The EDLENi sensor is an intra-oral x-ray sensor driven via CMOS technology indicated for the acquirement of intra-oral dental radiographs and intended for dental patients. The EDLENi will be handled via qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The sensors will be used to provide intra-oral radiographic images that ultimately diagnose general dental complications or abnormalities. The EDLENI sensor can be used in combination with positioning devices to facilitate alignment with the x-ray beam, or it may be positioned manually.

Device Description

The EDLENi sensor is an electronic medical device used to acquire intra-oral radiographic images. The sensor can be operated by Radiologists, Dentists, Dental Assistants and other healthcare professionals, who are both trained and competent to take Dental X-ray radiographs. Intra-oral positioning of the sensor is accomplished by the use of dedicated intra-oral positioning devices that facilitate the accurate alignment of the x-ray beam. The sensor may also be aligned with the assistance of the patient. The EDLENi sensor is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium Iodide (CsI) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The EDLENi allows for automatic detection of such incident x-rays in order to generate data. Software interprets this data into images used for dental applications. The EDLENi sensor supports USB 2.0 direct connectivity to personal computers and or laptops with dedicated electronics and a sensor software driver.

AI/ML Overview

The provided document is a 510(k) Summary for the EDLENi Intra-Oral Sensor. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria based on diagnostic performance. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth types is not available in this document.

Here's an analysis of what can be extracted and what is not present:

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

Acceptance Criteria: Not explicitly stated in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy for specific clinical conditions). The primary acceptance criterion seems to be demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness, and compliance with relevant standards.
Reported Device Performance: The document states, "Performance testing data according to the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices have been provided to demonstrate substantial equivalence." However, the specific performance data itself (e.g., image quality metrics like spatial resolution, contrast resolution, DQE, noise) is not detailed in this summary.

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: Not specified.
Data Provenance: Not specified.
The document explicitly states: "Clinical images were not provided; clinical images were not necessary to establish substantial equivalence based on the modifications of the device." This indicates that if performance testing involved image acquisition, it likely did so under phantom or laboratory conditions, not with patient data.

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)

Not applicable. Since clinical images were not used, and the goal was substantial equivalence based on technical modifications rather than diagnostic performance, there was no need for expert ground truth establishment in a diagnostic context.

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

Not applicable. No clinical test set requiring adjudication was used.

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

No, an MRMC study was not done. This document pertains to an intra-oral x-ray sensor, which is a hardware device for image acquisition, not an Artificial Intelligence (AI) or CAD software for diagnosis. Therefore, AI assistance is not relevant to this submission.

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

No. This device is a sensor, not a standalone diagnostic algorithm. Its performance is related to image acquisition quality, which is then interpreted by human professionals.

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

Not applicable for diagnostic ground truth. The "ground truth" for the performance testing performed would likely revolve around objective technical measurements (e.g., measuring line pairs per millimeter for spatial resolution, signal-to-noise ratios, etc.) against expected or predicate device performance. This is not a clinical ground truth.

8. The sample size for the training set

Not applicable. This device is a sensor and does not utilize a training set in the context of machine learning or AI.

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

Not applicable.

Summary of available information:

Device: EDLENi Intra-Oral Sensor
Purpose of Submission: Demonstrate substantial equivalence to predicate devices for acquiring intra-oral dental radiographs.
Key Argument for Substantial Equivalence: The only modifications compared to the predicate are the use of two new Hamamatsu CMOS sensors (instead of CCD) for readout, while maintaining the same detection material (Cesium Iodide).
Performance Testing: "Performance testing data according to the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices have been provided to demonstrate substantial equivalence." (Specific metrics are not detailed in this summary).
Clinical Data: "Clinical images were not provided; clinical images were not necessary to establish substantial equivalence based on the modifications of the device."
Safety and Effectiveness: Confirmed through compliance with IEC 60601-1-2 (Electromagnetic Compatibility), software design, verification, validation testing, and risk assessment.

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 the department's name encircling a stylized symbol. The symbol consists of a caduceus-like design with three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity.

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

August 26, 2015

Edlen Imaging LLC % Nick Radachi General Manager 16441 North 91st Street Suite 102 SCOTTSDALE, AZ 85250

Re: K150823

Trade/Device Name: EDLENi Intra-Oral Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: MUH Dated: August 11, 2015 Received: August 13, 2015

Dear Nick Radachi,

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 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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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,

Robert A Ochs

Robert Ochs, Ph.D. Acting 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) K150823

Device Name EDLENi Intra-Oral Sensor

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

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

Submitter:	Edlen Imaging LLC
	16441 N 91st Street Suite 102Scottsdale, Arizona USA 85260
Contact Person:	Nick Radachi
	480-452-2939
	nick@edlenimaging.com
Date Prepared:	March 24, 2015
Trade Name:	EDLENi Intra-Oral Sensor
Common Name:	Digital x-ray sensor
Classification Name:	872-1800 Extraoral source x-ray system
Class:	II
Product Code:	MUH
Predicate Devices:	The EDLENi is compared with the following predicate devices:
	Edlen Imaging's Gemini-DUSB system Classification Name: System, X-ray, Extraoral Source, Digital 510K Number: K103290 Product Code: MUH Schick Technologies' CDR system Classification Name: System, X-ray, Extraoral Source, Digital 510K Number: K072134 Product Code: MUH

Product Description: The EDLENi sensor is an electronic medical device used to acquire

intra-oral radiographic images. The sensor can be operated by Radiologists, Dentists, Dental Assistants and other healthcare professionals, who are both trained and competent to take Dental X-ray radiographs. Intra-oral positioning of the sensor is accomplished by the use of dedicated intra-oral positioning devices that facilitate the accurate alignment of the x-ray beam. The sensor may also be aligned with the

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assistance of the patient. The EDLENi sensor is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium Iodide (CsI) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The EDLENi allows for automatic detection of such incident x-rays in order to generate data. Software interprets this data into images used for dental applications. The EDLENi sensor supports USB 2.0 direct connectivity to personal computers and or laptops with dedicated electronics and a sensor software driver.

Indication for Use: The EDLENi sensor is an intra-oral x-ray sensor driven via CMOS

technology indicated for the acquirement of intra-oral dental radiographs and intended for dental patients. The EDLENi will be handled via qualified dental and healthcare professionals in order to perform basic dental intraoral x-ray imaging procedures. The sensors will be used to provide intraoral radiographic images that ultimately diagnose general dental complications or abnormalities. The EDLENi sensor can be used in combination with positioning devices to facilitate alignment with the x-ray beam, or it may be positioned manually.

Rationale for

Substantial Equivalence: The only modifications in the subject device compared to the predicate are the two new Hamamatsu CMOS sensors. The detectors compared to the predicate have the same detection material; the modification is the readout using CMOS instead of CCD.

Safety and Effectiveness

Information: The device labeling contains operating instructions for safe and effective use of EDLENi. The software development for this device follows documented processes for software design, verification and validation testing. Final device validation and risk assessment has been conducted, to identify potential design hazards that could cause an error or injury based on the use of this device. Appropriate steps have been taken to control all identified risks. The device has been tested for compliance to IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

Add'l Statements: Performance testing data according to the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices have been provided to demonstrate substantial equivalence. Clinical images were not provided; clinical images were not necessary to establish substantial equivalence based on the modifications of the device.

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Conclusion: EDLENi performs the same functions in the same environment as the predicate devices. It shares the same technology as the predicate devices. It is based on well known technology. It is as safe and effective as the predicate devices. We believe it does not introduce any new safety risks and is substantially equivalent to the predicate devices.

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.