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 establishing a bone surface model for the target surgery and in planning the surgical implant location, based on intraoperativelydefined 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-theshelf 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 cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved in two ways:

Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the NAVIO system retracts the bur inside the guard, disabling cutting.
. Speed control regulates the signal going to the drill motor controller itself and will limit the speed of the drill if the target surface is approached. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes and fixation features for femoral and tibial cut guides.

Additionally, the surgeon can disable both controls and operate the NAVIO system handpiece as a standard navigated surgical drill. The surgeon must press on a footpedal to activate the surgical bur and enable cutting in all modes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the NAVIO™ Surgical System (NAVIO system) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format. Instead, it states that the device was verified against the "same accuracy specifications required for the predicate device." The reported performance is a qualitative statement of meeting these specifications.

Acceptance Criteria (Implied)	Reported Device Performance
Meet accuracy specifications of the predicate device (K170360)	The updated NAVIO system meets the same accuracy specifications.
Perform as intended with updated tracking camera and OS	The changes did not impact the accuracy and performed as intended.
As safe and effective as predicate device	The updated NAVIO system is as safe and effective as the predicate.

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

Sample Size: Not explicitly stated. The text mentions "simulated knees (sawbones)". The number of sawbones used is not provided.
Data Provenance: The test data comes from bench testing using "simulated knees (sawbones)." This implies a controlled, non-clinical environment, not human data. The country of origin is not specified but is presumably where Blue Belt Technologies (or its successor, Smith & Nephew) conducts R&D/testing.

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.
Qualifications of Experts: The testing was "performed by trained technical support personnel." Specific qualifications (e.g., years of experience, medical background) are not detailed beyond "trained technical support personnel."

4. Adjudication Method for the Test Set

Not applicable. The testing was described as "verification accuracy testing" using simulated knees performed by technical support personnel, not a process involving adjudication of expert opinions on a test set.

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

MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a surgical navigation and burring system (a robotic surgical assistant), not a diagnostic AI system typically evaluated with MRMC studies.

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

The study was primarily focused on verifying the accuracy and performance of the device's components (tracking camera, OS) in assisting the surgeon with predefined spatial boundaries and controlled burring. While the accuracy testing itself might assess the core algorithm's precision, the overall device is designed to be human-in-the-loop. The text indicates the surgeon uses the system: "The NAVIO system is intended to assist the surgeon..." and "...aids the surgeon in executing the surgical plan..." Therefore, a purely standalone clinical assessment would not be relevant for this type of device. The accuracy testing performed on sawbones could be considered a form of standalone performance assessment in a controlled environment as it evaluates the system's ability to accurately control the bur, but it's not a clinical standalone performance study.

7. The Type of Ground Truth Used

The ground truth for the "verification accuracy testing" was based on the "planned target surface" and "predefined boundaries generated during the planning process." In a bench setting with sawbones, the "ground truth" would be the precise, known dimensions and locations of the planned cuts or shapes defined by the system's software and verified against physical measurements or ideal models. It's not pathology, expert consensus on images, or outcomes data, but rather engineering-defined specifications for cutting accuracy.

8. The Sample Size for the Training Set

Not applicable. This submission concerns updates to an existing device (a new tracking camera and OS upgrade), and the study described is a verification and validation study for these changes, not the initial development or training of a machine learning model. The device itself is a computer-assisted surgical system, not explicitly described as employing a machine learning algorithm that requires a training set in the way a diagnostic AI would.

This document focuses on demonstrating that hardware/software updates did not negatively impact the already cleared device's performance, rather than on the initial establishment of performance for a novel AI algorithm.

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

Not applicable, as there was no mention of a training set for a machine learning model.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

April 6, 2018

Blue Belt Technologies, Inc. Corrine Herlinger Senior Regulatory Affairs Associate 2905 Northwest Blvd., Ste. 40 Plymouth, Minnesota 55441

Re: K180271

Trade/Device Name: NAVIO™ Surgical System (NAVIO system) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 12, 2018 Received: March 13, 2018

Dear Corrine Herlinger:

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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K180271

Device Name NAVIO™ Surgical System (NAVIO system)

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/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a stylized blue swirl 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 modern, with a focus on the company name.

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	Corrine HerlingerSenior Regulatory Affairs AssociateTel: (412) 683-3844 x 4128Email: corrine.herlinger@smith-nephew.com
Date of Submission	January 29, 2018
Classification Reference	21 CFR 882.4560
Product Code	OLO
Supported Codes	HSX, HRY, KRR, NPJ, JWH
Common/Usual Name	Orthopedic Stereotaxic Instrument
Trade/Proprietary Name	NAVIO™ Surgical System (NAVIO system)
Predicate Device(s)	NAVIO system (K170360)
Reason for Submission	The NAVIO system has been updated toincorporate a newer model of the optical trackingcamera and upgrade the NAVIO system's OperatingSystem.

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Image /page/4/Picture/1 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 clean and professional, suggesting a technology-oriented company.

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 and Indications for Use statements are the same as the predicate device.

Device Description

Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the NAVIO system retracts the bur inside the guard, disabling cutting.
. Speed control regulates the signal going to the drill motor controller itself and will limit the speed of the drill if the target surface is approached. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes and fixation features for femoral and tibial cut guides.

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Image /page/5/Picture/1 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, light gray, sans-serif font. The overall design is clean and modern.

Currently Supported Total Knee Implants

The following total knee implants are supported on the Navio system:

Table 1: Currently Supported Total Knee Implants

Implant Model Name	Manufacturer	510(k) Number
JOURNEY II CR	Smith and Nephew	K121443
JOURNEY II BCS	Smith and Nephew	K111711
JOURNEY II XR	Smith and Nephew	K141471, K152726
GENESIS II CR/PS	Smith and Nephew	K951987, K962557
LEGION CR/PS	Smith and Nephew	K951987, K962557, K093746
NEO Total Knee System	New Era Orthopedics	K142388

Discussion of Similarities and Differences

The NAVIO system presented in this 510(k) submission is substantially equivalent to the predicate NAVIO, K170360. The intended use, indications for use, and the general functionality of the NAVIO system are unchanged from the previously submitted device.

This submission supports the following updates to the NAVIO system:

the NAVIO system tracking camera change, and
. the NAVIO system Operating System upgrade.

The implant product codes supported by the subject device are consistent with the predicate device. The established technologies that are used by the NAVIO system to prepare bone for attachment of implant components or for the attachment of the TKA femur and tibia cutting guides are unchanged. The UKR, PFA, and TKA workflows have not changed from the predicate device, cleared via K170360.

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Image /page/6/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a stylized blue swirl 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 modern, and the blue color suggests trust and reliability.

Table 2: Summary of Technological Similarities with Predicate

	Subject Device	Predicate Device
	NAVIO [Subject]	NAVIO [K170360]
Intended use	Same as Predicate.	The NAVIO system is intended to assistthe surgeon in providing software-definedspatial boundaries for orientation andreference information to anatomicalstructures during orthopedic procedures.
Indications for Use	Same as Predicate.	The NAVIO system is indicated for use insurgical knee procedures in which the useof stereotactic surgery may beappropriate, and where reference to rigidanatomical bony structures can bedetermined. These procedures includeunicondylar knee replacement (UKR),patellofemoral arthroplasty (PFA), andtotal knee arthroplasty (TKA).The NAVIO system is indicated for usewith cemented implants only.
Supported ProductCode(s)	Same as Predicate.	HSX, HRY, KRR, NPJ, JWH
Environment of Use	Same as Predicate.	Intended for use by trained orthopedicsurgeons in an orthopedic surgical suite.
TechnologicalCharacteristics	Same as Predicate.	The NAVIO system uses establishedtechnologies to prepare bone forattachment of UKR, PFA, or TKA implantcomponents. In the case of a total kneearthroplasty, the bone surface may also beprepared to receive the femoral and tibialcutting guides.NAVIO uses intraoperative data collection(image-free or non-CT data generation) tocreate a model of the patient's femurand/or tibia, dependent on the procedurebeing performed, and allows the surgeonto prepare a surgical plan.The NAVIO system uses predefinedboundaries generated during the planningprocess to control the motion of thesurgical bur and limit the amount of bone
		removed in order to shape the condyles,tibial plateau, or patellofemoral joint inpreparation for placement of the surgicalimplant.
		During a TKA procedure, the surgeon maychoose to prepare the bone surface forreceiving the implant by utilizing the BurAll method or the bone surface may beprepared to receive the femoral and tibialcutting guides (if cut guides are utilized,the bone surface is prepared using astandard surgical saw).
		Bur cutting is controlled either byretracting the bur in a guard, or bycontrolling the speed of the bur as thetarget surface is approached.

ReshapingMobility™

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Image /page/7/Picture/1 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 clean and modern, with a focus on the company name.

Non-Clinical Testing (Bench)

Design verification and validation tests were performed on the NAVIO system to support the updates presented in this submission. Testing included software database reviews, bench testing, labeling verification, and drawing inspections.

Trained technical support personnel performed verification accuracy testing using simulated knees (sawbones) to ensure that the changes made to the tracking camera and Operating System performed as intended and did not impact the accuracy of the NAVIO system. The testing verified that the NAVIO system with the updated optical tracking camera and upgraded Operating System is as safe and effective as the predicate device.

Clinical Testing

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

Conclusions

The NAVIO system described in this submission has the same intended use and the same technological characteristics as the NAVIO system, most recently cleared per K170360. The differences in the updated tracking camera and Operating System do not raise any new questions of safety or effectiveness.

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Image /page/8/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo consists of a stylized blue swirl 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 modern, with a focus on the company name.

The key determining factor is whether NAVIO control can be applied accurately to accomplish the desired cutting in accordance with the plan. The accuracy testing performed demonstrates that the updated NAVIO system meets the same accuracy specifications required for the predicate device.

The NAVIO system presented in this 510(k) premarket notification demonstrates that the updated NAVIO system, with the updated optical tracking camera and upgraded Operating System continues to be as safe and effective as the predicate NAVIO system (K170360).

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).