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 Navio™ system, an orthopedic stereotaxic instrument for computer-assisted knee procedures. The submission is a Traditional 510(k) for expanded indications to include patellofemoral arthroplasty (PFA).

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria in terms of specific performance metrics or thresholds (e.g., accuracy, precision) for the device. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical testing.

The "reported device performance" is primarily qualitative, stating that the device is "as safe and effective and performs as well as the Blue Belt Technologies NavioPFS™ (K121936) or the MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867)."

Therefore, a table of acceptance criteria and reported device performance as explicitly stated in quantified terms is not present in the provided document. The acceptance was based on the successful completion of nonclinical tests and a demonstration of equivalency in technological characteristics and workflow to predicate devices.

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

Test Set Sample Size: Not specified quantitatively. The "clinical simulation (usability testing)" and "simulated-use testing included testing in simulated knees (sawbones) and cadaver lab testing" do not provide specific numbers for the test set or the number of simulated knees/cadavers used.
Data Provenance: The testing was non-clinical. The document does not mention the country of origin for the cadaver lab testing or if any specific demographic data was considered for the sawbones. It's retrospective in the sense that no new human clinical trials were conducted to generate prospective clinical data for this specific submission.

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

Number of Experts: Not explicitly stated. The document mentions "Users included surgeons, physician's assistants, and technical support personnel" for usability testing. It does not quantify how many of each were involved or what their specific role was in establishing "ground truth," which implies a reference standard rather than just users.
Qualifications of Experts: General qualifications are provided: "surgeons, physician's assistants, and technical support personnel." Specific experience levels (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Since the testing was non-clinical (simulated-use, cadaver, bench) and primarily focused on verifying design, software, and usability, a formal adjudication method typically seen in clinical trials with multiple human readers for diagnostic accuracy is not described. The document states that users "were able to successfully use the Navio system and place implants per Blue Belt Technologies' specifications," implying an internal assessment rather than an adjudicated consensus.

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

No. The document explicitly states: "No human clinical tests were conducted to determine safety and effectiveness of the Navio system." Therefore, no MRMC comparative effectiveness study was performed.

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

The device itself is an "Orthopedic Sterotaxic Instrument" designed to "assist the surgeon" and is described as a "computer-assisted orthopedic surgical navigation and surgical burring system." Its function inherently involves human interaction, as it controls a surgical bur based on a plan developed by the surgeon with the system's aid. Therefore, a standalone (algorithm only without human-in-the-loop performance) study would not be applicable for this type of device, as its core function is to augment a human surgeon's actions. The non-clinical testing focused on the system's performance in aiding a user.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" implicitly refers to:

Blue Belt Technologies' specifications: Implants were placed "per Blue Belt Technologies' specifications."
Planned target surface: The system controls the bur relative to a "planned target surface."
Bone Model Refinement: The system aids in creating a model, and the burring is controlled based on this model and planned surfaces.

This suggests that the ground truth was primarily based on the predefined surgical plan and specifications established by the device's design and intended surgical outcomes, potentially verified against physical measurements in simulated and cadaveric models. It does not refer to external pathology reports or long-term patient outcomes for this type of non-clinical evaluation.

8. The Sample Size for the Training Set

Not applicable/Not specified. This device is a surgical navigation and burring system, not an AI/ML algorithm that requires a "training set" in the traditional sense of machine learning for image analysis or diagnosis. The software's functionality is based on established engineering principles for navigation and robotic control, not learning from a dataset of cases.

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

Not applicable. As noted above, there is no "training set" in the context of supervised machine learning for this device. The software logic and control parameters are designed and verified against engineering specifications and real-world biomechanical principles, not trained on a dataset of ground-truthed "examples."

Summary

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JUL 0 2 2014

Traditional 510(k) 005_510(k) Summary

K140596

Navio™

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510(k) Owner	Blue Belt Technologies, Inc.2828 Liberty Ave., Suite 100Pittsburgh, PA 15222Tel: (412) 683-3844Fax: (412) 683-6447
Contact Person	Richard G. ConferVice President of Quality Assurance and Regulatory AffairsTel: (412) 683-3844 x 4106Email: rconfer@bluebelttech.com
Date of Submission	June 27, 2014
Classification Reference	21 CFR 882.4560
Product Code	OLO
Product Codes of Implants Supported by the Navio	HSX, HRY, KRR
Common/Usual Name	Orthopedic Sterotaxic Instrument
Trade/Proprietary Name	Navio™
Predicate Device(s)	Blue Belt Technologies, Inc. NavioPFS™ (K121936)MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867)
Reason for Submission	Expanded Indications

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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, MAKO TGS (K081867) and expands the intended use statement of the NavioPFS (K121936) to include the patellofemoral knee replacement application.

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.

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During Patient Registration, the user selects the operative procedure to be completed: Navio - UKR for Unicondylar Knee Replacement

Hardware Connection Handpiece Connection

Bur/Control Selection

Handpiece Retraction

Handpiece Calibration

Handpiece Home Position

Homing Validation

Bone Tracker Attachment

Camera Orientation Adjustment

Point Probe Verification

Checkpoint Definition

Malleoli Point Collection

Hip Center Calculation

Femur Neutral Postion

Femur Kinematic Axis

Stressed ROM Collection

Femur Landmark Point Selection

Femur Free Collection

Tibia Landmarks Collection

Tibia Free Collection

Prosthesis Placement

Gap Planning

Adjust Component ML Position

Checkpoint Verification

Bone Model Refinement

Bone Removal

Evaluate Knee ROM

During Patient Registration, the user selects the operative procedure to be completed: Navio - PFA for Patellofemoral Arthroplasty

Hardware Connection Handpiece Connection

Bur/Control Selection

Handpiece Retraction

Handpiece Calibration

Handpiece Home Position

Homing Validation

Bone Tracker Attachment

Camera Orientation Adjustment

Point Probe Verification

Checkpoint Definition

Hip Center Calculation

Femur Landmark Point Selection

Femur Free Collection

Prosthesis Placement

Checkpoint Verification Bone Model Refinement

Bone Removal

Blue Belt Technologies, Inc.

Navio™

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Navio™

Summary of Similarities and DifferencesNavio, NavioPFS™, and Tactile Guidance System v2.0
Devices	Premarket NotificationSubject Device	Predicate A	Predicate B
	Blue Belt TechnologiesNavio™	Blue Belt TechnologiesNavioPFS™(K121936)	MAKO Surgical Corp.Tactile Guidance System v2.0(K081867)
	TechnologicalCharacteristics	The Navio system usesestablished technologies,as described for theNavioPFS, to prepare bonefor attachment of implantcomponents. Navio usesintraoperative datacollection (image free ornon-CT data generation) tocreate a model of thepatient's femur and/or tibia,dependent on theprocedure being performed,and allows the surgeon toprepare a surgical plan.This is equivalent to themethodology used by theNavioPFS.The Navio uses predefinedboundaries generatedduring the planning processto control the motion of thesurgical bur and limit theamount of bone removed inorder to shape thecondyles, tibial plateau, orpatellofemoral joint inpreparation for placementof the surgical implant.Bur cutting is controlledeither by retracting the burin a guard, or by controllingthe speed of the bur as thetarget surface isapproached.	The NavioPFS™ usesintraoperative datacollection (image free ornon-CT data generation)to create a model of thepatient's femur and tibiaand allows the surgeon toprepare a surgical plan.The NavioPFS™ usespredefined boundariesgenerated during theplanning process tocontrol the motion of thesurgical bur and limit theamount of bone removedin order to shape thecondyles and tibialplateau in preparation forplacement of the surgicalimplant.Bur cutting is controlledeither by retracting thebur in a guard, or bycontrolling the speed ofthe bur as the targetsurface is approached.
Construction	Consists of an IR imagesystem (Northern DigitalPolaris), reflective trackers,computer, user interfacedisplay, various probes, asurgical bur, reusable burguards, bone screws andclamps	Consists of an IR imagesystem (Northern DigitalPolaris), reflectivetrackers, computer, userinterface display, variousprobes, a surgical bur,sterile bur guards, bonescrews and clamps	Consists of an IR imagesystem (Northern DigitalPolaris), reflective trackers,computer, user interfacedisplay, various probes, asurgical bur, bone screws andclamps.
	clamps.
Summary of Similarities and Differences
Navio, NavioPFSTM, and Tactile Guidance System v2.0
Devices	Premarket NotificationSubject Device	Predicate A	Predicate B
	Blue Belt TechnologiesNavioTM	Blue Belt TechnologiesNavioPFSTM(K121936)	MAKO Surgical Corp.Tactile Guidance System v2.0(K081867)
Pre-SurgicalPlanningMethod	Uses data collected intra-operatively by surgeonduring the initial surgicalprocedure to generate areal time plan of cutsurfaces.	Uses data collected intra-operatively by surgeonduring the initial surgicalprocedure to generate areal time plan of cutsurfaces.	Uses DICOM data importedfrom pre-operative CT scans.
ImagingRequirements	None preoperative.Possible post-operative toverify implant placementafter surgeon finalizesplacement	None preoperative.Possible post-operative toverify implant placementafter surgeon finalizesplacement	CT Scans requiredpreoperatively.Possible post-operative scansto confirm implant placementafter surgeon finalizesplacement.

Summary of Technological Similarities with Predicates:

Blue Belt Technologies, Inc.

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Navio™

Nonclinical testing:

Design verification tests were performed on the Blue Belt Technologies Navio system as a result of the risk analysis and product requirements. Testing included software code reviews, software unit testing, software integration testing, 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 implants per Blue Belt Technologies' specifications after being adequately trained.

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 allows the surgeon to prepare a surgical plan. The Navio uses predefined boundaries generated during the planning process to control 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 is similar to the methods used by the MAKO TGS system to prepare the condyles, tibial plateau, and patellofemoral joint, although the MAKO TGS system uses a preoperative CT scan in addition to intra-operatively acquired data to plan the position of implant components.

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 bi-compartmental 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.

Blue Belt Technologies, Inc.

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Clinical testing

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

Summary and Conclusions

The Navio system has the same intended use as the MAKO TGS system (K081867) and has the same technological characteristics as the NavioPFS system (K121936). Non clinical testing was completed to verify that the differences in technological characteristics and workflow do not raise any new issues of safety or effectiveness. The information presented in this 510(k) notification demonstrates that the Navio is as safe and effective and performs as well as the Blue Belt Technologies NavioPFS™ (K121936) or the MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three lines representing its wings and body. The eagle is facing left, and the overall design is simple and iconic.

Public Health Service

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

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

July 2, 2014

Re: K140596

Trade/Device Name: Navio Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HSX, HRY, KRR Dated: June 5, 2014 Received: June 6. 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. Iisting 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 he advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 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/ResourcesforYou/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 yours,

Mark N. Melkerson -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) unknown

K140596

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)

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.

... のお店での中国の一部に、採用・保育・保育・FOR FOR FOR FOR FOR FOR FOR FOR MAN Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

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).