(268 days)
The 3D Accuitomo 150N Model X800N is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.
The 3D Accuitomo 150N Model X800N is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the ENT, dentomaxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by medical doctors, dentists, and other legally qualified professionals for pediatric and adult patients.
The X800N consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction.
The X800N has three main radiographic modes as follows:
- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- -Cone beam computed tomography
This document describes the 510(k) premarket notification for the J. Morita USA, Inc. 3D Accuitomo 150N Model X800N, an X-ray system for panoramic, cephalometric, and CBCT imaging. The primary purpose of this submission is to obtain clearance for a new ENT (Ear, Nose, and Throat) indication for an already cleared device, the Veraview X800 (K#171012).
An important note for this response: The provided text details the device itself and its equivalence to a predicate device, as well as the clinical evaluation performed for the new indication for use. However, it does not describe acceptance criteria for an AI/CADe device's performance. The clinical evaluation described here is to demonstrate the image quality of the X800N for ENT diagnosis is comparable to existing devices, not to validate an AI algorithm's diagnostic performance against specific metrics like sensitivity or specificity. Therefore, many of the requested points regarding AI acceptance criteria and studies cannot be addressed from the given text.
Here's an analysis based on the provided information, addressing what is present and noting what is absent:
Acceptance Criteria and Study for the 3D Accuitomo 150N Model X800N (K201378)
1. Table of Acceptance Criteria and Reported Device Performance
As this submission is for a medical imaging device (CT scanner) and not an AI/CADe device, the "acceptance criteria" presented are related to image quality and comparability to predicate devices, rather than performance metrics for an algorithm (e.g., sensitivity, specificity, AUC). The study aims to demonstrate that the image quality of the X800N is sufficient for the expanded ENT indication.
| Criterion Type | Acceptance Criteria (Stated Goal) | Reported Device Performance (Study Results) |
|---|---|---|
| Clinical Acceptability for ENT Diagnosis | The CT images obtained by the X800N for general examination and diagnosis of the ENT area should be substantially equivalent to or better than those obtained by the reference devices (X550 and MCT-1) for this indication. | All evaluators ranked the images of the X800N as "Excellent Quality for Diagnosis" or "Acceptable Quality for Diagnosis." The overall results for X800N were reported as "better than that of the X550" and "comparable to the MCT-1." This supports sufficiency for ENT diagnosis. |
Missing Information: There are no quantitative acceptance criteria for AI algorithm performance (e.g., specific thresholds for sensitivity, specificity, F1-score, or agreement rates) because this is not an AI/CADe device submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states that "skull phantoms made from resin molding on real human dry skulls" were used. It does not provide the specific number of phantoms or images in the test set.
- Data Provenance:
- Country of Origin: The images were obtained in "J. Morita's facility." The company (J. Morita USA, Inc.) is located in Irvine, CA, USA, suggesting the facility is likely in the USA. The manufacturer is "J. MORITA MFG. CORP." (not specified where this is located, but typically these are from Japan for J. Morita).
- Retrospective or Prospective: The use of phantoms implies a prospective acquisition specifically for this evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The text states, "Experienced doctors who are using CBCT for their ENT medical practice subjectively evaluated images..." It does not specify the exact number of doctors.
- Qualifications: "Experienced doctors who are using CBCT for their ENT medical practice." Specific experience (e.g., years, board certification) is not detailed beyond "experienced" and "using CBCT for their ENT medical practice."
4. Adjudication Method for the Test Set
- Adjudication Method: The text indicates that experts "subjectively evaluated images" and "ranked by the evaluators according to five categories." It does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus, or independent arbitration) if there were discrepancies between evaluators. It implies individual evaluations were then aggregated to determine overall results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: While multiple readers (the "experienced doctors") evaluated multiple "cases" (skull phantoms/images), this was not an MRMC study comparing human performance with and without AI assistance. It was a subjective evaluation by human readers of image quality from different devices.
- Effect Size: Not applicable, as there was no AI assistance and no comparison of human reader performance with/without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is an imaging system, not an AI algorithm. The "performance" being evaluated is the image quality produced by the system for human interpretation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this evaluation was essentially expert subjective evaluation of image quality and diagnostic suitability. The phantoms themselves provide a known anatomical structure, which serves as a "true" anatomical baseline against which the image quality is judged for its clarity and accuracy for ENT diagnosis. It is not "pathology" or "outcomes data" in the traditional sense, but rather "fitness for purpose" as judged by experts.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is an imaging system, not an AI algorithm that requires a training set. The device's "training" involves engineering and design, informed by physics and medical requirements, not machine learning from image datasets.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable, as there is no AI training set for this device.
Summary of Scope and Missing AI-Specific Details:
The provided document describes a 510(k) submission for a conventional medical imaging device (CBCT scanner) with an expanded indication for use (ENT). The "clinical testing" performed was an evaluation of the image quality produced by the device, judged subjectively by medical experts, to demonstrate its suitability for the new indication compared to existing cleared devices.
Crucially, this document does not pertain to an AI/CADe device or an AI algorithm’s performance validation. Therefore, many of the requested points related to AI acceptance criteria, training sets, and human-in-the-loop studies (beyond clinicians interpreting images) are not present in the provided text. The "acceptance criteria" here are implicitly showing that the images are of sufficient quality for an experienced clinician to make a diagnosis, similar to images from currently cleared devices.
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February 18, 2021
Image /page/0/Picture/1 description: The image shows 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 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.
J. Morita USA, Inc. % Mr. Keith Barritt Attorney Fish & Richardson P.C. 1000 Maine Avenue. S.W., Suite 1000 WASHINGTON DC 20024
Re: K201378
Trade/Device Name: 3D Accuitomo 150N Model X800N Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS, MUH Dated: December 30, 2020 Received: December 31, 2020
Dear Mr. Barritt:
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 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.
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) K201378
Device Name 3D Accuitomo 150N Model X800N
Indications for Use (Describe)
The 3D Accuitomo 150N Model X800N is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.
The 3D Accuitomo 150N Model X800N is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the ENT, dentomaxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by medical doctors, dentists, and other legally qualified professionals for pediatric and adult patients.
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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K#201378
510(k) Summary J. Morita USA Inc. 3D Accuitomo 150N Model X800N X-ray system for Panoramic, Cephalometric and CBCT imaging
The following information is provided pursuant to 21 CFR 807.92.
807.92(a)(1): Submitter's Name/Address, Contact, and Preparation Date
(i) 510(k) Submitter
Registration No. 2081055 J. Morita USA, Inc. 9 Mason, Irvine, CA 92618, USA Phone: 949-581-9600 Fax: 949-581-9688
(ii) 510(k) Submitter Contact
Keith A. Barritt Fish & Richardson P.C. 1000 Maine Avenue, S.W., Suite 1000 Washington DC 20024, USA Phone: (202) 626-6433 Fax: (202) 783-2331 Email: barritt@fr.com
(iii) Preparation Date
February 17, 2021
807.92(a)(2): Name of Device
| Trade or Proprietary Name: | 3D Accuitomo 150N Model X800N |
|---|---|
| Common Name: | Dental Computed Tomography X-ray System imaging |
| Device Classification Name: | System, X-Ray, Tomography, Computed |
| Review Panel: | 892 Radiology device |
| Product Code: | OAS, MUH |
| Regulation: | 21 CFR 892.1750 Class II |
| Device Class: | Traditional |
| 510(k) Type: |
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807.92(a)(3): Predicate Device
This device is substantially equivalent for purposes of FDA medical device regulations to the following predicate device:
| Trade or Proprietary Name: | Veraview X800 (K#171012) |
|---|---|
| Common Name: | Dental Computed Tomography X-ray System imaging |
| Classification Name: | Computed tomography x-ray system |
| Device Classification Panel: | Class II, Radiology |
| Product Code: | OAS |
| Regulation: | 21 CFR 892.1750 |
As discussed further below, the following J. Morita reference devices were used to confirm the suitability of the images of the 3D Accuitomo 150N Model X800N (the "X800N") for the general examination and diagnostic ENT indication being added: Veraviewepocs X550 (K#073696) and MCT-1 (K#073695).
807.92(a)(4): Device Description
The purpose of this 510(k) application is to obtain clearance from FDA for a new ENT indication for J. Morita's already cleared device, the Veraview X800 (K#171012). The new indication is for general examination and diagnosis of the skull including the ENT.
The X800N consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction.
The X800N has three main radiographic modes as follows:
- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- -Cone beam computed tomography
807.92(a)(5): Intended Use
The intended use of the X800N is:
- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- Cone beam computed tomography -
- General examination and diagnosis of the skull including the ENT. -
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Indication for Use
X800N is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. X800N is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the ENT, dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation.
The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by medical doctors, dentists, and other legally qualified professionals for pediatric and adult patients.
807.92(a)(6): Technological Characteristics
The predicate device Veraview X800 (K#171012) is identical in regards to mechanical performance, imaging area, and the other safety and efficacy related parameters. For the X800N, exactly the same image as the dental application for the X800 is taken and utilized for the ENT application.
| Item | Device submitted in this 510(k) | Predicate device | ||
|---|---|---|---|---|
| Product name | 3D Accuitomo 150N | Veraview X800 | ||
| Model | X800N | X800 | ||
| Manufacturer | J. MORITA MFG. CORP. | Same as left | ||
| Indications for use | X800N is intended to be used forpanoramic tomography includinglinear tomography and scanogram,cephalometric radiography, andcone beam computed tomography.X800N is an extraoral source X-ray unit that is used for dental andhead radiographic examinationand diagnosis of teeth, jaw, oralstructure, temporomandibularjoint, skull including the ENT,dento-maxillofacial areas, andhand for maturity assessment, byexposing an X-ray image receptorto ionizing radiation.The device uses a cone shaped X- | Veraview X800 is intended to beused for panoramic tomographyincluding linear tomography andscanogram, cephalometricradiography, and cone beamcomputed tomography.Veraview X800 is an extraoralsource X-ray unit that is used fordental and head radiographicexamination and diagnosis ofteeth, jaw, oral structure,temporomandibular joint, skullincluding the dento-maxillofacialareas, and hand for maturityassessment, by exposing an X-ray image receptor to ionizing | ||
| Item | Device submitted in this 510(k) | Predicate device | ||
| ray beam projected on to a flatpanel detector, and the examinedvolume image is reconstructed tobe viewed in 2D or 3D viewingstations.The device is to be operated andused by medical doctors, dentists,and other legally qualifiedprofessionals for pediatric andadult patients. | radiation.The device uses a cone shapedX-ray beam projected on to a flatpanel detector, and the examinedvolume image is reconstructed tobe viewed in 2D or 3D viewingstations.The device is to be operated andused by dentists and otherlegally qualified professionalsfor pediatric and adult patients. | |||
| Energy used and/ordelivered | AC 120 V, 60 Hz | Same as left | ||
| Design | Loading factors | Tube Potential: 60-100kVTube Current: 2-10mALoading time: max. 18.5s | Same as left | |
| X-ray tubeassembly | Nominal focal spot: 0.5 at targetangleInherent filtration min. 2.5mmAL | Same as left | ||
| X-ray detector 1 | Internal parts code: D001-15038-50*See column in predicate device. | Same as left | ||
| X-ray detector 2 | Internal parts code: D001-16044-50*CMOS flat panelScintillator: CsIPixel size for Pan: 0.1 mmPixel size for CBCT: 0.1 mm,0.2 mm | Same as left | ||
| Item | Device submitted in this 510(k) | Predicate device | ||
| X-ray detector 3 | Internal parts code: D001-04188-50*See column in predicate device. | Same as left- | ||
| Soft-ware | Viewer(general purposeviewer: notincluded in thissubmission ofthe device) | Viewer software:510K number: K073704Device name: i-Dixel | Same as left | |
| Performance | Panoramic- spatialresolution | Line pair resolution on IEC61223-3-4: min. 2.5 LP/mm | Same as left | |
| Panoramic- noise | Low contrast resolution on IEC61223-3-4: min. diameter 2.0 mmat High speed mode, min.diameter 1.0 mm at Highresolution mode | Same as left | ||
| Cephalometric- spatialresolution | Line pair resolution on IEC61223-3-4: min. 2.5 LP/mm | Same as left | ||
| Cephalometric- noise | Low contrast resolution on IEC61223-3-4: min. diameter 2.5 mm | Same as left | ||
| CBCT- spatialresolution | min. 10% MTF at 2.0 LP/mm atstandard modemin. 10% MTF at 2.5 LP/mm athigh resolution mode | Same as left | ||
| CBCT- noise | The standard deviation of the grayscale of the center region of theContrast phantom shall be lessthan 12.5 (10% of the full scale). | Same as left |
A comparison table of the X800N to the predicate device is shown below:
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807.92(b)(1): Non-clinical Testing
The new X800N has been tested for compliance and developed in accordance with the following international standards:
| IEC/ISO Standard | FDA Recognition number |
|---|---|
| IEC 60601-1:2005+A.MD1:2012 | 19-4 |
| IEC 60601-1-2:2014 | 19-8 |
| IEC 60601-1-3:2008+AMD1:2013 | 12-269 |
| IEC 60601-1-6:2010+AMD1:2013 | 5-89 |
| IEC 60601-2-54:2009+AMD1:2015 | 12-296 |
| IEC 60601-2-63:2017 | 12-310 |
| IEC 61223-3-4:2000 | 12-221 |
| IEC 62304:2006+AMD1:2015 | 13-79 |
| IEC 62366:2015 | 5-114 |
| ISO 10993-1:2009/Cor1:2010 | 2-220 |
| ISO 14971:2007 | 5-40 |
The software changes were validated pursuant to the FDA's 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
807.92(b)(2): Clinical Testing
Clinical evaluation was performed to evaluate if the CT image obtained by the X800N for general examination and diagnosis of the ENT area is substantially equivalent to that obtained by J. Morita's reference devices, the X550 (K#073696) and MCT-1 (K#073695), which are FDAauthorized for "dental radiographic examination and diagnosis of teeth, jaw, oral structure, TMjoints and skull, including the ENT and dento-maxillofacial areas" and for taking x-ray images "of the head and neck areas, including the ENT and dento-maxillofacial areas, for use in diagnostic support," respectively.
Methods:
Experienced doctors who are using CBCT for their ENT medical practice subjectively evaluated images taken by the X800N, X550, and MCT-1.
The images they evaluated were obtained in J. Morita's facility from adult and child human skull phantoms made from resin molding on real human dry skulls. The use of phantom image for evaluation was judged to be appropriate in the majority of cases and no evaluator judged it is not suitable to use the phantom image.
The images were then ranked by the evaluators according to five categories: "Excellent Quality for Diagnosis," "Acceptable Quality for Diagnosis," Not Acceptable Quality for Diagnosis," "Not reviewed," and "Other."
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Results:
All the evaluators ranked the images of the X800N as "Excellent Quality for Diagnosis" or "Acceptable Quality for Diagnosis." The overall results were better than that of the X550. Thus, the images of the X800N are comparable to the images from the X550. And the results of the X800N were comparable to the MCT-1.
807.92(b)(3): Conclusions from Testing
The clinical evaluation results show that the image quality of the X800N is comparable to the images quality of both the X550 and MCT-1. Thus, the images taken by X800N are sufficient to use for general examination and diagnosis of the ENT area.
As the only changes from the previous device are indication for use, change of display icon from dental figure, and the description of operation instructions for the ENT application, the X800N is substantially equivalent to the 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.