legally marketed devices: This notification is for a MODIFIED device. This device COMBINES two 510(k) cleared devices, the SEDECAL X PLUS LP PLUS Universal Radiographic Systems K062335 AND a version of the DRtech Digital Panel, K080064. This combination is functionally identical to a SEDECAL cleared device, Sedecal URS LP X-Ray Units with Digital Detector, K.042876..
1. Indications for Use (intended use) DDR Digital 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 Devices: The DDR MAK-800 is the digital panel available alone for upgrading current systems. The DDR MAK-1000 FS is a complete system with a straight tube stand/detector combination. The DDR MAK-1100FA is a complete system with a "C-arm" shaped tube stand/detector combination which permits lateral positioning. These systems have been designed as a direct digital imaging system for use in hospital emergency rooms, imaging centers and all general radiology applications. The C-arm design maintains constant alignment between the x-ray tube and image receptor, regardless of C-arm tilt positions or image receptor angle. Its extraordinary flexibility makes the system ideal for all patients in standing, sitting or laying position, including those who are disabled or physically restricted. The DDR MAK-1100 digital flat panel detector provides advanced technology to capture radiographic images in a digital format almost instantly. The nearly 17 x 17 inch imaging area allows for the capture of chest and abdominal images without having to rotate the detector unit.
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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6. Substantial Equivalence Chart

Characteristic	Sedecal URS X-Ray Units withDigital DetectorK042876	SEDECAL XPLUS LP PLUSUniversalRadiographicSystems K062335	DDR MAK-800;the Model # DDRMAK-1000 FS, andthe Model DDRMAK-1100 FA(This Submission):Combines twocleared devices:K062335 ANDK080064
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 to 64 kW	SAME as originalunits.	SAME
Image Acquisition	Digital: CANONCXDI-50G.K031447	Film	Digital: DRTechPortable DigitalRadiographic DetectorK080064
Digital Panel Size	Up to 14" x 17" activearea	N/A	17" x 17" or 14" x17"
Digital Resolution	160 x 160 micronspixel pitch, withapproximately 6million pixels	N/A	139 x 139 OR 160 x160 micron pixelpitch, either 6.8 or 7.8million 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	SAME

7. Conclusion

After analyzing bench, user, and standards testing data, it is the conclusion of Medicatech USA that the DDR MAK-800; the Model # DDR MAK-1000 FS, and the Model DDR MAK-1100 FA Radiographic Systems with Digital Detectors are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them 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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medicatech USA % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015

MAY 15 2008

Re: K080582

Trade/Device Name: Models # DDR MAK-800, DDR MAK-1000 FS, and DDR MAK-1100 FA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: February 27, 2008 Received: March 27, 2008

Dear Mr. Kamm:

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 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.

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Page 2

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.

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 Iogal] 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this lettoo.

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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/1276-3474. For questions regarding the reporting of device adverse events (Medical Device Leportion (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html

Sincerely yours,

Nancy 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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Indications for Use

510(k) Number (if known):
K080582

Device Name: Model # DDR MAK-800; the Model # DDR MAK-1000 FS, and the Model DDR MAK-1100 FA.

Indications For Use:

Indications for Use: The DDR Digital 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.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Hogue Martinez

(Division Sian-C Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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.