The EAGLE EDGE AXR90 and AXR120 are CBCT / Panoramic / Cephalometric X-Ray units designed to obtain 2D and 3D radiological images of the oral anatomy, including teeth, maxillofacial areas, oral structures, carpal images and head-neck bone regions. This system is exclusively for dental use and should be handled only by qualified health professionals.

Device Description

EAGLE EDGE Models AXR90, AXR120 are complete 3-in-1 dental imaging systems capable of generating panoramic, cephalometric and tomographic images using cone beam computerized tomography (CBCT) technique. The AXR90 has a maximum kVp of 90 while the AXR120 has a maximum kVp of 120. The digital acquisition process utilizes one or more X-ray sensors and automatic image processing that allow you to increase the speed of diagnosis and improve the workflow of your clinic.

AI/ML Overview

The provided document does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics in a table. It primarily outlines the non-clinical and clinical testing performed to establish substantial equivalence to a predicate device.

However, based on the information provided, here's a breakdown of what can be extracted and inferred regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with corresponding device performance metrics. Instead, it offers a qualitative assessment of imaging equivalence and software feature effectiveness.

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Safety Standards (Electrical, EMC)	All standards tests passed.
Biocompatibility	All tests passed.
Software Validation	Performed according to FDA guidance for moderate level of concern.
Cybersecurity	Compliance with FDA Guidance recommendations.
Image Quality (Equivalence to predicate)	Images found to be equivalent or better than predicate device.
Effectiveness of Motion Artifact Reduction Software	Found to be effective.
Effectiveness of Metal Artifact Reduction Software	Found to be effective.

2. Sample Size and Data Provenance:

Test Set Sample Size: The document does not specify a numerical sample size for the "Sample X-Ray images" taken for evaluation. It only states that images were taken "across the different operational modes".
Data Provenance: The document indicates that the evaluation was performed by a "USA Board Certified Radiologist" implying the data was evaluated in the USA, but the country of origin of the actual patients for the "Sample X-Ray images" is not explicitly stated. The manufacturer is from Brazil (Alliage S/A Indústrias Médico Odontológica, Rodovia Abrão Assed, ... Ribeirão Preto - São Paulo- Brazil), so it's possible the images were generated in Brazil. The study is retrospective in the sense that the images were taken and then evaluated, but it's not explicitly labeled as such.

3. Number of Experts and Qualifications:

Number of Experts: At least one expert. The document states, "Image evaluation was performed by both licensed dentist and a USA Board Certified Radiologist." and "These images were evaluated by an American Board of Radiology certified radiologist." This indicates one radiologist and at least one licensed dentist.
Qualifications of Experts:
- "USA Board Certified Radiologist" or "American Board of Radiology certified radiologist."
- "licensed dentist."

4. Adjudication Method:

The document does not describe a formal adjudication method (like 2+1 or 3+1). It states that image evaluation was performed by multiple individuals ("both licensed dentist and a USA Board Certified Radiologist"), but it doesn't detail how disagreements, if any, were resolved or if a consensus mechanism was employed.

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

A full MRMC comparative effectiveness study, comparing human readers with and without AI assistance to quantify improvement, was not reported. The study focused on assessing the device's image quality and the effectiveness of its built-in software features (motion and metal artifact reduction) in a standalone capacity.

6. Standalone Performance:

Yes, a standalone performance assessment was done. The "Sample X-Ray images" taken by the device were evaluated by a radiologist to determine image quality and the effectiveness of the software features (motion and metal artifact reduction). This evaluation was of the algorithm's output without direct human-in-the-loop interaction for diagnostic decision-making improvement.

7. Type of Ground Truth:

The ground truth used for evaluating image quality and software effectiveness appears to be expert consensus/opinion. The "USA Board Certified Radiologist" and "licensed dentist" provided their professional opinions on the equivalence of images to the predicate and the effectiveness of the artifact reduction software. There is no mention of pathology or outcomes data as ground truth.

8. Sample Size for the Training Set:

The document does not specify a sample size for the training set. It mentions "software validation" but doesn't detail any machine learning models or their training data. The entire submission focuses on the X-ray units and their imaging capabilities, not on an AI diagnostic algorithm.

9. How Ground Truth for Training Set was Established:

Since a training set for an AI model is not explicitly mentioned, the method for establishing its ground truth is not provided. The document describes validations for safety, EMC, biocompatibility, and software in general, but not the specific training process for an AI component with an associated ground truth.

Summary

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August 10, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.

Alliage S/A Industrias Médico Odontológica % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K210820

Trade/Device Name: EAGLE EDGE AXR90 and AXR120 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: July 9, 2021 Received: July 12, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

. for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210820

Device Name EAGLE EDGE AXR90 and AXR120

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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Image /page/3/Picture/0 description: The image contains the title "510(k) Summary K210820" at the top. Below the title is the word "alliage" in a large, bold, dark blue font. The text "Alliage S/A Indústrias Médico Odontológica" is below the word "alliage". The address "Rodovia Abrão Assed, Km 53+450m" is on the next line.

Rodovia Abrão Assed, Km 53+450m Recreio Anhanguera, CEP 14097-500, Ribeirão Preto - São Paulo- Brazil Tel +55 16 3512-1212

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date prepared: August 6, 2021

1. Company and Correspondent making the submission:
Name: Alliage S/A Indústrias Médico Odontológica
Address: Rod. Abrão Assed, Km 53+450m Recreio Anhanguera, CEP 14097-500, BRAZI
Telephone: +55 16 3512-1212
Contact: Daniel Camargo

2. Trade /Proprietary Name:	EAGLE EDGE AXR90 and AXR120
Device:	X-Ray, Tomography, Computed, Dental
Regulation Description:	Computed tomography x-ray system.
Regulation Medical Specialty:	Radiology
Review Panel:	Radiology
Product Code:	OAS
Regulation Number:	892.1750
Device Class:	2

3. Legally Marketed Predicate Device Information:

510(k) Number:	K152489
Manufacturer:	Panoramic Corp
Trade /Proprietary Name	ENCOMPASS Eagle 3D CBCT
Device:	X-Ray, Tomography, Computed, Dental
Regulation Description:	Computed tomography x-ray system.
Regulation Medical Specialty:	Radiology
Review Panel	Radiology
Product Code	OAS
Regulation Number	892.1750
Device Class	2

4. Description:

Models: (Customer decides which modalities are desired)

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Pan only Pan + Ceph (Single Sensor) Pan + Ceph (Two Sensors) CBCT + PAN CBCT + PAN + CEPH

Sensor Technology Discussion:

For Panoramic only configuration we have validated two possible detector models are: The Alliage SPB PAN (CMOS 157.5x6.4) OR the XINEOS 1501 (CMOS 152x6.8) for panoramic acquisition

For Panoramic with Cephalostat configuration it has two options it depends on the client choice if he wants one single mobile digital sensor or two fixed digital sensor. For option with one single mobile digital sensor two possible detector models are: Alliage SPB CEPH (CMOS 220x6.4) OR XINEOS 2301 (CMOS 225.2x6.8) for panoramic and cephalometric acquisitions

For the option with two fixed digital sensor possible detector models are: Alliage SPB PAN (CMOS 157.5x6.4) OR the XINEOS 1501 (CMOS 152x6.8) for panoramic acquisition Alliage SPB CEPH (CMOS 220x6.4) OR XINEOS 2301 (CMOS 225.2x6.8) for cephalometric acquisition

For Tomography configuration, the detector model is VIVIX 0606C (CMOS 153.2x153.2) for CBCT and Panoramic acquisition

For Tomography with cephalostat configuration possible detector models are: VIVIX 0606C (CMOS 153.2x153.2) for CBCT and Panoramic acquisition Alliage SPB CEPH (CMOS 220x6.4) OR XINEOS 2301 (CMOS 225.2x6.8) for cephalometric acquisition

5. Indications for use:

6. Comparison with predicate devices:

The Encompass Eagle 3D CBCT/panoramic/cephalometric Dental X-ray consists of a configuration which implements 3D use a Cone beam Computed Tomography. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. The new device EAGLE EDGE AXR90 and AXR120 CBCT / Panoramic / Cephalometric X-Ray is digital capture type CBCT / Panoramic / Cephalometric system. The technologies employed by the predicate and our new device are almost identical.

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ITEM		ENCOMPASS 3D K152489	EAGLE EDGE AXR90, AXR120
Indications for use		Intended to acquire two-dimensionaldigital panoramic and cephalometricradiographies, and multi-field of view3D computed tomography images ofdento-maxillo-facial region for thepurpose of advanced diagnosis at thedirection of qualified dentalhealthcare professionals.	The EAGLE EDGE AXR90 and AXR120are CBCT / Panoramic / CephalometricX-Ray units designed to obtain 2D and3D radiological images of the oralanatomy, including teeth, maxillofacialareas, oral structures, carpal imagesand head-neck bone regions. Thissystem is exclusively for dental use andshould be handled only by qualifiedhealth professionals. (SAME, differentwording)
X-RayGenerationDevice	Tubevoltage	60-85 kV	AXR90: 60- 90kV(at 90kV max. 12.5mA)AXR120: 60-120 kV(at 120kV max. 8mA)(Higher kV can provide better images)
	TubeCurrent	4-8 mA	3.2-16 mA
	Focal spotSize	0.5 mm	0.5 mm
	Detector	CMOS (CT)CCD (Panoramic)CCD (Ceph)	CMOS/a-Si (CT)CMOS (Panoramic)CMOS (Ceph)
	Pixel Size	100 μm (CT)108 μm (Panoramic)108 μm (Ceph)	119 μm (CT)100 μm (Panoramic)100 μm (Ceph)
X-Ray imagecapturingdevice	Size ofAreareceivingX-Ray	131.6 x 131.2 mm (CT)6.9 x 151 mm (Panoramic)6.9 x 221 mm (Ceph)	214.9 x 215,5 (CT)6.8 x 225,2 (Panoramic)6.8 x 228 (Ceph)Larger panel size for CT. Otherwisenot an important difference.
	Numberof Bits	14 bits (CT)16 bits (Ceph, Panoramic)	16 bits (CT)14 bits (Panoramic, Ceph)Not a useful difference
	SID/SOD	634mm/400mm(CT)564mm/400mm (Panoramic)1681mm/1511mm (Ceph)	620mm/400mm (CT)620mm/400mm (Panoramic)1732,5mm/1473,65mm (Ceph)
Scanner	Dimension(WxDxH)	1511mm x 1074mm x 1742mm	Main Unit: 1711 x 586 x 1318Cephalostat: 1105 x 665 x 963mmBase: 1215 x 770 x 300mmComparable dimensions
ITEM		ENCOMPASS 3D K152489	EAGLE EDGE AXR90, AXR120
Weight		152 Kg	160 Kg Comparable weight
Imaging Mode		CT scan, Panoramic scan,Cephalometric radiography	CT scan, Panoramic scan,Cephalometric radiography SAME
Panoramic ScanPerformance		Standard Panoramic: 14 secTMJ Panoramic: 14 secMaxillary Sinus: 8 secImproved Orthogonality Panoramic: 14secLow Dose Panoramic: 11 secChild Panoramic: 10.5 secBitewing: 7.6 secImproved Bitewing: 7.6 sec	Standard Panoramic: 14 secFast Panoramic: 10 secImproved orthogonality: 14 secInfant: 10 secMaxillary sinus: 8 secTMJ: 10 secTMJ PA: 10 secBitewing: 7.6 secLateral section: 6 secCenter section: 3.5 sec
CephalometricRadiography		LA, PA, Carpus, Oblique:6.6, 10, 11, 16.5 sec	AP/PA, LL, Carpal, Oblique: 4~16,5 sec
CT ScanPerformance	Scan Time	Low Dose: 16.5 secStandard Dose: 20.5 secHigh Definition: 25.5 secUltra High Definition: 32.0 sec	Fast Scout: 0.1 secFull Scout: 0.2 secLow Dose: 10 secStandard: 15 secHigh Definition: 20 secUltra High definition 25 sec
	FOV(VoxelSize)	5x5mm; 6x8mm; 8x8mm; 8x12mm8x16mm	5x5mm; 6x9mm; 9x9mm; 9x16mm15x16mm; 21x16mm
Photo		Image: ENCOMPASS 3D K152489	Image: EAGLE EDGE AXR90, AXR120

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1. Non-clinical Testing Performed: Safety, EMC, Biocompatibility and Performance Data: Safety and performance testing was conducted by an internationally recognized testing laboratory Underwriters Laboratories standard(s) for Safety: ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, CSA CAN/CSA-C22.2 NO. 60601-1:14, IEC 60601-1 Edition 3.1 (2012), IEC 60601-1 Edition 3.1 (2012) Additional Standards applied:

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IEC 60601-1-3:2008 (Second Edition) + A1:2013, IEC 60601-1-6:2010 (Third Edition) + A1:2013, IEC 60601-2-63:2012 (First Edition)

A different accredited laboratory "IBEC" (Instituto Brasileiro de Conformidade Ltda) tested the system according to IEC 60601-1-2 Ed. 4.0 (2014) —Collateral standard: Electromagnetic disturbance - Requirements and tests. All standards tests passed.

Biocompatibility evaluation was performed in accordance with EN ISO 10993-1: 2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. These tests were conducted for irritation, sensitization, and cytotoxicity. All tests passed. Risk analysis and software validation was performed according to the FDA guidance document Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (for a moderate level of concern.)

Consideration was given to cybersecurity via compliance with the recommendations of the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff.

Each unit manufactured is 100% tested for Connection to the Software, Exposure Accuracy, Tube Voltage and Exposure Time, Reproducibility, Beam Quality, Tube Efficiency, and Leakage Radiation. Image evaluation was performed by both licensed dentist and a USA Board Certified Radiologist.. Dental images were compared to the images obtained on the predicate device and found to be equivalent or better. In addition, the Radiologist evaluated the effectiveness of the motion artifact reduction software and the metal artifact reduction software. These software features were found to be effective.

1. Clinical Testing Performed: Sample X-Ray images were taken by the Eagle Edge AXR90 and AXR120 across the different operational modes, i.e. Panoramic, Cephalometric, tomographic/CBCT scans. These images were evaluated by an American Board of Radiology certified radiologist.

9. Conclusions:

According to the Federal Food, Drug and Cosmetic Law, 21 CFR Part 807 and based on the information provided in this pre-marketing notification, Alliage S/A Indústrias Médico Odontológica concludes that EAGLE EDGE AXR90 and AXR120 CBCT / Panoramic / Cephalometric X-Ray is safe and effective and substantially equivalent to predicate devices, as described in this document.

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Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.