The Z-Ray digital radiography system was designed for the sole purpose of capturing radiographic images of teeth and the surrounding structures limited to the oral cavity. This device should be used under the direction of a licensed Dentist when it is deemed necessary to perform a radiographic series of a patient for diagnostic purposes.

Device Description

The Zuma Dental Z-ray x-ray image sensor is a fully integrated CMOS photodiode array specifically designed for dental radiography. The sensor is available in two image sizes that correspond to a #2 size and a #1 size dental film. Each consists of a matrix of silicon photodiodes on 22.5 um centers. An integrated scintillator screen converts x-ray photons to visible light sensed by the silicon photodiodes. A rugged thermoplastic enclosure, with rounded corners for patient comfort, protects the sensor from everyday handling and cleaning. The CMOS sensor connects directly to a USB/PC connection without the need for an intermediate electrical interface. Zuma Z-Ray works with standard dental extra-oral x-ray sources without connection to the x-ray source. Zuma Z-Ray captures an image automatically upon sensing the external x-ray source and after completion of the x-ray procedure, transfers the image to an imaging software program on the PC for diagnostic evaluation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Zuma Dental Z-Ray Intra-Oral Digital Radiography System. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study with detailed metrics like sensitivity, specificity, or reader performance.

The submission claims that the Z-Ray system is "as safe and effective as the referenced predicate devices" (Schick Computed Oral Radiography System K072134 and Dexis Sensor K090458) due to "minimal technological differences."

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for image quality or diagnostic performance (e.g., minimum sensitivity, specificity, or reader agreement percentages). Instead, it relies on a qualitative assessment of "diagnostic quality images" and equivalence to predicate devices.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance
Image Quality	Produce "diagnostic quality images."	"continually produce diagnostic quality images"
Equivalence	Equivalent to predicate devices (Schick CDR K072134) in performance.	"diagnostic images produced by the Z-Ray System are equivalent to those produced by the predicate device."

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

The document refers to "in-vitro bench testing" and a "test protocol for comparison evaluation" but does not specify the sample size for the test set (number of images or cases). The data provenance is also not specified, although "in-vitro bench testing" implies a controlled laboratory setting rather than patient data from a specific country or a retrospective/prospective study.

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

The document mentions "qualified examiners" who "concluded and certified that the diagnostic images produced by the Z-Ray System are equivalent to those produced by the predicate device." However, it does not specify the number of experts or their qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or confirming the equivalence of diagnostic images. The examiners "concluded and certified," suggesting a consensus or independent assessment, but the process is not detailed.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench testing primarily aimed at demonstrating substantial equivalence in performance, not a clinical trial evaluating human reader improvement with or without AI assistance.

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

The Z-Ray system is an intra-oral digital radiography system, which is a hardware device for capturing images. It is not an AI algorithm. Therefore, the concept of a "standalone (i.e., algorithm only without human-in-the-loop performance)" study does not apply to this device in the traditional sense of AI performance evaluation. The "performance" being evaluated is of the image capture hardware itself.

7. The Type of Ground Truth Used

The ground truth or comparison standard used was the diagnostic image quality produced by a predicate device (Schick CDR K072134) and the assessment of "diagnostic quality images" by "qualified examiners." This is an expert consensus/comparison-based ground truth related to image fidelity and diagnostic utility, rather than pathology, outcomes data, or a pre-defined objective reference standard.

8. The Sample Size for the Training Set

The Z-Ray system is an image capture device, not an AI model that requires a "training set" in the context of machine learning. Therefore, this question is not applicable. The document describes a "Summary of Bench Test" which would be more akin to a validation or test set for the hardware's performance.

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

As stated above, this question is not applicable as the device is not an AI model requiring a training set.

Summary

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K 133206
Page 1 of 5
000018

510k Number: To be determir

MAY 1-3 2014

Section 5 Premarket Notification 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with requirements of 21 CFR Part 807 and FDA Guidance Document "Format for Traditional and Abbreviated 510(K)s"

Submitters Name and Address:

Zuma Dental, LLC 2775 San Nicolo Lane League City, TX 77573 Contact Person: Ekram Khan Tel: (973) 703-4437

Device Name:

· Trade Name Z-Ray Intra-Oral Digital Radiography System
· Common Name Digital Dental X-ray System
· Classification Name Extra-oral source x-ray system

Regulatory Classification:

Class II, per 21 CFR 872.1800 Product Code: MUH

Devices for Which Substantial Equivalence is claimed:

· Schick Computed Oral Radiography System (K072134)
· Dexis Sensor (K090458)

Device Description:

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Image /page/1/Picture/2 description: The image shows the logo for Zuma Dental. The word "zuma" is written in large, bold, black letters. Below the word "zuma" is the word "DENTAL" written in smaller, black letters.

Device Description cont :

A rugged thermoplastic enclosure, with rounded corners for patient comfort, protects the sensor from everyday handling and cleaning.

The CMOS sensor connects directly to a USB/PC connection without the need for an intermediate electrical interface. Zuma Z-Ray works with standard dental extra-oral x-ray sources without connection to the x-ray source. Zuma Z-Ray captures an image automatically upon sensing the external x-ray source and after completion of the x-ray procedure, transfers the image to an imaging software program on the PC for diagnostic evaluation.

Intended/Indications for Use:

Statement of Substantial Equivalence:

The technological characteristics of the Zuma Dental Z-Ray System is essentially the same as the referenced predicate devices with respect to intended use, design, materials and operating characteristics. Minor technological differences do not raise any new questions regarding the safety or effectiveness of the device.

Comparison Table:

The following table compares the technological characteristics between the Zuma Z-Ray System and the referenced predicate devices, Schick Computed Oral Radiography System (K072134) and the Dexis Sensor (K090458).

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510k Number: To be determined

Image /page/2/Picture/3 description: The image shows the logo for Zuma Dental. The word "zuma" is in large, bold, black letters on the top line. Below that, the word "DENTAL" is in smaller, black letters with a sans-serif font. The logo is simple and modern.

Comparison to Predicate Devices:

Parameter	Z-Ray510k #: TBD	Schick CDR System(K072134)	Dexis Sensor(K090458)
Indications for Use	The Z-Ray digitalradiography system wasdesigned for the solepurpose of capturingradiographic images ofteeth and the surroundingstructures limited to theoral cavity. This deviceshould be used under thedirection of a licensedDentist when it is deemednecessary to perform aradiographic series of apatient for diagnosticpurposes.	The Computed OralRadiology System isintended for intra-oral x-rayexaminations and indicatedfor dental patients. Itproduces instant, digitalintra-oral x-ray images of apatient's mouth whilereducing the necessary x-ray dosage.	The Dexis sensor is aUSB-driven digital sensorwhich is intended toacquire dental intra-oralradiology images. TheDexis sensor shall beoperated by healthcareprofessionals who areeducated and competentto perform the acquisitionof dental intra-oralradiographs. The Dexissensor can be used eitherin combination withspecial positioning devicesto facilitate positioning andalignment with the x-raybeam or it may also bepositioned by hand withthe assistance of apatient.
Number of Sensors	2	3	1
Sensor size (mm)Active Area	32.6 x 20.5mm36 x 27mm	31 x 22mm37 x 24mm43 x 30mm	30 x 39mm
Sensor Technology	CMOS	CMOS	CMOS
System Technology	Computed DirectRadiography	Computed DirectRadiography	Computed DirectRadiography
Interface to PC	USB	USB	USB
Data BoxConnection to PC	Standard USB Cable	Standard USB Cable	Standard USB Cable
Power Supply	Powered through USBconnection	Powered through USBconnection	Powered through USBconnection
Dynamic Range	4096:1	4096:1	16,384:1
Image Capture S/WReq'd	Yes	Yes	Yes
Sensor CableLength (m)	2.0m	2.0m	2.8m

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Image /page/3/Picture/2 description: The image shows the logo for Zuma Dental. The word "zuma" is in large, bold, black letters on the top line. Underneath, the word "DENTAL" is in smaller, black letters.

Safety and Effectiveness Information:

Summary of Non-Clinical Tests and Evaluations Performed:

Electrical, mechanical and performance safety testing and evaluations were conducted in accordance with ANSI/UL 60601-1 Standard for Safety, Medical Electrical Equipment, Part 1 and, IEC 60601-1-2, Medical Electrical Equipment - Part 1 - 2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. All test results were satisfactory.

Non-Clinical considerations were conducted in accordance with FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, Section VI". All test results were satisfactory.

The software of the Zuma Z-Ray System has been validated according to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and applicable requirements contained in the guidance document.

Summary of Bench Test:

In-vitro bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, Section 18, Performance Testing - Bench". Results of the bench testing confirmed substantial equivalence in performance between the Zuma Z-Ray System and the predicate device Schick CDR (K072134) included in the test protocol for comparison evaluation. The qualified examiners concluded and certified that the diagnostic images produced by the Z-Ray System are equivalent to those produced by the predicate device.

The Zuma Z-Ray System was also tested at varying external x-ray source exposure parameters and found to continually produce diagnostic quality images as concluded by the examiners.

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510k Number: To be determin

Image /page/4/Picture/7 description: The image shows the logo for Zuma Dental. The word "zuma" is written in large, bold, sans-serif letters. Below "zuma" is the word "DENTAL" in a smaller, sans-serif font. There is a horizontal line below the word "DENTAL".

Conclusion:

Based on analyzing the device characteristics, bench-test, safety and non-clinical testing to applicable standards, it is the conclusion of Zuma Dental, LLC that the Z-Ray Digital Imaging System is as safe and effective as the referenced predicate devices. The Z-Ray system has minimal technological differences compared to the legally marketed predicate devices and is safe and effective for its intended use as well as substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

May 13, 2014

Zuma Dental, LLC % Albert Rego, Ph.D. Regulatory Consultant 27001 La Paz Road, Suite 312 MISSION VIEJO CA 92691

Re: K133206

Trade/Device Name: Z-Ray Intra-Oral Digital Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 12, 2014 Received: April 16, 2014

Dear Dr. Rego:

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 cnactment date of the Medical Device Amendments, or 10 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 notc: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not mislcading.

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.

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Page 2-Dr. Rego

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" (21CFR 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/McdicalDevices/Safetv/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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133206

Device Name

Zuma Dental Z-Ray Intra-Oral Digital Radiography System

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)

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) (Signalure)

Imgur

FORM FDA 3881 (9/13)

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.