The NavioPFS™ 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 NavioPFS™ 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.

Device Description

The NavioPFS™ 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 targery and to plan the surgical implant location based on predefined bone landmarks and known configuration of the surgical implant. The NavioPFS™ System then aids the surgeon in executing the surgical plan by using a standard off-theshelf surgical drill motor and bur (Anspach/Synthes eMax2 plus (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 handbiece. In the NavioPFSM System the software controls the position 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 posterior surfaces of the condyle as well as placing post holes.

After the bone is prepared the surgeon is prompted to do a trial range of motion (ROM) test. Data collected using the tibial and femoral trackers is displayed as the knee and limb through a series of flexion, extension and rotational movements. Data is collected from the trackers and displayed in graphical formation is for use by the surgeon in determining fit of the implant (either the trial implant or the final implants after cementing) prior to finalization of the procedure.

The NavioPFS™ 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 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

Here's an analysis of the provided text regarding the NavioPFS™ system's acceptance criteria and studies:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria with specific thresholds (e.g., "accuracy must be within X mm"). Instead, it describes a series of verification and validation activities designed to demonstrate that the device performs as intended and is as safe and effective as its predicate devices. The "reported device performance" is thus articulated through the successful completion of these tests.

Acceptance Criterion (Inferred from testing)	Reported Device Performance (Summary of Study Findings)
Software Functionality and Reliability	Software code reviews, unit testing, and integration testing were successfully performed, indicating that the software operates as designed.
Biocompatibility	Biocompatibility testing was completed, suggesting that the device materials are safe for human contact.
Usability and User Proficiency	Clinical simulation (usability testing) in simulated knees (sawbones) and cadaver labs demonstrated that trained users (surgeons, PAs, technical support) could successfully use the system and place implants per specifications.
Mechanical/Physical Performance (e.g., Bur Control, Navigation Accuracy)	Bench verification testing was performed, although specific quantitative results are not provided. The system's ability to control bur motion (retraction or speed control) as planned was implied by the successful simulation and cadaver testing.
Adherence to International Standards (Safety)	The device complied with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), AAMI/ANSI/ISO 11607-1 (packaging materials), ISO 11607-2 (packaging processes), ISO 10993-1 (biological evaluation), and ANSI/AAMI/ISO 11137-2 (sterilization dose), indicating it meets established safety standards.
Equivalence to Predicate Devices (Overall Safety and Effectiveness)	Based on the non-clinical testing, the NavioPFS™ was concluded to be "as safe and effective and performs as well as" the MAKO Surgical Robotic Arm Interactive Orthopedic System ("MAKO RIO") (K081867) and The Zimmer (ORTHOsoft) Navitrack® System - OS Unicondylar Knee Universal (K071714).

Study Details:

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated with specific numbers for each test (e.g., number of sawbones or cadavers). The document mentions "simulated knees (sawbones) and cadaver lab testing."
- Data Provenance: The studies are non-clinical verification and validation tests, not human clinical trials. The provenance would be the test environment (e.g., US-based lab for bench testing and cadaver labs). These were prospective tests performed specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: Not specified.
- Qualifications of Experts: The document states "Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the NavioPFS™ system." Specific experience levels (e.g., "10 years of experience") are not provided. For cadaver and sawbones testing, the "ground truth" would likely be established by the physical measurements or the known geometry of the prepared bone, and verified by the experienced clinical users performing the procedures.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not described. For non-clinical, performance-based testing, an adjudication method in the context of expert review for ground truth is generally not used in the same way as for diagnostic imaging studies. The "ground truth" for these tests (e.g., whether the bur cut accurately, or if the implant was placed according to specifications) would be determined by objective measurement and successful completion of the surgical steps.
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:
- No MRMC comparative effectiveness study was done. The submission explicitly states: "No human clinical tests were conducted to determine safety and effectiveness of the NavioPFS™ System." The device (NavioPFS™) is a surgical navigation and burring system, not an AI-assisted diagnostic imaging device that involves "human readers."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The NavioPFS™ System is inherently a "human-in-the-loop" device. Its function is to "assist the surgeon" and control the bur, so a standalone algorithm-only performance test separate from human interaction would not be relevant and was not performed/described. The verification tests (software code reviews, unit testing, integration testing, bench verification) assess the algorithmic and mechanical components, but the overall "performance" is always in the context of aiding a human surgeon.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the non-clinical tests would have been established through:
  - Design Specifications/Product Requirements: For software and bench testing, compliance with predetermined functional and performance specifications.
  - Physical Measurements/Known Geometries: For sawbones and cadaver testing, the accuracy of bone preparation and implant placement would be measured against the surgical plan or known anatomical landmarks.
  - User Assessment: For usability, the ability of trained clinical users to successfully perform procedures and place implants to specification.
The sample size for the training set:
- Not applicable. This device is a surgical navigation and burring system, not an AI/ML device that requires a distinct "training set" in the sense of supervised learning from labeled data. The system relies on intraoperative data collection and predefined mathematical models/algorithms.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of AI/ML. The device's "knowledge" is based on established anatomical models, surgical planning algorithms, and real-time intraoperative data collection, rather than learning from a labeled training dataset.

Summary

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Traditional 510(k)
Tab 6 – 510(k) Summary_

NOV-3-0-2012-

Navio™ PFS

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TAB 6
510(K) SUMMARY
	K121936
Official Contact	Richard G. ConferVice President, Regulatory Affairs and Quality AssuranceBlue Belt Technologies2828 Liberty Ave.Pittsburgh, PA 15222Email: rconfer@bluebelttech.com412-683-3844 X 106412-683-6447
Date of Submission	June 29, 2012
Classification Reference	21 CFR 882.4560
Product Code	OLO
Common/Usual Name	Orthopedic Sterotaxic Instrument
Proprietary Name	NavioPFSTM
Predicate Device(s)	MAKO Surgical Tactile Guidance System v2.0 ("MAKO RIO")(K081867)The Zimmer (ORTHOsoft) Navitrack® System - OS UnicondylarKnee Universal (K071714)

Reason for submission

New Device

・

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Indications for Use

Device Description

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Summary of technological similarities with predicates

Summary of Similarities and DifferencesNavioPFS™, MAKO RIO and Navitrack System - OS Unicondylar Knee Universal
Devices	Blue Belt TechnologiesNavioPFS™	Predicate A.MAKO Surgical TactileGuidance System v2.0("MAKO RIO") (K081867)	Predicate B.The Zimmer (Orthosoft)Navitrack® System -OS Unicondylar KneeUniversal (K071714)
TechnologicalCharacteristics	The NavioPFS™ Systemuses a combination of twoestablished technologiesto prepare bone forattachment of implantcomponents. TheNavioPFS™ 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.This is equivalent to themethodology used by theNavitrack system.The NavioPFS™ usespredefined boundariesgenerated during theplanning process tocontrol the motion of thesurgical bur and limit theamount of bone removedin order to shape thecondyles and tibial plateauin preparation forplacement of the surgicalimplant.Bur motion is controlledeither by retracting thebur in a guard, or bycontrolling the speed ofthe bur.	The MAKO RIO usespreoperative CT imagingto create a model of thepatient's femur and tibiawhich allows the surgeonto prepare a surgical plan.The plan is then verifiedintra-operatively duringthe procedure.The MAKO RIO usespredefined boundariesgenerated during theabove described planningprocess to control themotion of the surgical burand limit the amount ofbone removed in order toshape the condyles andtibial plateau inpreparation for placementof the surgical implant.The motion is controlledby a robotic arm whichprovides resistance tomovement as the targetboundary is approached.	The Navitrack System -OS Unicondylar KneeUniversal deviceconsists of software, acomputer workstation,an optical trackingsystem, surgicalinstruments, andtracking accessories,designed to assist thesurgeon in theplacement ofunicondylar kneereplacementcomponents.Tracking devices areincorporated with givensurgical instruments, aswell as on fixationbases that attach toeach of the femur andtibia, such to allow theability to track anddisplay to the user theirrespective positionsintra-operatively. Thefemur and tibia aredisplayed to the user inthe form of their main .alignment axes. Thealignment axes aredetermined andrecorded intra-operatively byidentifying the keyanatomical referencesthat are used clinicallyto align and position thecomponents. TheNavitrack system doesnot require apreoperative CT scan.
Summary of Similarities and DifferencesNavioPFS™, MAKO RIO and Navitrack System - OS Unicondylar Knee Universal
Devices	Blue Belt TechnologiesNavioPFS™	Predicate A.MAKO Surgical TactileGuidance System v2.0("MAKO RIO") (K081867)	Predicate B.The Zimmer (Orthosoft)Navitrack® System -OS Unicondylar KneeUniversal (K071714)
Construction	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), reflectivetrackers, computer, userinterface display, variousprobes, a surgical burbone screws and clamps.	Consists of an IR imagesystem (Northern DigitalPolaris), reflectivetrackers, computer,user interface display,various probes, bonescrews and clamps.
Pre-SurgicalPlanning Method	Uses data collected intra-operatively by surgeonduring the initial surgicalprocedure to generate areal time plan of cutsurfaces.	Uses DICOM dataimported from pre-operative CT scans.	Uses data collectedintra-operatively bysurgeon during initialsurgical procedure togenerate real time planof cut surfaces. Doesnot require a pre-operative CT scan.
ImagingRequirements	None preoperative.Possible post-operative toverify implant placementafter surgeon finalizesplacement	CT Scans requiredpreoperatively.Possible post-operativescans to confirm implantplacement after surgeonfinalizes placement.	None preoperative.Possible post-operativeto verify implantplacement aftersurgeon finalizesplacement

06/29/2012

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Nonclinical testing:

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

In addition to the bench and simulated use testing cited above, compliance testing to the following standards was completed.

IEC 60601-1:2005 Medical Electrical Equipment Part 1: General Requirements for Safety .
. IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests.
AAMI/ANSI/ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: . Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation .

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requirements for forming, sealing and assembly processes

ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a . risk management system
ANSI/AAMI/ISO 11137-2:2006 Sterilization of health care products Radiation Part 2: . Establishing the sterilization dose

Discussion of similarities and differences

The NavioPFS™ System uses a combination of two established technologies to prepare bone for
attachment of implant components. The NavioPFS™ uses intraoperative data collectio non-CT data generation) to create a model of the patient's femur and tibia and allows the surgeon to prepare a surgical plan. This is equivalent to the methodology used by the Navitrack system.

The NavioPFS™ 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 and tibial plateau in preparation for placement of the surgical implant. This is similar to the methods used by the Mako TGS (RIO) system, although the Mako TGS (RIO) system uses a preoperative CT scan in addition to intraoperatively acquired data to plan the position of implant components.

Clinical testing

No human clinical tests were conducted to determine safety and effectiveness of the NavioPFS™ System.

Summary and Conclusions

In summary, based on the results of the clinical and non-clinical testing, the NavioPFS™ is as safe and effective and preforms as well as to the MAKO Surgical Robotic Arm Interactive Orthopedic System ("MAKO RIO") (K081867) and The Zimmer (ORTHOsoft) Navitrack® System - OS Unicondylar Knee Universal (K071714).

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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

Re: K121936

Trade/Device Name: NavioPFS™ Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: October 28, 2012 Received: November 01, 2012

November 30, 2012

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Peter D. Rumm -S

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

Enclosure

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Traditional 510(k)

Tab 5 - Indication for Use Statement

ISE

510(k) Number (if known): Device Name:

K121936 NavioPFs™

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwight Yen 2012.11.30 11:09:16 -05'00'

(Division Sign-off) Division of Surgical Devices 510(k) Number_ K121936

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).