The Practical Navigation Surgical Guidance System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in rigid patient anatomy and fiducials that can be identified on an O-arm scan. The Practical Navigation Surgical Guidance System is indicated for assisting the surgeon in placing pedicle in the posterior lumbar region (1-S1).

The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Integrity LineSider Pedicle Spinal System.

Device Description

The Practical Navigation Surgical Guidance System (PNSGS) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a Camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The PNSGS system allows for registration of the patient's anatomy to O-arm images. Once the patient anatomy is registered, a surgical plan can be created and optically-tracked surgical instruments can be used to follow the surgical plan.

AI/ML Overview

The provided text describes the "Practical Navigation Surgical Guidance System" and its substantial equivalence to a predicate device, focusing on its technical characteristics and indications for use. However, the document does not contain a detailed study report that proves the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

While the document mentions performance data, it lists only the types of tests conducted (non-clinical verification/validation, cadaver/simulated-use, and adherence to specific ASTM and IEC standards) rather than reporting the actual quantitative results or outlining acceptance criteria for those results.

Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, ground truth establishment, and MRMC studies cannot be extracted directly from this document.

Here's an analysis of what information is available:

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

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated in Document: The document outlines the types of tests performed (e.g., non-clinical verification, cadaver studies), but does not specify quantifiable acceptance criteria (e.g., "accuracy must be within X mm" or "sensitivity must be > Y%").	Not Explicitly Stated in Document: The document mentions that the system "was tested in accordance with the design requirements" and lists the types of tests conducted (e.g., ASTM F2554-10 for Positional Accuracy). However, it does not provide the numerical results or metrics from these tests. It concludes generally that "the Practical Navigation Surgical Guidance System has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness," implying the tests met their underlying objectives.

Acceptance Criteria

Reported Device Performance

Not Explicitly Stated in Document: The document outlines the types of tests performed (e.g., non-clinical verification, cadaver studies), but does not specify quantifiable acceptance criteria (e.g., "accuracy must be within X mm" or "sensitivity must be > Y%").

Not Explicitly Stated in Document: The document mentions that the system "was tested in accordance with the design requirements" and lists the types of tests conducted (e.g., ASTM F2554-10 for Positional Accuracy). However, it does not provide the numerical results or metrics from these tests. It concludes generally that "the Practical Navigation Surgical Guidance System has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness," implying the tests met their underlying objectives.

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

Sample Size for Test Set: Not specified. The document mentions "cadaver and simulated-use testing," but no number of cadavers or simulated scenarios is provided.
Data Provenance: Not specified. The document does not indicate the country of origin of any data or whether it was retrospective or prospective.

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)

Not specified. The document does not detail how ground truth was established for any performance testing, nor does it mention the involvement or qualifications of experts for this purpose.

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

Not specified. The document does not describe any adjudication method used for the 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

No MRMC study was done, nor is it applicable in this context. The device is a surgical guidance system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The closest related "assistance" would be its guidance for surgeons, but the document does not present any comparative effectiveness study with and without the device.

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

A standalone performance evaluation of the system's accuracy was implicitly done. The document states: "ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." This standard inherently evaluates the accuracy of the system itself (algorithm and hardware) in positioning, which can be considered a form of standalone performance. However, the results of this test are not provided.

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

Not explicitly stated for the cadaver/simulated-use testing. For "Positional Accuracy," the ground truth typically involves highly accurate measurements from a reference system or physical targets, which serves as the "true" position against which the device's measurements are compared.

8. The sample size for the training set

Not applicable / Not specified. This device is a surgical navigation system, not a machine learning model that would typically require a "training set" in the conventional sense (e.g., for image classification or diagnosis). Its software is likely developed using engineering principles and verification/validation against specifications, rather than trained on a large dataset of patient images in an AI/ML context.

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

Not applicable / Not specified. As noted above, typical machine learning training sets are not relevant here.

Summary

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February 24, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Practical Navigation, LLC % Roger White President Phiama, Inc 236 McKinley Park Lane Louisville, Colorado 80027

Re: K202184

Trade/Device Name: Practical Navigation Surgical Guidance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 22, 2021 Received: January 25, 2021

Dear Roger White:

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 Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202184

Device Name

Practical Navigation Surgical Guidance System

Indications for Use (Describe)

The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Integrity LineSider Pedicle Spinal System.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Practical Navigation Surgical Guidance System

1. Submitter Information

Submitter:	Practical Navigation, LLC
Address:	720 E. Wiggins Street
	Superior, CO 80027
Telephone:	(303) 517-0506
Telefax:	N/A

Roger N. White Contact: rwhite@phiama.com (303) 550-2451
Date Prepared: February 24, 2021

2. Device Information

Trade Name:	Practical Navigation Surgical Guidance System
Common Name:	Stereotaxic Instrument
Classification:	Class II per 21 CFR 882.4560
Classification Name:	Stereotaxic Instrument
Product Code:	OLO

3. Purpose of Submission

The purpose of this submission is to gain clearance for a new Image Guided System, the Practical Navigation Surgical Guidance System.

4. Predicate Device Information

The Practical Navigation Surgical Guidance System described in this submission is substantially equivalent to the following predicate:

Predicate Device	Manufacturer	510(k) No.
Excelsius GPS	Globus Medical, Inc.	K171651

The following device is referenced in this submission:

Reference Device	Manufacturer	510(k) No.
LineSider™ Spinal System	Integrity Implants, Inc.	K203367

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5. Device Description

1. The patient is placed in the appropriate position on the OR table.
The compact tracking Camera is rigidly affixed to the OR table using a multi-2. functional mechanical support arm in the appropriate position to track the surgical site.
1. The Camera is also affixed to a pin placed in the patient's iliac to provide a fixed location relative to the patient's spinal anatomy.
1. The Targeting Platform is affixed to the OR Table using a multi-functional mechanical support arm, ensuring that the Targeting Platform has sufficient range of motion to be placed over the surgical site.
1. The Registration Array is affixed to planned surgical site.
The appropriate area of spine is scanned with an O-arm. 6.
1. The scans are transferred to the PNSGS workstation, which reconstructs the images and uses the registration array image to register the patient's spine relative to the Camera location.
1. The registration is confirmed by placing an image guided instrument with a Tracking Array at various points in the surgical field.
1. The surgical paths are planned on the workstation.
1. The Targeting Platform is gross-positioned manually close to the first surgical plan location.
1. The Targeting Platform is activated to set the fine location and the trajectory based on the surgical plan.
1. Instruments with tracking arrays are used through the tool guide of the Targeting Platform to prepare the pedicle and place a pedicle screw.

6. Indications for Use

The Practical Navigation Surgical Guidance System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on an O-arm scan. The Practical Navigation Surgical Guidance System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1).

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The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Integrity LineSider Pedicle Spinal System.

7. Comparison of Technological Characteristics

The substantial equivalence of the Practical Navigation Surgical Guidance System to the predicate devices is shown by the similarity in intended use, indications for use, mechanism of action, mode of operation, and performance. The table below provides a comparison of technological characteristics and principles of operation of the PNSGS and the predicate system:

Feature	Practical Navigation Surgical GuidanceSystem(Subject Device)	Globus Medical, Inc.Excelsius GPS(K171651)
Indications for Use:	The Practical Navigation Surgical GuidanceSystem is intended for use as an aid for preciselylocating anatomical structures and for the spatialpositioning and orientation of a tool holder orGuide Tube to be used by surgeons for navigatingand/or guiding compatible surgical instruments inopen or percutaneous spinal procedures inreference to rigid patient anatomy and fiducialsthat can be identified on an O-arm scan. ThePractical Navigation Surgical Guidance System isindicated for assisting the surgeon in placingpedicle screws in vertebrae in the posteriorlumbar region (L1-S1).	The EXCELSIUS GPSTM is intended for use as an aidfor precisely locating anatomical structures and for thespatial positioning and orientation of an instrumentholder or Guide Tube to be used by surgeons fornavigating and/or guiding compatible surgicalinstruments in open or percutaneous proceduresprovided that the required fiducial markers and rigidpatient anatomy can be identified on CT scans orfluoroscopy. The system is indicated for the placementof spinal and orthopedic bone screws.
Principles ofOperation	- Intraoperative/preoperative images- Patient registration- Surgical planning- Real-time tracking ofnavigated instruments- Guidance of instruments	- Intraoperative/preoperative images- Patient registration- Surgical planning- Real-time tracking ofnavigated instruments- Guidance of instruments
Input Images	3D Intraoperative images	3D Pre-operative images3D Intraoperative images2D Intraoperative images
Integrated PlanningSoftware	PNSGS Planning and Navigation Software	Excelsius™ GPS Planning and Navigation Software
Save/load Planning	Yes	Yes
Image Merging	No	Yes
Trajectory planningparameters	Entry point, target point, length of the instrument,diameter	Entry point, target point, length of the instrument,diameter
Localization method	Optical System (infrared Camera)	Optical System (infrared Camera)
Camera system	Monocular	Stereo
Image-guidedController	YesManual macro adjustmentsForce-controlled movement of Targetingplatform	YesForce-controlled movement allowing robotic armpositioning
Patient RegistrationMethod	Registration fixture in place during 3Dintraoperative images	Registration fixture during 3D intraoperative images.Fluoroscopic merge to pre-op CTRegistration fixture in place during fluoroscopy
Accuracyverification onanatomicallandmarks	Yes	Yes
Real time display ofinstrument position	Yes	Yes
InstrumentGuidance	Trajectory and location set by Targetingplatform. Instruments are manually	Trajectory and location set by the robotic arm.Instruments are manually positioned by the
Feature	Practical Navigation Surgical GuidanceSystem(Subject Device)	Globus Medical, Inc.Excelsius GPS(K171651)
	positioned by the surgeon through theGuide Tube on the Targeting Platform.	surgeon through the Guide Tube on the roboticarm.
Patient fixation	Tracking Camera is fixed to OR table and tothe patient's iliac crest.	Dynamic reference system is fixed to patient'sbony structure such as a long bone, iliac crest,spinous process, vertebra, etc.

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8. Performance Data

Practical Navigation Surgical Guidance System was tested in accordance with the design requirements. Testing included the following:

Non-clinical system, software, and instrument verification and validation.
Cadaver and simulated-use testing under clinically relevant scenarios.
ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of . Computer Assisted Surgical Systems.
ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012Medical Electrical ● Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General ● Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Testing.

9. Conclusion

Based on the indications for use, technological characteristics, performance results, and comparison to the predicates, the Practical Navigation Surgical Guidance System has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness.

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).