The EVA SELECT Digital Dental Imaging System is intended to be used with standard dental X-ray systems and computer stations for system operation, archive data storage, digital dental image input capture and enhancement, and patient data and support.

Device Description

The EVA SELECT System (previously named the EVA System) has been modified to incorporate a new sensor component. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent EVA Digital Dental Imaging System. The modifications are limited to changing the sensor from a proprietary design to a commercially available sensor which is already used in at least 2 devices with pre-market clearances (K112380 and K102456). As with the original EVA Sensor, the CMOS sensor when exposed to radiation uses a scintillator to indirectly capture the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized and sent to a computer via a USB interface. The images are then available for display on a computer monitor screen.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EVA Select Digital Dental Imaging System:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in the typical sense for performance metrics like sensitivity, specificity, or image quality scores. Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices, focusing on demonstrating that the new device is "as safe and effective" and offers "equal or better image quality." The technical characteristics table serves as a comparison against established devices.

Acceptance Criteria (Implicit from Predicate Comparison)	Reported Device Performance (EVA SELECT)
Intended Use: For use with standard dental X-ray systems and computer stations for system operation, archive data storage, digital dental image input capture and enhancement, and patient data and support.	Meets: Intended use is identical to the original EVA Digital Dental Imaging System.
Number of Sensors: 2 Sizes (e.g., matching or exceeding predicate)	Meets: 2 Sizes. Both sizes match the pixel dimensions of the predicate Clear Vision and BelSensor Gold.
Sensor Sizes (mm): Comparable to or exceeding predicate devices (e.g., 19.95mm x 30.02mm, 36.00mm x 25.99mm)	Meets: 19.95 mm x 30.02 mm and 36.00 mm x 25.99 mm (matches Clear Vision and BelSensor Gold).
Pixel Size (μm): Comparable to or lower than predicate devices (indicating higher resolution potential)	Meets/Exceeds: 19 μm (improves upon original EVA's 30 μm, matches Clear Vision and BelSensor Gold).
Resolution (lp/mm): Theoretical and actual resolution comparable to or exceeding predicate devices.	Meets/Exceeds: 26.3 lp/mm (theoretical), 18.0 lp/mm (actual). Improves upon original EVA, matches Clear Vision and BelSensor Gold.
Technology: CMOS	Meets: CMOS (matches all predicates).
Scintillation: Comparable to predicate devices (e.g., CsI or GadOx)	Meets: CsI (improves upon original EVA's GadOx, matches Clear Vision and BelSensor Gold).
Interface with PC: USB	Meets: USB (matches all predicates).
Power Source: 5 V (USB)	Meets: 5 V (USB) (matches all predicates).
Gray Shades: 4096	Meets: 4096 (matches all predicates).
Cable Length (m): Minimum or comparable to predicate devices	Meets: 3m (improves upon original EVA's 2m, matches Clear Vision and BelSensor Gold).
Electrical Safety and EMC: Compliance with IEC Standards.	Meets: Bench testing confirms compliance.
Risk Analysis and Software Validation: In accordance with FDA guidance.	Meets: Bench testing confirms compliance.
Image Quality: Clinical images demonstrate equal or better image quality compared to predicates.	Meets: Concluded by a qualified dentist.

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

Sample Size for Test Set: Not explicitly stated with a specific number of images or patients. The text mentions "Clinical images were acquired" and "Clinical images collected," implying a sample was used but without a quantitative count.
Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

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

Number of Experts: "a qualified dentist" (singular).
Qualifications of Experts: "qualified dentist." No further details on years of experience, specialization (e.g., oral radiologist), or any specific board certifications are provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not explicitly described. As only "a qualified dentist" evaluated the images, there's no mention of a multi-reader adjudication process (e.g., 2+1, 3+1). The evaluation appears to be a single expert's opinion.

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

MRMC Study Done: No. The submission does not describe an MRMC study comparing human readers with AI assistance versus without AI assistance. The focus is on the device's technical specifications and a single expert's assessment of image quality against predicates. The device itself is an imaging system, not an AI-assisted diagnostic tool in this context.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study Done

Standalone Study Done: Not applicable in the context of an imaging system. This device is a digital dental imaging system (hardware and software for image capture and display), not an algorithm designed for standalone diagnostic performance. The "algorithm" here refers to image processing within the system for display, not an AI diagnostic algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for image quality was based on expert opinion/consensus (from a single "qualified dentist") comparing the EVA Select images to those acquired with predicate panels. It is not based on pathology reports or clinical outcomes data in this submission.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The device is a digital imaging system, and the submission describes its hardware and basic software functions (image capture, enhancement, display). There is no mention of a machine learning algorithm that would require a "training set" in the conventional AI sense. The device uses standard image processing techniques.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for machine learning.

Summary

{0}------------------------------------------------

K123419

510(k) Summary 510(k) Number K12 AFP Imaging Corporation dba ImageWorks 250 Clearbrook Road, Suite 240 Elmsford, NY 10523 USA 914.592.6100 - Voice 800.592.6666 - Toll Free 914.592.6148 - Fax Prepared by: James Johnson, Director of Engineering Date Prepared: 23 October 2012

DEC 2 7 2012

Device Name 1.

Proprietary Name: Common/Usual Name: Classification Name: Classification Code:

EVA Select Digital Dental Imaging System Accessory to Extra oral X-Ray System Extra oral Source X-Ray System Accessory MUH

PREDICATE DEVICES 2.

AFP Imaging EVA Digital Dental Imaging System K030647 .
Midmark Clearvision K112380 .
Takara Belmont Belsensor Gold K102456 ●

3. Intended Use

Device Description র্বা

6. Substantial Equivalence and Technological Characteristics

{1}------------------------------------------------

DescriptionInformation	EVA K030647	Clear VisionK112380	BelSensor GoldK102456	EVA SELECT
Manufacturer	AFP Imaging	Mid Mark	Takara Belmont	AFP Imaging dbaImageWorks
Intended Use	The EVA DigitalDental ImagingSystem is intendedto be used withstandarddigital dental X-raysystems andcomputer stationsfor systemoperation, archivedata storage, inputcapture andenhancement, andpatient data andsupport.	ClearVision isintended to beused by dentistsand otherqualifiedprofessionals forproducingdiagnostic x-rayradiographs ofdentition,jaws and otheroral structures.	The BelSensor GOLDis a USB-driven digitalsensor which is intendedto acquire dental intra-oral radiology images.The BelSensor GOLDshall be operated byhealthcare professionals,who are educated andcompetent to performthe acquisition of dentalintra-oral radiographs.The BelSensor GOLDcan be used either incombination withspecial positioningdevices to facilitatepositioning andalignment with the x-ray beam or it mayalso be positioned byhand with theassistance of a patient.	The EVASELECT DigitalDental ImagingSystem isintended to beused withstandard dentalX-ray systemsand computerstations forsystem operation,archive datastorage, digitaldental imageinput capture andenhancement,and patient dataand support.
Number ofSensors	2 Sizes	2 Sizes	2 Sizes	2 Sizes
Sensor Sizes(mm)	19.92mm x 29.97mm36.03 mm x 25.83mm	19.95 mm x 30.02mm36.00 mm x 25.99mm	19.95 mm x 30.02 mm36.00mm x 25.99 mm	19.95 mm x 30.02mm36.00 mm x 25.99mm
Pixel Size	30 μm	19 μm	19 μm	19 μm
Resolution	Resolutiontheoretical(optical)= 16.67 lp/mmResolution actual =12 lp / mm	26.3 lp/mm(theoretical)18.0 lp/mm(actual)	26.3 lp/mm(theoretical)18.0 lp/mm (actual)	26.3 lp/mm(theoretical)18.0 lp/mm(actual)
Technology	CMOS	CMOS	CMOS	CMOS
Scintillation	GadOx	CsI	CsI	CsI
Interface withPC	USB	USB	USB	USB
Power source	5 V (USB)	5 V (USB)	5 V (USB)	5 V (USB)
Gray Shades	4096	4096	4096	4096
Cable Length	2 m	3 m	3 m	3 m

:・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

7. 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.

{2}------------------------------------------------

Summary of Bench Testing Conducted: 8.

Line pair phantoms and step wedge images were evaluated. IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility standards compliance. Risk Analysis and Software validation was conducted in accordance with FDA guidance documents.

9. Summary of Clinical Testing:

Clinical images were acquired and evaluated by a qualified dentist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel.

10. Conclusion:

After analyzing bench, image, and external laboratory testing to applicable standards, it is the conclusion of AFP Imaging Corporation that the EVA SELECT is as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 27,2012

AFP Imaging Corporation c/o Daniel Kamm. P.E. Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114

Re: K123419

Trade/Device Name: EVA Select Dental Imaging System Regulation Number: 21 CFR 892.1800 Regulation Name: Extraoral Source X-ray System Regulatory Class: Class II Product Code: MUH Dated: Oct. 29, 2012 -Received: Nov. 6, 2012

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, Trug, 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 I ( 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. .

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. Yourse of 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

{4}------------------------------------------------

Page 2 - Mr. Kamm

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Michael D. O'Hara

Louis M. Vlahos

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

Enclosure

{5}------------------------------------------------

510(k) Number (if known): K123419

Device Name: EVA Select Digital Dental Imaging System

The EVA SELECT Digital Dental Imaging System is intended to be used Indications for Use: with standard dental X-ray systems and computer stations for system operation, archive data storage, digital dental image input capture and enhancement, and patient data and support.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) < 12 3 41 9

Page 1 of 1

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.