(108 days)
The DENTAL CT SCANNER AXR is 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.
The Dental CT Scanner AXR is a complete 4-in-1 dental imaging system capable of generating panoramic, cephalometric and tomographic images using cone beam computerized tomography technique (Cone Beam). The AXR90 has a maximum kVp of 90 while the AXR120 has a maximum kVp of 120. The digital acquisition process utilizes an X-ray sensor and automatic image processing that allow you to increase the speed of diagnosis and improve the workflow of your clinic.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dental CT Scanner AXR, presented in the requested format.
It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report for novel AI algorithms. Therefore, specific details common in AI/ML performance studies, such as effects of AI assistance on human readers, detailed ground truth establishment for a large test set, and precise metrics for algorithm-only performance against acceptance criteria, are not present in this type of document. The "device" in this context refers to the entire CT scanner, not a specific AI component for interpretation.
Acceptance Criteria and Device Performance Study for Dental CT Scanner AXR
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Safety | General Electrical Safety (IEC 60601-1) | All tests passed | Met |
| Electromagnetic Compatibility (IEC 60601-1-2) | All tests passed | Met | |
| Radiation Safety (IEC 60601-1-3, IEC 60601-2-63) | All tests passed | Met | |
| Biocompatibility (EN ISO 10993-1) | All tests passed | Met (for irritation, sensitization, cytotoxicity) | |
| Risk Analysis & Software Validation | Performed according to FDA guidance for moderate level of concern | Met | |
| Cybersecurity | Complied with FDA guidance recommendations | Met | |
| Performance | Image Evaluation | Images found to be equivalent or better than predicate device | Met (Qualitative assessment) |
| Manufacturing/Quality | Connection to Software | 100% tested | Met |
| Exposure Accuracy | 100% tested | Met | |
| Tube Voltage and Exposure Time | 100% tested | Met | |
| Reproducibility | 100% tested | Met | |
| Beam Quality | 100% tested | Met | |
| Tube Efficiency | 100% tested | Met | |
| Leakage Radiation | 100% tested | Met |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention a specific "test set" in the context of an AI algorithm's performance evaluation against ground truth. The performance data presented refers to the overall system's image quality and technical specifications.
- Sample Size: Not applicable in the context of an AI test set. The document states that "Each unit manufactured is 100% tested" for certain technical parameters. For image evaluation, a single statement is made: "Dental images were compared to the images obtained on the predicate device." This suggests a qualitative comparison rather than a quantitative study on a defined test set.
- Data Provenance: Not specified. Based on the manufacturer's location (Brazil), it's likely the "dental images" used for comparison were generated internally or through clinical partners in Brazil. The data is implicitly retrospective as it compares images from the new device to a predicate, not a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Two experts are mentioned for image evaluation: "both licensed dentist and a USA Board Certified Radiologist." The exact number of licensed dentists is not specified (e.g., one or multiple).
- Qualifications:
- "licensed dentist" (general qualification)
- "USA Board Certified Radiologist" (specific high-level qualification in radiology)
4. Adjudication Method for the Test Set
No formal adjudication method (e.g., 2+1, 3+1) is described. The text states that "Dental images were compared to the images obtained on the predicate device and found to be equivalent or better," implying a consensus or agreement was reached by the experts during their evaluation, but no structured adjudication process is 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 explicitly done. The document does not describe any study comparing human readers with and without AI assistance, nor does it provide an effect size for human reader improvement. The "Mult Slice" functionality is a software feature that enhances image quality for the reader by allowing virtual adjustment of the cutting plane, but it's not described as an AI-assisted diagnostic tool requiring an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is not described as having a standalone artificial intelligence component that performs diagnostic tasks without human-in-the-loop. The "Mult Slice" panoramic software functionality described is an image processing feature, not a diagnostic AI algorithm. Therefore, no standalone algorithm-only performance study was conducted or is relevant based on the provided information.
7. The Type of Ground Truth Used
The concept of "ground truth" for a diagnostic AI is not directly applicable here. The evaluation of the device relied on:
- Technical Standards Compliance: Successful completion of tests against established international safety and performance standards (IEC, ANSI/AAMI, EN ISO).
- Expert Qualitative Image Comparison: Subjective assessment by a licensed dentist and a USA Board Certified Radiologist, comparing images from the new device to those from the predicate device.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical imaging device (CT scanner) demonstrating substantial equivalence to a predicate, not an AI/ML algorithm that requires a training set. The "Mult Slice" function is described as a software functionality rather than a machine learning model that would be trained on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML algorithm is described in this submission.
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April 7, 2023
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alliage S/A Industrias Medico Odontológica. % Daniel Kamm Principal Engineer Kamm & Assosciates 8870 Ravello Ct Naples, FL 34114
Re: K223816
Trade/Device Name: Dental CT Scanner AXR Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: December 20, 2022 Received: December 20, 2022
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. 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
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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 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 (OS) 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 mediation-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,
Digitally signed by Gabriela M. Rodal -S
for
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of 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) K223816
Device Name DENTAL CT SCANNER AXR
Indications for Use (Describe)
The DENTAL CT SCANNER AXR is 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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 shows the text "510(k) Summary K223816" in bold font. The text is underlined. The image appears to be a document or report header.
Alliage S/A Industrias Medico Odontológica. 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: April 7, 2023
| 1. Company and Correspondent making the submission: |
|---|
| Name: Alliage S/A Industrias Medico Odontológica |
| Address: Rod. Abrão Assed, Km 53+450m Recreio Anhanguera, CEP 14097-500, BRAZIL |
| Telephone: +55 16 3512-1212 |
| Contact: Daniel Camargo |
| 2. Trade/Proprietary Name: | DENTAL CT SCANNER AXR |
|---|---|
| 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 |
-
- Legally Marketed Predicate Device Information:
| 510(k) Number: | K210820 |
|---|---|
| Manufacturer: | Alliage S/A Industrias Medico Odontológica |
| Trade /Proprietary Name | EAGLE EDGE AXR90, 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 |
- Description: The Dental CT Scanner AXR is a complete 4-in-1 dental imaging system capable of 4. generating panoramic, cephalometric and tomographic images using cone beam computerized tomography technique (Cone Beam).
The AXR90 has a maximum kVp of 90 while the AXR120 has a maximum kVp of 120. The digital acquisition process utilizes an X-ray sensor and automatic image processing that allow you to increase the speed of diagnosis and improve the workflow of your clinic.
Models: (Customer decides which modalities are desired)
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Pan only Pan + Ceph (Single Sensor) Pan + Ceph (Two Sensors) CBT + 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.
"Mult Slice" is a new software functionality that allows the user to adjust the position of the flattened arch image on the image cutting plane. To better explain, for dental panoramic image, the cutting plane is a region in which the structures positioned in it are reasonably well defined in the final image. In a conventional software, the equipment generate only one Slice of the panoramic image in the most favorable theoretical position in the cutting plane. In that case, image definition will depend on the patient being physically positioned on the equipment as close as possible to this ideal position. With the Mult Slice function, the software generates multiple images varying the ideal theoretical position. Thus, even if the patient is poorly positioned, it is possible to find the position where the image is best defined for the exam. Thus, by virtually moving the patient's ideal position, we can seek the bestdefined image in the final image for each exam."
-
- Indications for use: The DENTAL CT SCANNER AXR is designed to obtain 2D and 3D radiological images of the oral anatomy, including teeth, maxillofacial areas, oral images and head-neck bone regions. This system is exclusively for dental use and should be handled only by qualified health professionals.
-
- Comparison with predicate devices: The DENTAL CT SCANNER AXR 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
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compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. The new device DENTAL CT SCANNER AXR is a digital capture type CBCT / Panoramic / Cephalometric system. The technologies employed by the predicate and our new device are almost identical.
| Comparison Table | ||||
|---|---|---|---|---|
| ITEM | EAGLE EDGE AXR90 and AXR120X-Ray, Tomography, Computed,Dental K210820 | EAGLE EDGE and DABI ATLANTE /AXR120 and AXR90Dental CT Scanner AXR | ||
| Indications for use | EAGLE EDGE / DABI ATLANTE isdesigned to obtain radiologicalimages of the oral anatomy,including teeth, maxillofacialareas, oral structures, carpalimages and head-neck boneregions, and the same system, ofexclusive dental use should behandled by health professionalswith qualification and dulyqualified. | The DENTAL CT SCANNER AXR isdesigned to obtain 2D and 3Dradiological images of the oralanatomy, including teeth,maxillofacial areas, oral structures,carpal images and head-neck boneregions. This system is exclusivelyfor dental use and should behandled only by qualified healthprofessionals.(SAME) | ||
| X-Ray | Tube voltage | 60-120 kV | 60-120 kV (SAME) | |
| Generation | Tube Current | 3.2-16 mA | 1.8-16 mA (Greater range) | |
| Device | Focal spotSize | 0.5 mm | 0.2/0.5 mm (Smaller focal spotallows for detail enhancement) | |
| Detector | CMOS/a-Si (CT)CMOS (Panoramic)CMOS (Ceph) | CMOS/a-Si (CT)CMOS (Panoramic)CMOS (Ceph)(SAME) | ||
| X-Ray imagecapturing | Pixel Size | 151 µm (CT)100 μm (Panoramic)100 μm (Ceph) | 151 μm (CT)100 μm (Panoramic)100 μm (Ceph)(SAME) | |
| device | Size of Areareceiving X-Ray | 214.9 x 215.5 (CT)6.8 x 225.2 (Panoramic)6.8 x 228 (Ceph) | 214.9 x 215.5 (CT)6.8 x 225.2 (Panoramic)6.8 x 228 (Ceph)(SAME) | |
| Number ofBit | 16 bits (CT)14 bits (Panoramic, Ceph) | 16 bits (CT)14 bits (Panoramic, Ceph)(SAME) | ||
| Scanner | SID/SOD | 620mm/400mm (CT)620mm/400mm (Panoramic)1732.5mm/1473.65mm (Ceph) | 620mm/400mm (CT)620mm/400mm (Panoramic)1732.5mm/1473.65mm (Ceph)(SAME) | |
| Dimension(WxDxH) | 1607mm x 1007mm x 1504mm | 1607mm x 1007mm x 1504mm(SAME) |
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| ITEM | EAGLE EDGE AXR90 and AXR120X-Ray, Tomography, Computed,Dental K210820 | EAGLE EDGE and DABI ATLANTE /AXR120 and AXR90Dental CT Scanner AXR |
|---|---|---|
| Weight | 160 Kg | 160 kg (SAME) |
| Imaging Mode | CT scan, Panoramic scan,Cephalometric radiography | CT scan, CT scan 0.2FS, Panoramicscan, Mult slice panoramic scan,Cephalometric radiography(Mult slice added)(Different) |
| PanoramicScanPerformance | Standard Panoramic: 14 sFast Panoramic: 10 sImproved orthogonality: 14 sInfant: 10 sMaxillary sinus: 8 sTMJ: 10 sTMJ PA: 10 sBitewing: 7.6 sLateral section: 6 s | Standard Panoramic: 14 sFast Panoramic: 10 sImproved orthogonality: 14sInfant: 10sMaxillary sinus: 8sTMJ: 10sTMJ PA: 10sBitewing: 7.6sLateral section (left or right): 6sCenter section: 3.5s(SAME) |
| Cephalometric Radiography | AP/PA, LL, Carpal, Oblique: 4.1-16,5sec | AP/PA, LL, Carpal, Oblique: 4.1-16.5sec , Fast Ceph Mode from 2.5 to10s (Different) |
| CT ScanPerformance | Scan TimeFOV (VoxelSize) | Fast Scout: 0.1 secFull Scout: 0.2 secLow Dose: 10 secStandard: 15 secHigh Definition: 20 secUltra High definition 25 sec(SAME)5x5mm; 6x9mm; 9x9mm;15x16mm; 21x16mm(SAME) |
| 5x5mm; 6x9mm; 9x9mm;15x16mm; 21x16mm | Fast Scout: 0.1 secFull Scout: 0.2 secLow Dose: 10 secStandard: 15 secHigh Definition: 20 secUltra High definition 25 sec | |
| Photo | Image: EAGLE EDGE AXR90 and AXR120 | Image: EAGLE EDGE and DABI ATLANTE / AXR120 and AXR90 |
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7. 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:
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. We also took into consideration the FDA Guidance Document: Pediatric Information for X-ray Imaging Device Premarket Notifications when creating our labeling.
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.
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.
-
- 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 Industrias Medico Odontológica concludes that DENTAL CT SCANNER AXR is safe and effective and substantially equivalent to predicated devices, as described in this document.
§ 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.