(123 days)
Yes
The device explicitly states that it uses "fixed/static machine learning (ML) algorithms" for tasks such as "detecting landmarks and performing segmentation" and "generating a 3D model." It also mentions "Machine Learning (ML) algorithms for Sacral Slope landmark added for x-ray images."
No
The device is an intraoperative image-guided localization system that aids a surgeon in navigating compatible prostheses during orthopedic hip surgical procedures, rather than directly providing a therapeutic effect.
No.
The device is described as an intraoperative image-guided localization system that aids surgeons in navigating compatible prostheses, and its purpose is for planning and guiding orthopedic surgical procedures, not for diagnosing diseases or conditions.
No
The device description explicitly states, "OTS Hip is comprised of software systems and hardware components that work together to form a stereotaxic system." It then lists several hardware components, including a camera and computer stand, footswitch, keyboard, tracers, adapters, and various surgical tools and instruments. This clearly indicates it is not a software-only medical device.
No.
This device is an image-guided surgery system used for surgical planning and navigation, not for in vitro examination of specimens derived from the human body.
No
The letter does not mention that a Predetermined Change Control Plan (PCCP) has been reviewed, approved, or cleared by the FDA for this specific device.
Intended Use / Indications for Use
OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT and X-Ray medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data being processed by the OTS platform.
The system is indicated for orthopedic hip surgical procedures where a reference to a rigid anatomical structure, such as the pelvis, can be identified relative to a system generated model of the anatomy. The system aids the surgeon to accurately navigate a compatible prosthesis to the preoperatively planned position.
The system is designed for orthopedic surgical procedures including:
- Pre-operative planning of total hip arthroplasty (THA)
- Intraoperative navigated surgery for THA using a posterior approach
Product codes
OLO
Device Description
OTS Hip is a system to support a surgeon with preoperative planning and intraoperative guidance during orthopedic hip joint replacement surgery.
The OTS Hip device is a modified device from the company's previously cleared OTS Hip (K232140).
OTS Hip is comprised of software systems and hardware components that work together to form a stereotaxic system. The system uses medical imaging data in DICOM format that is loaded into the system for access in the software that are part of the system.
OTS Hip software consists of OTS Hip Plan (OHP), which is a 3D preoperative planning software, and OTS Hip Guide (OHG) that provides intraoperative real-time navigation for the guidance of surgical tools and prosthetic components in relation to the preoperatively determined goal positions.
OHP is a software for preoperative planning prior to a THA (Total Hip Arthroplasty) surgery. OHP enables the orthopedic surgeon to prepare surgery by analyzing the patient anatomy in a 3D environment based on medical imaging data.
OHG imports the result from the preceding planning stage, a released plan, with the 3D model and planned data, from the database of the OTS system. In addition, OHG monitors the real-time information of the position of instruments and prosthetic components in a 3D environment by means of medical imaging data.
The components of the OHG device include a camera and computer stand with an electrical system to which a camera and a medical panel PC are attached, a footswitch, a keyboard, Tracers (passive markers), adapters that hold the Tracers and can be mounted to compatible surgical instruments and that are used for calibration, and tools and instruments that are used during surgery.
The OTS Hip is compatible with the following components:
- PINN GB OFFSET GRATER HANDLE, DePuy Synthes 2550-00-100
- Emphasys offset reamer, DePuy Synthes 4811-00-510
- Greatbatch Offset Cup Impactor, DePuy Synthes 2550-00-115
- Pinnacle straight impactor, DePuy Synthes 2217-50-041
- Emphasys straight impactor, DePuy Synthes 4812-00-150
- Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-002 (long)
- Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-012 (short)
- Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-001 (long)
- Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-012 (short)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Mentions ML (Machine Learning).
Input Imaging Modality
CT, X-Ray
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended User: Orthopedic surgeon
Care Setting: Office of user and Operating room
Description of the training set, sample size, data source, and annotation protocol
CT Algorithm Segmentation and Landmark Validation: "Cases were then separated into training and testing datasets in an unbiased fashion." "Appropriately qualified clinical experts established the ground truth." "The test datasets were independent from the training dataset, where none of the datasets used for training was used for testing." For OUS datasets, "independent datasets were used between training and testing, though the two datasets were collected from the same site."
Sacral Slope Landmark Identification Algorithm Validation: "Cases were then separated into training and testing datasets in an unbiased fashion." "Appropriately qualified clinical experts established the ground truth." "The test datasets were independent from the training dataset, where none of the x-ray images or patients included in the training dataset were re-used in the test dataset."
Description of the test set, sample size, data source, and annotation protocol
CT Algorithm Segmentation and Landmark Validation: "The results of segmentation and landmark ML algorithms were compared with the manually annotated "ground truth" segmentations and landmarks of the test dataset. Appropriately qualified clinical experts established the ground truth. Using objective criteria, cases were evaluated by blinded annotators. Cases were then separated into training and testing datasets in an unbiased fashion. Cases assigned to the test dataset were then validated by a third reviewer who was not included in the annotation process of the training data. The test datasets consisted of 90 datasets from both US and OUS data which were representative of the US population in terms of gender, age, and ethnicity and included images from multiple CT equipment manufacturers. The dataset consisted of patients from the US (45.6%), Japan (33.3%), and the European Union (21.1%). Notably, the data from Japan included a high percentage of dysplastic hips with accompanying marked degenerative change representing a worst case scenario for the intended US intended use population. The OUS dataset was unblinded. For the OUS datasets, independent datasets were used between training and testing, though the two datasets were collected from the same site. Subgroup analyses were conducted based on data variables such as scanner manufacture, slice thickness and imaging parameters. The test datasets were independent from the training dataset, where none of the datasets used for training was used for testing."
Sacral Slope Landmark Identification Algorithm Validation: "The results of the Sacral Slope landmark ML algorithm were compared with the manually annotated "ground truth" landmarks of the test dataset. Appropriately qualified clinical experts established the ground truth. Using objective criteria, cases were evaluated by blinded annotators. Cases were then separated into training and testing datasets in an unbiased fashion. Cases assigned to the test dataset were then validated by a third reviewer who was not included in the annotation process of the training data. The test datasets consisted of 503 x-ray images from 276 US patients which were representative of the US population in terms of gender, age, and ethnicity and included images from multiple x-ray equipment manufacturers. Subgroup analyses were conducted based on patient covariates and data acquisition covariates such as scanner type, x-ray tube current and imaging parameters. The test datasets were independent from the training dataset, where none of the x-ray images or patients included in the training dataset were re-used in the test dataset."
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Quantitative System Level Validation: "Quantitative system level validation testing was performed using data collected from human cadaver studies enabling validation of system level accuracy and specific functionality within the system. The results demonstrated that the inclination, anteversion, the mean deviation for position error, and leg length inequality were equivalent to results obtained for the predicate device."
Electrical Safety and Electromagnetic Compatibility (EMC): "Electrical safety and EMC assessment demonstrates conformance to IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION and IEC 60601-1-2:2014 [Including AMD 1:2021]."
Machine Learning Algorithm Validation (CT Algorithm Segmentation and Landmark Validation): "Validation testing demonstrated the accuracy of Machine Learning (ML) algorithms for segmentation and landmark identification. The results of segmentation and landmark ML algorithms were compared with the manually annotated "ground truth" segmentations and landmarks of the test dataset... The test datasets consisted of 90 datasets from both US and OUS data... The ML-models overall met the acceptance criteria."
Machine Learning Algorithm Validation (Sacral Slope Landmark Identification Algorithm Validation): "Validation testing demonstrated the accuracy of Machine Learning (ML) algorithms for Sacral Slope landmark added for x-ray images. The results of the Sacral Slope landmark ML algorithm were compared with the manually annotated "ground truth" landmarks of the test dataset... The test datasets consisted of 503 x-ray images from 276 US patients... The ML-model met the acceptance criteria."
Design Verification: "Verifying the accuracy performance of the localization and tracking technology using the standardized test procedure according to ASTM Standard F2554-18. Functional testing to ensure that all functional requirements are fulfilled for new compatible systems and revised components. Safety testing verifying the effectiveness of all risk controls determined in the device risk analysis. Risk assessment was performed per ISO 14971:2019 Medical devices – Application or Risk Management to medical devices. A detailed verification was performed covering the detailed functionality of the software (e.g., calculations of measurements from CT scans and X-Ray images). Non-clinical tests were performed to confirm the system targets. Specific OR setups and surgical procedures were simulated in laboratory environments and human cadaver labs."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Quantitative System Level Validation: inclination, anteversion, the mean deviation for position error, and leg length inequality.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter and Documentation
Page 1
May 16, 2025
Ortoma AB
℅ John Smith
Partner
Hogan Lovells, LLC
Columbia Square, 555 Thirteenth Street, NW
Washington, District of Columbia 20004
Re: K250086
Trade/Device Name: OTS Hip
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: January 13, 2025
Received: April 17, 2025
Dear John Smith:
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.
Page 2
K250086 - John Smith 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 systems (QS) regulation (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 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-
Page 3
K250086 - John Smith Page 3
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,
Shumaya Ali -S
Shumaya Ali, M.P.H.
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K250086
Device Name
OTS Hip
Indications for Use (Describe)
OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT and X-Ray medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data being processed by the OTS platform.
The system is indicated for orthopedic hip surgical procedures where a reference to a rigid anatomical structure, such as the pelvis, can be identified relative to a system generated model of the anatomy. The system aids the surgeon to accurately navigate a compatible prosthesis to the preoperatively planned position.
The system is designed for orthopedic surgical procedures including:
- Pre-operative planning of total hip arthroplasty (THA)
- Intraoperative navigated surgery for THA using a posterior approach
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
Traditional 510(k) Submission
510(k) SUMMARY
Ortoma AB OTS Hip
K250086
Submitter
Ortoma AB
Falkenbergsgatan 3
412 85 Göteborg
Sweden
Phone: +46 73 688 88 70
Contact Person: John Smith
Hogan Lovells, LLC
Columbia Square, 555 Thirteenth Street, NW
D.C., 20004
+1 202 367 3638
john.smith@hoganlovells.com
Date Prepared: May 13, 2025
Name of Device: OTS Hip
Common or Usual Name: Stereotaxic Instrument
Classification Name: 21 CFR Section 882.4560, Stereotaxic Instrument
Regulatory Class: II
Product Code: OLO
Predicate Devices
Ortoma AB, OTS Hip (K232140)
Page 6
Traditional 510(k) Submission
Device Description
OTS Hip is a system to support a surgeon with preoperative planning and intraoperative guidance during orthopedic hip joint replacement surgery.
The OTS Hip device is a modified device from the company's previously cleared OTS Hip (K232140).
OTS Hip is comprised of software systems and hardware components that work together to form a stereotaxic system. The system uses medical imaging data in DICOM format that is loaded into the system for access in the software that are part of the system.
OTS Hip software consists of OTS Hip Plan (OHP), which is a 3D preoperative planning software, and OTS Hip Guide (OHG) that provides intraoperative real-time navigation for the guidance of surgical tools and prosthetic components in relation to the preoperatively determined goal positions.
OHP is a software for preoperative planning prior to a THA (Total Hip Arthroplasty) surgery. OHP enables the orthopedic surgeon to prepare surgery by analyzing the patient anatomy in a 3D environment based on medical imaging data.
OHG imports the result from the preceding planning stage, a released plan, with the 3D model and planned data, from the database of the OTS system. In addition, OHG monitors the real-time information of the position of instruments and prosthetic components in a 3D environment by means of medical imaging data.
The components of the OHG device include a camera and computer stand with an electrical system to which a camera and a medical panel PC are attached, a footswitch, a keyboard, Tracers (passive markers), adapters that hold the Tracers and can be mounted to compatible surgical instruments and that are used for calibration, and tools and instruments that are used during surgery.
The OTS Hip is compatible with the following components:
- PINN GB OFFSET GRATER HANDLE, DePuy Synthes 2550-00-100
- Emphasys offset reamer, DePuy Synthes 4811-00-510
- Greatbatch Offset Cup Impactor, DePuy Synthes 2550-00-115
- Pinnacle straight impactor, DePuy Synthes 2217-50-041
- Emphasys straight impactor, DePuy Synthes 4812-00-150
- Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-002 (long)
- Kincise Pinnacle Straight Shell Impactor, DePuy Synthes 2000-02-012 (short)
- Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-001 (long)
- Kincise Emphasys Straight Shell Impactor, DePuy Synthes 2000-03-012 (short)
Indications for Use
OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT and X-Ray medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data being processed by the OTS platform.
Page 7
Traditional 510(k) Submission
The system is indicated for orthopedic hip surgical procedures where a reference to a rigid anatomical structure, such as the pelvis, can be identified relative to a system generated model of the anatomy. The system aids the surgeon to accurately navigate a compatible prosthesis to the preoperatively planned position.
The system is designed for orthopedic surgical procedures including:
- Pre-operative planning of total hip arthroplasty (THA)
- Intraoperative navigated surgery for THA using a posterior approach
Additional Considerations for Use
The device should not be used for patients with implants in the treatment side.
Summary of Technological Characteristics
Both the predicate device and the subject device enable pre-operative planning and navigation of prosthetic components. OTS Hip is comprised of software systems and hardware components that work together to form a stereotaxic system.
Like the predicate device, the subject device includes software for pre-operative planning of orthopedic prosthetic components. The predicate device and the subject device have the same workflow for anatomical landmarks and planning of implant size and positions. Both devices detect landmarks and perform segmentation using fixed/static machine learning (ML) algorithms and generate a 3D model based on the segmentation.
The changes include pre-processing and additional use of x-ray medical imaging data. The proposed device includes a customer specific configuration that utilizes both standing and flexed seated x-rays during a pre-operative plan. The configuration provides initial cup angles for planning that are patient specific. The user shall always review and approve the values to be exported to OTS Hip (OTS Hip Guide SW). The customer specific configuration includes an algorithm component previously cleared in K231503.
Like the predicate device, the subject device enables intraoperative image-guided navigated surgery using the OHG software and hardware components. The subject device and the predicate device include hardware components and a software for real-time navigation of surgical instruments and implants relative to the patient. Both devices use similar tracking arrays (tracers). The software included in OHG of the subject device and the predicate device is workflow based, where the user is guided to perform various steps in the workflow.
Page 8
Traditional 510(k) Submission
OTS Hip includes additional minor changes to hardware components and additional compatibility with tools for Kincise Surgical Automated System Components.
The performance testing demonstrates that the performance characteristics of the OTS Hip are equivalent to those of the predicate device, and therefore supports a determination of Substantial Equivalence for the proposed indications for use.
Differences between the subject and predicate device do not impact or affect the safety or effectiveness of the device, or raise different questions of safety and effectiveness.
Performance Testing
The following performance testing has been completed for the subject device, in support of the substantial equivalence decision:
Quantitative System Level Validation
Quantitative system level validation testing was performed using data collected from human cadaver studies enabling validation of system level accuracy and specific functionality within the system.
The results demonstrated that the inclination, anteversion, the mean deviation for position error, and leg length inequality were equivalent to results obtained for the predicate device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC assessment demonstrates conformance to IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION and IEC 60601-1-2:2014 [Including AMD 1:2021].
Machine Learning Algorithm Validation
CT Algorithm Segmentation and Landmark Validation
Validation testing demonstrated the accuracy of Machine Learning (ML) algorithms for segmentation and landmark identification.
The results of segmentation and landmark ML algorithms were compared with the manually annotated "ground truth" segmentations and landmarks of the test dataset. Appropriately qualified clinical experts established the ground truth. Using objective criteria, cases were evaluated by blinded annotators. Cases were then separated into training and testing datasets in an unbiased fashion. Cases assigned to the test dataset were then validated by a third reviewer who was not included in the annotation process of the training data.
The test datasets consisted of 90 datasets from both US and OUS data which were representative of the US population in terms of gender, age, and ethnicity and included images from multiple CT equipment manufacturers.
Page 9
Traditional 510(k) Submission
The dataset consisted of patients from the US (45.6%), Japan (33.3%), and the European Union (21.1%). Notably, the data from Japan included a high percentage of dysplastic hips with accompanying marked degenerative change representing a worst case scenario for the intended US intended use population.
The OUS dataset was unblinded.
For the OUS datasets, independent datasets were used between training and testing, though the two datasets were collected from the same site.
Subgroup analyses were conducted based on data variables such as scanner manufacture, slice thickness and imaging parameters. The test datasets were independent from the training dataset, where none of the datasets used for training was used for testing.
The ML-models overall met the acceptance criteria.
Sacral Slope Landmark Identification Algorithm Validation
Validation testing demonstrated the accuracy of Machine Learning (ML) algorithms for Sacral Slope landmark added for x-ray images.
The results of the Sacral Slope landmark ML algorithm were compared with the manually annotated "ground truth" landmarks of the test dataset. Appropriately qualified clinical experts established the ground truth. Using objective criteria, cases were evaluated by blinded annotators. Cases were then separated into training and testing datasets in an unbiased fashion. Cases assigned to the test dataset were then validated by a third reviewer who was not included in the annotation process of the training data.
The test datasets consisted of 503 x-ray images from 276 US patients which were representative of the US population in terms of gender, age, and ethnicity and included images from multiple x-ray equipment manufacturers.
Subgroup analyses were conducted based on patient covariates and data acquisition covariates such as scanner type, x-ray tube current and imaging parameters. The test datasets were independent from the training dataset, where none of the x-ray images or patients included in the training dataset were re-used in the test dataset.
The ML-model met the acceptance criteria.
Design Verification
The following design verification activities have been performed to ensure the correct functionality of the system as it has been specified. Tests were successfully completed.
• Verifying the accuracy performance of the localization and tracking technology using the standardized test procedure according to ASTM Standard F2554-18.
Page 10
Traditional 510(k) Submission
• Functional testing to ensure that all functional requirements are fulfilled for new compatible systems and revised components.
• Safety testing verifying the effectiveness of all risk controls determined in the device risk analysis.
• Risk assessment was performed per ISO 14971:2019 Medical devices – Application or Risk Management to medical devices.
• A detailed verification was performed covering the detailed functionality of the software (e.g., calculations of measurements from CT scans and X-Ray images).
Non-clinical tests were performed to confirm the system targets. Specific OR setups and surgical procedures were simulated in laboratory environments and human cadaver labs.
Substantial Equivalence Comparison
| Characteristic | OTS Hip – Subject Device | OTS Hip – Predicate Device | Equivalence Assessment |
|---|---|---|---|
| 510(k) Number | TBD | K232140 | N/A |
| Manufacturer | Ortoma AB | Ortoma AB | N/A |
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | Same |
| Product Code | OLO | OLO | Same |
| Intended Use | To enable planning of orthopedic surgical procedures and enable intraoperative image-guided surgery. | To enable planning of orthopedic surgical procedures and enable intraoperative image-guided surgery. | Same |
| Indications for Use | OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT and X-Ray medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data | OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data being processed by the OTS platform. | Similar |
Page 11
Traditional 510(k) Submission
| Characteristic | OTS Hip – Subject Device | OTS Hip – Predicate Device | Equivalence Assessment |
|---|---|---|---|
| being processed by the OTS platform. The system is indicated for orthopedic hip surgical procedures where a reference to a rigid anatomical structure, such as the pelvis, can be identified relative to a system generated model of the anatomy. The system aids the surgeon to accurately navigate a compatible prosthesis to the preoperatively planned position. The system is designed for orthopedic surgical procedures including: • Pre-operative planning of Total Hip Arthroplasty (THA) • Intraoperative navigated surgery for THA using a posterior approach | The system is indicated for orthopedic hip surgical procedures where a reference to a rigid anatomical structure, such as the pelvis, can be identified relative to a CT-based model of the anatomy. The system aids the surgeon to accurately navigate a compatible prosthesis to the preoperatively planned position. The system is designed for orthopedic surgical procedures including: • Pre-operative planning and of Total Hip Arthroplasty (THA) • Intraoperative navigated surgery for THA using a posterior approach. | ||
| User Population | Orthopedic surgeon | Orthopedic surgeon | Same |
| Anatomical Site | Hip | Hip | Same |
| Where Used | Office of user and Operating room | Office of user and Operating room | Same |
| Technological Principle of Operation | Intraoperative image-guided localization system allowing user to plan surgery using premeasurements of patient anatomy. Software tracks anatomy, implants and surgical tools in real-time. | Intraoperative image-guided localization system allowing user to plan surgery using premeasurements of patient anatomy. Software tracks anatomy, implants and surgical tools in real-time. | Same |
| Main Technology of MIS | The technology of Minimally Invasive Surgery (MIS) is based on Image Guided Surgery (IGS) devices. | The technology of Minimally Invasive Surgery (MIS) is based on Image Guided Surgery (IGS) devices. | Same |
Page 12
Traditional 510(k) Submission
| Characteristic | OTS Hip – Subject Device | OTS Hip – Predicate Device | Equivalence Assessment |
|---|---|---|---|
| Principle of Operation Flow | Preoperative image > surgical planning > surgical guiding > recording | Preoperative image > surgical planning > surgical guiding > recording | Same |
| Major Components | Software for planning and guiding Functionality added for new configuration Minor SW updates and bug fixes | Software for planning and guiding | Similar |
| Calibration Adapter Unit OTD with holes removed that are not needed. | Calibration Adapter Unit OTD | Similar | |
| Calibration Adapter Unit OTD Emphasys with holes removed that are not needed. | Calibration Adapter Unit OTD Emphasys | Similar | |
| Inserter Adapter OTD | Inserter Adapter OTD | Same | |
| Reamer Adapter OTD | Reamer Adapter OTD | Same | |
| Inserter Adapter OTD Straight - Improved interface toward tool and added compatibility for additional tools. | Inserter Adapter OTD Straight | Similar | |
| Inserter Adapter OTD Pinnacle Straight | Inserter Adapter OTD Pinnacle Straight | Same | |
| Attachment Adapter Fix OT | Attachment Adapter Fix OT | Same | |
| Attachment Adapter Twin OT - Minor design adjustment of pin hole position | Attachment Adapter Twin OT | Similar | |
| Stylet & Pin | Stylet & Pin | Same | |
| Pointer OT | Pointer OT | Same | |
| Pointer Holder | Pointer Holder | Same | |
| Tracers – minor change reflective tape | Tracers | Similar | |
| OTS Instrumentation – Improved interface towards the Threaded Pin | OTS Instrumentation | Similar |
Page 13
Traditional 510(k) Submission
| Characteristic | OTS Hip – Subject Device | OTS Hip – Predicate Device | Equivalence Assessment |
|---|---|---|---|
| Camera (NDI) | Camera (NDI) | Same | |
| Computer (Baaske, e-medic Silence TP2) | Computer (Baaske, e-medic Silence TP2) | Same | |
| Computer and Camera Stand (with integrated Power inlet and MSO (Jansen Medicars, Flexx one 2G 180 - Ortoma, 3012.00.00.071)) The Computer and Camera Stand has been updated to add support for replacement of the cable. | Computer and Camera Stand (Jansen Medicars, Flexx one 180 – Ortoma, 3005.00.00.130) | Similar | |
| Keyboard (ProKeys e.K., K10 MED Compact-LS-USB-US/JP) | Keyboard (ProKeys e.K., K10 MED Compact-LS-USB-US/JP) | Same | |
| Footswitch (Herga, MD3G-DGA-GZ1-AAA-001) | Footswitch (Herga, MD3G-DGA-GZ1-AAA-001) | Same | |
| Tracking/Navigation Technology | Real-time Optical Tracking System (OPS) | Real-time Optical Tracking System (OPS) | Same |
| Input Image Planning | Computer Tomography (CT), X-Ray with extended pre-processing and additional use of x-ray medical imaging data. | Computer Tomography (CT), X-Ray | Similar |
| Input Image Guiding | 3D image of the unique patient´s anatomy | 3D image of the unique patient´s anatomy | Same |
| DICOM compliance | Yes | Yes | Same |
| Save/load planning | Yes | Yes | Same |
| Accessories | None | None | Same |
| Power Source | Mains | Mains | Same |
| Biocompatibility | Tested per ISO 10993 | Tested per ISO 10993 | Same |
| Software | SW application for preoperative planning and navigation Functionality added for new Configuration Minor SW updates and bug fixes | SW application for preoperative planning and navigation | Similar |
Page 14
Traditional 510(k) Submission
| Characteristic | OTS Hip – Subject Device | OTS Hip – Predicate Device | Equivalence Assessment |
|---|---|---|---|
| Sterilization | Steam sterilization for reusable components Gamma sterilization for single use components | Steam sterilization for reusable components Gamma sterilization for single use components | Same |
Conclusions
The OTS Hip is as safe and effective as the Ortoma Treatment Solution system (K232140). The OTS Hip has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in the indications do not alter the intended therapeutic use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the OTS Hip and the predicate OTS Hip device raise no new issues of safety or effectiveness. Performance data demonstrate that the OTS Hip is as safe and effective as the predicate OTS Hip (K232140). Thus, the OTS Hip is substantially equivalent.