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

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.

AI/ML Overview

The document describes the performance testing and validation of the OTS Hip device, particularly focusing on its Machine Learning (ML) algorithms for segmentation and landmark identification.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the ML-models overall met the acceptance criteria for segmentation and landmark identification, though it also notes two clinically complex cases that did not pass for segmentation. While specific numerical acceptance criteria (e.g., minimum dice score for segmentation, specific distance for landmark identification) are not explicitly provided in a table, the qualitative statement indicates successful validation.

Given the information provided, a table attempting to present this would look like:

Feature/Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Segmentation Accuracy	ML-models should achieve acceptable accuracy when compared to manually annotated ground truth.	Overall met acceptance criteria. Two clinically complex cases did not pass.
Landmark Identification Accuracy	ML-models should achieve acceptable accuracy when compared to manually annotated ground truth.	Overall met acceptance criteria. (No specific failures mentioned for landmarks)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 90 datasets
Data Provenance:
- Countries of Origin: US (45.6%), Japan (33.3%), and the European Union (21.1%).
- Retrospective/Prospective: Not explicitly stated, but the description of "real-life data from surgeries under clinical conditions" and "collected from the same site" for OUS datasets suggests retrospective collection of existing CT medical imaging data.
- Representativeness: The datasets were described as "representative of the US population in terms of gender, age, and ethnicity" and included "images from multiple CT equipment manufacturers." The data from Japan included a "high percentage of dysplastic hips with accompanying marked degenerative change."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated as a single number. The text mentions "Appropriately qualified experts established the ground truth" and "Cases were then validated by a third reviewer who evaluated the initial annotation." This implies at least two annotators (initial) and a third for validation/adjudication.
Qualifications of Experts: "Appropriately qualified experts." Specific qualifications (e.g., years of experience, sub-specialty) are not detailed.

4. Adjudication Method for the Test Set

Method: The document states, "Cases were then validated by a third reviewer who evaluated the initial annotation." This suggests a form of conflict resolution or quality control, where a third expert steps in after initial annotation to confirm or correct. The exact rules (e.g., majority vote, senior expert decision) are not specified, but it implies a process where disagreements or initial annotations are reviewed. There is no mention of "2+1" or "3+1" specifically, but the "third reviewer" role aligns with adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance. The validation focuses on the standalone performance of the ML algorithms compared to expert ground truth.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, standalone performance of the ML algorithms was done. The "Machine Learning Algorithm Validation" section explicitly states that "The results of segmentation and landmark ML algorithms were compared with the manually annotated 'ground truth' segmentations and landmarks of the test dataset." This describes an algorithm-only evaluation.

7. The Type of Ground Truth Used

Ground Truth Type: Expert consensus/manual annotation. The ground truth was established by "Appropriately qualified experts" through "manually annotated 'ground truth' segmentations and landmarks."

8. The Sample Size for the Training Set

Training Set Sample Size: The exact sample size for the training set is not specified. The document only mentions that the "test datasets were independent from the training dataset, where none of the datasets used for training was used for testing."

9. How the Ground Truth for the Training Set Was Established

Training Set Ground Truth: The document states that "Cases were then separated into training and testing datasets in an unbiased fashion." It implies that the same method used for establishing ground truth for the test set (i.e., "manually annotated 'ground truth' segmentations and landmarks" by "appropriately qualified experts" with potential "third reviewer" validation) would have been applied to the data that eventually formed the training set. However, the details for the training set ground truth establishment are not explicitly elaborated further than this general statement for all cases.

Summary

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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.

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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

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and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232140

Device Name OTS Hip

Indications for Use (Describe)

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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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)

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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 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 designed for orthopedic surgical procedures including:

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. 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.

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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.

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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 TreatmentSolution – PredicateDevice	EquivalenceAssessment
510(k) Number	K232140	K181449	N/A

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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 oforthopedic surgicalprocedures and enableintraoperative image-guided surgery.	To enable planning oforthopedic surgicalprocedures and enableintraoperative image-guided surgery.	Identical
Indications forUse	OTS Hip is indicated toenable planning oforthopedic surgicalprocedures based on CTmedical imaging data of thepatient anatomy. It is anintraoperative image-guided localization systemthat enables navigatedsurgery. It links a freehandprobe, tracked by a passivemarker sensor system, tovirtual computer imagespace on a patient'spreoperative image databeing processed by theOTS platform.The system is indicated fororthopedic hip surgicalprocedures where areference to a rigidanatomical structure, suchas the pelvis, can beidentified relative to a CT-based model of theanatomy. The system aidsthe surgeon to accuratelynavigate a compatibleprosthesis to thepreoperatively plannedposition.The system is designed fororthopedic surgicalprocedures including:	The Ortoma TreatmentSolution system is intendedto be an intraoperativeimage-guided localizationsystem to enable navigatedsurgery. It links a freehandprobe, tracked by a passivemarker sensor system, tovirtual computer imagespace either on a patient'spreoperative image databeing processed by OTSplatform, or on an individual3D-model of the patient'sbone, which is generatedthrough acquiring multiplelandmarks on the bonesurface.The system is indicated forhip surgical procedures, inwhich the use of navigatedsurgery is considered to besafe and effective, andwhere a reference to a rigidanatomical structure, suchas the skull, a long bone, orvertebra, can be identifiedrelative to a CT-basedmodel of the anatomy. Thesystem aids the surgeon toaccurately navigate a hipprosthesis to thepreoperatively plannedposition.Example orthopedicsurgical procedures includebut are not limited to:	EquivalentRevised indicationsdo not affect thedevice's diagnosticor therapeuticeffects.
	Pre-operative planningand of Total HipArthroplasty (THA) Intraoperativenavigated surgery forTHA using a posteriorapproach.	Total Hip Arthroplasty(THA) using posteriorapproach. Preoperative planningand intraoperativenavigated surgery forjoint replacement withStryker Exeter X3 Rimfitcups.
User Population	Orthopedic surgeon	Orthopedic surgeon	Identical
Anatomical Site	Hip	Hip	Identical
Where Used	Office of user andOperating room	Operating room	SubstantiallyEquivalent.Support for pre-operative planningin the user office tosupport userstandard workingenvironment.Preoperativeplanning is notdependent onenvironment inoperating roomsince input data isgenerated beforeentering theoperating room.
TechnologicalPrinciple ofOperation	Intraoperative image-guided localization systemallowing user to plansurgery usingpremeasurements ofpatient anatomy. Softwaretracks anatomy, implantsand surgical tools in real-time.	Intraoperative image-guided localization systemallowing user to plansurgery usingpremeasurements ofpatient anatomy. Softwaretracks anatomy, implantsand surgical tools in real-time.	Identical
MainTechnology ofMIS	The technology ofMinimally Invasive Surgery(MIS) is based on ImageGuided Surgery (IGS)devices.	The technology ofMinimally Invasive Surgery(MIS) is based on ImageGuided Surgery (IGS)devices.	Identical
Principle ofOperation Flow	Preoperative image >surgical planning > surgicalguiding > recording	Preoperative image >surgical planning > surgicalguiding > recording	Identical
MajorComponents	Software for planning andguiding	Software for planning andguiding	SubstantiallyEquivalent.
	Calibration Adapter UnitOTD	Calibration Adapter Unit	SubstantiallyEquivalent.
			Updated version tosupport compatibleimplant system andnew tracking array(Tracers).
	Calibration Adapter UnitOTD Emphasys	Calibration Adapter Unit	SubstantiallyEquivalent.
			New version tosupport compatibleimplant system andnew tracking array(Tracers).
	Inserter Adapter OTD	Inserter Adapter	SubstantiallyEquivalent.
			Updated version tosupport compatibleimplant system andnew tracking array(Tracers).
	Reamer Adapter OTD	Reamer Adapter	SubstantiallyEquivalent.
			Updated version tosupport compatibleimplant system andnew tracking array(Tracers).
	Inserter Adapter OTDStraight	Inserter Adapter	SubstantiallyEquivalent.
			New version tosupport compatibleimplant system andnew tracking array(Tracers).
	Inserter Adapter OTDPinnacle Straight	Inserter Adapter	SubstantiallyEquivalent.New variant tosupport compatibleimplant system andnew tracking array(Tracers).
	Attachment Adapter Fix	Attachment Adapter forStryker OrthoLock EX-Pin4x150	SubstantiallyEquivalentUpdated version tosupport Ortomasupplied screws.
	Attachment Adapter Twin	Calibration Adapter Unit	SubstantiallyEquivalentAdded variant tosupport two pointsfixation.
	Stylet & Pin	Stylet & Pin	Identical
	Pointer	Pointer 1	SubstantiallyEquivalent.Updated version tosupport newtracking array(Tracers).
		Pointer 2
		Pointer 3
	Pointer Holder	None	Different - Addedcomponent forsupport of leg lengthfunctionality. Thisdifference issupported byadequate benchtesting.
	Tracers	Markers	SubstantiallyEquivalent.
		Marker Reflector Disc	Two componentscombined in onesingle component.
		Disc Inserter/ RemoverTool	No need of Tool tomount MarkerReflector Disc inMarker.
	OTS Instrumentation	External components	SubstantiallyEquivalent.Components are notnew but are now
			supplied by Ortomarather than left tothe user to procure.
	Camera (NDI)	Camera (Atracsys)	SubstantiallyEquivalent.
			Same technology,different supplier.
	Computer (Baaske, e-medic Silence TP2)	Computer (supplied byuser).	SubstantiallyEquivalent.Component is nowsupplied by Ortomarather than left tothe user to procure.
	Computer and CameraStand (Jansen Medicars,Flexx one 180 - Ortoma,3005.00.00.130)	Computer and Camerastand	SubstantiallyEquivalent.Updated version
	Keyboard (ProKeys e.K.,K10 MED Compact-LS-USB-US/JP)	Keyboard (Supplied byuser)	SubstantiallyEquivalent.Component is nowsupplied by Ortomarather than left tothe user to procure.
	Footswitch (Herga, MD3G-DGA-GZ1-AAA-001)	Footswitch	SubstantiallyEquivalent.
			Updated version
Tracking/NavigationTechnology	Real-time Optical TrackingSystem (OPS)	Real-time Optical TrackingSystem (OPS)	Identical
Input ImagePlanning	Computer Tomography(CT), X-Ray	Computer Tomography(CT)	SubstantiallyEquivalent.
			Functionality addedfor X-Ray asoptional input, andas support forplanning (as a userreference only).
Input ImageGuiding	3D image of the uniquepatient's anatomy	3D image of the uniquepatient's anatomy	Identical
DICOMcompliance	Yes	Yes	Identical
Save/loadplanning	Yes	Yes	Identical
Accessories	None	None	Identical

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Power Source	Mains	Mains	Identical
Biocompatibility	Tested per ISO 10993	Tested per ISO 10993	Identical
Software	SW application for pre-operative planning andnavigation	SW application for pre-operative planning andnavigation	Identical
Sterilization	Steam sterilization forreusable componentsGamma sterilization forsingle use components	Steam sterilization forreusable componentsGamma sterilization forsingle 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.

Regulation Number and Section

§ 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).