Opal Chiro and 20/20 P-DR are intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography.

Device Description

The Opal Chiro and 20/20 P-DR system represents the straightforward integration of a new digital x-ray receptor panel (cleared in K062376) and our previously cleared (K123644 and K133139) software. The Opal Chiro and 20/20 P-DR are Digital Radiography systems, featuring an integrated flat panel digital detector (FPD). The Opal Chiro and 20/20 P-DR 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 Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion + DR, K123644, wherein we combined our OPAL-RAD software with two new digital panels. The upgrade kits are compatible with modern HF diagnostic X-ray generators like Sedecal and CPI. The 20/20 P-DR has been tested with X-Cel 700/900 series of generators.

AI/ML Overview

The provided text describes Opal Chiro and 20/20 P-DR, a Digital Radiography system. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics that would allow for a comprehensive answer to all parts of your request. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on a qualitative assessment compared to a predicate device.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Image Quality	Equal to or better than predicate device (ViZion + DR, K123644)	"Clinical images collected demonstrate equal or better image quality as compared to our predicates."
Safety and Effectiveness	As safe and effective as 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 devices."

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

The document does not specify the sample size used for the clinical image acquisition and review. It states that "Clinical images were acquired and evaluated." The provenance of the data (country of origin, retrospective or prospective) is also not mentioned.

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

The test set involved evaluation by "a board certified radiologist." The number of experts is one. Their specific qualifications beyond "board certified radiologist" are not detailed (e.g., years of experience, subspecialty).

4. Adjudication Method for the Test Set

With only one radiologist evaluating the images, an adjudication method like 2+1 or 3+1 is not applicable or mentioned. The single expert's evaluation served as the basis for comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not indicated. The document describes a comparison of images by a single radiologist against a predicate, not a study of human reader improvement with or without AI assistance.

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

The device itself is a digital X-ray receptor panel and associated software for image capture and processing. The performance evaluated here is essentially the standalone performance of the imaging system in producing images. It's not an AI algorithm in the sense of making diagnoses, but rather an image acquisition and processing system. The evaluation focused on the quality of the output images.

7. The Type of Ground Truth Used

The ground truth for the clinical images was established through expert visual assessment/consensus by a board-certified radiologist, comparing the images to those from a predicate device. There is no mention of pathology or outcomes data being used as ground truth.

8. The Sample Size for the Training Set

The document does not provide any information about a training set since the device described is an imaging system (hardware and associated software for image processing), not a machine learning model that typically requires a distinct training set. The software mentioned (OpalRad Software) is described as "previously cleared" and its major functions and principle of operation "were not changed," implying it was not "trained" in the typical AI sense for this submission.

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

Since there is no mention of a training set for an AI model, the method for establishing its ground truth is not applicable or described in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized symbol. The symbol features a series of three interconnected human profiles facing to the right, creating a sense of unity and collaboration.

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

August 27, 2014

20/20 Imaging % Daniel Kamm, P.E. Principal Engineer 8870 Ravello Ct. Naples, Florida 34114

Re: K141435 Trade/Device Name: Opal Chiro, 20/20 P-DR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: Class II Product Code: MQB Dated: May 28, 2014 Received: Mav 30, 2014

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/ResourcesforYou/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,

Smh.7)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141435

Device Name Opal Chiro and 20/20 P-DR

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary 510(k) Number K141435 20/20 Imaging 2217 U.S. Highway 70 East Garner, NC 27529 Phone: 866.734.6234 Fax: 919.772.2810 Date Prepared: July 30, 2014 Contact: Bruce Ashby, Sales and Marketing Manager

1. Identification of the Device:
  Proprietary-Trade Name: Opal Chiro and 20/20 P-DR Flat Panel X-Ray Detector upgrade kits. Classification Name: Stationary X-ray System, Product Code MQB, Regulation 892.1680 Common/Usual Name: Digital X-Ray Receptor Panel
1. Equivalent legally marketed devices: K123644, Vizion +DR, Viztek LLC.
1. Indications for Use (intended use) Opal Chiro and 20/20 P-DR are intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography.
1. Description of the Device: The Opal Chiro and 20/20 P-DR system represents the straightforward integration of a new digital x-ray receptor panel (cleared in K062376) and our previously cleared (K123644 and K133139) software. The Opal Chiro and 20/20 P-DR are Digital Radiography systems, featuring an integrated flat panel digital detector (FPD). The Opal Chiro and 20/20 P-DR 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 Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion + DR, K123644, wherein we combined our OPAL-RAD software with two new digital panels. The upgrade kits are compatible with modern HF diagnostic X-ray generators like Sedecal and CPI. The 20/20 P-DR has been tested with X-Cel 700/900 series of generators.
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 devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates.

Characteristic	ViZion + DR, K123644	Opal Chiro and 20/20 P-DR
Intended Use:	ViZion + DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion + allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities	Opal Chiro, model 20/20 C-DR and 20/20 P-DR are intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography.
Configuration	This submission is for the Digital Panel and Software only, no generator or stand provided.	This submission is for the Digital Panel and Software only, no generator or stand provided.

6. Substantial Equivalence Chart

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Characteristic	ViZion + DR, K123644	Opal Chiro and 20/20 P-DR
Digital Panel Sizes	iRay Technology (Shanghai) Ltd. For the17" x 17" panel or 14" x 17" panel	The 17" x 17" panel stays the same. The14" x 17" panel becomes a Naomimodel. A smaller size of 10" x 12" isadded for podiatry applications.
Digital panelresolutions	17" x 17"Pixel size 139 μm$3064x3072$ pixels14" x 17"Pixel size 150 μm$2288×2800$ pixels	14" x 17"Pixel pitch: Horiz. 7.2 μm x Vert. 5.6 μm$7,872 x 6,144$ (48.36 megapixels)10" x 12"Horiz. 7.2 μm x Vert. 5.6 μm$4608 x 5904$ (27.2 megapixels)
Software	OpalRad Software,outputs a DICOM image.	SAME
DICOM	Yes	Yes
Power source	AC Line	AC Line
Electrical safety andEMC	Electrical Safety per IEC 60601-1 andEMC per IEC 60601-1-2.	Electrical Safety per IEC 60601-1 andEMC per IEC 60601-1-2.

1. Summary of Bench Testing Conducted: The included products have been separately cleared by FDA and are provided to the user unmodified. Verification of operation has been performed via clinical image acquisition and review. See the paragraph below.
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 the images acquired with the predicate panel.
1. Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of 20/20 Imaging that the Opal Chiro and 20/20 P-DR are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it 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.