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 (UKR), patellofemoral arthroplasty (PFA), and total knee arthroplasty (TKA).

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 both establishing a bone surface model for the target surgery and in planning the surgical implant location, based on intraoperatively-defined bone landmarks and known geometry 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 (Anspach eMax2 Plus System, cleared via K080802), which has been adapted using a tracking system.

The surgical bur is inserted into a handpiece, which allows the bur to move within the handpiece. The Navio system 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. This is referred to as Exposure Control mode.

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 target 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 and fixation features.

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 each data line entry, patient and procedure ID, implant ID, step in process, and error messages received by the user during the procedure. This data can be archived to a CD upon demand at the end of the procedure and is anonymized.

AI/ML Overview

This document is a 510(k) summary for the Navio® system, specifically addressing an expanded indication for use to include total knee arthroplasty (TKA). Since it's a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, rather than to prove absolute safety and effectiveness through extensive clinical trials.

Therefore, the information regarding acceptance criteria and statistical proof of meeting those criteria is limited and framed within the context of establishing substantial equivalence for an expanded indication.

Here's an analysis of the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in a table. Instead, it relies on the concept of "substantial equivalence" and the demonstration that the expanded use for TKA does not raise new issues of safety or effectiveness compared to the predicate device.

The reported device performance, in this context, is that the system could successfully assist in TKA procedures in simulated environments.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance
Performance of Navio system for TKA is equivalent to predicate Navio for UKR/PFA in terms of safety and effectiveness.	"Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system to place total knee implant systems per Blue Belt Technologies' and implant manufacturer's specifications after being adequately trained."
No new issues of safety or effectiveness are raised by the expanded TKA indication.	"Nonclinical testing was completed to verify that the use of the Navio system to assist with placement of total knee implants does not raise any new issues of safety or effectiveness."
The device functions as intended in surgical knee procedures (including TKA).	The testing concluded that the Navio system, when used for TKA, is "as safe and effective as the currently cleared Navio system."
The system accurately provides software-defined spatial boundaries for orientation and reference information for TKA.	The description confirms the system uses "intraoperative data collection... to create a model of the patient's femur and/or tibia" and "pre-defined boundaries generated during the planning process to control the motion of the surgical bur."
The system controls bone removal as intended for TKA, involving placement of cutting guides.	The system "controls the cutting action of the bur during the placement of the cutting guides."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document mentions "simulated-use testing included simulated knee (sawbones) and cadaver laboratory testing." It does not provide specific numbers for the cadaver lab or sawbones used. It does not mention any human clinical testing.
Data Provenance: The testing was "Non-Clinical Testing (Bench)" and performed by "Blue Belt Technologies, Inc." This suggests it was likely internal testing. There is no information about the country of origin of the data or whether it was retrospective or prospective, as it was bench/simulated testing.

3. 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)

The document states, "Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system..."
It does not specify the number of experts, nor their detailed qualifications (e.g., years of experience, specific certifications). It only broadly categorizes them.
The "ground truth" in this context would be the "specifications" of Blue Belt Technologies and the implant manufacturer, which these users were tasked to follow.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any formal adjudication method for the test set. The statement "Users... were able to successfully use the Navio system to place total knee implant systems per Blue Belt Technologies' and implant manufacturer's specifications" implies that adherence to these specifications was the measure of success, but it does not detail how this "success" was adjudicated (e.g., by independent observers, a panel, etc.).

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

No MRMC comparative effectiveness study was conducted or mentioned in this document. The submission is a 510(k) for an expanded indication, relying heavily on non-clinical bench testing and similarity to a predicate device, not a comparative effectiveness study involving human readers/users in a clinical setting against a control group.

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

The Navio system is explicitly described as assisting the surgeon (human-in-the-loop). Therefore, a standalone (algorithm only) performance study would not be relevant and was not performed or mentioned. The system's function is to aid the surgeon, not to operate autonomously.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical testing appears to be based on:

Manufacturer's Specifications: The ability of testers to "successfully use the Navio system to place total knee implant systems per Blue Belt Technologies' and implant manufacturer's specifications."
Expected Surgical Plan Execution: The system's ability to create a model, plan the surgery, and control bone removal as described in the device description.

This is not "expert consensus" in the sense of multiple independent experts agreeing on a diagnosis or measurement, nor is it pathology or outcomes data. It's more akin to validation against defined engineering and procedural standards for surgical preparation.

8. The sample size for the training set

The document does not mention any machine learning or AI training sets. The Navio system described uses "established technologies of navigation" and "pre-defined boundaries generated during the planning process" to control the surgical bur. It's a navigation and burring system, not explicitly described as an AI/ML device in this context. Therefore, a "training set" in the context of AI is not applicable here.

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

As no training set (in the AI/ML sense) is mentioned, this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

May 19, 2016

Blue Belt Technologies, Incorporation Mr. Richard Confer Vice President of Regulatory Affairs 2905 Northwest Boulevard, Suite 40 Plymouth, Minnesota 55441

Re: K160537 Trade/Device Name: Navio® Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HSX, HRY, KRR, NPJ, JWH Dated: February 24, 2016 Received: February 26, 2016

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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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Indications for Use

510(k) Number (if known) K160537 XIXIXXXXXXX

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)

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Image /page/3/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.

2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com

510(k) Summary

510(k) Owner	Blue Belt Technologies, Inc.2905 Northwest Blvd Ste. 40Plymouth, MN 55441 USATel: (763) 452-4950Fax: (763) 452-4675
Contact Person	Richard G. ConferVice President of Regulatory AffairsTel: (412) 683-3844 x 4106Email: Rick.Confer@smith-nephew.com
Date of Submission	February 24, 2016
Classification Reference	21 CFR 882.4560
Product Code	OLO
Supported Codes	HSX, HRY, KRR, NPJ, JWH
Common/Usual Name	Orthopedic Sterotaxic Instrument
Trade/Proprietary Name	Navio®
Predicate Device(s)	Navio® (K152574)
Reason for Submission	Expanded indications for use to include total kneearthroplasty (TKA), which adds JWH as a supportedproduct code

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Image /page/4/Picture/0 description: The image contains the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters. The logo is clean and professional, with a focus on the company name.

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.

Indications for Use

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

The Intended Use Statement is consistent with that of Navio®, the predicate device, cleared via K121936, K140596, K143668, and K152574. This expanded Indications for Use Statement includes the addition of total knee arthroplasty and support for product code JWH, per regulation number 888.3560.

Device Description

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Image /page/5/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.

The following diagram shows the primary workflow steps in each application: UKR, PFA, and TKA. The three procedures are mutually independent and cannot be planned or completed in parallel.

Note: The workflow for UKR and PFA procedures has not changed from the predicate device, cleared via K152574.

ReshapingMobility™

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Image /page/6/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The logo is clean and modern, with a focus on the company name.

2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com

Figure 007-1a. Comparison of Workflows (Part 1 of 2)

Image /page/6/Figure/3 description: The image shows three flowcharts that describe the operative procedures for Navio-UKR, Navio-PFA, and Navio-TKA. Each flowchart lists the steps involved in the procedure, starting with hardware connection and ending with evaluating knee ROM. The Navio-UKR procedure includes steps such as malleoli point collection, femur kinematic axis, and gap planning, while the Navio-PFA procedure includes hip center calculation and prosthesis placement. The Navio-TKA procedure includes surgery options and a selection between femur first or tibia first.

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Image /page/7/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.

2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com

Image /page/7/Figure/2 description: The image shows two flowcharts comparing the steps for Navio-TKA for femur first and tibia first. The femur first flowchart includes the following steps: Joint Laxity Extension/Flexion, Place Femur Implant, Place Tibia Implant, Gap Planning, Place Femur Cut Guide, Place Tibia Cut Guide, Checkpoint Verification, Femur Bone Removal, Checkpoint Verification, Tibia Bone Removal, and Evaluate Knee ROM. The tibia first flowchart includes the following steps: Place Tibia Implant, Place Tibia Cut Guide, Checkpoint Verification, Tibia Bone Removal, Joint Laxity Extension/Flexion, Place Femur Implant, Gap Planning, Place Femur Cut Guide, Checkpoint Verification, Femur Bone Removal, and Evaluate Knee ROM.

Figure 007-1b. Comparison of Workflows (Part 2 of 2)

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Currently supported implants include:

Implant Model Name	Manufacturer	510(k) number
NEO Total Knee System	New Era Orthopedics	K142388
Journey II CR	Smith and Nephew	K121443

Table 007-1. Summary of Technological Similarities with Predicate

Devices	Subject Device	Predicate Device
	Navio with Total KneeArthroplasty Application	Navio [K152574]
Intended use	Same as Predicate	The Navio system is intended toassist the surgeon in providingsoftware-defined spatialboundaries for orientation andreference information toanatomical structures duringorthopedic procedures.
Indications for Use	The Navio System is indicatedfor use in surgical kneeprocedures in which the use ofstereotactic surgery may beappropriate, and wherereference to rigid anatomicalbony structures can bedetermined.These procedures includeunicondylar knee replacement,patellofemoral arthroplasty, andtotal knee arthroplasty.	The Navio System is indicatedfor use in surgical kneeprocedures in which the use ofstereotactic surgery may beappropriate, and wherereference to rigid anatomicalbony structures can bedetermined.These procedures includeunicondylar knee replacementand patellofemoral arthroplasty.The Navio system is indicatedfor use with cemented implantsonly.
	The Navio system is indicatedfor use with cemented implantsonly.
Supported Product Code(s)	HSX, HRY, KRR, NPJ, JWH	HSX, HRY, KRR, NPJ
Devices	Subject Device	Predicate Device
	Navio with Total KneeArthroplasty Application	Navio [K152574]
Environment of Use	Same as Predicate	Intended for use by trainedorthopedic surgeons in anorthopedic surgical suite.
Technological Characteristics	The Navio system usesestablished technologies toprepare bone for attachment ofimplant components, or in thecase of a total kneearthroplasty, the bone surface isprepared to receive the femoraland tibial cutting guides.	The Navio system usesestablished technologies toprepare bone for attachment ofimplant components.
	Navio uses intraoperative datacollection (image-free or non-CTdata generation) to create amodel of the patient's femurand/or tibia, dependent on theprocedure being performed, andallows the surgeon to prepare asurgical plan.	Navio uses intraoperative datacollection (image-free or non-CTdata generation) to create amodel of the patient's femurand/or tibia, dependent on theprocedure being performed, andallows the surgeon to prepare asurgical plan.
	The Navio system uses pre-defined boundaries generatedduring the planning process tocontrol the motion of thesurgical bur and limit theamount of bone removed, inorder to shape the condyles,tibial plateau, or patellofemoraljoint in preparation forplacement of the surgicalimplant, or in the case of a totalknee arthroplasty, the bonesurface is prepared to receivethe femoral and tibial cuttingguides.Bone surface forreceiving the implant is	The Navio system uses pre-defined boundaries generatedduring the planning process tocontrol the motion of thesurgical bur and limit theamount of bone removed, inorder to shape the condyles,tibial plateau, or patellofemoraljoint in preparation forplacement of the surgicalimplant.
Devices	Subject Device	Predicate Device
	Navio with Total KneeArthroplasty Application	Navio [K152574]
	prepared using a standardsurgical saw.
	Bur cutting is controlled eitherby retracting the bur in a guard,or by controlling the speed ofthe bur as the target surface isapproached.	Bur cutting is controlled eitherby retracting the bur in a guard,or by controlling the speed ofthe bur as the target surface isapproached.

ReshapingMobility™

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Image /page/9/Picture/0 description: The image contains the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters.

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Image /page/10/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters. The logo is simple and modern, and the use of blue and gray gives it a professional look.

Non-Clinical Testing (Bench)

Design verification tests were performed on the Blue Belt Technologies, Inc. Navio system to support total knee arthroplasty, as a result of the risk analysis and product requirements. Testing included software database reviews, bench testing, labeling inspection, drawing inspections, and a clinical simulation (usability testing). Simulateduse testing included simulated knee (sawbones) and cadaver laboratory testing. Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system to place total knee implant systems per Blue Belt Technologies' and implant manufacturer's specifications after being adequately trained.

Clinical Testing

No human clinical testing was conducted to determine safety and effectiveness of the Navio system.

Discussion of Similarities and Differences

The predicate, Navio, uses established technologies to prepare bone for attachment of implant components. The predicate uses intraoperative data collection (image-free or non-CT data generation) to create a model of the patient's femur and/or tibia and allow the surgeon to prepare a surgical plan. The predicate uses pre-defined 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 methodology is equivalent to what is used by the Navio, the subject of this 510(k), with the exception of the Navio's expanded indication to prepare the knee for a total

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Image /page/11/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The logo is clean and modern, with a focus on the company name.

knee arthroplasty. During a total knee arthroplasty procedure, the Navio controls the cutting action of the bur during the placement of the cutting guides. The surgeon then uses the Navio-placed cutting guides to finish the preparation of the bone surface using standard surgical saws and the manual instrumentation technique established by each implant's manufacturer to prepare the remainder of the bone surface to receive the total knee implant components.

The Navio surgical system uses pre-defined 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, or in the case of a total knee arthroplasty, the bone surface is prepared to receive the femoral and tibial cutting guides. This submission supports the expanded indication for use of the Navio system to place total knee implants using the same techniques used in the predicate Navio system.

The UKR, PFA, and TKA applications are mutually independent and cannot be planned or completed in parallel.

Conclusions

The Navio system described in this submission has the same intended use and the same technological characteristics as the Navio system, cleared per K121936, K140596, K143668, and K152574, with the additional indication of total knee arthroplasty. Nonclinical testing was completed to verify that the use of the Navio system to assist with placement of total knee implants does not raise any new issues of safety or effectiveness. The information presented in this 510(k) premarket notification demonstrates that the Navio, when used to place total knee implants, is as safe and effective as the currently cleared Navio system.

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).