The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Navio system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement and patellofemoral arthroplasty.

The Navio system is indicated for use with cemented implants only.

Device Description

The Navio system is a computer-assisted orthopedic surgical navigation and surgical burring system. The system uses established technologies of navigation via a passive infrared tracking camera to aid the surgeon in establishing a bone surface model for the target surgery and to plan the surgical implant location based on predefined bone landmarks and known configuration of the surgical implant. The Navio system then aids the surgeon in executing the surgical plan by using a standard off-the-shelf surgical drill motor and bur (eMax 2 Plus System -K080802), which has been adapted using a tracking system. The surgical bur is located in a handpiece, which allows the bur to move within the handpiece. In the Navio system the software controls the position of the tip of the surgical bur relative to the end of a guard attached to the handpiece and prohibits the bur from cutting bone as it approaches the planned target surface. As the planned surface is reached, the tip of the bur is fully retracted within the guard.

An alternate mode of operation is the speed control mode. In this mode the speed of the bur is controlled and the bur stops as the planned surface is reached. In this mode of operation the bur does not retract into the guard. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes.

The Navio computer system maintains a log of the patient data and procedure data. Each entry is date and time stamped. Data log entries include date and time stamp for data line entry, patient and procedure ID, implant ID, step in process, and error messages. This data can be archived to a CD upon demand at the end of the procedure.

AI/ML Overview

The provided text describes the acceptance criteria and a study proving the device meets these criteria for the Navio™ system, specifically for its expanded indication of placing inlay patellofemoral implants.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for the expanded indication seem to be demonstrating that the accuracy for inlay patellofemoral implant placement is comparable to or better than the accuracy previously established for onlay patellofemoral components with the predicate device.

Acceptance Criteria Category	Specific Metric/Description	Reported Device Performance (Navio for Inlay Patellofemoral)
Accuracy of Implant Placement	Onlay Patellofemoral component RMS placement error along any single axis averaged: 0.884 mm and 1.013° (Predicate device performance established in K140596, serving as benchmark for "same placement accuracies").	Inlay Patellofemoral component RMS placement error along any single axis averaged: 0.462 mm and 1.028°
Safety and Effectiveness	No new issues of safety or effectiveness.	Non-clinical testing demonstrated no new issues of safety or effectiveness.
Functionality	Successfully use the Navio system and place inlay patellofemoral implants per specifications.	Users were able to successfully use the Navio system and place inlay patellofemoral implants.

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

Sample Size: Not explicitly stated as a number. The testing involved "simulated knees (sawbones) and cadaver lab testing." The number of sawbones or cadavers used is not specified.
Data Provenance: The testing was "nonclinical testing" and involved "simulated-use testing included testing in simulated knees (sawbones) and cadaver lab testing." This implies prospective, controlled lab experiments rather than retrospective patient data. The country of origin is not explicitly stated, but given the FDA submission, it's likely U.S.-based or regulated.

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

Number of Experts: Not explicitly stated. The text mentions "Users included surgeons, physician's assistants, and technical support personnel." It doesn't specify how many of each, nor how many were involved in establishing "ground truth" (which seems to be implicitly defined by the system's ability to achieve specified placement accuracy and these users' successful operation of the device).
Qualifications: "Surgeons," "physician's assistants," and "technical support personnel" who were "adequately trained" on the Navio system. Specific years of experience or board certifications are not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly described. The determination of "successful" placement was "per Blue Belt Technologies' specifications and implant manufacturer's specifications." This suggests an objective measurement against predefined targets rather than a human consensus-based adjudication for ground truth.

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

MRMC Study: No. The study described is a non-clinical, performance-based test, not an MRMC study comparing human readers with and without AI assistance. The device is a surgical navigation system, not an AI for image interpretation.

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

Standalone Performance: Not directly applicable in the typical sense for an image-analysis AI. The Navio system inherently involves "human-in-the-loop" as it's a surgical assistance system ("intended to assist the surgeon"). The accuracy measurements (RMS placement error) represent the system's performance when used by a human. However, the control algorithms for bur retraction/speed are standalone in their operation relative to the software-defined spatial boundaries. The accuracy numbers reported (0.462 mm and 1.028°) reflect the end-to-end performance of the system in achieving the planned surgical outcome, which is highly dependent on the algorithm's control.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the device's performance (specifically the placement accuracy) was based on objective measurements against predefined specifications. This is derived from the "Blue Belt Technologies' specifications and implant manufacturer's specifications." For surgical navigation systems, this usually involves measuring the deviation of the actual performed cut or implant placement from the pre-planned surgical model within controlled lab settings (e.g., using metrology tools or comparing post-procedure scans to planned models).

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable/not provided. This document describes a 510(k) submission for a medical device (surgical navigation system), which is a defined hardware/software product. It is not an AI model that undergoes "training" in the machine learning sense with a distinct training dataset. The device's "training" in a developmental context would involve iterative design, development, and testing cycles, but not a "training set" of data in the way an AI algorithm uses for learning.

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

Ground Truth for Training Set: Not applicable, as this is not a machine learning AI model with a training set. The "ground truth" for the device's design and development would have been established through engineering specifications, biomechanical data, anatomical models, and surgical requirements derived from established medical knowledge and clinical practice.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other, resembling a stylized human figure.

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

March 20, 2015

Blue Belt Technologies, Incorporated Mr. Richard G. Confer Vice President of Regulatory Affairs 2828 Liberty Avenue, Suite 100 Pittsburgh, Pennsylvania 15222

Re: K143668

Trade/Device Name: Navio™M Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HSX, HRY, KRR, NPJ Dated: December 22, 2014 Received: December 24, 2014

Dear Mr. Confer:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Richard G. Confer

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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

Lori A. Wiggins -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143668

Device Name Navio

Indications for Use (Describe)

The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Navio system is indicated for use with cemented implants only.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 6: 510(k) Summary

510(k) Summary

510(k) Owner	Blue Belt Technologies2905 Northwest Blvd Ste. 40Plymouth, MN 55441UNITED STATESTel: (763) 452-4905Fax: (763) 452-4675
Contact Person	Richard G. ConferVice President of Regulatory Affairs and QualityAssuranceTel: (412) 683-3844 x 4106Email: rconfer@bluebelttech.com
Date of Submission	December 22, 2014
Classification Reference	21 CFR 882.4560
Product Code	OLO
Supported Codes	HSX, HRY, KRR, NPJ
Common/Usual Name	Orthopedic Sterotaxic Instrument
Trade/Proprietary Name	NavioTM
Predicate Device(s)	Blue Belt Technologies Navio System (K140596)
Reason for Submission	Expanded Indications to add NPJ as a supportedproduct code

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Intended Use

The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Navio system is indicated for use with cemented implants only.

This intended use statement is the same as the predicate, Navio System per K140596, and adds product code NPJ per regulation 888.3560 as a supported product code.

Device Description

The following diagram shows the primary workflow steps in each application, UKR and PFA. Though the two procedures are very similar, they are mutually independent and cannot be planned or completed in parallel.

Note: The workflow has not changed from the predicate, Navio per K140596.

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Figure 6-1

Image /page/5/Figure/2 description: The image shows two flowcharts outlining the steps for two different operative procedures: Navio-UKR for Unicondylar Knee Replacement and Navio-PFA for Patellofemoral Arthroplasty. Both procedures start with hardware and handpiece connections, followed by bur/control selection, handpiece retraction, calibration, and homing validation. The UKR procedure includes steps like malleoli point collection, femur neutral position, tibia landmarks collection, gap planning, and evaluate knee ROM. The PFA procedure includes hip center calculation and skips the tibia-related steps and gap planning.

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Devices	Blue Belt TechnologiesNavio	Predicate ABlue Belt TechnologiesNavio (K14059)
Indications for use	The same as Predicate	The Navio system is intended to assistthe surgeon in providing software-defined spatial boundaries fororientation and reference informationto anatomical structures duringorthopedic procedures.The Navio System is indicated for use insurgical knee procedures in which theuse of stereotactic surgery may beappropriate, and where reference torigid anatomical bony structures can bedetermined.These procedures include unicondylarknee replacement and patellofemoralarthroplasty.The Navio system is indicated for usewith cemented implants only.
Supported ProductCode	Supported ProductCodes:HSX, HRY, KRR, NPJ	Supported Product Codes:HSX, HRY, KRR
Environment of Use	Same as Predicate	Used by trained orthopedic surgeons inan Orthopedic surgical suite.
TechnologicalCharacteristics	Same as Predicate	The Navio system uses establishedtechnologies to prepare bone forattachment of implant components.Navio uses intraoperative datacollection (image- free or non-CT datageneration) to create a model of thepatient's femur and/or tibia,dependent on the procedure beingperformed, and allows the surgeon toprepare a surgical plan.The Navio system uses predefinedboundaries generated during theplanning process to control the motionof the surgical bur and limit the amountof bone removed in order to shape the
Devices	Blue Belt TechnologiesNavio	Predicate ABlue Belt TechnologiesNavio (K14059)
Construction	Same as Predicate	patellofemoral joint in preparation forplacement of the surgical implant.Bur cutting is controlled either byretracting the bur in a guard, or bycontrolling the speed of the bur as thetarget surface is approached.
Pre-Surgical PlanningMethod	Same as Predicate	Consists of an IR image system(Northern Digital Polaris), reflectivetrackers, computer, user interfacedisplay, various probes, a surgical bur,bur guards, bone screws, and clamps.
ImagingRequirements	Same as Predicate	Uses data collected intra-operatively bysurgeon during the initial surgicalprocedure to generate a real-time planof cut surfaces.
Tool manipulation	Same as Predicate	None preoperative.Possible post-operative to verifyimplant placement after surgeonfinalizes placement.
Feedback thatboundary has beenreached	Same as Predicate	Controlled by retracting surgical burinto a guard as a function of proximityof bur to planned cut surface. Also,speed of bur changes as a function ofproximity to planned cut surface.The surgeon has control of the tool atall times. Position of the bur is basedon navigated guidance and planning ofdesired cut surface.
Visual indicator	Same as Predicate	Visual (color-coded surface on GUI) andaudio indicators as feedback that theboundary has been reached.Withdrawal of bur or reduced burspeed.
	Same as Predicate	Color changes as surgical burapproaches planned cut boundary.Magenta (purple) is the starting bonesurface (>3 mm from target surface).Intermediate colors (blue and green)indicate bone to be removed. Blueindicates 2 mm to target surface.Green indicates 1 mm to target surface.Colors are correlated to the distance.
Devices	Blue Belt TechnologiesNavio	Predicate ABlue Belt TechnologiesNavio (K14059)
		from planned cut surface in 1mmincrements. Red indicates over cutexceeding 0.5 mm.
User Override	Same as Predicate	Surgeon has full control of handpieceat all times. Cutting bur operationspeed is enabled by surgeon operatedfootswitch. The computer programonly modifies the speed up to the limitset by the surgeon pressing thefootswitch.The surgeon always has the ability tomove the handpiece away from the cutsurface or disable the footswitch.
Accuracy ofplacement ofimplant	Same placementaccuracies as Predicatefor patellofemoral kneereplacements(algorithms have notchanged).Onlay Patellofemoralcomponent RMSplacement error alongany single axis averaged0.884 mm and 1.013°.Inlay Patellofemoralcomponent RMSplacement error alongany single axis averaged0.462 mm and 1.028°.	Onlay Patellofemoral component RMSplacement error along any single axisaveraged 0.884 mm and 1.013°.

Table 6-1: Summary of Technological Similarities with Predicates

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Nonclinical Testing

Design verification tests were performed on the Blue Belt Technologies Navio system to support inlay patellofemoral implant placement as a result of the risk analysis and product requirements. Testing included software data base reviews, bench verification testing, user manual/labeling inspection, drawing inspections, and a clinical simulation (usability testing). Simulated-use testing included testing in simulated knees (sawbones) and cadaver lab testing. Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system and place inlay patellofemoral implants per Blue Belt Technologies' specifications and implant manufacturer's specifications after being adequately trained.

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Discussion of Similarities and Differences

The Navio system uses established technologies to prepare bone for attachment of implant components. Navio uses intraoperative data collection (image-free or non-CT data generation) to create a model of the patient's femur and tibia and allow the surgeon to prepare a surgical plan. The Navio uses predefined boundaries generated during the planning process to control the motion of the surgical bur and limit the amount of bone removed in order to shape the condyles, tibial plateau, or patellofemoral joint in preparation for placement of the surgical implant. This is equivalent to the methodology used by the NavioPFS™ system except for the Navio's additional capability to prepare the patellofemoral joint for implant.

The Navio uses predefined boundaries generated during the planning process to control the motion of the surgical bur and limit the amount of bone removed in order to shape the condyles, tibial plateau, and/or the patellofemoral joint in preparation for placement of the surgical implant.

This submittal supports the expanded indication for use of the Navio system to place inlay patellofemoral implants using the same techniques used in the predicate Navio system.

Though the UKR and PFA procedures are very similar, they are mutually independent and cannot be planned or completed in parallel. If the user is completing a bicompartmental knee joint replacement in which a patellofemoral arthroplasty and a unicondylar knee replacement are both being performed, preparation of the patellofemoral joint must be completed independently of the preparations of the femoral condyle and tibial plateau surfaces.

Clinical Testing

No human clinical tests were conducted to determine safety and effectiveness of the Navio system.

Summary and Conclusions

The Navio system described in this submittal has the same intended use and the same technological characteristics as the Navio system (K140596). Non-clinical testing was completed to verify that the use of the Navio system to assist with the placement of inlay patellofemoral implants does not raise any new issues of safety or effectiveness. The information presented in this 510(k) notification demonstrates that the Navio, when used to place an inlay patellofemoral implant, is as safe and effective as Navio™ (K140596).

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).