The KrystalRAD (ATAL8) Digital X-Ray System is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).

Device Description

The KrystalRAD (ATAL8) System is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The KrystalRAD (ATAL8) device differs from traditional Xray systems in that, instead of exposing a film and chemically processing it to create a hard convenial 71 a device called a Detector Panel is used to capture the image in electronic form.

Once the system captures a radiographic image and subsequently displaying and storing an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a work station.

Hardcopy images can also be made from digital printers, optimizing for the user's preference. The system can have DICOM-compliant output to ensure compatibility with existing imaging network infrastructure.

AI/ML Overview

The provided text describes the KrystalRAD (ATAL8) System, a flat-panel digital X-ray detector, and its 510(k) submission (K102285) for market clearance. The submission relies on demonstrating substantial equivalence to a predicate device, the DRTech FLAATZ 750 (K080064). The acceptance criteria and supporting study are primarily focused on this comparison and general safety/effectiveness rather than a detailed clinical performance study with specific acceptance criteria for a diagnostic task.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly or explicitly based on comparing the KrystalRAD (ATAL8) System's technical specifications and performance metrics directly against its predicate device, the DRTech FLAATZ 750 (K080064). The goal is to demonstrate "substantial equivalence," meaning that the new device is as safe and effective as the legally marketed predicate.

Metric / Characteristic	Acceptance Criteria (from predicate K080064)	Reported Device Performance (KrystalRAD (ATAL8) System)
Indication for Use	General radiographic images of human anatomy; replaces film/screen in general diagnostic procedures (excluding fluoroscopic, angiographic, mammographic)	Same as predicate.
User Interface	Software Driven Touch Panel LCD + remote control unit + remote console	Same as predicate.
Software	ECOM OmniVue	OmniVision
Panel Shape	Square	Square Panel
Detector Size	42.9 x 42.9 cm	43 x 43 cm
Dimensions (W x L x H)	482 x 482 x 35 mm	500 x 500 x 40 mm
Pixel Pitch	168 µm	143 µm
Image Size	3072 x 3072 pixels	3072 x 3072 pixels
Selenium Thickness	500 µm	no selenium
Weight (Detector)	6.2 kg	12.7 kg
Materials	Amorphous Selenium (a-Se) Detector	Amorphous Silicon (a-Si)
DQE	48.5% @ 0.5 lp/mm	68% @ 0.5 lp/mm
MTF	78% @ 3.5 lp/mm	52.5% @ 3.5 lp/mm
Resolution	3.6 lp/mm	3.5 lp/mm
Ghosting	<1% @ RQA5 Condition	<1% @ RA5 condition
Anatomical Sites	General Radiography	General Radiography
Power Requirement	100~~240V~~, 50/60 Hz, Max 2A, Single Phase	90V - 260V, 47/63 Hz, 3.15A, Single Phase

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as a combination of bench testing, electrical safety testing, and performance testing against established standards and direct comparison to the predicate device's specifications. The document states:

"Bench testing and electrical safety further substantiate equivalence to the predicate."
"Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/EC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-23 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2202. All test results were satisfactory."
The "Substantial Equivalence Table" explicitly lists the performance metrics of the KrystalRAD (ATAL8) against the predicate, indicating that these measurements were taken for the new device.

The "Conclusion" states: "The results of all testing demonstrate that the KrystalRAD (ATAL8) does not raise any new significant issues of safety, effectiveness or performance of the device when compare to the existing predicate devices." This confirms that the device was deemed to meet the "acceptance criteria" of being substantially equivalent to the predicate.

2. Sample Size for the Test Set and Data Provenance

The document does not detail a specific "test set" in the context of clinical images or patient data for evaluating diagnostic performance. The evaluation is primarily technical and comparative against a predicate device. The "performance testing" mentioned refers to engineering and physics measurements like DQE, MTF, resolution, and ghosting, which are conducted in a lab setting, not typically on patient images from a specific provenance.

Therefore, this information is not provided in the given text.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the submission is for substantial equivalence of a general X-ray system based on technical and safety specifications, not a diagnostic AI algorithm that requires expert-established ground truth for clinical performance evaluation on a test set.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

This information is not applicable. The KrystalRAD (ATAL8) System is a digital X-ray detector, not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or described.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The device is an X-ray imaging system, not a standalone diagnostic algorithm. Its performance is evaluated based on image quality metrics and safety standards, as detailed in the substantial equivalence comparison.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the established technical specifications and performance characteristics of the predicate device, and the general safety and electrical standards (EN/IEC 60601 series). The KrystalRAD (ATAL8) System's performance was measured against these engineering and physics-based "truths."

There is no mention of clinical ground truth like pathology, expert consensus on disease, or outcomes data, as this is not a diagnostic AI device requiring such validation for a specific clinical task.

8. Sample Size for the Training Set

This information is not applicable. The KrystalRAD (ATAL8) System is not an AI algorithm that undergoes "training" on a dataset. It is a hardware device (digital X-ray detector) with associated software for image control and management.

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

This information is not applicable for the same reasons as point 8.

Summary

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510(k) Summary K102285

This 510k summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Initial Importer/Distributor	MedicaTechUSA
Address:	50 MaxwellIrvine, CA 92618
Phone number:	(800) 817-5030
Fax number:	(949) 679-2882
	JAN - 3
Contact Person	George Makar
Email:	george@medicatechusa.com
Phone:	(800) 817-5030
Cell:	(949) 929-5910
Fax:	(949) 679-2882
Manufacturer	Atlaim1018/19 Sicox Tower SangdaewonSeongnam Gyeonggi462-120, Republic of KoreaTel #: +82 70 7997 2900Fax #: +82 31 749 0777
Device Name and Classification
Trade name/Product Name:	KrystalRAD (ATAL8) System
Classification name:	Stationary X-ray System
Common name:	General purpose diagnostic X-ray System
Classification Panel:	Radiology
Product Code:	MQB
Regulation Number:	892.1680
Date Prepared	December 15, 2010
Substantial Equivalence claimed to:	DRTech FLAATZ 750 (K080064)

Device Description

The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network. 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 11 : 33m .

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2010

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Indications for Use

Substantial Equivalence

The KrystalRAD (ATAL 8) is substantially equivalent to the commercially available DRTech FLAATZ 750 system cleared on January 23, 2010 via 510k K080064. Bench testing and electrical safety further substantiate equivalence to the predicate. The KrystalRAD (ATAL 8) utilizes OmniVision Software while the DRTech FLAATZ 750 system utilizes the proprietary ECOM OmniVue software to control the system and manage digital images collected.

510(k) Number		DRTech Corporation(K080064)	KrystalRAD (ATAL8)
	Indication for Use	The FLAATZ 750 is indicated foruse in general radiographic imagesof human anatomy. It is intendedto replace radiographic film/screensystems in all general-purposediagnostic procedures (excludingfluoroscopic, angiographic, andmammographic applications).	Same as predicate.
	User Interface	Software DrivenTouch Panel LCD +remote control unit +remote console	Same as predicate.
	Software	ECOM OmniVue	OmniVision
Design	Panel Shape	Square	Square Panel
	Detector Size	42.9 x 42.9 (cm)	43 x 43 cm
	Dimensions(W x L x H)	482 x 482 x 35 (mm)	500 X 500 X 40mm
	Pixel Pitch	168 (um)	143 um
	Image Size	3072 x 3072 (pixels)	3072 x 3072 pixel
	Selenium Thickness	500 (µm)	no selenium
	Weight (Detector)	6.2 (kg)	12.7 kg
Materials		Amorphous Selenium(a-Se) Detector	Amorphous Silicon (a-Si)
Performance	DQE	48.5% @ 0.5 lp/mm	68%@ .5 lp/mm

+ 1 . 1411 Substantial Equivalence Table

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510(k) Number	DRTech Corporation(K080064)		KrystalRAD (ATAL8)
	MTF	78% @ 3.5 lp/mm	525 @ 3.5 lp/mm
	Resolution	3.6 lp/mm	3.5 lp/mm
	Ghosting	<1% @ RQA5 Condition	<1% @ RA5 condition
Anatomical Sites		General Radiography	General Radiography
Energy Used and/or Delivered	The Control Box has the followingPower Requirement:100~~240V~~, 50/60 Hz, Max 2A,Single Phase		The Control Box has the followingPower Requirement:90V - 260V, 47/63 Hz, 3.15A,Single Phase

General Safety and Effectiveness Concerns

Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/EC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-23 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-12202 All test results were satisfactory. 学大利:"%。

Conclusion

The results of all testing demonstrate that the KrystalRAD (ATAL8) does not raise any new significant issues of safety, effectiveness or performance of the device when compare to the existing predicate devices.

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Image /page/3/Picture/0 description: The image contains the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Medicatech USA % Mr. Daniel Kamm New Submission Correspondent Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

JAN - 3 2010

Re: K102285

Trade/Device Name: KrystalRad (ATAL8) System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: December 16, 2010 Received: December 21, 2010

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 Mav 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 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,

signature

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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510(k) Number (if known):

JAN - 3 2010

Device Name: KrystalRAD (ATAL8) System

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Indications For Use:

The KrystalRAD (ATAL8) Digital X-Ray Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiolo Office of In

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.