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 PIXX series are digital radiography systems, featuring an integrated flat panel digital detector (FPD). They are 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 updated panels are the same as our previous panel retaining the Wi-Fi wireless features.

AI/ML Overview

The provided document details the 510(k) summary for PIXXGEN Corporation's Digital Diagnostic X-Ray Receptor Panels. It does not describe a study involving an AI/algorithm that meets specific acceptance criteria. Instead, it focuses on the substantial equivalence of new digital X-ray receptor panels (PIXX 1717, PIXX 1417, PIXX 1212) to a legally marketed predicate device (ATAL 9, K152151).

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving an AI/algorithm device meets those criteria based on the provided text. The document primarily discusses the performance of the physical imaging devices and their comparison to a predecessor, not the performance of an AI or algorithm itself.

The clinical "study" mentioned is purely for image quality validation by a radiologist against a predicate device, not for assessing an AI's diagnostic performance. There is no mention of a test set, training set, ground truth acquisition methodology (beyond radiologist evaluation), or any of the detailed metrics typically associated with AI/algorithm performance studies.

However, I can extract information related to the device's technical specifications and the "clinical testing" that was done to demonstrate equivalent image quality for the new panels as compared to the predicate device.

Here's a breakdown of what is available in the document, framed as if it were a "device performance" rather than an "AI performance" study:

Acceptance Criteria and Device Performance (for the X-ray Receptor Panels)

The acceptance criteria for these X-ray receptor panels are based on demonstrating "equal or better image quality" compared to the predicate device, alongside meeting various technical and safety standards.

1. Table of Acceptance Criteria and Reported Device Performance (for X-ray Panels):

Criterion (for X-ray Receptor Panels)	Acceptance/Predicate Performance (ATAL 9, K152151)	Reported Device Performance (PIXX 1717, 1417, 1212)
I. Imaging Performance
Limiting Resolution	Over 3 lp/mm	Same (Over 3 lp/mm)
DQE (CSI) at 2 lp/mm	29.5%	26.5%
MTF (CSI) at 2 lp/mm	42%	44%
DQE (GOS) at 2 lp/mm	18%	21%
MTF (GOS) at 2 lp/mm	33%	35%
II. Image Quality (Clinical)	Subjective comparison to predicate	As good as or better than predicate
III. Technical Specifications
Pixel Pitch	139um	140um/168um (PIXX 1717); 140um (PIXX 1417, 1212)
A/D Conversion	16 bits	16 bits
Active Area	17x17 inch	Varies per model (e.g., 17x17, 14x17, 12x12 inch)
Software	Outputs a DICOM image	Same as K152151 (unchanged)
DICOM	Yes	Yes
Scintillator	Csl or GOS	Unchanged
Interface	Wired: Gigabit Ethernet; Wireless: IEEE802.11ac	Unchanged
IV. Safety & Standards
Electrical Safety	IEC 60601-1	IEC 60601-1:2012
EMC	IEC 60601-1-2	IEC 60601-1-2:2007+AC:2010
FCC Requirements	Meets FCC requirements	Meets FCC requirements

Note: The document states "some measurements are slightly higher, and some are very slightly lower" for DQE/MTF, but overall concluded "very similar" and within "possible measurement error." The table reflects the reported values.

2. Sample Size and Data Provenance (for "Clinical Testing" of Image Quality):

Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical images were acquired." It does not specify the number of images or cases.
Data Provenance: Not specified regarding country of origin. The study was retrospective in nature, as images were "acquired and evaluated." There is no indication of a prospective study design.

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: One.
Qualifications of Experts: "a board certified radiologist." No mention of years of experience.

4. Adjudication Method for the Test Set:

Adjudication Method: None. A single board-certified radiologist made the evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No, an MRMC study was not done. The evaluation was performed by a single radiologist to subjectively compare the image quality of the new panels against the predicate.

6. Standalone Performance (i.e. algorithm only without human-in-the-loop performance):

This question is not applicable as the document is about physical X-ray receptor panels, not an AI or algorithm. The performance metrics reported (DQE, MTF, Limiting Resolution) are intrinsic to the hardware.

7. Type of Ground Truth Used:

The "ground truth" for the image quality comparison was established by expert consensus (of a single radiologist), who concluded that "the images from the new panels are as good as or better than the images acquired with the predicate panel." This is a subjective assessment of image quality, not disease presence/absence based on pathology or outcomes data.

8. Sample Size for the Training Set:

Not applicable. This document describes a medical device (X-ray panels) and does not involve a "training set" for an AI or algorithm. The "clinical images" evaluated were for validation/comparison, not for training.

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

Not applicable. As there is no training set for an AI, this question is irrelevant to the provided document.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

May 24, 2018

PIXXGEN Corporation % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K180976

Trade/Device Name: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: April 25, 2018 Received: April 27, 2018

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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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Page 2 - Daniel Kamm

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hole 2. Nils

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

Enclosure

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Indications for Use

510(k) Number (if known) K180976

Device Name

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary 510(k) Number K180976 PIXXGEN Corporation 5F, SMART BAY, 123, Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14056, Korea Tel +82.70.4846.8888 Date Prepared: May 18, 2018 Contact: Young Kim, President

1. Identification of the Device: Proprietary-Trade Names: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels Device: Solid State X-Ray Imager (Flat Panel/Digital Imager) Regulation Name: Stationary x-ray system. Product Code: MQB Regulation Number: 892.1680 Device Class: 2
1. Equivalent legally marketed device: ATAL 9, K152151, Atlaim Corporation. (Company name changed now to Pixxgen Corporation)

Device:	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation Name:	Stationary x-ray system.
Product Code:	MQB
Regulation Number:	892.1680
Device Class:	2

1. Indications for Use (intended use) 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, and mammographic applications.
1. Description of the Device:

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.

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6. Substantial Equivalence Chart

	ATAL 9, K152151	PIXX 1717	PIXX 1417	PIXX 1212
Intended Use	Indicated for use in generalradiographic images of humananatomy. It is intended toreplace radiographic film/screensystems in all general-purposediagnostic procedures, excludingfluoroscopic, angiographic, andmammographic applications	UNCHANGED	UNCHANGED	UNCHANGED
Configuration	This submission is for theDigital Panel and Softwareonly, no generator or standprovided.	UNCHANGED	UNCHANGED	UNCHANGED
Pixel Pitch	139um	140um/168um	140 um	140 um
LimitingResolution	Over 3 lp/mm	SAME	SAME	SAME
DQE(CSI)	At 2 lp/mm 29.5%	At 2 lp/mm 26.5%	At 2 lp/mm 26.5%	At 2 lp/mm 26.5%
MTF(CSI)	At 2 lp/mm 42%	At 2 lp/mm 44%	At 2 lp/mm 44%	At 2 lp/mm 44%
DQE(GOS)	At 2 lp/mm 18	At 2 lp/mm 21	At 2 lp/mm 21	At 2 lp/mm 21
MTF(GOS)	At 2 lp/mm 33%	At 2 lp/mm 35%	At 2 lp/mm 35%	At 2 lp/mm 35%
DQE and MTFComments	The MTF and DQE measurements are very similar between our predicate and the new PIXX series ofdigital panels. Some measurements are slightly higher, and some are very slightly lower. The 7% MTFdifference for CSI performance is comparable to thepossible measurement error.
A/D Conversion	16 bits	16 bits	16 bits	16 bits
Active Area	17 x 17 inch	17 x 17 inch	14 x 17 inch	12 x 12 inch
Dimensions(mm)/Weights(Kg)	460(W)x461(L)x15(H)/(2.9Kgw/o Battery)(up to 10 hoursof battery life)	460(W)x461(L)x15(H)/3.0Kg	385(W) x 460(L) x15(H)/ 2.8Kg	308.5(W) x 319.5(L) x15(H)/ 1.9Kg
Pixels	3,072x3,072	3,072 x 3,072	2,560 x 3,072	2,048 x 2,048
Software	Outputs a DICOM image	SAME as K152151The software isunchanged.	SAME as K152151The software isunchanged.	SAME as K152151The software isunchanged.
DICOM	Yes	Yes	Yes	Yes
Scintillator	Csl orGOS	UNCHANGED	UNCHANGED	UNCHANGED
Interface	Wired: Gigabit Ethernet(1000BASE-T)Wireless:IEEE802.11ac,backward compatible	Wired: GigabitEthernet(1000BASE-T)Wireless:IEEE802.11ac,backward compatible	Wired: GigabitEthernet(1000BASE-T)Wireless:IEEE802.11ac,backwardcompatible	Wired: GigabitEthernet(1000BASE-T)Wireless:IEEE802.11ac,backward compatible
Power source	AC Line and/or RechargeableLithium Battery	AC Line	AC Line	AC Line
	ATAL 9, K152151	PIXX 1717	PIXX 1417	PIXX 1212
Standards	Electrical Safety per IEC60601-1 and EMC per IEC60601-1-2 as well asIEEE802.11ac. Meets FCCrequirements.	Electrical Safety perIEC 60601-1:2012 andEMC per IEC 60601-1-22007+AC:2010as well asIEEE802.11ac. MeetsFCC requirements.	Electrical Safety perIEC 60601-1:2012and EMC per IEC60601-1-22007+AC:2010as well asIEEE802.11ac. MeetsFCC requirements.	Electrical Safety perIEC 60601-1:2012 andEMC per IEC 60601-1-22007+AC:2010as well asIEEE802.11ac. MeetsFCC requirements.
Photos	Image: ATAL 9, K152151	Image: PIXX 1717	Image: PIXX 1417	Image: PIXX 1212

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1. Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety, IEC60601-1 and Electromagnetic Compatibility, IEC60601-1-2 as shown in the comparison table above. MTF and DQE measurements, Risk Analysis and Software verification were conducted in accordance with the FDA guidance documents: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff and Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. As expected the DQE and MTF measurements show minimal differences, and the limiting resolution is the same. The software remains the same as in K152151. Wireless communication testing was performed to verify wireless connectivity. The device was also found to comply with FCC requirements for wireless operation. In addition, the following FDA Guidance Documents were consulted during the development of this device: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff and Pediatric Information for X-ray Imaging Device Premarket Notifications.
1. Summary of Clinical Testing: Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the new panels are as good as or better than the images acquired with the predicate panel, as required by the applicable FDA guidance on solid state imaging devices. The core technology of the panel remains the same.
1. Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Pixxgen that the PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels are as safe and effective as the predicate device, have few technological differences, and has the identical indications for use, thus rendering them substantially equivalent to the predicate device.

Regulation Number and Section

N/A