Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion DR + Wireless allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

Device Description

The ViZion DR + Wireless system represents the straightforward integration of a modified digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K152279 wherein we have changed the panel scintillator to Cesium Iodide in addition to having the GOS scintillator available. Changing the scintillator is the only modification.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vizion DR + Wireless device, presented in the requested format:

1. A table of acceptance criteria and the reported device performance

The document describes a modification to an existing device (K152279) where the scintillator material was changed from Gadolinium Oxysulfide (GOS) to Cesium Iodide (CSI). The primary acceptance criteria for equivalence appear to be related to imaging performance metrics (MTF and DQE) and clinical image quality.

Acceptance Criteria / Characteristic	Predicate Device (Viztek ViZion DR + Wireless K152279 - GOS Scintillator)	Modified Device (ViZion DR + Wireless, CSI Scintillator)	Performance vs. Predicate
Intended Use	Unchanged	Unchanged	Equivalent
Configuration	Unchanged	Unchanged	Equivalent
Digital Panel (size, pixel size)	iRay Technology Mars1417V-PSI 14" x 17", 150 µm	iRay Technology Mars1417V-TSI 14" x 17", 150 µm	Not a meaningful difference
Internal image storage	200 full size images	Unchanged	Equivalent
Image acquisition time	< 5 Seconds	Unchanged	Equivalent
DICOM 3	Yes	Yes	Equivalent
A/D Conversion	14 bit	Unchanged	Equivalent
Scintillator	DRZ-Plus Gd2O2S:Tb (GOS)	CSI (Cesium Iodide)	Changed
MTF (0.5 (1/mm))	0.75	0.83	Better (0.83 > 0.75)
DQE (0.5 (1/mm))	0.27	0.55	Better (0.55 > 0.27)
Interface	Unchanged	Unchanged	Equivalent
Power source	Unchanged	Unchanged	Equivalent
Electrical safety and EMC	Complies with IEC 60601-1, IEC 60601-1-2, FCC Part 15	Same	Equivalent
Clinical Image Quality	Predicate panel images	Modified panel images	As good as or better

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated for either the quantitative (MTF/DQE) or clinical image evaluation. For the clinical images, it states "Clinical images were acquired," implying a set of images, but no number is given.
Data Provenance: Not explicitly stated. The document is from the US FDA, and the company address is in North Carolina, USA, suggesting the study was likely conducted in the USA, but this is not confirmed. It is implied to be prospective or specifically acquired for this evaluation, as it mentions "Clinical images were acquired and evaluated..."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: One
Qualifications of Experts: "a board certified radiologist" (no mention of years of experience).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

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

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. The study described is a comparison of two imaging technologies (different scintillators), not an AI-assisted reading study. The device is a digital X-ray receptor, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This device is an imaging acquisition system, not an AI algorithm. The performance evaluation focuses on the image quality produced by the system itself before interpretation. The quantitative metrics (MTF, DQE) are "standalone" in the sense that they measure the physical performance of the sensor, but this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth:
- For MTF and DQE: These are objective physical measurements of image quality, not dependent on a "ground truth" derived from patient data in the same way clinical diagnostics are. They are measured against known physical standards.
- For Clinical Image Quality: The "ground truth" for clinical image quality comparison was the subjective opinion of a board-certified radiologist, who evaluated whether images from the modified panel were "as good as or better than" images from the predicate panel. This is a form of expert opinion/subjective evaluation rather than an objective clinical endpoint like pathology.

8. The sample size for the training set

Training Set Sample Size: Not applicable. The Vizion DR + Wireless is a hardware device (digital X-ray detector) and associated software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software" was previously cleared and confirmation testing was performed after the hardware modification.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.

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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

May 20, 2016

Viztek LLC % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K160810

Trade/Device Name: Vizion Dr + Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: March 21, 2016 Received: March 24, 2016

Dear Daniel 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,

For

Robert Ochs 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) K16

Device Name ViZion DR + Wireless

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) Summarv 510(k) Number K160810 Viztek, LLC. 2217 US HWY 70 East • Garner, NC 27529 Phone: 800.366.5343 Fax: 904.448.9936 Date Prepared: April 5, 2016 Bruce Ashby, Sales and Marketing Manager Contact:

1. Identification of the Device: Proprietary-Trade Name: ViZion DR + Wireless Classification Name: Stationary x-ray system. Product Code MOB Common/Usual Name: Digital X-Ray Receptor Panel Device Class/Regulation Number: Class II per regulation 892.1680
1. Equivalent legally marketed device: ViZion DR + Wireless, K152279, Viztek. Classification Name: Stationary x-ray system, Product Code MQB Common/Usual Name: Digital X-Ray Receptor Panel Device Class/Regulation Number: Class II per regulation 892.1680
1. Indications for Use (intended use) ViZion DR + Wireless 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 + Wireless allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
1. Description of the Device: The ViZion DR + Wireless system represents the straightforward integration of a modified digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K152279 wherein we have changed the panel scintillator to Cesium Iodide in addition to having the GOS scintillator available. Changing the scintillator is the only modification.

ViZion DR + Wireless is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD). ViZion DR + Wireless 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 predicate is ViZion DR + Wireless, K152279. We do not supply the router, but any router meeting the IEEE 802.11 a/b/g/n specifications will work. With the advent of AED (automatic exposure detection) by the panel, integration with or connection to specific generators is no longer required. If the user decides NOT to use AED, wired synchronization with Sedecal Series SHF generators is known to work.

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

	Viztek ViZion DR + Wireless K152279	ViZion DR + Wireless, CSI Scintillator
Intended Use:	Intended for digital image capture use ingeneral radiographic examinations, whereverconventional screen-film systems may beused, excluding fluoroscopy, angiography andmammography. ViZion + Wireless allowsimaging of the skull, chest, shoulders, spine,abdomen, pelvis, and extremities.	UNCHANGED
Configuration	Digital Panel and Software only, no generatoror stand provided.	UNCHANGED
Digital Panel	iRay Technology (Shanghai) Ltd.Mars1417V-PSI 14" x 17" panel:Pixel size 150 µm$2304\times2800$ (6.45 million pixels)	iRay Technology (Shanghai) Ltd.Mars1417V-TSI 14" x 17" panel:Pixel size 150 µm$2288x2784$ (6.37 million pixels)NOT a meaningful DIFFERENCE.
Internalimage storage	200 full size images	UNCHANGED
Imageacquisitiontime	< 5 Seconds	UNCHANGED
DICOM 3	Yes	YES
A/DConversion	14 bit	UNCHANGED
Scintillator	DRZ-Plus Gd2O2S:Tb	CSI (Cesium Iodide)
MTF	0.75 at 0.5 (1/mm) (GOS)	0.83 at 0.5 (1/mm) (CSI) (Better)
DQE	0.27 at 0.5 (1/mm) (GOS)	0.55 at 0.5 (1/mm) (CSI) (Better)
Interface	Wired : Gigabit Ethernet (1000BASE-T)Wireless : IEEE802.11a/b/g/n	UNCHANGED
Power source	AC Line and/or Rechargeable Lithium Battery(4 hr run time)	UNCHANGED
Photo: Panel	Image: Panel	Image: Panel
Photo:ChargingStation
Electricalsafety andEMC	Electrical Safety per IEC 60601-1 and EMC perIEC 60601-1-2. Complies with FCC Part 15Rules and Regulations	SAME

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1. Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility. We compared MTF and DQE measurements for the original and wireless versions of the panel and found them to be similar enough not to make a notable difference in acquired images. Risk Analysis and System operation verification tests were conducted in accordance with FDA guidance documents. Since no software modifications were required, confirmation testing was performed. Wireless communication testing was performed to verify wireless connectivity. We used a Cisco Linksys EA2700. The device was also found to comply with FCC requirements for wireless operation.
Summary of Clinical Testing: Clinical images were acquired and evaluated by a board certified 8. radiologist who concluded the images from the modified panel are as good as or better than 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 Viztek Inc that the ViZion DR + Wireless is as safe and effective as the predicate device, has few technological differences, and has no new 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.