OOOPDS

{0} **U.S. FOOD & DRUG** ADMINISTRATION Taiwan Main Orthopaedic Biotechnology Co., Ltd. Jacky Fan Regulatory Affairs Manager 2f., # 41, Keya Rd., Daya Dist TAIWAN (R.O.C.) TAICHUNG, 428015 TAIWAN September 15, 2026 Re: K254214 Trade/Device Name: OOOPDS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: August 13, 2026 Received: August 13, 2026 Dear Jacky Fan: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254214 - Jacky Fan Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the {2} K254214 - Jacky Fan Page 3 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-devices/device-advice-comprehensive-regulatory-assistance/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, Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} # Indications for Use Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K254214 Please provide the device trade name(s). OOOPDS Please provide your Indications for Use below. OOOPDS is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. OOOPDS is also intended for measuring and treatment planning. The OOOPDS output can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replicas generated from digital output files are not for diagnostic purposes and may be used in orthopedic and maxillofacial applications. OOOPDS should be used in conjunction with expert clinical judgement. Please select the types of uses (select one or both, as applicable). ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) ? {4} 510(k) #: K254214 # 510(k) Summary Prepared on: 2026-09-13 Contact Details 21 CFR 807.92(a)(1) Applicant Name Taiwan Main Orthopaedic Biotechnology Co., Ltd. Applicant Address 2F., No. 41, Keya Rd., Daya Dist., Taichung City 428015, Taiwan (R.O.C.) Taichung City 428015 Taiwan Applicant Contact Telephone +886-4-25652818 Applicant Contact Mr. Jacky Fan Applicant Contact Email tbk.jacky@surglasses.com Device Name 21 CFR 807.92(a)(2) Device Trade Name OOOPDS Common Name System, Image Processing, Radiological. Classification Name Medical image management and processing system Regulation Number 892.2050 Product Code(s) LLZ Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K183105 Mimics Medical LLZ Device Description Summary 21 CFR 807.92(a)(4) OOOPDS (Model: Asclepius) is image processing software that allows the user to import, visualize and segment CT medical images, check and correct the segmentations, and create digital 3D models. The 3D models can be used in OOOPDS for measuring, treatment planning and producing an output file to be used for additive manufacturing (3D printing). The physical model printed through the output file is only used to print the unaltered anatomical structure and is not used for diagnostic use, does not contact with the patient, and is not intended for use in a surgical environment. OOOPDS includes the following functionality: -Importing medical images in DICOM format for visualization and analysis. -Viewing medical imaging data in the axial, coronal and sagittal views. -Calculating a digital 3D model and editing the model. -Measuring images and 3D models -Segmenting specific anatomy using dedicated semi-automatic tools. -Treatment planning on 3D models with cutting planes and the ability to move cut objects. -File export for 3D Printing. Intended Use/Indications for Use 21 CFR 807.92(a)(5) OOOPDS is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. OOOPDS is also intended for measuring and treatment planning. The OOOPDS output can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replicas generated from digital output files are not for diagnostic purposes and may be used in orthopedic and maxillofacial applications. {5} OOOPDS should be used in conjunction with expert clinical judgement. ## Indications for Use Comparison 21 CFR 807.92(a)(5) The intended uses of OOOPDS and its predicate device, Mimics Medical (K183105) are substantially equivalent. OOOPDS and the predicate device are intended for use in the transfer and processing of medical data, as well as visualizing treatment options, with 3D models as output. ## Technological Comparison 21 CFR 807.92(a)(6) The subject and predicate device share similar image segmentation functionalities. The subject and predicate device both have similar abilities to process, review and analyze medical imaging data. The subject and predicate device both generate an output file that is used for the additive manufacture of anatomic models, with the difference that the physical models by the subject device are not for diagnostic use. The subject device is more limited in its application to the orthopedic and maxillofacial, as opposed to Mimics Medical (maxillofacial, orthopedic and cardiovascular applications). Both the subject and predicate device are virtual preoperative planning. The subject device "OOOPDS" has been compared with predicate device "Mimics Medical" (K183105). The subject device has same intended use, principle of operation and similar technological characteristics as the predicate device. Although there should be some different specifications among these devices, the tests performed on subject device ensure the safety and effectiveness of it. Therefore, we think the difference among the subject device, predicate did not raise any new issue of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, design and performance claims. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by the FDA guidance "Content of Premarket Submissions for Device Software Functions." This included verification against defined software requirements and validation against user needs. Both bench testing and end-user validation were performed. The subject device software was developed in accordance with ANSI/AAMI IEC 62304, Medical device software — Software life cycle processes. Cybersecurity Testing Security requirements testing, vulnerability scanning, and penetration testing of the end-to-end system were conducted as recommended by the FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." All findings were assessed and dispositioned in the security risk assessment, and no unresolved anomalies affecting the safety or effectiveness of the device remain. Geometric Accuracy Test The purpose of this test was to evaluate the geometric accuracy of the digital 3D models generated by OOOPDS. Digital 3D models generated by the subject device from clinical CT image data sets covering the anatomical regions within the indications for use were compared with the corresponding models generated by the predicate device from the same image data sets. All deviations were within the pre-defined acceptance criteria. Measurement Function Verification The purpose of this test was to verify the distance and angle measurement functions of OOOPDS. Measurements obtained using the subject device on clinical CT image data sets were compared with the corresponding measurements obtained using the predicate device on the same image data sets. Therefore, the testing results support the substantial equivalence of OOOPDS to MIMICS with respect to measurement accuracy and measurement performance. Conclusion The non-clinical performance testing conducted demonstrates that OOOPDS performs as intended and supports a determination of substantial equivalence to the predicate device. No clinical studies were necessary to support the determination of substantial equivalence. After comparing the devices and analyzing non-clinical safety & performance testing data, it can be concluded that the OOOPDS is substantially equivalent to the predicate devices.