The OMNIBotics® Knee System is indicated for stereotaxic surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The Active Spacer is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics® Knee System supports OMNI Apex Knee™ System implants.

Device Description

The OMNIBotics® Knee system is a computer-assisted navigation system with a motorized bone cutting guide that is used by surgeons and OR staff to assist in performing stereotaxic total knee arthroplasty (TKA). The OMNIBotics® Knee System consists of the OMNIBotics® Station, ART Knee Application software, the iBlock® cutting guide for guiding femoral bone resections, and the Active Spacer, an active (motorized) knee spacer and ligament tensioning device for knee ligament balancing.

The OMNIBotics® Station includes a 3D optoelectronic localizer mounted on an articulated arm, a laptop hosting the ART Knee Software and equipped with a touchscreen, an external LCD monitor and a three-button footswitch as a means for the user to interact with the system. The power supply and communication hardware required for the camera, the iBlock® and the Active Spacer are contained within a single enclosure, the control box, located at the base of the Station.

AI/ML Overview

The provided text describes the OMNIBotics® Knee System, a computer-assisted navigation system for Total Knee Arthroplasty (TKA), and argues for its substantial equivalence to predicate devices, but it does not provide a detailed report of acceptance criteria and a study proving the device meets those criteria with specific performance metrics.

Instead, the document focuses on demonstrating that the OMNIBotics® Knee System is substantially equivalent to existing predicate devices (TOTAL KNEE SURGETICS Navigation System with iBlock®, VERASENSE Knee System, and eLibra® Soft Tissue Force Sensor) based on similar technological characteristics and intended use.

Therefore, much of the requested information regarding specific acceptance criteria, reported performance, sample sizes, ground truth establishment, and details of clinical studies (like MRMC or standalone performance) is not present in the provided document.

However, based on the available information, here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states that "Analyses demonstrate that system accuracy and performance are adequate for the established intended use," but it does not specify what those accuracy and performance criteria are, nor does it quantify the reported device performance against them.

2. Sample size used for the test set and the data provenance

The document mentions "cadaver testing" and "verification and validation performance testing" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided.

4. Adjudication method

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader, multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The device is a surgical navigation system, not an AI-based diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" as typically applied to imaging analysis is not directly relevant here. The system is designed to assist surgeons in locating anatomical structures and aligning endoprostheses during TKA.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the OMNIBotics® Knee System as a "computer-assisted navigation system with a motorized bone cutting guide that is used by surgeons and OR staff to assist in performing stereotaxic total knee arthroplasty." This implies a human-in-the-loop system. A standalone (algorithm-only) performance study is not mentioned, and given the nature of a surgical navigation system, it is unlikely to be applicable in that sense.

7. The type of ground truth used

The document mentions "cadaver testing." For a surgical navigation system, ground truth would typically involve precise measurements of anatomical landmarks and implant placement, potentially validated by imaging (e.g., CT scans with fiducials) or highly accurate mechanical measurement systems. However, the exact type of ground truth and how it was established (e.g., expert consensus, pathology, precise physical measurements) is not explicitly stated.

8. The sample size for the training set

The document does not mention a training set. Surgical navigation systems like this typically rely on pre-programmed anatomical models and algorithms rather than machine learning models that require a "training set" in the conventional sense.

9. How the ground truth for the training set was established

As no training set is mentioned, this information is not applicable/provided.

Summary of available information from the document:

Device Type: Computer-assisted navigation system for Total Knee Arthroplasty (TKA), including a motorized bone cutting guide and an active knee spacer/ligament tensioning device.
Purpose of Study/Testing: To demonstrate substantial equivalence to predicate devices and ensure accuracy and performance are adequate for the established intended use.
Testing Mentioned: Cadaver testing, verification and validation performance testing.
Conclusion of Testing: System accuracy and performance are adequate, and no new safety and efficacy issues are raised. The device is substantially equivalent to predicate devices.
Key Components of the System: OMNIBotics® Station (3D optoelectronic localizer, laptop with ART Knee Application software, touchscreen, external LCD monitor, footswitch, control box), iBlock® cutting guide, and Active Spacer.
Ground Truth (implied): Implied through "cadaver testing" and "verification and validation performance testing" as physical measurements against known anatomical structures and precise instrument references, but not detailed.

In essence, the provided text is a 510(k) summary focused on establishing substantial equivalence to predicate devices rather than a detailed report of a performance study against specific, quantified acceptance criteria.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 1, 2017

OMNIlife Science Inc. Christina Rovaldi Regulatory Affairs Specialist 480 Paramount Drive Raynham, Massachusetts 02767

Re: K163338

Trade/Device Name: OMNIBotics® Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 18, 2017 Received: August 21, 2017

Dear Christina Rovaldi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Katherine D. Kavlock -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163338

Device Name OMNIBotics® Knee System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for OMNI Precision in Mobility. The logo consists of a green circular icon on the left and the word "OMNI" in large, bold, blue letters on the right. Below the word "OMNI" is the phrase "PRECISION IN MOBILITY" in smaller, lighter blue letters. The green circular icon appears to be an abstract representation of a person in motion.

510(k) Summary

Submitter:	OMNIlife Science Inc.
Address:	480 Paramount DriveRaynham, Ma. 02767
Phone number:	800-448-6664
Fax number:	508-822-6030
FDA Registration #:	1226188
Contact person:	Christina Rovaldi, Regulatory Affairs Specialist
Phone number:	1-774-226-1857
Fax number:	508-822-6030
Date prepared:	July 27, 2017
Trade name:	OMNIBotics® Knee System
Classification Name:	Orthopedic Stereotaxic Instrument
Product Code:	OLO
Regulation:	21 CFR 882.4560

Substantial equivalence claimed to: K090953: TOTAL KNEE SURGETICS Navigation System with IBlock® (Primary Predicate) K150372: VERASENSE Knee System K132104: eLibra® Soft Tissue Force Sensor

Description:

Indications for Use:

The OMNIBotics® Knee System is indicated for stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during Total

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Image /page/4/Picture/0 description: The image shows the logo for OMNI Precision in Mobility. The logo consists of a green circular graphic on the left and the word "OMNI" in large, bold, blue letters on the right. Below the word "OMNI" is the phrase "PRECISION IN MOBILITY" in smaller, blue letters. The circular graphic appears to be an abstract representation of a person in motion.

Knee Arthroplasty. The Active Spacer is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics® Knee System supports OMNI Apex Knee™ System implants.

Technological Characteristics

The underlying technology of the OMNIBotics® Knee System is the same as the predicate device TOTAL KNEE SURGETICS Navigation System with iBlock® K090953. The system is based on the same operating principle and control, mechanism to provide the user with the same kind of information and guidance for the same surgery. The main changes with respect to the predicate device concern the modification of the ART software suite for navigation, and the addition of the Active Spacers for tensioning balance of the knee.

GeneralCharacteristic	OMNIBotics® Knee System	TOTAL KNEE SURGETICSNavigation System with iBlock®(K090953)
Indications forUse	The OMNIBotics® Knee System isindicated for stereotaxic surgery to aidthe surgeon in locating anatomicalstructures and aligning endoprostheseswith these anatomical structuresduring Total Knee Arthroplasty. TheActive Spacer is indicated as a tool foradjustment of soft tissue and thefemoral implant to reduce instabilityfrom flexion gap asymmetry. TheOMNIBotics® Knee System supportsOMNI Apex Knee™ System implants.	The Total Knee Surgetics NavigationSystem with iBlock® is intended foruse stereotaxic surgery to aid thesurgeon in locating anatomicalstructures and aligning theendoprostheses with the anatomicalstructures.It is specifically indicated for: TotalKnee Arthroplasty
Station	- A 3D optical localizer (OTS camera)- A Microsoft Windows based laptopcomputer that runs applicationspecific (ART knee) software- One electronics enclosurecontaining power supplies andcommunication hardware for theiBlock®, optical camera, and activespacer- 31.5 inch display monitor- A mobile OTS cart	- A 3D optical localizer (OTS camera)- A Microsoft Windows based panelcomputer that runs applicationspecific (TKS knee) software- Two electronics enclosurescontaining power supplies andcommunication hardware for theiBlock®, and optical camera- 17inch display monitor- A mobile custom designed cart

Technological Characteristics Compared to Predicate Device:

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Image /page/5/Picture/0 description: The image contains the logo for OMNI Precision in Mobility. The logo consists of a green circular graphic on the left, which appears to be an abstract representation of a person in motion. To the right of the graphic is the word "OMNI" in large, bold, dark blue letters. Below "OMNI" are the words "PRECISION IN MOBILITY" in a smaller, sans-serif font, also in dark blue.

GeneralCharacteristic	OMNIBotics® Knee System	TOTAL KNEE SURGETICSNavigation System with iBlock®(K090953)
ARTSoftware:	- Total knee navigation software- based on imageless (CT-free)registration of the knee morphologyand leg mechanical axis- Measured resection and ligamentbalancing profiles- Tibiofemoral gap measurementsthroughout flexion- Flexible workflows though the useof an onscreen menu- GUI formatted for 16:9 displayratio	- Total knee navigation software- based on imageless (CT-free)registration of the knee morphologyand leg mechanical axis- Measured resection and ligamentbalancing profiles- Tibiofemoral gap measurementsthroughout flexion- Linear workflows pre-establishedin user profile preferences- GUI formatted for 5:4 display ratio
Instruments:	- Rigid bodies equipped with sterilesingle-use markers- Adjustable cutting guide for tibialcut and/or distal femoral cut	- Rigid bodies equipped with sterilesingle-use markers- Adjustable cutting guide for tibialcut and/or distal femoral cut
iBlock®motorizedcutting guide	- Universal motorized cutting guidefor positioning a saw-guide to thefive femoral component resections	- Universal motorized cutting guidefor positioning a saw-guide to thefive femoral component resections

In addition to the comparison of the core functionality of the OMNIBotics® Knee System to the TOTAL KNEE SURGETICS Navigation System with iBlock®, new features are provided with the OMNIBotics® Knee System through the use of the Active Spacer. The Active Spacer includes two independently controlled actuators for distraction and two force sensors for sensing loads on the medial and lateral compartments of the knee. The actuators are controlled in position control (to apply a controlled height) and in force control (to apply a controlled force, in Newtons), equivalent to the VERASENSE Knee System (K150372) and the eLibra® Soft Tissue Force Sensor (K132104) respectively.

In summary, the OMNIBotics® Knee System with the Active Spacer is substantially equivalent to the TKS Navigation System when combined with the Versasense and the eLibra® devices in device functionality and intended use, and safety and effectiveness is supported by the testing performed.

Verification and Validation Documentation

The OMNIBotics® Knee System tests include cadaver testing and verification and validation performance testing to demonstrate no new safety and efficacy issues are raised with this new device. Analyses demonstrate that system accuracy and performance are adequate for the established intended use. In conclusion, the modified OMNIBotics® Knee System is substantially equivalent to the predicate devices.

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Image /page/6/Picture/0 description: The image shows the logo for OMNI Precision in Mobility. The logo consists of a green circular graphic on the left and the word "OMNI" in large, bold, blue letters on the right. Below the word "OMNI" is the phrase "PRECISION IN MOBILITY" in smaller, thinner, blue letters. The green circular graphic appears to be an abstract representation of a person.

Conclusion:

This performance of the OMNIBotics® Knee System is substantially equivalent to that of the TOTAL KNEE SURGETICS Navigation System with iBlock® (K090953) combined with the Versasense position control and the eLibra® force control. The OMNIBotics® Knee System has been demonstrated to be substantially equivalent to the predicate devices and raises no new concerns related to safety or efficacy.

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).