The ATAL 8 and ATAL 8c 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.

Device Description

The ATAL 8 and ATAL 8C are flat-panel type digital X-ray detectors that capture 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 ATAL 8 and ATAL 8C device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector Panel is used to capture the image in electronic form. Once the system captures a radiographic image and subsequently displays and stores an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a workstation. 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. The ATAL 8 and ATAL 8C differ only in the enclosure type. They have identical technological characteristics.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence or superiority to the predicate device in diagnostic quality of clinical images.	"a board certified Radiologist reviewed the images and declared the new panel to be equivalent or better than the predicate device, and that the images are of diagnostic quality."
Device produces images suitable for "general radiographic images of human anatomy" and can "replace radiographic film/screen systems in all general-purpose diagnostic procedures."	The clinical evaluation concluded the device provides images of diagnostic quality, indirectly confirming suitability for its intended use. The conclusion of substantial equivalence also supports this, implying it meets the requirements for general radiography.
Compliance with non-clinical performance standards (MTF, DQE, Quantum Limited Performance, Effects of Aliasing, Output Signal Level and Linearity, Lag).	"Non-clinical testing included performance tests, EMC tests, Electrical Safety and software validation tests. The performance testing was based on the requirements of the FDA Guidance Document for Solid State Imaging Devices and included tests for MTF, DQE, Quantum Limited Performance, Effects of Aliasing, Output Signal Level and Linearity, and Lag or residual signal level from prior exposure." Results are implied to be satisfactory as per the substantial equivalence conclusion.

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

Sample Size for Test Set: 30 pairs of clinical images (30 images from the ATAL 8/8C and 30 corresponding images from the predicate device).
Data Provenance: Not explicitly stated, but based on the nature of clinical image acquisition, it would be prospective for the purposes of this equivalency study, as these images were specifically obtained for the comparison. The country of origin is not specified.

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

Number of Experts: One
Qualifications of Experts: "a board certified Radiologist"

4. Adjudication Method for the Test Set

Adjudication Method: None explicitly mentioned beyond a single radiologist's review. The radiologist "declared the new panel to be equivalent or better than the predicate device, and that the images are of diagnostic quality." This suggests a direct comparison and qualitative assessment by a single expert, without a formal adjudication process involving multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described. The study involved a single radiologist's assessment of paired images.
Effect Size: Not applicable, as an MRMC study was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable/not explicitly stated in the context of this device. The ATAL 8 and ATAL 8C are digital X-ray detectors, not an AI algorithm. Their performance is inherently tied to producing images for human interpretation. The clinical study assessed the diagnostic quality of the images produced by the device, which are then interpreted by a human (the radiologist). Therefore, the concept of a "standalone" algorithmic performance isn't directly relevant in the same way it would be for an AI-powered diagnostic tool.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the clinical comparison was based on expert consensus (or in this case, expert declaration by a single board-certified radiologist) that the images were of diagnostic quality and equivalent or better than those from the predicate device. This is a form of expert review for diagnostic suitability.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. The document describes a medical device (digital X-ray detector), not an AI algorithm that requires a training set. The "development" of the device would involve engineering and physical testing, not machine learning training.

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

Ground Truth for Training Set: Not applicable, as this device does not involve an AI algorithm with a training set. The "ground truth" for non-clinical development would be established through physical and engineering specifications, validation against known standards, and performance test results (e.g., MTF, DQE).

Summary

{0}------------------------------------------------

MAY – 3 2012

. ·

. :

510(k) Summary K113812
Date prepared:	May 1, 2012
Applicant:	Atlaim Corp.1018/19 Sicox Tower, Sangdaewon, SeongnamGyeonggi, 462-120 Korea
Contact person:	John Ross, General Manager, 949-929-5910
Trade name:	ATAL 8 and ATAL 8 C
Common name:	Solid state X-ray imager	Class:	2
Classification name:	Solid state x-ray imager (flat panel/digitalimager)	Product code:	MQI
Predicate device:	DRTech FLAATZ 750 K080064
Device description:	The ATAL 8 and ATAL 8C are flat-panel type digital X-ray detectors thatcapture radiographic images in digital format within seconds, eliminatingthe need for an entire X-ray film or an image plate as an image capturemedium. The ATAL 8 and ATAL 8C device differs from traditional X-raysystems in that, instead of exposing a film and chemically processing it tocreate a hard copy image, a device called a Detector Panel is used tocapture the image in electronic form. Once the system captures aradiographic image and subsequently displays and stores an image,radiologists or physicians can adjust the image electronically to optimizethe view of the desired anatomy at a workstation. The system enables auser to duplicate images without having to take additional exposures sothat the user can easily transmit a duplicate to the second physician whoneeds the duplicate image through the network. The ATAL 8 and ATAL 8Cdiffer only in the enclosure type. They have identical technologicalcharacteristics.
Intended use:	The ATAL 8 and ATAL 8C are indicated for use in general radiographicimages of human anatomy. It is intended to replace radiographicfilm/screen systems in all general-purpose diagnostic procedures,excluding fluoroscopic, angiographic, and mammographic applications.
Technologicalcharacteristics:	Amorphous silicon detector producing an image of 3072x3072 pixels. Theimage area is 430x430 mm with a resolution of 3.1 lp/mm. The intendedapplication of this detector is general radiography.
Non-clinical testssubmitted or relied upon:	Non-clinical testing included performance tests, EMC tests, ElectricalSafety and software validation tests. The performance testing was basedon the requirements of the FDA Guidance Document for Solid StateImaging Devices and included tests for MTF, DQE, Quantum LimitedPerformance, Effects of Aliasing, Output Signal Level and Linearity, andLag or residual signal level from prior exposure
Clinical tests submitted orrelied upon:	Clinical image sets were obtained for both the ATAL 8 and the predicatedevice and they were compared to show equivalence. The clinicalevaluation was performed in accordance with the FDA Guidance Documentwherein 30 pairs of clinical images are acquired and a board certifiedRadiologist reviewed the images and declared the new panel to beequivalent or better than the predicate device, and that the images are ofdiagnostic quality.
Substantial equivalenceconclusion:	The ATAL 8 and ATAL 8C and its predicate are different in minor details,but they are substantially equivalent with respect to intended use,technological and performance characteristics. The devices are as safe, aseffective, and perform as well as or better than the legally marketedpredicate device.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three curved lines, which are meant to represent the department's mission of promoting health and well-being. The seal is black and white.

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

MAY - 3 2012

Atlaim % Daniel Kamm, P.e. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K113812

Trade/Device Name: ATAL 8 and ATAL 8c Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 22, 2012 Received: March 26, 2012

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, 1 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

{2}------------------------------------------------

Page 2

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

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known): K113812_

Device Name: ATAL 8 and ATAL 8c

Indications For Use:

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 In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K Kil3812

Page 1 of 1

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.