The Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instrument System reusable instruments are specifically designed for use with the Brainlab Vector Vision system and the Medtronic StealthStation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Use of the Navigated Instrument System is limited to use only with the Firebird Spinal Fixation System / Phoenix MIS Spinal Fixation Systems.

Device Description

The Navigated Instrument System is comprised of manual surgical instruments for use with the Brainlab VectorVision System and the Medtronic StealthStation Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. Use of the Navigated Instrument System is limited to Taps ranging in sizes of 4.5mm to 8.5mm and bone screws ranging from 4.5mm to 8.5mm with length ranging from 25mm to 55mm.

The Navigated Instrument System Medtronic and Brainlab compatible instruments are comprised of Bone Awl, Bone Taps, Bone Probes and a variety of Screw Drivers.

AI/ML Overview

The provided text, a 510(k) summary for the Orthofix Navigated Instrument System, describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance data. However, it does not contain a detailed study report that includes specific acceptance criteria and reported device performance in a table format, nor does it provide details on sample sizes, provenance, expert qualifications, or adjudication methods.

Here's an analysis of what information is available and what is missing, based on your request:

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

Missing. The document states "Engineering analysis and performance data demonstrate that the subject Navigated Instruments are substantially equivalent to the predicate devices in compatibility, accuracy, function and performance." It also mentions "accuracy and performance testing...in a simulated surgical navigation use environment." However, it does not provide a table outlining specific acceptance criteria (e.g., "Accuracy within X mm") or the numerical results achieved by the device against those criteria.

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

Missing. The document mentions "physical testing with all Navigated Instrument System Screwdrivers" but does not specify the sample size for this test set or the provenance of any data used (e.g., if it was from a specific country, or if 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 applicable / Missing. Given that this is a non-clinical evaluation for navigation instruments, the "ground truth" would likely relate to objective measurements of accuracy and compatibility rather than expert interpretation of medical images or outcomes. There is no mention of experts establishing a ground truth for a test set in the traditional sense of clinical studies.

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

Not applicable / Missing. Adjudication methods are typically used in studies involving human interpretation or subjective assessments where discrepancies need to be resolved. This document describes an engineering analysis and physical testing, so an adjudication method is not relevant.

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

Not applicable. This device is a "Navigated Instrument System" used with existing navigation systems (BrainLab VectorVision and Medtronic StealthStation). It is a physical instrument for surgical guidance, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance in image interpretation. Therefore, an MRMC study is not relevant to this device.

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

Not applicable. This is a system of physical instruments, not an algorithm. The performance evaluation is related to the physical instruments' compatibility, accuracy, and function within established navigation systems, which inherently involve a "human-in-the-loop" (the surgeon).

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

Inferred, but not explicitly stated. For an "accuracy and performance testing...in a simulated surgical navigation use environment," the ground truth would likely be established through precise measurements of the instrument's tip position relative to a known target or planned trajectory, validated by high-precision measurement systems (e.g., optical trackers, coordinate measuring machines). The inherent "ground truth" for compatibility would be successful functional integration with the navigation systems and the specific screws. However, the document does not explicitly describe the "type of ground truth" in detail.

8. The sample size for the training set

Not applicable. This device is a physical instrument system. It does not involve machine learning or AI models that require a "training set" of data.

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

Not applicable. As there is no training set mentioned, this information is not relevant.

Summary of what is available from the text:

Device Name: Navigated Instrument System
Purpose of Evaluation: To demonstrate substantial equivalence to predicate devices (K153442, K070106, K162921) regarding "compatibility, accuracy, function and performance."
Testing Information:
- "Engineering analysis and performance data"
- "Dimensional measurements of both the predicate devices and subject devices and geometrical comparisons to currently marketed Orthofix Instruments."
- "Validation testing includes physical testing with all Navigated Instrument System Screwdrivers..."
- "...to ensure compatibility with the system software and 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment."
Systems used for compatibility testing: Medtronic StealthStation S7 Orange, Violet, and Gray Navlock Tracker, Medtronic Navigation Instrument Driver, Navlock Reference Frame, and Navigated CD Horizon Solera Operative Technique; Brainlab VectorVision System.

In conclusion, while the document asserts that testing was performed to demonstrate substantial equivalence in compatibility, accuracy, function, and performance, it lacks the specific quantitative details, study methodologies, and explicit acceptance criteria that your request requires. The information provided is at a high-level summary suitable for a 510(k) submission, not a detailed study report.

Summary

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March 8, 2018

Orthofix Inc. Jacki Koch Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K172115

Trade/Device Name: Navigated Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 1, 2018 Received: February 6, 2018

Dear Jacki Koch:

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) K172115

Device Name Navigated Instrument System

Indications for Use (Describe)

The Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instrument System reusable instruments are specifically designed for use with the BrainLab Vector Vision system and the Medronic StealthStation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Use of the Navigated Instrument System is limited to use only with the Firebird Spinal Fixation System / Phoenix MIS Spinal Fixation Systems.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X 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 Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. The abstract shape is a stylized design, possibly representing movement or connection. The word "ORTHOFIX" is the main element of the logo, clearly indicating the brand name.

510(k) SUMMARY

Navigated Instrument System

510(k) Owner Information
Name:	Orthofix Inc.
Address:	3451 Plano ParkwayLewisville, TX 75056
Telephone Number:	214.937.2100
Fax Number:	214-937-3322
Email:	jackikoch@orthofix.com
Registration Number:	2183449
Contact Person:	Jacki Koch, Senior Regulatory Affairs Specialist
Date Prepared:	March 7, 2018
Name of Device
Trade Name / Proprietary Name:	Navigated Instrument System
Common Name:	Instrument, Stereotaxic
Product Code:	OLO
Regulatory Classification:	Class II - 21 CFR § 882.4560
Review Panel:	Orthopedic Device Panel
Predicate Devices:	K153442 - Medtronic Navigated Instrument System – NavigatecReusable Instruments for Use with StealthStation
	K070106 - Brainlab Navigated Instruments for use with theVectorVision System (Individually/Manual Calibrated)
	K162921 - Navigated Instrument System - Orthofix
	K153428 – Firebird Spinal Fixation System / Phoenix MIS SpinalFixation System - Orthofix

Reason for 510(k) Submission:

Due to the advancements in surgical techniques and surgeon requests, Orthofix is submitting this Special 510(k) request for the following:

1. Addition of Navigated MDT Screw Drivers
- a. Modular Screw Driver, Firebird Navigated MDT
- b. Multi-Axial Screw Driver, Firebird Navigated MDT
- c. Mono-Axial Screw Driver, Firebird Navigated MDT
- d. Multi-Axial Screw Driver, Phoenix Navigated MDT
- e. Reduction Screw Driver, Firebird Navigated MDT
1. Addition of Navigated MDT and BL Duckbill Probes with depth markings
1. Modification of Navigated MDT and BL Straight Probes to add depth markings

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Image /page/4/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. The "®" symbol is located to the right of the word "ORTHOFIX".

Device Description

The Navigated Instrument System Medtronic and Brainlab compatible instruments are comprised of Bone Awl, Bone Taps, Bone Probes and a variety of Screw Drivers.

The Navigated Instrument System instruments were tested for compatibility utilizing the Medtronic StealthStation S7 Orange, Violet, and Gray Navlock Tracker (Part Numbers 9734683, 9733482, 9734590 and 9732353), Medtronic Navigation Instrument Driver (Part Number 9734279) and the Navlock Reference Frame (Part Number 9732353) while utilizing the Navigated CD Horizon Solera Operative Technique with control number PMD016466-1.0 31441.

Intended Use / Indications for Use

Use of the Navigated Instrument System is limited to use only with the Firebird Spinal Fixation System / Phoenix MIS Spinal Fixation Systems.

Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices

The technological characteristics of the subject Navigated Instrument System were compared to the predicate devices in indications for use, intended use, design, technology, materials, function and performance. It was demonstrated that the subject Navigated Instrument System technology is substantially equivalent to the predicate devices.

PERFORMANCE DATA – Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

Engineering analysis and performance data demonstrate that the subject Navigated Instruments are substantially equivalent to the predicate devices in compatibility, accuracy, function and performance. Engineering analysis includes dimensional measurements of both the predicate devices and subject devices and geometrical comparisons to currently marketed Orthofix Instruments. Validation testing includes physical testing with all Navigated Instrument System Screwdrivers to ensure compatibility with the system software and 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment.

Therefore, it can be concluded that the compatibility, accuracy, function, and performance of the subject Navigated Instrument System are substantially equivalent to the predicate devices.

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Image /page/5/Picture/1 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a blue, curved shape. A small, circled R is located to the upper right of the word.

Conclusion

Based upon the information provided in this Special 510(k) submission, it has been demonstrated that the subject Navigated Instrument System subject devices are substantially equivalent to the legally marketed predicate devices in regards to indications for use, intended use, design, technology, functionality and performance.

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).