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 applications

Device Description

The PIXX2430 is s digital radiography system, featuring an integrated flat panel digital detector (FPD). It 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 updated panels are the same as our previous panels (K182533, PIXX 1717, PIXX 1212) retaining the Wi-Fi wireless features and rechargeable battery operation. The scintillator is Csl only. The only size available is 12 x 10 inch. It operates either wirelessly or by hard wired Ethernet connection. The power source is rechargeable battery, which lasts for 360 images or 6 hours in standby. It has a finer than usual pixel pitch at 85 µm (finer resolution). Our imaging software is unchanged from our predicate device, K182533. Image storage functionality: PIXX2430 supports the internal storage of raw image data. Wireless Information: This digital panel employs the same wireless functionality as our predicate panels (K182533) using IEEE802.11ac, backward compatible. The operational characteristics can be summarized this way: Transfer power, ~ 100mW; Frequency: 2.4 gHz, or 5 gHz. Security, WPA2; Signal range: Approximately 100 feet. Both medical and nonmedical devices can use IEEE802.11ac Wi-Fi, and this technology is designed to handle multiple devices using the same technology simultaneously.

AI/ML Overview

The provided text is a 510(k) summary for the PIXX2430 Digital Diagnostic X-Ray Receptor Panel. It focuses on demonstrating substantial equivalence to a predicate device (K182533) rather than defining and proving acceptance criteria for an AI/ML powered device. Therefore, much of the requested information regarding AI/ML acceptance criteria, study design (MRMC, standalone), ground truth adjudication, and training/test set details is not present in the provided document.

However, based on the non-AI device context, I can extrapolate and provide information where available, and indicate where the information is missing.

Here's an attempt to answer your request based on the provided document, highlighting the missing AI/ML specific details:

The PIXX2430 Digital Diagnostic X-Ray Receptor Panel is a digital radiography system intended to replace radiographic film/screen systems for general radiographic images of human anatomy. The acceptance criteria and the study proving the device meets these criteria are framed within the context of demonstrating substantial equivalence to a predicate device (K182533), rather than the performance of an AI/ML algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a non-AI device seeking substantial equivalence, the "acceptance criteria" are generally aligned with demonstrating that the new device is "as safe and effective" as the predicate. The performance metrics focus on image quality and physical/electrical characteristics.

Acceptance Criterion (Implicitly for Substantial Equivalence)	Reported Device Performance (PIXX2430)	Predicate Device Performance (K182533)
Intended Use	UNCHANGED (General radiographic images of human anatomy, excluding fluoroscopic, angiographic, and mammographic applications)	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
Configuration	UNCHANGED (Digital Panel and Software only, no generator or stand)	Digital Panel and Software only, no generator or stand provided.
Pixel Pitch	85 µm (finer resolution)	140um
Limiting Resolution	5.8 lp/mm (finer resolution)	Over 3 lp/mm
DQE(CSI) @ 2 lp/mm	50 % (better)	26.5%
MTF(CSI) @ 2 lp/mm	60 % (better)	44%
A/D Conversion	SAME (16 bits)	16 bits
Active Area Size	12 x 10 inch	17 x 17 inch, 14 x 17 inch, 12 x 12 inch
Dimensions / Weights	328(W)X265(L)X15(H) / 1.3Kg	Varies by active area size of predicate devices
Pixels	2816 X 3584	Varies by active area size of predicate devices
Software	SAME (Outputs a DICOM image)	Outputs a DICOM image
DICOM Compliance	Yes	Yes
Scintillator Type	CsI ONLY	CsI or GOS
Interface	SAME (Wired: Gigabit Ethernet; Wireless: IEEE802.11ac, backward compatible)	Wired: Gigabit Ethernet (1000BASE-T); Wireless: IEEE802.11ac, backward compatible
Power Source / Battery Life	AC Line and/or Rechargeable Lithium Battery; 6 hours/360 images	AC Line and/or Rechargeable Lithium Battery; 5 hours/300 images
Compliance with Standards	SAME (Electrical Safety per IEC 60601-1:2012, EMC per IEC 60601-1-2:2007+AC:2010, IEEE802.11ac, FCC, IEC 62133 Battery safety, ISO 14971:2012, EN 62304)	Electrical Safety per IEC 60601-1:2012 and EMC per IEC 60601-1-22007+AC:2010 as well as IEEE802.11ac. Meets FCC requirements plus IEC 62133 Battery safety.
Clinical Image Quality	Excellent diagnostic quality (as evaluated by a Board Certified Radiologist)	Not explicitly quantified for predicate, but stated as basis for equivalence for new device.

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

Sample Size for Test Set: The document mentions "Clinical images collected" and "Clinical images obtained in accordance with Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices." However, the specific sample size of the clinical image test set is not provided.
Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be internally conducted by Pixxgen.
Retrospective or Prospective: Not specified whether the clinical images were collected retrospectively or prospectively.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: "a Board Certified Radiologist" (singular) was used.
Qualifications: "Board Certified Radiologist." No further detail (e.g., years of experience, subspecialty) is provided.

4. Adjudication Method for the Test Set

Adjudication Method: "evaluated by a Board Certified Radiologist." This implies a single reader assessment, hence no multi-reader adjudication method (like 2+1 or 3+1) was used or described.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done (or at least, not described in this 510(k) summary). The evaluation was by a single radiologist to confirm "excellent diagnostic quality" of the new device's images, comparing them to the predicate's as a basis for equivalence.
Effect Size: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Not applicable. This device is a digital X-ray receptor panel, not an AI/ML algorithm. Its performance is assessed as a component producing images for human interpretation, not as an algorithm providing diagnostic outputs independently.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the "clinical image inspection" was expert consensus (from a single Board Certified Radiologist) on the diagnostic quality of the images produced by the device. It was not based on pathology, outcomes data, or a panel of experts.

8. Sample Size for the Training Set

The document describes the device itself, not an AI/ML algorithm. Therefore, there is no concept of a "training set" for an algorithm. The device's design and engineering are based on established X-ray detector physics and comparison to a predicate device.

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

Not applicable, as there is no AI/ML algorithm with a training set. The device's "training" in the manufacturing sense involves engineering, quality control, and adherence to performance specifications, not data-driven machine learning.

Summary

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April 4, 2019

Image /page/0/Picture/1 description: The image contains 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.

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

Re: K190691

Trade/Device Name: PIXX2430 Digital Diagnostic X-Ray Receptor Panel Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: March 10, 2019 Received: March 18, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

for Thalia T. Mills, 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)

K190691

Device Name PIXX2430 Digital Diagnostic X-Ray Receptor Panel

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)

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510(k) Summary, 510(k) Number K190691 PIXXGEN Corporation 5F, SMART BAY, 123, Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14056, Korea Tel +82.70.4846.8888 Date Prepared: March 28, 2019 Contact: Young Kim, President

1. Identification of the Device: Proprietary-Trade Names: PIXX2430 Digital Diagnostic X-Ray Receptor Panel Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB
1. Equivalent legally marketed device: K182533 PlXX 1717; PlXX 1212; Digital Diagnostic X-Ray Receptor Panels Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB
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, angiographic, and mammographic applications.

4. 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

	K182533, PIXX 1717, PIXX 1417, PIXX 1212	PIXX2430
Intended Use	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
Pixel Pitch	140um	85 µm (finer resolution)
Limiting Resolution	Over 3 lp/mm	5.8 lp/mm (finer resolution)
DQE(CSI)	At 2 lp/mm 26.5%	At 2 lp/mm 50 % (better)
MTF(CSI)	At 2 lp/mm 44%	At 2 lp/mm 60 % (better)
DQE(GOS)	At 2 lp/mm 21	N/A
MTF(GOS)	At 2 lp/mm 35%	N/A
A/D Conversion	16 bits	SAME
Active Area	17 x 17 inch14 x 17 inch12 x 12 inch	12 x 10 inch
Dimensions(mm)/Weights(Kg)	460(W)x461(L)x15(H)/3.0Kg385(W) x 460(L) x 15(H)/ 2.8Kg308.5(W) x 319.5(L) x 15(H)/ 1.9Kg	328(W)X265(L)X15(H) / 1.3Kg
Pixels	3,072 x 3,0722,560 x 3,0722,048 x 2,048	2816 X 3584
Software	Outputs a DICOM image	SAME
DICOM	Yes	Yes
Scintillator	Csl or GOS	CsI ONLY
Interface	Wired: Gigabit Ethernet(1000BASE-T)Wireless: IEEE802.11ac, backward compatible	SAME
Power source	AC Line and/or Rechargeable LithiumBattery;5 hours/300 images	AC Line and/or Rechargeable LithiumBattery;6 hours/360 images
Standards	Electrical Safety per IEC 60601-1:2012 andEMC per IEC 60601-1-22007+AC:2010 as wellas IEEE802.11ac. Meets FCC requirementsplus IEC 62133 Battery safety.	SAME

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1. Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility, and Battery Safety Tests. Standards met: Electrical safety per: IEC/UL 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety. (General) Electromagnetic Compatibility per IEC 60601-1-2, Collateral Standard: Electromagnetic compatibility Requirements and tests. IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications Risk Analysis was conducted in accordance with ISO 14971:2012 and EN 62304. The software remains the same as in K182533. MTF and DQE measurements were made in accordance with Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016 Battery life testing was conducted to confirm that the PIXX2430 runs for 6 hours/300 images. Cybersecurity precautionary labeling was added per the FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, Document Issued on: October 2, 2014.
1. Summary of Clinical Testing: Clinical images obtained in accordance with Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices 1 Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016. The images were evaluated by a Board Certified Radiologist and found to be of excellent diagnostic quality.
1. Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Pixxgen that the PIXX2430 Digital Diagnostic X-Ray Receptor Panel is 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

§ 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.