(61 days)
PreXion3D Explorer is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
PreXion3D Explorer consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explorer Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.
X-ray image data is acquired while the rotation around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, CT-Panoramic scan) and Cephalometric Scan.
This document is a 510(k) premarket notification for the PreXion3D Explorer, a Computed Tomography X-Ray System. It primarily focuses on demonstrating substantial equivalence to a predicate device (PreXion3D Excelsior) rather than providing detailed clinical efficacy study results for an AI-powered device. Therefore, much of the requested information regarding acceptance criteria for AI performance and detailed study methodologies (like MRMC studies, ground truth establishment for AI, sample sizes for training/test sets for AI models, etc.) is not present in this document, as the device is not described as having an AI component in the manner of a diagnostic AI algorithm.
However, I can extract the acceptance criteria and performance data for the device itself based on the provided tables and text, treating "performance" as the device's physical capabilities and measured output rather than AI diagnostic performance.
Here's the closest interpretation of your request based on the provided document:
Device Name: PreXion3D Explorer
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the PreXion3D Explorer (Subject Device) to its predicate device (PreXion3D Excelsior) to demonstrate substantial equivalence. The "acceptance criteria" here are implicitly meeting or improving upon the predicate's performance and complying with relevant standards. The "reported device performance" is the measured characteristics of the PreXion3D Explorer.
| Acceptance Criteria (Implicit - based on Predicate and Standards) | Reported Device Performance (PreXion3D Explorer) | Comparison / Notes |
|---|---|---|
| Indications for Use: | ||
| - Produce 2D (panoramic, cephalometric) & 3D images of dental, oral, maxillofacial, ENT, neck regions for diagnosis in adult & pediatric patients. Cephalometric includes hand/wrist for growth/maturity assessment. | - Identical, with minor wording differences that "do not raise any additional questions of safety or efficacy." | Same |
| Target Population: Children aged 6+ to elderly | Children aged 6+ to elderly | Same |
| Anatomical Site: Dental, oral, maxillofacial, ENT, neck region | The dental, oral, maxillofacial, ENT, neck region | Same |
| Users: Health care professionals | Health care professionals | Same |
| Technological Characteristics: | ||
| - Patient Contact Material Biocompatibility: Safe for intended use (Polycarbonate, Silicone, PVC for predicate) | CHIN REST: polycarbonate, HEAD SUPPORT: carbon, HANDLE GRIP: silicone rubber | "Biocompatibility test results support that the material is safe for the intended use." (Implies acceptance criteria met) |
| - Sterility: Non-sterile | Non-sterile | Same |
| - X-ray Tube Voltage: Comparable/Safe (60-110KV for predicate) | 90-110KV | "Applied current is reduced so that the dose level is equivalent." (Implies meeting dose safety criteria despite higher minimum voltage) |
| - Pulse Exposure Function: Yes | Yes | Same |
| - X-ray Tube Current: Comparable/Safe (1-6mA for predicate) | 1-3mA | "Applied current is reduced so that the dose level is equivalent." (Implies acceptance criteria for dose met) |
| - Focal Spot Size: Consistent (0.3mm x 0.3mm for predicate) | 0.3mm x 0.3mm | Same |
| - Detector: FPD (TFT) | FPD (TFT) | Same |
| - Pixel Size: Comparable or improved | 248 μm x248μm (With binning), 124 μm x124μm (Without binning) for CT, CT-Panoramic, Ceph | Predicate has 125 μm x125μm, 125μm x250μm (CT), 125 μm x 125μm (Panoramic), 140 μm x 140μm (Ceph). The different binning options suggest flexibility. |
| - Pixel Number: Comparable or improved | 1024x1280 (With binning), 2560x2048 (Without binning) | "FPD has been changed and gets bigger. The performance gets better." (Implies acceptance criteria met or exceeded) |
| - Size of Area Receiving X-ray: Comparable or improved | 253.95mm x 317.44mm (CT, CT-Panoramic, Ceph) | Predicate has 160mm x 128mm (CT), 160mm x 12.5mm (Panoramic), 295.68 x 245.56mm (Ceph). "FPD gets bigger so that it can scan larger object." (Implies acceptance criteria met or exceeded) |
| - Number of Bits: Comparable (16 bits for CT/Panoramic, 14 bits for Ceph in predicate) | 16bits (CT, CT-Panorama, Ceph) | Improved for Ceph (16 bits vs 14 bits in predicate) |
| - SID/SOD (Scanner Geometry): Comparable | 700mm/ 420mm (CT, CT-Panoramic, Ceph) | Predicate has 700mm/ 470mm (CT, Panoramic), 1735mm / 1500mm (Ceph). "Radius of rotation gets smaller so that they are substantially equivalent." (Implies acceptance criteria for image quality/dose met despite change) |
| - Dimensions & Weight: Practical and safe | (WHD) 880 mm x 1237 mm x 2268 mm, 165 kg | "Cephalo is integrated, thus, it gets lighter." (Refers to weight comparison with predicate's separate ceph unit, implying improvement or equivalence on design) |
| - Imaging Mode: CT Scan, Panoramic Scan, Cephalometric Radiography | CT scan, CT-Panoramic scan, Cephalometric radiography | Equivalent |
| - Scan Time (Panoramic): Comparable (18s for predicate) | 8-16sec | "Irradiance level is equivalent." (Implies shorter scan time does not compromise safety/efficacy) |
| - Scan Time (Cephalometric): Comparable (0.1s for predicate) | 0.5-0.8 sec | "Improved" (Implies faster scan time) |
| - Scan Time (CT): Comparable (5.2-25.6s for predicate) | 10-20sec | "Similar" |
| - FOV (Voxel Size): Comparable or improved | Diameter 150mm x H156mm, 150mm x H78mm, 50mm x H50mm (all 0.100 - 0.200mm) etc. | Predicate has 100mm x H81mm, 100mm x H50mm, 50mm x H50mm (all 0.100 - 0.200mm). "FPD gets bigger so that it can scan larger object." (Implies acceptance criteria met/exceeded for imaging area) |
| - Volume Size: Comparable | 500x500x500, 750x750x780 | Predicate has 512x512x512, 512x512x950, 1024x1024x816, 1024x1024x1515. "Volume Size is smaller; thus, the file size gets smaller." (Implies efficiency while maintaining equivalence, within acceptance range) |
| - Dose Level (CTDIw): Comparable or improved | Standard (110KV, 2mA, 10s): 1.7mGy (15cm), 0.5mGy (5cm) etc. | "Dose Level is similar and improved." (Detailed comparison shows various modes for both, all within acceptable safety limits, often lower for the subject device.) |
| - Spatial Resolution (MTF): Comparable or improved | Standard mode: 50%MTF: 0.95LP/mm, 20%MTF: 2.0LP/mm etc. | "Spatial Resolution is similar and improved." (Predicate has 50%MTF: 1.2LP/mm, 20%MTF: 2.3LP/mm. The subject device has slightly lower LP/mm than the predicate, but it is stated as "similar and improved," indicating it meets the relevant performance thresholds. This might reflect different measurement methodologies or acceptable variations). |
| - Viewer Software (Image Analysis System Software): Compare features | Display High-resolution 2D and 3D Images, Image Processing (Airway measurement), Image Operation | Same function |
| - Console Software System Settings: Compare features | Output Function, CT Scan (include CT-Panoramic mode) | Same function |
| Compliance with Standards: | ||
| - Electrical Safety: ANSI/AAMI ES60601-1, IEC 60601-1-3, IEC 60601-1-6 | Complies | Same (Listed as tested and passed) |
| - Electromagnetic Compatibility: IEC 60601-1-2 | Complies | Same (Listed as tested and passed) |
| - Usability Safety: IEC 60601-1-6, IEC 62366-1 | Complies | Same (Listed as tested and passed) |
| - Software Lifecycle: IEC 62304 | Complies | Same (Listed as tested and passed) |
| - Dental Extra-Oral X-ray Equipment Essential Performance: IEC 60601-2-63 | Complies | Same (Listed as tested and passed) |
| - Imaging Performance Acceptance Tests: IEC 61223-3-4, IEC 61223-3-5 | Complies | Same (Listed as tested and passed) |
| - Laser Safety: IEC 60825-1 | Complies | Same (Listed as tested and passed) |
| - Risk Management: ISO 14971 | Complies | Same (Listed as tested and passed) |
| - DICOM: NEMA PS 3.1 - 3.20 | Complies | Same (Listed as tested and passed) |
| - Biocompatibility: ISO 10993-1, -5, -10 | Complies | Same (Listed as tested and passed) |
| - Storage and Transport: ISO 4180 | Complies | (Listed as tested and passed) |
Study Proving Device Meets Acceptance Criteria:
The key study mentioned is "Non-Clinical Performance Data."
- Study Type: Non-clinical bench testing, electrical safety testing, software validation, biocompatibility testing, and compliance with various international and national standards. This is a device validation study, not a clinical study on diagnostic accuracy or AI performance.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of patient cases or images for testing the device's performance. The testing refers to engineering tests performed on the device and its components, often using phantoms or controlled environments, not clinical image sets as one would use for an AI diagnostic algorithm.
- Data Provenance: Not applicable in the context of clinical images for an AI study. The "data" here refers to measurements from bench tests performed by PreXion Corporation. The company is based in Tokyo, Japan. The testing is reported as a "non-clinical" effort, not involving human subjects or clinical data in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is an imaging system itself, not an AI diagnostic algorithm that requires expert-established ground truth on clinical images for its performance evaluation. The "ground truth" for this submission are the technical specifications, measured physical parameters, and compliance with safety and performance standards.
4. Adjudication Method for the Test Set:
- Not applicable. No expert adjudication process for image interpretation (as would be typical for an AI diagnostic device) is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC study was not done. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." This means no study was performed to assess human reader performance with or without the device, as is common for AI diagnostic devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device is the imaging equipment itself, not a separate diagnostic algorithm. Its "performance" refers to its ability to acquire images meeting technical specifications and safety standards, not a diagnostic output from an algorithm.
7. The Type of Ground Truth Used:
- The ground truth for this submission is based on engineering specifications, physical measurements (e.g., dose, spatial resolution on phantoms), and compliance with established national and international standards for medical electrical equipment, radiation safety, and imaging performance (e.g., IEC 60601 series, ISO 10993). It is not based on expert consensus, pathology, or outcomes data from human subjects.
8. The Sample Size for the Training Set:
- Not applicable. This document describes the clearance of an imaging device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as #8.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
April 15, 2019
PreXion Corporation % Hiroaki Takahashi General Manager, Quality Assurance & Regulatory Division 1-14-1, Kanda Suda-cho Chiyoda-ku, Tokyo101-0041 JAPAN
Re: K190320
Trade/Device Name: PreXion3D Explorer Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: February 8, 2019 Received: February 13, 2019
Dear Hiroaki Takahashi:
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
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Please wait...
If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.
You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.
For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.
Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image contains the logo for PreXion. The logo features the word "PreXion" in a stylized font, with the "IT" in the tagline "make IT visible" in blue. Above and to the right of the text is a curved, blue and gray graphic element, adding a modern and technological feel to the logo.
Section 5 – 510(k) Summary
Device Name: PreXion3D Explorer
K190320
1. Submission Sponsor
PreXion Corporation 1-14-1, Kanda Suda-cho, Chiyoda-ku, Tokyo 101-0041 Japan Hiroaki Takahashi General Manager, Quality Assurance & Regulatory Division Email: px-ra@prexion.co.jp Office number: +81-3-5297-7551
2. Submission Correspondent
Same as above
3. Date Prepared
February 8th, 2019
4. Device Identification
| Trade/Proprietary Name: | PreXion3D Explorer |
|---|---|
| Common/Usual Name: | OAS: Computed Tomography X-Ray System |
| Regulation Number: | OAS: 21 CFR 892.1750 |
| Product Code: | OAS |
| Device Class: | Class II |
| Classification Panel: | Radiology |
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for PreXion, a company that appears to be in the IT sector. The logo features the company name in a stylized font, with the "Pre" portion in a light gray color and the "Xion" portion in a darker gray. Above the "Xion" part of the name is a blue swoosh design. Below the company name is the tagline "make IT visible" in a smaller font.
5. Legally Marketed Predicate Device(s)
K181983, PreXion3D Excelsior, PreXion Corporation
6. Indication for Use Statement
PreXion3D Explorer is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
7. Device Description
PreXion3D Explorer consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explorer Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.
X-ray image data is acquired while the rotation around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, CT-Panoramic scan) and Cephalometric Scan.
The operating principle of the device is as follows.
X-rays are generated by the conversion of electron kinetic energy.
Part of the kinetic energy which is generated when electrons moving at high speed are decelerated inside matter becomes the conversion source.
Use a high-voltage transformer to boost the commercial voltage (100 to 240 V) to direct current high voltage (several tens of kV) and apply it to the X-ray tube to accelerate the X-ray tube's thermal electrons, and then the X-ray will be generated.
The change in the voltage (tube voltage) and current) applied to the X-ray tube brings the following features.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for PreXion. The logo features the company name in a stylized font, with the word "Pre" in a lighter shade of gray and "Xion" in a darker shade. Below the company name is the tagline "make IT visible" in a smaller font. Above the company name is a blue swoosh design that adds a modern and dynamic element to the logo.
· The higher the X-ray tube voltage is, the greater the penetration strength of X-rays is.
- · The higher the current (tube current) is, the more the X-ray dose is.
With the consideration of the above features, X-ray devices are designed to be able to control the X-ray dose and strength according to the intended use.
X-ray photography is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed.
X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm).
The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan) and the tomographic image (CT scan, Panoramic scan).
Based on cephalometric radiography, a plain radiographic image of the properly positioned "patient's head" between X-ray generator and flat panel detector with stable magnification ratio, can be acquired. Also, the image of "patient's hand" can be obtained.
8. Substantial Equivalence Discussion
The following table compares the PreXion3D Explorer to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Manufacturer | PreXion Corporation | PreXion Corporation | |||
|---|---|---|---|---|---|
| Trade Name | PreXion3D Explorer | PreXion3D Excelsior | Comparison toPredicate | ||
| 510(k) Number | TBD | K181983 | N/A | ||
| Product Code | OAS | OAS | Same | ||
| Regulation Number | OAS: 21 CFR 892.1750 | OAS: 21 CFR 892.1750 | Same | ||
| Regulation Name | OAS: Computed tomography x-ray system | OAS: Computed tomography x-ray system | Same | ||
| Device ClassificationName | X-Ray, Tomography, Computed,Dental | X-Ray, Tomography, Computed,Dental | Same | ||
| Indications for use: | PreXion3D Explorer is intendedto produce two-dimensionaldigital x-ray images includingpanoramic and cephalometricimage, and three-dimensionaldigital x-ray images of thedental, oral, maxillofacial region,ENT (Ear, Nose and Throat) andneck region at the direction ofhealthcare professionals asdiagnostic support for adult andpediatric patients.Cephalometric imaging alsoincludes the hand and wrist toobtain carpus images for growthand maturity assessment. | PreXion 3D Excelsior is intendedto produce two-dimensionaldigital panoramic andcephalometric images, andthree-dimensional digital x-rayimages of the dental(oral),maxillofacial, and ENT (Ear,Nose and Throat) region at thedirection of healthcareprofessionals as diagnosticsupport for adult and pediatricpatients.Cephalometric imaging alsoincludes the hand and wrist toobtain carpus images forgrowth and maturityassessment. | Minor wordingdifferences donot raise anyadditionalquestions ofsafety orefficacy. | ||
| Target Population | Children aged 6 (except infants)to elderly | Children aged 6 (except infants)to elderly | Same | ||
| Anatomical Site | The dental, oral, maxillofacialregionENT (Ear, Nose and Throat) andneck region | The dental, oral, maxillofacialregionENT (Ear, Nose and Throat) andneck region | Same | ||
| Users | Health care professionals | Health care professionals | Same | ||
| Technological Characteristics and Performance | |||||
| Patient Contact Material | CHIN REST: polycarbonateHEAD SUPPORT: carbonHANDLE GRIP: silicone rubber | CHIN REST: polycarbonateHEADREST: silicone rubberBELT: polyvinyl chloride | Biocompatibilitytest resultssupport that thematerial is safefor the intendeduse. | ||
| Sterility | Non-sterile | Non-sterile | Same | ||
| X-rayGenerationDevice | TubeVoltage | 90-110KV | 60-110KV | Applied currentis reduced sothat the doselevel isequivalent. | |
| PulseExposurefunction | Yes | Yes | Same | ||
| TubeCurrent | 1-3mA | 1-6mA | Applied currentis reduced sothat the doselevel isequivalent. | ||
| Focal SpotSize | 0.3mm x 0.3mm | 0.3mm x 0.3mm | Same | ||
| Detector | FPD (TFT) | FPD (TFT) | Same | ||
| X-ray ImageCapturingDevice | Pixel Size | 248 μm x248μm (With binning)(CT, CT-Panoramic, Ceph) | 125 μm x125μm,125μm x250μm (CT) | ||
| 124 μm x124μm (Withoutbinning)(CT, CT-Panoramic, Ceph) | 125 μm x 125μm (Panoramic) | ||||
| 140 μm x 140μm (Ceph) | |||||
| PixelNumber | 1024x1280(With binning)(CT, CT-Panoramic)2560x2048(Without binning)(CT, CT-Panoramic, Ceph) | 1280x1024 (CT)128x1280 (Panoramic)2112x1754 (Cephalometric) | FPD has beenchanged andgets bigger. Theperformancegets better. | ||
| Size ofAreaReceivingX-ray | 253.95mm x 317.44mm(CT, CT-Panoramic, Ceph) | 160mm x 128mm (CT)160mm x 12.5mm (Panoramic)295.68 x 245.56mm (Ceph) | |||
| Numberof Bits | 16bits (CT, CT-Panorama, Ceph) | 16bits (CT, Panorama)14bits (Ceph) | |||
| Scanner | SID/SOD | 700mm/ 420mm (CT, CT-Panoramic, Ceph) | 700mm/ 470mm (CT,Panoramic)1735mm / 1500mm (Ceph) | Radius ofrotation getssmaller so thatthey aresubstantiallyequivalent. | |
| Dimension(WxDxH) | 880 mm x 1237 mm x2268 mm (CT, CT-Panoramic,Ceph) | 930 mm x 1230 mm x2220 mm (CT, Panoramic)1747 mm x 1230 mm x2220 mm (with Ceph) | |||
| Weight | 165 kg (CT, CT-Panoramic, Ceph) | 165 kg (CT, Panoramic)200kg (Ceph) | Cephalo isintegrated, thus,it gets lighter. | ||
| Imaging Mode | CT scan, CT-Panoramic scan,Cephalometric radiography | CT scan, Panoramic scan,Cephalometric radiography | Equivalent | ||
| Panoramic ScanPerformance (Scan Time) | 18sec | 8-16sec | Irradiance levelis equivalent. | ||
| CephalometricRadiography (Scan Time) | 0.1 sec | 0.5-0.8 sec | Improved | ||
| CT ScanPerformance | Scan Time | 10-20sec | 5.2-25.6sec | Similar | |
| FOV(VoxelSize) | Diameter 150mm x H156mm(0.100 - 0.200mm)Diameter 150mm x H78mm(0.100 - 0.200mm)Diameter 50mm x H50mm | Diameter 100mm x H81mm(0.100 - 0.200mm)Diameter 100mm x H50mm(0.100 - 0.200mm)Diameter 50mm x H50mm | FPD gets biggerso that it canscan largerobject. |
Table-5A: Comparison of Characteristics
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image contains the logo for PreXion. The logo features the name "PreXion" in a stylized font, with the "IT" in the tagline "make IT visible" in a slightly bolder font. Above and to the right of the name is a blue and white swoosh design, adding a modern and dynamic element to the logo.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for PreXion. The logo features the company name in a light gray, italicized font, with the "IT" in "make IT visible" in blue. Above and behind the name is a curved, swooping graphic that transitions from light blue to white, adding a sense of motion and technology to the overall design.
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for PreXion. The logo features the company name in a stylized font, with the "Pre" in a lighter gray and the "Xion" in a darker gray. Above and to the right of the name is a blue and gray swoosh design. Below the company name is the tagline "make IT visible" in a smaller font.
| (0.100 - 0.200mm) | (0.100 - 0.200mm) | ||
|---|---|---|---|
| Diameter 150mm x H130mm(0.100 - 0.200mm) | |||
| Volume Size | 500x500x500750x750x780 | 512x512x512512x512x9501024x1024x8161024x1024x1515 | Volume Size issmaller; thus,the file size getssmaller. |
| Dose Level(CTDIw) | Standard (110KV, 2mA, 10s)15cm: 1.7mGy5cm: 0.5mGyHigh Definition (110KV, 2.0mA, 18s)15cm: 3.1mGy5cm: 0.9mGyUltra-High Definition (110KV, 2.0mA, 20s)15cm: 2.3mGy5cm: 0.7mGyStandard Child (90KV, 1mA, 10s)15cm: 0.5mGy5cm: 0.1mGy | Standard (110KV, 2.4mA, 9.6s)10cm: 2.9mGy5cm: 1.9mGyRapid (110KV, 2.4mA, 5.2s)10cm: 0.9mGy5cm: 0.8mGyHigh Definition (110KV, 2.4mA, 12.8s)10cm: 4.9mGy5cm: 3.2mGyUltra-High Definition (110KV, 2.4mA, 23.6s)10cm: 8.7mGy5cm: 4.3mGyStandard Child (95KV, 1.6mA, 9.6s)10cm: 1.4mGy5cm: 1.0mGyRapid Child (95KV, 1.6mA, 5.2s)10cm: 0.5mGy5cm: 0.4mGyComplete (110KV, 2.4mA, 19.2s)10cm: 5.8mGyComplete Child (95KV, 1.6mA, 19.2s)10cm: 2.9mGy | Dose Level issimilar andimproved. |
| Spatial Resolution | Standard mode:50%MTF: 0.95LP/mm20%MTF:2.0LP/mmRapid Mode:50%MTF: 0.95LP/mm20%MTF:2.0LP/mm | Standard mode:50%MTF: 1.2LP/mm20%MTF:2.3LP/mmRapid Mode:50%MTF: 1.2LP/mm20%MTF:2.3LP/mm | SpatialResolution issimilar andimproved. |
| 50%MTF: 0.95LP/mm20%MTF:2.0LP/mm | 50%MTF: 1.2LP/mm20%MTF:2.3LP/mm | ||
| High contrast mode:50%MTF: 0.95LP/mm20%MTF:2.0LP/mm | High contrast mode:50%MTF: 1.2LP/mm20%MTF:2.3LP/mm | ||
| Display High-resolution 2D and3D Images Function | Display High-resolution 2D and3D Images Function | ||
| Viewer Software (ImageAnalysis SystemSoftware) | Image Processing Functionincludes Airway measurementImage Operation Function | Image Processing Functioninclude Airway measurementImage Operation Function | Same |
| Console SoftwareSystem Settings | Output FunctionCT Scaninclude CT-Panoramic mode | Output FunctionCT Scaninclude CT-Panoramic mode | Same |
| Applied Standard | |||
| Electrical Safety Standard | ANSI/AAMI ES60601-1 | ANSI/AAMI ES60601-1 | |
| ElectromagneticCompatibility Standard | IEC 60601-1-2 | IEC 60601-1-2 | |
| Radiation Safety Standard | IEC 60601-1-3 | IEC 60601-1-3 | |
| Electrical EquipmentUsability Safety Standard | IEC 60601-1-6 | IEC 60601-1-6 | |
| Usability EngineeringStandard | IEC 62366 -1 | IEC 62366 | |
| Software LifecycleProcess Standard | IEC 62304 | IEC 62304 | |
| Essential performance ofdental extra-oral X-rayequipment Standard | IEC 60601-2-63 | IEC 60601-2-63 | |
| Acceptance tests ofImaging performance ofdental X-ray equipmentStandard | IEC 61223-3-4 | IEC 61223-3-4 | Same |
| Acceptance tests ofImaging performance ofcomputed tomography X-ray equipment Standard | IEC 61223-3-5 | IEC 61223-3-5 | |
| Laser Safety Standard | IEC 60825-1 | IEC 60825-1 | |
| Risk ManagementStandard | ISO 14971 | ISO 14971 | |
| DICOM Standard | NEMA PS 3.1 - 3.20 | NEMA PS 3.1 - 3.20 | |
| Biocompatibility StandardCompliance | ISO 10993-1 | ISO 10993-1 | |
| Biocompatibility StandardCompliance | ISO 10993-5 | ISO 10993-5 | |
| Biocompatibility StandardCompliance | ISO 10993-10 | ISO 10993-10 |
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for PreXion. The logo features the word "PreXion" in a stylized font, with the "Pre" in a light gray color and the "Xion" in a darker gray. Below the word "PreXion" is the tagline "make IT visible" in a smaller font. Above and to the right of the word "PreXion" is a blue and white swoosh design.
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for Prexion, a company that appears to be in the IT sector. The logo features the company name in a stylized font, with the "Pre" portion in a light gray color and the "xion" portion in a darker gray. Below the company name is the tagline "make IT visible" in a smaller font. Above and to the right of the company name is a blue and white swoosh design, which adds a modern and dynamic element to the logo.
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of PreXion3D Explorer and in showing substantial equivalence to the predicate device, PreXion Corporation completed a number of non-clinical The PreXion3D Explorer meets all the requirements for overall design, performance tests. biocompatibility, performance, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.
The PreXion3D Explorer passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Biocompatibility testing per ISO 10993-1, ISO 10993-5 and ISO 10993-10
- Electrical safety testing per ABSI/AAMI ES 60601-1, IEC 60601-1-3 and IEC 60601-1-6
- . Electromagnetic Safety testing per IEC 60601-1-2
- . Dental extra-oral X-ray equipment testing per IEC 60601-2-63
- . Acceptance testing of X-ray equipment per IEC 61223-3-4 and IEC 61223-3-5
- Laser safety testing per IEC 60825-1
- DICOM testing per NEMA PS 3.1 - 3.20
- Usability testing per IEC 62366-1
- . Software verification and validation per IEC 62304
- . Storage and Transport Testing per ISO 4180
10. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image shows the logo for PreXion. The logo features the word "PreXion" in a stylized font, with "Pre" in a darker gray and "Xion" in a lighter gray. Below the name is the tagline "make IT visible" in a smaller font. Above and behind the text is a curved, blue graphic element that resembles a stylized eye or lens, with a subtle shadow effect that gives it a three-dimensional appearance.
does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).
The PreXon3D Explorer, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.
§ 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.