The VIPER® and EXPEDIUM® navigated instruments are image guided surgical instruments for use in the implantation of VIPER® and EXPEDIUM® pedicle screws in an open or percutaneous approach. The navigated instruments are designed for use only with Brainlab Image Guided Surgery hardware and software. The navigated instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, where the use of the VIPER® and/or EXPEDIUM® Spine Systems is indicated and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

Device Description

The VIPER® and EXPEDIUM® navigated instruments are surgical instruments, for use in the implantation of VIPER® and EXPEDIUM® pedicle screws, which have been modified for use with Brainlab image guided surgery (IGS) hardware and software. The navigated instrument shafts mate with modified handles containing tracking arrays with Brainlab proprietary designs, or contain a dedicated interface for receiving a Brainlab owned tracking array. The passive tracking arrays enable the VIPER® and EXPEDIUM® navigated instruments to be tracked by the Brainlab system to virtual computer image space on a patient's preoperative or intra-operative 2D or 3D image data.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VIPER® and EXPEDIUM® navigated instruments, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in the typical format of a performance study with defined thresholds (e.g., accuracy must be within X mm). Instead, the submission relies on the concept of substantial equivalence to a predicate device.

Therefore, the "acceptance criteria" can be inferred as demonstration that the modified instruments perform similarly to or do not raise new questions of safety and effectiveness compared to the predicate device. The "reported device performance" is a statement that this equivalence has been achieved through verification and validation.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance
Maintain the same indications for use as the predicate.	Achieved
Utilize passive markers/arrays for tracking.	Achieved
Function with the same compatible Brainlab navigation software.	Achieved
Be non-sterile and reusable, like the predicate.	Achieved
Demonstrate compatible technological characteristics and principles of operation to the predicate devices.	Verification and validation of the VIPER® and EXPEDIUM® navigated instruments integration into the Brainlab Navigation Software was performed. (This is the direct performance statement.)

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

The document does not specify a sample size for a test set in the conventional sense of a clinical trial or performance study involving patients or a large number of simulated cases. The "study" described is an engineering verification and validation of integration.

Sample Size: Not Applicable (as no test set in the traditional sense is described).
Data Provenance: Not Applicable (no patient data or specific study location is mentioned for a test set). The verification and validation were likely performed internally by the manufacturer, Medos International, Sárl, and DePuy Spine, Inc.

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

No information is provided regarding experts or ground truth establishment for a test set. This type of regulatory submission for modifications to an existing device (navigated instruments for an existing navigation system) typically focuses on engineering verification rather than independent clinical validation with expert ground truth.

4. Adjudication Method for the Test Set

Not Applicable, as no test set or expert evaluation requiring adjudication is described.

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 conducted or described in this submission. The focus is on the substantial equivalence of the modified instruments, not on the comparative effectiveness of human readers with or without AI assistance.

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

Yes, in a way, the entire submission effectively functions as verification of a standalone component within a larger system. The "device" being reviewed (VIPER® and EXPEDIUM® navigated instruments) is an algorithm-only component. Its performance is demonstrated as its ability to integrate with the existing Brainlab Image Guided Surgery hardware and software. There is no human-in-the-loop performance evaluation described for these specific instruments beyond their successful integration into the navigation workflow. The core functionality relies on the Brainlab system's algorithms, and this submission verifies the new instruments' compatibility with that proven system.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI or diagnostic accuracy studies (e.g., pathology, outcomes data, expert consensus) is not directly relevant here. The ground truth for this device's performance is implicitly the correct and accurate tracking and navigation provided by the Brainlab system when using these integrated instruments. Verification would confirm that the instruments are correctly recognized and tracked by the Brainlab system, and that their displayed position accurately reflects their physical position.

8. The Sample Size for the Training Set

Not Applicable. The submission describes a medical device (surgical instruments) that are modified for use with an existing image-guided surgery system. This is not an AI/machine learning algorithm that requires a training set in the sense of predictive modeling. The "training" for the system would be its initial development and calibration, which predates this submission.

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

Not Applicable, as this is not an AI/machine learning algorithm requiring a training set.

Summary

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120867

; SEP 2 0 2012

P. 114

A.	Submitter Information
	Manufacturer:	Medos International, SárlChemin-Blanc 38Le Locle, CH-NE 2400, Switzerland
	Submitter:	DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767
	Contact Person:	Laura Bleyendaal325 Paramount DriveRaynham, MA 02767
	Telephone number:	(508) 828-3267
	Fax number:	(508) 828-3797
	Email:	LBleyend@its.jnj.com
B.	Date Prepared	May 2012
C.	Device Name
	Trade/Proprietary Name:	VIPER® and EXPEDIUM® navigatedinstruments
	Common/Usual Name:	Stereotaxic Instrument
	Device Classificationand Regulatory Class:	Class II, per 21 CFR § 882.4560
	Device Product and PanelCode:	OLO; Orthopedic

D. Predicate Device Name

510(K) SUMMARY

Brainlab VectorVision Fluoro 3D system (K070106) Trade name:

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E. Device Description

The VIPER® and EXPEDIUM® navigated instruments are surgical instruments, for use in the implantation of VIPER® and EXPEDIUM® pedicle screws, which have been modified for use with Brainlab image guided surgery (IGS) hardware and software. The navigated instrument shafts mate with modified handles containing tracking arrays with Brainlab proprietary designs, or contain a dedicated interface for receiving a Brainlab owned tracking array. The passive tracking arrays cnable the VIPER® and EXPEDIUM® navigated instruments to be tracked by the Brainlab system to virtual computer image space on a patient's preoperative or intra-operative 2D or 3D image data.

F. Indications for Use

MEDOS International, Sárl

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G. Summary of Similarities and Differences in Technological Characteristics, Performance and Indications for Use

	G. Summary of Similarities and Differences in Technological Characteristics, Performance and Indications for Use	Predicate Brainlab VectorVision Fluoro 3D system (K070106)
Indications for Use	VIPER® and EXPEDIUM® navigated instrumentsThe VIPER® and EXPEDIUM® navigated instruments are image guided surgical instruments for use in the implantation of VIPER® and EXPEDIUM® pedicle screws in an open or percutaneous approach. The navigated instruments are designed for use only with Brainlab Image Guided Surgery hardware and software. The navigated instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, where the use of the VIPER® and/or EXPEDIUM® Spine Systems is indicated and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.	Brainlab VectorVision fluoro3D is intended as an intra-operative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intra-operative 2D or 3D image data. VectorVision fluoro3D enables computer-assisted navigation of medical image data which can either be acquired preoperatively or intra-operatively by an appropriate image acquisition system. The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and individually-calibrated surgical tools. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
PassiveMarker/ Array	Yes; same tracking arrays as predicate instruments	Yes
Instruments	Awls, Probes, Taps, Screwdrivers and Jamshidi Needle	Awls, Probes, Chisels and Drill Guide with Trocar Insert
Sterility	Non-sterile	Non-sterile
Computer Aided	Yes	Yes
Reusable	Yes	Yes
Compatible Brainlab Navigation Software	Navigation Software VectorVision Spine (Version 5.5 and 5.6)Navigation Software Kolibri Spine (Version 2.0)Navigation Software VectorVision Trauma (Version 2.6)Navigation Software VectorVision Fluoro3D (Version 1.6 and 2.0)Navigation Software Spine & Trauma iCT (Version 1.0)Navigation Software Trauma (Version 3.0)Navigation Software Spine & Trauma 3D (Version 2.0)	Navigation Software VectorVision Spine (Version 5.5 and 5.6)Navigation Software Kolibri Spine (Version 2.0)Navigation Software VectorVision Trauma (Version 2.6)Navigation Software VectorVision Fluoro3D (Version 1.6 and 2.0)Navigation Software Spine & Trauma iCT (Version 1.0)Navigation Software Trauma (Version 3.0)Navigation Software Spine & Trauma 3D (Version 2.0)

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H. Materials

The VIPER® and EXPEDIUM® navigation handles are manufactured from stainless steels 630, 431, 301, 303, 316, Silicone Elastosil R 401/80, Radel® and titanium nitride. The navigated instrument shafts are manufactured from stainless steels 17-4PH, custom 455, custom 465, 18-8, 316, 316L, 420, and aluminum 6061-T6.

Performance Data I.

Verification and validation of the VIPER® and EXPEDIUM® navigated instruments integration into the Brainlab Navigation Software was performed.

J. Conclusion

The VIPER® and EXPEDIUM® navigated instruments intended use, principles of operation and technological characteristics are substantially equivalent to those of the predicate Brainlab instruments.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

SEP 20 2012

Medos International Sarl % Johnson and Johnson (Depuy Spine) Ms. Laura Bleynedaal Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K120867

Trade/Device Name: VIPER® and EXPEDIUM® navigated instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: September 04, 2012 Received: September 05, 2012

Dear Ms. Bleynedaal:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated 776 the enactment date of the Medical Device Amendments, or to Commerce prior to May 20, 1978, tive excordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic rece (110) that to her subject to the general controls provisions of the Act. The T ou may, therefore, manel as act include requirements for annual registration, listing of general controls provision gractice, labeling, and prohibitions against misbranding and devices, good manufacturing particles, not evaluate information related to contract liability adultieration. Trease note: ODFET assess and 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 If your device is classified (see above) into the major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may found in the Oods of I casial 115 concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination ante of the Att Please be auvised that FDA s issuation of a coloride with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has made a determination that Jour acceral agencies. You must of any Federal statures and regulations as annuality of the registration and listing (21

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Page 2 - Ms. Laura Bleynedaal

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lia 9

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K120867

Device Name: VIPER® and EXPEDIUM® navigated instruments

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR § 801 Subpart D)

ﺮ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

(21 CFR § 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nel R.P. Ryder fir hxm

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

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).