ATAL 9 by ATLAIM CORPORATION | FDA 510(k) Summary

The ATAL 9 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 9 is a digital radiography system, featuring an integrated flat panel digital detector (FPD). ATAL 9 is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the modified panel are the same as our previous panel with a Wi-Fi wireless feature added.

AI/ML Overview

The provided document is a 510(k) summary for the ATAL 9 digital radiography system. It focuses on demonstrating substantial equivalence to a predicate device (ATAL 8, ATAL 8c, K113812), primarily due to the addition of wireless functionality. As such, the study design and acceptance criteria are geared towards proving this equivalence rather than establishing de novo performance for a new type of device or AI algorithm.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (ATAL 9 vs. ATAL 8/8c)
Technological Characteristics
Pixel Pitch: Same as predicate	SAME (139 μm)
Limiting Resolution: Same as predicate	SAME (Over 3 lp/mm)
DQE (CSI) at 2 lp/mm: Comparable to predicate	26% (Predicate: 27%)
MTF (CSI) at 2 lp/mm: Comparable to predicate	42% (Predicate: 43%)
A/D Conversion: 14 bits or better	16 bits (Predicate: 14 bits)
Active Area: Same as predicate	SAME (17 x 17 inch)
Pixels: Same as predicate	SAME (3,072 x 3072)
Software: Same functionality	SAME as K113812
DICOM output: Yes	YES
Scintillator: Same options	UNCHANGED (Csl/GOS)
Interface: Gigabit Ethernet and/or wireless functionality	Wired: Gigabit Ethernet (1000BASE-T); Wireless: IEEE802.11ac, backward compatible
Power source: AC line and/or rechargeable battery	AC Line and/or Rechargeable Lithium Battery (10 hr run time)
Dimensions/Weights: Changed (due to wireless/battery)	460(W)×461(L)×15(H)/ 2.9kg (2.4kg w/o Battery) (Predicate: 500(W)×500(L)×25(H)/ 7.8kg)
Safety and Effectiveness
Electrical Safety: Compliance with IEC 60601-1	Complies with IEC 60601-1
EMC: Compliance with IEC 60601-1-2	Complies with IEC 60601-1-2
Wireless operation: Compliance with IEEE 802.11ac and FCC	Complies with IEEE 802.11ac, Meets FCC requirements
Image Quality (Clinical): As good as or better than predicate	Concluded "as good as or better than" by board-certified radiologist.
Risk Analysis: Conducted	Conducted (as per bench testing summary)
Software Verification: Conducted	Conducted (as per bench testing summary)
Wireless connectivity: Verified	Verified

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

The document states: "Clinical images were acquired and evaluated by a board certified radiologist..." However, it does not specify the number of clinical images (sample size) used for the test set.

Sample Size: Not explicitly stated for the clinical image evaluation.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). While "clinical images were acquired," it doesn't specify if these were newly acquired for the study (prospective) or selected from an existing archive (retrospective).

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

Number of Experts: One.
Qualifications of Experts: A "board certified radiologist." No further details on years of experience or sub-specialty are provided.

4. Adjudication Method for the Test Set

The document indicates that "Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel." This implies a single-reader evaluation against the predicate device, not a multi-reader adjudication process. Therefore, the adjudication method was essentially none in the sense of comparing multiple experts' opinions. The single expert provided the judgment.

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

MRMC Study: No, an MRMC study was not done.
AI Improvement Effect Size: Not applicable. This submission is for a digital radiography panel, not an AI software/algorithm intended to assist human readers or provide automated diagnoses. The device being cleared (ATAL 9) is a hardware device for image acquisition.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: No, a standalone performance study as described (algorithm only without human-in-the-loop performance) was not done. The ATAL 9 is a digital X-ray panel, where the "performance" relates to image acquisition and quality, not an algorithm's diagnostic output. The clinical evaluation involved a human radiologist examining the acquired images.

7. The Type of Ground Truth Used

For the clinical evaluation, the "ground truth" was established by the expert opinion/conclusion of a single board-certified radiologist. The radiologist compared images from the new panel against those from the predicate panel. This is a form of expert consensus, albeit from a single expert, comparing image quality.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable/not provided. The ATAL 9 is a hardware device (digital X-ray panel). It is not an AI algorithm that undergoes a "training" phase with a large dataset. The "software" component remains the same as its predicate (K113812), implying no new algorithm training was performed for the ATAL 9.

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

Ground Truth for Training Set: Not applicable. As explained above, this device does not involve an AI algorithm with a training phase requiring a "ground truth" to be established for training data.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 10, 2015

ATLAIM Corporation % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K152151

Trade/Device Name: ATAL 9 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 14, 2015 Received: October 16, 2015

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K152151

Device Name ATAL 9

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary 510(k) Number K152151 ATLAIM Corporation 5F, SMART BAY, 123, Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 431-804, Korea Tel +82-70-4846-8888 FAX +82-2-6455-2905 Date Prepared: November 3, 2015 Contact: Young Kim, President

1. Identification of the Device: Proprietary-Trade Name: ATAL 9 Classification Name: Stationary X-ray System Common/Usual Name: Digital X-Ray Receptor Panel Product Code: MOB Device Class/Regulation Number: Class II per regulation 892.1680
1. Equivalent legally marketed device: ATAL 8, ATAL 8c, K113812, Atlaim Corporation. Classification Name: Stationary X-ray System Common/Usual Name: Digital X-Ray Receptor Panel Product Code: MQB Device Class/Regulation Number: Class II per regulation 892.1680
1. Indications for Use (intended use) The ATAL 9 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.
1. Description of the Device: The ATAL 9 is a MODIFICATION of our clearance K113812 wherein we have changed panel to a wireless version of the previously cleared panel/software combination. Going wireless with battery operation are the ONLY modifications. The available scintillators (CsI or GOS) remain the same. The triggering methods (AED or manual trigger) remain the same. When used with an electrical synchronization circuit the following generators are known to properly synchronize: Sedecal SHF Series and CPI 200 Series.

1. Safety and Effectiveness, comparison to predicate device. The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate device. Clinical images collected demonstrate equal or better image quality as compared to our predicate.

{4}------------------------------------------------

6. Substantial Equivalence Chart

	ATAL 8 ATAL 8c, K113812	ATAL 9
IntendedUse:	Indicated for use in general radiographicimages of human anatomy. It is intended toreplace radiographic film/screen systems inall general-purpose diagnostic procedures,excluding fluoroscopic, angiographic, andmammographic applications.	UNCHANGED
Configuration	This submission is for the Digital Panel andSoftware only, no generator or standprovided.	UNCHANGED
	Digital Panel
Pixel Pitch	139 μm	SAME
LimitingResolution	Over 3 lp/mm	SAME
DQE (CSI)	At 2 lp/mm 27%	At 2 lp/mm 26%
MTF (CSI)	At 2 lp/mm 43%	At 2 lp/mm 42%
A/DConversion	14 bits	16 bits
Active Area	17 x 17 inch	SAME
Dimensions/Weights	500(W)×500(L)×25(H)/ 7.8kg	460(W)×461(L)×15(H)/ 2.9kg (2.4kg w/oBattery) (up to 10 hours of battery life)
Pixels	3,072 x 3072 (9.4 M. pixels)	SAME
Software	Outputs a DICOM image.	SAME as K113812
DICOM	Yes	YES
Scintillator	Csl/GOS	UNCHANGED
Interface	Gigabit Ethernet	Wired : Gigabit Ethernet (1000BASE-T)Wireless : IEEE802.11ac, backward compatible
Power source	AC Line	AC Line and/or Rechargeable Lithium Battery(10 hr run time)
Photo	Image: ATAL 8 ATAL 8c, K113812	Image: ATAL 9
	ATAL 8 ATAL 8c, K113812	ATAL 9
Standards	Electrical Safety per IEC 60601-1 and EMC perIEC 60601-1-2.	Electrical Safety per IEC 60601-1 and EMC perIEC 60601-1-2 as well as IEEE 802.11ac.Meets FCC requirements.

{5}------------------------------------------------

1. Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility. MTF and DQE measurements, Risk Analysis and Software verification were conducted in accordance with FDA guidance documents. As expected the DQE and MTF measurements show minimal differences, and the limiting resolution is the same. The software remains the same as in K113812. Wireless communication testing was performed to verify wireless connectivity. The device was also found to comply with FCC requirements for wireless operation. Bench testing was performed in accordance with the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
1. Summary of Clinical Testing: Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel, as required by the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. The core technology of the panel remains the same. The provided clinical data was not used to support a determination of substantial equivalence due to the minor modifications and adequate bench testing data.
1. Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Atlaim that the ATAL 9 (Wireless) is as safe and effective as the predicate device. The Atlaim ATAL 9 has the same intended use as the legally marketed predicate device. Although the ATAL 9 has different technological characteristics, including the addition of wireless technology to the digital image receptor, those differences do not raise different questions of safety and effectiveness from the predicate device. The effects of these differences were adequately documented with bench testing data which showed that the ATAL 9 is substantially equivalent to the predicate device.

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.