(357 days)
AnatomicAligner is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as CT or MRI, in patients who have reached sketal and dental maturity.
AnatomicAligner is an image-processing software with a user-friendly interface for pre-operative simulation of orthognathic surgical treatment options based on imaging information from a medical scanner such as CT or MRI. The software planning results may be transferred to surgery.
The provided document describes the FDA 510(k) clearance for the AnatomicAligner software, which is intended for pre-operative simulation of orthognathic surgical treatment options. However, this document clearly states that "No clinical testing of AnatomicAligner was required or performed" (Section 1.8). Therefore, the direct information required to answer many of the questions regarding acceptance criteria, test sets, experts, and MRMC studies is not present in the provided text.
Based on the information available, here's a description of what is and isn't provided:
1. A table of acceptance criteria and the reported device performance:
The document states that "AnatomicAligner has successfully undergone extensive verification and validation testing to ensure that all requirements for the software have been met per FDA Guidance." It also mentions "These results provide objective evidence that the outputs of the software design activity meet all of the specified requirements for that activity."
However, the specific acceptance criteria (e.g., quantitative metrics like accuracy, precision, or specific user performance indicators) and the reported device performance against these criteria are NOT detailed in this document. The document implies that acceptance was based on successful completion of verification and validation testing in accordance with design controls.
2. Sample size used for the test set and the data provenance:
As no clinical testing was performed, there is no "test set" in the sense of patient data used for clinical performance evaluation. The document focuses on performance derived from verification and validation against software requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication method for the test set:
Not applicable, as no clinical test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was NOT done. The document explicitly states "no clinical testing of AnatomicAligner was required or performed." The AnatomicAligner is described as image-processing software for "pre-operative simulation," suggesting it's a tool for planning rather than a diagnostic aid that would directly assist human readers in interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document states that "extensive verification and validation testing" was performed to ensure the software met its requirements. While this would involve "algorithm only" testing, the specific metrics and results are not detailed. The software's function is to assist in "pre-operative simulation," implying a human-in-the-loop process for planning, but the FDA clearance did not require human-in-the-loop clinical performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Since no clinical testing was performed, there was no ground truth based on patient outcomes, pathology, or expert consensus on clinical cases. The ground truth for the "verification and validation testing" would have been derived from the design requirements of the software itself. This would typically involve:
- Software requirements specifications: The "ground truth" would be that the software functions as designed according to its established requirements (e.g., correctly segments anatomical structures, accurately performs calculations, generates correct output files).
- Test data or simulated data: Verification and validation would likely use synthetic and/or real (but not necessarily clinical trial-level) imaging data to confirm software functionality and accuracy against predefined expected outputs.
8. The sample size for the training set:
The document does not provide information on the training set size, as it's a 510(k) submission for a device that did not require clinical performance data. While the software likely uses algorithms, details about their development (including training data) are not part of this summary, especially since no clinical claims are being made based on AI performance in diagnostic accuracy or human reader improvement.
9. How the ground truth for the training set was established:
Not applicable based on the provided document, as no information on a training set or its ground truth establishment is included in this 510(k) summary. Given the nature of the device (pre-operative simulation software), any underlying algorithms would have been trained with data and ground truth relevant to their specific tasks (e.g., image segmentation, 3D reconstruction, landmark identification), but these details are not part of FDA's evaluation criteria for this specific substantial equivalence claim.
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March 16, 2020
The Methodist Hospital Research Institute d/b/a Houston Methodist Research Institute Christina Talley Director, Regulatory Affairs and Translational Management Methodist Research Institute 6670 Bertner Avenue Houston, Texas 77030
Re: K190767
Trade/Device Name: AnatomicAligner Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: July 13, 2019 Received: July 17, 2019
Dear Christina Talley:
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
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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 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 Srinivas "Nandu" Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices 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) K190767
Device Name AnatomicAligner
Indications for Use (Describe)
AnatomicAligner is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as CT or MRI, in patients who have reached sketal and dental maturity.
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: This image is a document with the title "AnatomicAligner Software" and the subtitle "510(k) Premarket Notification". The document number is AA-022, and the version is 3. The company is The Methodist Hospital Research Institute d/b/a Houston Methodist Research Institute, and the page number is 1 of 6.
1 510(K) SUMMARY K190767
In accordance with 21 CFR 807.92, the following summary of the information in the 510(k) submission is provided.
1.1 807.92(A)(1)
| Summary Date: | 3/16/2020 |
|---|---|
| Submitter: | The Methodist Hospital Research Instituted/b/a Houston Methodist Research Institute6670 Bertner Ave.Houston, Texas 77030 |
| Contact: | Christina Talley, MS, RAC, CCRP, CCRC.Program DirectorDirect: 713-363-9155Email: ctalley@houstonmethodist.org |
1.2 807.92(A)(2)
| Trade Name: | AnatomicAligner |
|---|---|
| Common Name: | Radiology Image Processing Software |
| Device: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Regulation Description: | Picture Archiving and Communication System |
| Review Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | LLZ |
| Indication For Use: | AnatomicAligner is software for pre-operativesimulation of orthognathic surgical treatmentoptions, based on imaging information from amedical scanner such as CT or MRI, in patientswho have reached skeletal and dental maturity. |
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| HOUSTONMethodistLEADING MEDICINE | TITLE: | AnatomicAligner Software | |||
|---|---|---|---|---|---|
| SUBTITLE: | 510(k) Premarket Notification | ||||
| NUMBER: | AA-022 | VER: | 3 | ||
| CONFIDENTIAL | COMPANY: | The Methodist Hospital Research Instituted/b/a Houston Methodist Research Institute | PAGE: | 2 of 6 |
1.3 807.92(A)(3) — PRIMARY PREDICATE
| Device Name: | SurgiCase, SurgiCase CMF, ProPlan CMF |
|---|---|
| Manufacturer: | Materialise N.V. |
| 510(k) Number: | K111641 |
| Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| RegulationDescription: | Picture Archiving & Communication System |
1.4 807.92(A)(4) — Device Description
| Device Description: | AnatomicAligner is an image-processing softwarewith a user-friendly interface for pre-operativesimulation of orthognathic surgical treatment optionsbased on imaging information from a medical scannersuch as CT or MRI. The software planning resultsmay be transferred to surgery. |
|---|---|
| --------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| TITLE: | AnatomicAligner Software | ||||
|---|---|---|---|---|---|
| SUBTITLE: | 510(k) Premarket Notification | ||||
| NUMBER: | AA-022 | VER: | 3 | ||
| CONFIDENTIAL | COMPANY: | The Methodist Hospital Research Instituted/b/a Houston Methodist Research Institute | PAGE: | 3 of 6 |
1.6 807.92(A)(6) — Technological Characteristics
1.6.1 Technological Similarities
The following table summarizes the similarities in the technological characteristics of AnatomicAligner and the predicate device ProPlan.
| Technology | AnatomicAligner | ProPlan (Predicate) | Comparison |
|---|---|---|---|
| Computer | The AA softwareinterfaces with thestandard WindowsPC devicesincluding: Storage,Mouse, Keyboard,Display, andPrinter. | Intel Core2Duo orequivalent; 3GBRAM; AMD Radeon orNVIDIA GeForcegraphics card with128MB RAM orequivalent. | Both products run ongeneral purposecommercialcomputers. |
| OperatingSystem | The AA softwareinterfaces with theunderlying Windowsoperating system. | Windows Vista SP2 x64Windows 7 x64Windows 8 x64 | Both products use ageneral purposecommercial operatingsystem. |
| Patient Images | To create a newsurgical simulation,select New from theAnatomicAlignermain screen. Aprompt to Select aDICOM Documentwill be presented. | After scanning yourpatient, you mustimport the images tothe PROPLAN CMFSoftware. | Both products useDICOM to importpatient images forprocessing. |
| Segmentationand 3Dreconstruction | A 3D object iscreated using theselected mask andapplying theselected options. | The "SegmentationWizard" will guide youstep-by-step throughthe process ofsegmenting bone partsand soft tissue. Theresult will be a 3Dobject that can be usedin planning wizards. | Both products providethe user software toolsto segment bone andsoft tissue to create3D objects from thepatient images. |
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| TITLE: | AnatomicAligner Software | ||||
|---|---|---|---|---|---|
| SUBTITLE: | 510(k) Premarket Notification | ||||
| CONFIDENTIAL | NUMBER: | AA-022 | VER: | 3 | |
| COMPANY: | The Methodist Hospital Research Instituted/b/a Houston Methodist Research Institute | PAGE: | 4 of 6 |
| Technology | AnatomicAligner | ProPlan (Predicate) | Comparison |
|---|---|---|---|
| RegistrationAndReorientation | Registration inAnatomicAligner isperformed usingTransformationand Auto-Registration tools. | The "RepositionWizard" can be used toreposition 3D objects.Selected 3D objectscan be translated. Theselected 3D object canbe rotated. | Both products providethe user software toolsto translate and rotate3D objects. |
| CephalometricAnalysis | 3D Cephalometry inthe AnatomicAligneris achieved bydefining acephalometricanalysis schemeand digitizinglandmarks for it. | The "CephalometryWizard" allows you toindicate anatomicallandmarks on objects inthe 2D or 3D view toperform acephalometric analysis. | Both products providethe user software toolsto perform acephalometricanalysis. |
| VirtualOsteotomy | Virtual osteotomy isused to cut a 3Dbone model intotwo bony segments. | Differentosteotomy planetypes can beselected. | Both products providethe user software toolsto perform anosteotomy. |
| SurgicalSimulation | Create a SurgicalPlan ororthognathicsurgery. | The Orthognathicsmodule in PROPLANCMF Software allowsyou to planOrthognathicsurgeries. | Both products providethe user software toolsto simulateorthognathic surgery. |
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| HOUSTONMethodistLEADING MEDICINE | TITLE: | AnatomicAligner Software | ||
|---|---|---|---|---|
| SUBTITLE: | 510(k) Premarket Notification | |||
| NUMBER: | AA-022 | VER: | 3 | |
| CONFIDENTIAL | COMPANY: | The Methodist Hospital Research Instituted/b/a Houston Methodist Research Institute | PAGE: 5 of 6 |
1.6.2 Technological Differences
The following table summarizes the differences in the technological characteristics of AnatomicAligner and the predicate device ProPlan.
| Technology | AnatomicAligner | ProPlan (Predicate) | Comparison |
|---|---|---|---|
| GraphicalUserInterface | 2D and 3D views | 2D and 3Dviews. | Both products providecommon 2D and 3D imageviews and mouse controls.Differences in graphicappearance are cosmeticand raise no newquestions. |
| Splintdesign | The splint design istransferred to anSTL file which canbe used by a 3rdparty lab tomanufacture thesplint. | Export 3D objects as.mdck files (thisproprietary file formatallows you toexchange 3D objectswithin relevantMaterialise softwaresolutions, for e.g.opening yourPROPLAN CMFSoftware planning filein 3-maticSTL in orderto design your ownguides and splints. | Both products provide amechanism to transfer asplint design to a lab forfabrication. As anexample, the STL filecreated by AnatomicAlignercan be read and edited by3-maticSTL. Thus,differences in file formatsused to transfer the designraise no new questions. |
1.7 807.92(B)(1) - Non-Clinical Performance Data
AnatomicAligner has successfully undergone extensive verification and validation testing to ensure that all requirements for the software have been met per FDA Guidance. These results provide objective evidence that the outputs of the software design activity meet all of the specified requirements for that activity. Therefore, the AnatomicAligner Software version 1.0 has been verified and validated as meeting all requirements.
1.8 807.92(B)(2) - CLINICAL PERFORMANCE DATA
Based on the criteria listed in FDA guidance documents, no clinical testing of AnatomicAligner was required or performed.
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| Image: Houston Methodist Logo | TITLE: | AnatomicAligner Software |
|---|---|---|
| SUBTITLE: | 510(k) Premarket Notification | |
| NUMBER: | AA-022 | |
| CONFIDENTIAL | COMPANY: The Methodist Hospital Research Institute d/b/a Houston Methodist Research Institute | VER: 3PAGE: 6 of 6 |
1.9 807.92(B)(3) - Conclusion
The intended uses of AnatomicAligner and ProPlan are the same. The technological characteristics of the AnatomicAliqner and the predicate device ProPlan are very similar. Any differences are minor and do not affect a determination of substantial equivalence.
AnatomicAligner was developed under the Quality System Regulation using Design Controls 21 CFR 820.30. This included establishing and maintaining procedures to ensure design requirements are met. All elements of the process have been documented, including design and development plan, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history file.
AnatomicAligner has successfully undergone extensive verification and validation testing to ensure that all requirements for the software have been met. These results provide objective evidence that the outputs of the software design activity meet all of the specified requirements for that activity. Therefore, the AnatomicAligner Software version 1.0 has been verified and validated as meeting all requirements.
No applicable mandatory performance standards or special controls exist for AnatomicAligner. The product design, development and manufacturing conform to Quality System Regulations. Results of testing and standards conformance demonstrate safety and effectiveness of AnatomicAligner. We conclude that AnatomicAligner and ProPlan are substantially equivalent.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).