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 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 offthe-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 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

This FDA 510(k) summary for the NAVIO Surgical System (K191223) states that no human clinical testing was conducted to determine the safety and effectiveness of the updated device. Therefore, a study proving the device meets acceptance criteria as typically understood for clinical performance (e.g., accuracy against a medical outcome or expert ground truth) has not been provided in this document.

Instead, the submission relies on non-clinical (bench) testing to demonstrate performance and establish substantial equivalence to a predicate device (NAVIO Surgical System, K180271). The acceptance criteria and "reported device performance" would therefore relate to engineering specifications and functional verification rather than clinical outcomes.

Here's an attempt to answer your questions based only on the provided document, acknowledging the limitations due to the absence of clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical performance targets or reported results in the traditional sense of a clinical study. It states that the device "meets the same accuracy specifications required for the predicate device." Without the predicate device's specific acceptance criteria documented here, we can only infer the type of performance evaluated.

Acceptance Criteria Category	Reported Device Performance (as stated or implied)
Functional Performance	"Performed as intended" (for updated TKA instrument kit, distal femur punches, updated labeling, new implant database, and software modifications).
Accuracy	"Meets the same accuracy specifications required for the predicate device." (Specific numerical accuracy values are not provided in this document.)
Safety	"Does not raise any new questions of safety."
Effectiveness	"Does not raise any new questions of... effectiveness." "Continues to be as safe and effective as the predicate NAVIO system (K180271)."
Software Functionality	Verified through "software code reviews" and "verification testing" ensuring updates to workflow, user interface, and infrastructure perform as intended.
Labeling Compliance	Verified through "labeling verification and validation testing."
Usability	Evaluated through "summative usability testing."

The "study that proves the device meets the acceptance criteria" referred to in the document is a set of Non-Clinical Testing (Bench) activities, specifically:

Software code reviews
Bench testing
Summative usability testing
Labeling verification and validation testing

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

Given that no human clinical testing was conducted, there is no "test set" in the context of patient data for this submission. The "test set" would refer to the artifacts and software modules tested during the non-clinical verification and validation activities. The document does not specify the number of instruments, software versions, or test cases used in this non-clinical testing.

Data Provenance: Not applicable in the context of patient data. The testing was likely conducted internally by the manufacturer.

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

This is not applicable as there was no test set derived from human patient data for which medical ground truth would be established by experts. Non-clinical testing typically relies on engineering specifications and gold-standard measurements or reference implementations to verify functionality and accuracy.

4. Adjudication Method for the Test Set

This is not applicable as there was no test set derived from human patient data.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as stated: "No human clinical testing was conducted to determine safety and effectiveness of the NAVIO system."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a "computer-assisted orthopedic surgical navigation and surgical burring system," implying a human-in-the-loop system. The non-clinical testing focused on verifying the changes to this system. While specific algorithm-only performance metrics are not detailed, the "software code reviews" and "bench testing" would inherently evaluate the algorithms' functionality according to their design specifications, which is a form of standalone evaluation in an engineering context. However, it's not a standalone clinical performance evaluation.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be:

Engineering Specifications: For functional performance and accuracy.
Predicate Device Performance: The primary "ground truth" or benchmark is that the updated device "meets the same accuracy specifications required for the predicate device."
Design Requirements: For software functionality and usability.
Regulatory Requirements: For labeling verification.

8. The Sample Size for the Training Set

This is not applicable as the NAVIO Surgical System is a navigation and surgical burring system, not an AI/ML device that requires a "training set" for model development in the sense of supervised learning on patient data. The software updates mentioned (workflow, UI, infrastructure) refer to enhancements of the existing system's operational aspects.

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

This is not applicable as there is no mention of a "training set" in the context of AI/ML model development.

Summary

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June 28, 2019

Blue Belt Technologies, Inc. Amy Winegarden Regulatory Affairs Specialist II 2905 Northwest Blvd., Ste. 40 Plymouth, Minnesota 55441

Re: K191223

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: May 23, 2019 Received: May 28, 2019

Dear Amy Winegarden:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For- Shumaya Ali, MPH Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191223

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)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K191223

510(K) SUMMARY

Submitted by:	Blue Belt Technologies, Inc.2905 Northwest Blvd Ste. 40Plymouth, MN 55441 USATel: (763) 452-4950Fax: (763) 452-4675
Date of Submission:	June 27, 2019
Contact Person:	Amy WinegardenRegulatory Affairs Specialist IIT (412) 683-3844 x4135Email: Amy.Winegarden@smith-nephew.com
Name of Device:	NAVIO ° Surgical System (NAVIO system)
Common Name:	Orthopedic Stereotaxic Instrument
Device Classification Name andReference:	21 CFR 882.4560
Device Class:	Class II
Product Code:	OLO
Supported Codes:	HSX, HRY, KRR, NPJ, JWH
Predicate Device:	NAVIO™ Surgical System (K180271)

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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.

Indications for Use

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

The Intended Use and Indications for Use statements are 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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Currently Supported Total Knee Implants

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

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, K180271. 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 modifications to the NAVIO system:

1. Updates to the NAVIO TKA instrument kit, including the addition of NAVIO system distal femur punches.
1. Updates to the NAVIO system labeling.
Qualification of a new implant database for the Smith & Nephew ANTHEM Total Knee 3. System (K142807).
1. Workflow, user interface, and infrastructure updates to the NAVIO system Total Knee Application (TKA) software.

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 and PFA workflows have not changed from the predicate device, cleared via K180271.

Table: Predicate DevicesManufacturer	Description	SubmissionNumber	Clearance Date
Blue Belt Technologies, Inc.	NAVIO Surgical System	K180271	2/12/2018

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Non-Clinical Testing (Bench)

Design verification and validation tests were performed on the NAVIO surgical system to support the changes presented in this submission. Testing included software code reviews, bench testing, summative usability testing, and labeling verification and validation testing.

Trained technical support personnel performed verification testing to ensure that the changes made to the NAVIO system, including the updates to the NAVIO TKA instrument kit, addition of distal femur punches, updated labeling, qualification of a new implant database, and software modifications, performed as intended and that the subject device 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 K180271. The updates to the instrument kit, addition of distal femur punches, updated labeling, qualification of a new implant database, and software modifications do not raise any new questions of safety or effectiveness.

The key determining factor is whether NAVIO control can be applied accurately to accomplish the desired cutting in accordance with the plan. The verification 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 continues to be as safe and effective as the predicate NAVIO system (K180271).

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).