(237 days)
Not Found
Yes
The summary explicitly mentions "Machine Learning (ML) algorithms" and describes their validation for segmentation and landmark identification.
No.
The device is an image-guided localization system that aids in surgical planning and navigation, rather than directly treating a disease or condition.
No
Explanation: The device is indicated for surgical planning and intraoperative guidance, aiding the surgeon in navigating prosthesis. It processes medical imaging data for planning and real-time navigation during orthopedic hip surgical procedures, rather than diagnosing a condition.
No
The device description explicitly states that OTS Hip is comprised of "software systems and hardware components that work together to form a stereotaxic system." It also lists several hardware components like a camera, computer stand, footswitch, keyboard, Tracers, adapters, tools, and instruments.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The OTS Hip system is an image-guided surgical navigation system. It uses medical imaging data (CT scans) of the patient's anatomy to plan and guide orthopedic surgical procedures (Total Hip Arthroplasty). It does not analyze biological specimens from the patient.
- Intended Use: The intended use is for surgical planning and intraoperative navigation, not for analyzing samples taken from the body.
Therefore, the OTS Hip system falls under the category of surgical navigation or image-guided surgery systems, not In Vitro Diagnostics.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
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.
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 of Total Hip Arthroplasty (THA)
- Intraoperative navigated surgery for THA using a posterior approach.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
OTS Hip is a system to support a surgeon with preoperative planning and intraoperative guidance during orthopedic hip joint replacement surgery.
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 quidance 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 imaqinq 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 is compatible with the following Depuy Synthes components:
- -PINN GB OFFSET GRATER HANDLE. DePuv Synthes 255000100
- Emphasys offset reamer, DePuy Synthes 4811-00-510 -
- Greatbatch Offset Cup Impactor, DePuy Synthes 255000115 -
- Pinnacle straight impactor, DePuy Synthes 221750041 l
- -Emphasys straight impactor, DePuy Synthes 4812-00-150
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computer Tomography (CT), X-Ray
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgeon, Office of user and Operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
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 thickens and imaging parameters. The test datasets were independent from the training dataset, where none of the datasets used for training was used for testing.
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 real-life data from surgeries under clinical conditions enabling validation of system level accuracy and specific functionality within the system.
The results demonstrated that the inclination and anteversion, and the mean deviation for position error were acceptable for stereotactic systems.
Leg length measurements were evaluated for residual Leg Length Inequality (LLI) and was found to be within clinically acceptable values and would not affect the safety or effectiveness, or raise different questions of safety and effectiveness.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing:
Electrical safety and EMC testing demonstrates conformance to IEC 60601-1:2005 (3rd Ed) and IEC 60601-1-2:2014 (4th Ed).
Machine Learning Algorithm 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 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 evaluated the initial annotation.
For the seqmentation validation, two clinically complex cases that would be difficult for clinicians to manually interpret did not pass the acceptance criteria. However, the ML-models overall 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.
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).
Non-clinical tests were performed to confirm the system targets. Specific OR setups and surgical procedures were simulated in laboratory environments and cadaver labs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
March 11, 2024
Ortoma AB % John Smith Partner Hogan Lovells, LLC Columbia Square, 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K232140
Trade/Device Name: OTS Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 9, 2024 Received: February 9, 2024
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.
1
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 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-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 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.
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-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).
Sincerelv.
Tejen D. Soni -S
For Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair
2
and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232140
Device Name OTS Hip
Indications for Use (Describe)
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.
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 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
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Image /page/4/Picture/0 description: The image shows the logo for ORTOMA. The logo consists of a blue geometric shape on the left and the word "ORTOMA" in black on the right. The geometric shape is made up of three triangles, two larger triangles on top and a smaller triangle on the bottom.
510(k) SUMMARY - K232140 Ortoma AB OTS Hip
| Submitter | Ortoma AB |
|---|---|
| Falkenbergsgatan 3 | |
| 412 85 Göteborg | |
| Sweden | |
| Phone: | +46 73 81 03 660 |
| 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: March 11, 2024
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, Ortoma Treatment Solution system (K181449)
5
Image /page/5/Picture/0 description: The image contains the word "ORTOMA" in bold, black letters. To the left of the word is a blue geometric shape that resembles a stylized letter A. The shape is made up of several triangles that are arranged to form the letter.
Device Description
OTS Hip is a system to support a surgeon with preoperative planning and intraoperative guidance during orthopedic hip joint replacement surgery.
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 quidance 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 imaqinq 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 is compatible with the following Depuy Synthes components:
- -PINN GB OFFSET GRATER HANDLE. DePuv Synthes 255000100
- Emphasys offset reamer, DePuy Synthes 4811-00-510 -
- Greatbatch Offset Cup Impactor, DePuy Synthes 255000115 -
- Pinnacle straight impactor, DePuy Synthes 221750041 l
- -Emphasys straight impactor, DePuy Synthes 4812-00-150
Intended Use / Indications for Use
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-quided 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 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:
6
Image /page/6/Picture/0 description: The image contains the logo for ORTOMA. The logo consists of a blue geometric shape on the left and the word "ORTOMA" in black, bold letters on the right. The geometric shape is made up of three triangles that are arranged to form a larger triangle.
- . 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, OTS Hip Plan (OHP). The predicate device and the subject device have the same workflow for anatomical landmarks, and planning of implant size and positions. In the subject device functionality is changed to detect landmarks and perform segmentation using fixed/static machine learning (ML) algorithms, and to generate a 3D model based on the segmentation.
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. A disposable tracking array called Tracer in the subject device replaces the combination of Marker and Marker Reflector Disc in the predicate device. 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.
The subject device includes a new version of the computer and with electrical components. A computer has been added to the subject device the camera of the system has been changed to a camera from a new supplier. The underlying technology with infra-red tracking of passive markers remains the same as in the predicate device. In the subject device, a new version of the passive markers, called Tracers, has replaced the passive markers in the predicate device.
Components that are used in surgery include adapters, which are used to hold the passive markers. The adapters have the same function, to hold the passive marker relative to a compatible instrument, in the predicate device and the subject device. In the subject device, new adapters have been added with a revised design to hold the Tracer and to fit to compatible instruments that are supported by the subject device. Components, OTS Instruments that includes screws and drivers, have been added in the subject device, replacing components from external suppliers.
The OTS Hip has the equivalent indications for use and similar design features as compared with the predicate system.
7
Image /page/7/Picture/1 description: The image shows the logo for ORTOMA. The logo consists of a blue geometric shape on the left and the word "ORTOMA" in black, bold letters on the right. The geometric shape is made up of three triangles arranged to form a larger triangle.
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.
Any differences between the subject and predicate device would not render the device NSE, affect the safety or effectiveness, 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 real-life data from surgeries under clinical conditions enabling validation of system level accuracy and specific functionality within the system.
The results demonstrated that the inclination and anteversion, and the mean deviation for position error were acceptable for stereotactic systems.
Leg length measurements were evaluated for residual Leg Length Inequality (LLI) and was found to be within clinically acceptable values and would not affect the safety or effectiveness, or raise different questions of safety and effectiveness.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing
Electrical safety and EMC testing demonstrates conformance to IEC 60601-1:2005 (3rd Ed) and IEC 60601-1-2:2014 (4th Ed).
Machine Learning Algorithm 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 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 evaluated the initial annotation.
For the seqmentation validation, two clinically complex cases that would be difficult for clinicians to manually interpret did not pass the acceptance criteria. However, the ML-models overall met the acceptance criteria.
8
Image /page/8/Picture/1 description: The image contains the logo for ORTOMA. The logo consists of a blue geometric shape on the left and the word "ORTOMA" in black, bold letters on the right. The geometric shape is made up of three triangles that are arranged to form a larger triangle.
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.
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 thickens and imaging parameters. The test datasets were independent from the training dataset, where none of the datasets used for training was used for testing.
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.
- . Functional testing to ensure that all functional requirements are fulfilled.
- 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).
Non-clinical tests were performed to confirm the system targets. Specific OR setups and surgical procedures were simulated in laboratory environments and cadaver labs.
Substantial Equivalence Comparison
| Characteristic | OTS Hip – Subject Device | Ortoma Treatment
Solution – Predicate
Device | Equivalence
Assessment |
|----------------|--------------------------|----------------------------------------------------|---------------------------|
| 510(k) Number | K232140 | K181449 | N/A |
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Image /page/9/Picture/0 description: The image contains the word "ORTOMA" in bold, black letters. To the left of the word is a blue graphic consisting of three triangles. The triangles are arranged in a way that they form a larger triangle shape.
| Manufacturer | Ortoma AB | Same | N/A |
|---|---|---|---|
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | Identical |
| Product Code | OLO | OLO | Identical |
| 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. | Identical | ||
| Indications for | |||
| Use | 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. | |||
| 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: | The Ortoma Treatment
Solution system is intended
to be an intraoperative
image-guided localization
system to enable navigated
surgery. It links a freehand
probe, tracked by a passive
marker sensor system, to
virtual computer image
space either on a patient's
preoperative image data
being processed by OTS
platform, or on an individual
3D-model of the patient's
bone, which is generated
through acquiring multiple
landmarks on the bone
surface.
The system is indicated for
hip surgical procedures, in
which the use of navigated
surgery is considered to be
safe and effective, and
where a reference to a rigid
anatomical structure, such
as the skull, a long bone, or
vertebra, can be identified
relative to a CT-based
model of the anatomy. The
system aids the surgeon to
accurately navigate a hip
prosthesis to the
preoperatively planned
position.
Example orthopedic
surgical procedures include
but are not limited to: | Equivalent
Revised indications
do not affect the
device's diagnostic
or therapeutic
effects. |
| | Pre-operative planning
and of Total Hip
Arthroplasty (THA) Intraoperative
navigated surgery for
THA using a posterior
approach. | Total Hip Arthroplasty
(THA) using posterior
approach. Preoperative planning
and intraoperative
navigated surgery for
joint replacement with
Stryker Exeter X3 Rimfit
cups. | |
| User Population | Orthopedic surgeon | Orthopedic surgeon | Identical |
| Anatomical Site | Hip | Hip | Identical |
| Where Used | Office of user and
Operating room | Operating room | Substantially
Equivalent.
Support for pre-
operative planning
in the user office to
support user
standard working
environment.
Preoperative
planning is not
dependent on
environment in
operating room
since input data is
generated before
entering the
operating room. |
| 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. | Identical |
| 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. | Identical |
| Principle of
Operation Flow | Preoperative image >
surgical planning > surgical
guiding > recording | Preoperative image >
surgical planning > surgical
guiding > recording | Identical |
| Major
Components | Software for planning and
guiding | Software for planning and
guiding | Substantially
Equivalent. |
| | Calibration Adapter Unit
OTD | Calibration Adapter Unit | Substantially
Equivalent. |
| | | | Updated version to
support compatible
implant system and
new tracking array
(Tracers). |
| | Calibration Adapter Unit
OTD Emphasys | Calibration Adapter Unit | Substantially
Equivalent. |
| | | | New version to
support compatible
implant system and
new tracking array
(Tracers). |
| | Inserter Adapter OTD | Inserter Adapter | Substantially
Equivalent. |
| | | | Updated version to
support compatible
implant system and
new tracking array
(Tracers). |
| | Reamer Adapter OTD | Reamer Adapter | Substantially
Equivalent. |
| | | | Updated version to
support compatible
implant system and
new tracking array
(Tracers). |
| | Inserter Adapter OTD
Straight | Inserter Adapter | Substantially
Equivalent. |
| | | | New version to
support compatible
implant system and
new tracking array
(Tracers). |
| | Inserter Adapter OTD
Pinnacle Straight | Inserter Adapter | Substantially
Equivalent.
New variant to
support compatible
implant system and
new tracking array
(Tracers). |
| | Attachment Adapter Fix | Attachment Adapter for
Stryker OrthoLock EX-Pin
4x150 | Substantially
Equivalent
Updated version to
support Ortoma
supplied screws. |
| | Attachment Adapter Twin | Calibration Adapter Unit | Substantially
Equivalent
Added variant to
support two points
fixation. |
| | Stylet & Pin | Stylet & Pin | Identical |
| | Pointer | Pointer 1 | Substantially
Equivalent.
Updated version to
support new
tracking array
(Tracers). |
| | | Pointer 2 | |
| | | Pointer 3 | |
| | Pointer Holder | None | Different - Added
component for
support of leg length
functionality. This
difference is
supported by
adequate bench
testing. |
| | Tracers | Markers | Substantially
Equivalent. |
| | | Marker Reflector Disc | Two components
combined in one
single component. |
| | | Disc Inserter/ Remover
Tool | No need of Tool to
mount Marker
Reflector Disc in
Marker. |
| | OTS Instrumentation | External components | Substantially
Equivalent.
Components are not
new but are now |
| | | | supplied by Ortoma
rather than left to
the user to procure. |
| | Camera (NDI) | Camera (Atracsys) | Substantially
Equivalent. |
| | | | Same technology,
different supplier. |
| | Computer (Baaske, e-
medic Silence TP2) | Computer (supplied by
user). | Substantially
Equivalent.
Component is now
supplied by Ortoma
rather than left to
the user to procure. |
| | Computer and Camera
Stand (Jansen Medicars,
Flexx one 180 - Ortoma,
3005.00.00.130) | Computer and Camera
stand | Substantially
Equivalent.
Updated version |
| | Keyboard (ProKeys e.K.,
K10 MED Compact-LS-
USB-US/JP) | Keyboard (Supplied by
user) | Substantially
Equivalent.
Component is now
supplied by Ortoma
rather than left to
the user to procure. |
| | Footswitch (Herga, MD3G-
DGA-GZ1-AAA-001) | Footswitch | Substantially
Equivalent. |
| | | | Updated version |
| Tracking/
Navigation
Technology | Real-time Optical Tracking
System (OPS) | Real-time Optical Tracking
System (OPS) | Identical |
| Input Image
Planning | Computer Tomography
(CT), X-Ray | Computer Tomography
(CT) | Substantially
Equivalent. |
| | | | Functionality added
for X-Ray as
optional input, and
as support for
planning (as a user
reference only). |
| Input Image
Guiding | 3D image of the unique
patient's anatomy | 3D image of the unique
patient's anatomy | Identical |
| DICOM
compliance | Yes | Yes | Identical |
| Save/load
planning | Yes | Yes | Identical |
| Accessories | None | None | Identical |
10
Image /page/10/Picture/0 description: The image shows the logo for ORTOMA. The logo consists of a blue geometric shape on the left and the word "ORTOMA" in black bold letters on the right. The geometric shape is made up of three triangles that are arranged to form a larger triangle.
11
Image /page/11/Picture/0 description: The image shows the logo for Ortoma. The logo consists of a blue geometric shape on the left and the word "ORTOMA" in black on the right. The geometric shape is made up of three triangles arranged to form a larger triangle.
12
Image /page/12/Picture/0 description: The image shows the word "ORTOMA" in bold, black letters. To the left of the word is a blue geometric shape. The shape is made up of several triangles that are arranged to form a larger triangle.
13
Image /page/13/Picture/0 description: The image contains the word "ORTOMA" in bold, black letters. To the left of the word is a blue graphic. The graphic is made up of four triangles that are arranged to form a larger triangle.
14
Image /page/14/Picture/0 description: The image shows the logo for ORTOMA. The logo consists of a blue geometric shape on the left and the word "ORTOMA" in black on the right. The geometric shape is made up of three triangles that are arranged to form a larger triangle.
| Power Source | Mains | Mains | Identical |
|---|---|---|---|
| Biocompatibility | Tested per ISO 10993 | Tested per ISO 10993 | Identical |
| Software | SW application for pre- | ||
| operative planning and | |||
| navigation | SW application for pre- | ||
| operative planning and | |||
| navigation | Identical | ||
| Sterilization | Steam sterilization for | ||
| reusable components | |||
| Gamma sterilization for | |||
| single use components | Steam sterilization for | ||
| reusable components | |||
| Gamma sterilization for | |||
| single use components | Identical |
Conclusions
The OTS Hip is as safe and effective as the Ortoma Treatment Solution system (K181449). 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 its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the OTS Hip is as safe and effective as the Ortoma Treatment Solution system (K181449). Thus, the OTS Hip is substantially equivalent.