The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of SYMPHONY OCT System is indicated,

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as a vertebrae 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 using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial sorew placement.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrac can be identified relative to the aquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The DePuy Synthes Navieation Ready Instrument, when used with UNAS, can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

Device Description

SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and nonnavigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes:

Brainlab compatible UNAS Navigation Arrays, ●
Brainlab compatible Navigation Ring and ●
Medtronic compatible Navigation Ring ST. ●

The Navigation Ring and Navigation Ring ST mates with compatible DePuy Synthes Navigation Ready Instruments. These instruments include drill guides, probe, taps and screwdrivers. Drills and trocar are indirectly navigable through the drill guide.

When the Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument, a UNAS Navigation Array can be attached and the instrument can be used only with the Brainlab Navigation System as either a manually calibrated or pre-calibrated instrument.

When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation navigation system.

AI/ML Overview

The provided text is a 510(k) summary for the SYMPHONY™ Navigation Ready Instruments and Universal Navigation Adaptor Set. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on demonstrating equivalence rather than establishing new acceptance criteria and conducting a primary study to prove them.

Therefore, the document does not contain information about:

Acceptance Criteria in the sense of predefined performance thresholds for a novel device. Instead, it describes performance evaluations to show that the new device's performance aligns with that of predicate devices.
A "study that proves the device meets the acceptance criteria" in the context of a clinical trial or a statistically powered study to demonstrate a new performance claim. The performance data presented are evaluations for substantial equivalence, not a standalone clinical validation study.
Effect size of human readers improving with AI vs. without AI assistance, as this device is a surgical instrument and navigation accessory, not an AI-powered diagnostic or assistive tool for image interpretation.
Standalone (algorithm only without human-in-the-loop performance), as this is not an algorithm-based device.
Ground truth types (expert consensus, pathology, outcomes data, etc.), as this is not a diagnostic device requiring this type of ground truth establishment.
Training set size and ground truth establishment for a training set, as this is not an AI/ML device.

However, it does provide information about the performance evaluations conducted to support substantial equivalence. Here's a breakdown of what is available:

1. Table of acceptance criteria and the reported device performance:

Since explicit acceptance criteria are not stated in a numerical or categorical format, and "reported device performance" refers to the results of assessments for substantial equivalence, I will list the evaluations performed and the implied objective (consistency with predicate devices).

Acceptance Criteria (Implied Objective)	Reported Device Performance (Evaluations Performed)
Fulfilment of navigation systems instrument accuracy requirements (consistent with predicate)	Accuracy Verification (to fulfill navigation systems instrument accuracy requirements)
Instrument Length consistent with predicate device (for SYMPHONY Navigation Ready Instruments)	Instrument Length Comparison to Predicate Device
Array Characteristics consistent with predicate device (for Universal Navigation Adaptor Set)	Array Characteristics Comparison to Predicate Device
Array Recognition by Brainlab Navigation System (functional)	Confirmation of Array Recognition by Brainlab Navigation System
Proper Mating of Implants/Instruments (functional)	Implant/instrument mating conditions
Repeatable Navigation Connection for Pre-Calibrated Instruments (functional)	Navigation Connection Repeatability for Pre-Calibrated Instruments
CAD Model Accuracy/Suitability (design verification)	CAD Model Evaluation
Safe and Effective Use in Surgical Scenarios (functional)	Simulated Use Evaluation

2. Sample size used for the test set and the data provenance:

The document does not detail specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for each of the performance evaluations. The evaluations appear to be bench testing and simulated use, not human subject studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The evaluations are primarily technical assessments against design specifications and functional requirements, not expert-based ground truth establishment as would be seen in diagnostic imaging studies.

4. Adjudication method for the test set:

Not applicable, as no expert-based ground truth or adjudication process is mentioned for these technical performance evaluations.

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 is not an AI-powered diagnostic device.

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

Not applicable. This is a surgical instrument and navigation accessory, not an algorithm. The "Navigation Connection Repeatability for Pre-Calibrated Instruments" and "Confirmation of Array Recognition" could be considered "standalone" functional tests of the device's interaction with navigation systems, but these are not the same as algorithmic performance.

7. The type of ground truth used:

The "ground truth" for these evaluations would be the engineering specifications, design requirements, and known performance characteristics of the predicate devices and compatible navigation systems. For example:

Accuracy Verification: Ground truth would be the defined accuracy requirements of the compatible navigation systems.
Instrument Length Comparison: Ground truth would be the measurements of the predicate device's instruments.
Array Characteristics Comparison: Ground truth would be the established specifications of the predicate device's arrays.
Implant/instrument mating conditions: Ground truth would be the design specifications for proper fit and mechanical integrity.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

September 16, 2020

Medos International, SARL % Nicole Aeschbacher Regulatory Affairs Specialist DePuy Synthes Spine Eimattstrasse 3 Oberdorf, CH-BL 4436 Switzerland

Re: K201661

Trade/Device Name: Symphony Navigation Ready Instruments, Universal Navigation Adaptor Set Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 17, 2020 Received: June 18, 2020

Dear Nicole Aeschbacher:

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.

{1}------------------------------------------------

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) 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 medical devices and radiation-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,

Shumaya Ali, M.P.H. 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K201661

Device Name

SYMPHONY™ Navigation Ready Instruments and Universal Navigation Adaptor Set

Indications for Use (Describe)

SYMPHONY Navigation Ready Instruments:

· the use of SYMPHONY OCT System is indicated,

· the use of stereotactic surgery may be appropriate, and

The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial sorew placement.

Universal Navigation Adaptor Set:

· the use of stereotactic surgery may be appropriate, and

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

A.	Submitter Information
	510(k) Sponsor:	Medos International, SARL
	Contact Person:	Nicole Aeschbacher, Regulatory AffairsSpecialistEimattstrasse 34436 OberdorfSwitzerland
	Telephone:	+41 61 965 61 18
	Fax:	+41 61 965 66 16
	Email:	naeschba@its.jnj.com
B.	Date Prepared	June 17, 2020
C.	Device Name
	Trade/Proprietary Name:	SYMPHONYTM Navigation ReadyInstruments and Universal NavigationAdaptor Set
	Common/Usual Name:	Orthopedic stereotaxic instrument
	Device Classification andRegulation:	Class II per 21 CFR § 882.4560
	Classification Product andPanel Code:	OLO; Orthopedic
D.	Predicate Device Names
	Primary Predicate Device:

SYMPHONY™ Navigation Ready Instruments and Universal Navigation Adaptor Set (K191943)

Additional Predicate Devices:

Synthes Navigable Pedicle Preparation (NPP) Instruments (K122211)

Brainlab Spine & Trauma Navigation (K183605)

{5}------------------------------------------------

E. Device Description

SYMPHONY Navigation Ready Instruments:

Universal Navigation Adaptor Set:

Brainlab compatible UNAS Navigation Arrays, ●
Brainlab compatible Navigation Ring and ●
Medtronic compatible Navigation Ring ST. ●

F. Indications for Use

SYMPHONY Navigation Ready Instruments:

{6}------------------------------------------------

the use of SYMPHONY OCT System is indicated, .
the use of stereotactic surgery may be appropriate, and .
reference to a rigid anatomical structure, such as a vertebrae 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 using a navigation system and associated tracking arrays.

The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial screw placement.

Universal Navigation Adaptor Set:

the use of stereotactic surgery may be appropriate, and
reference to a rigid anatomical structure, such as the pelvis or a vertebrae . 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 using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instrument, when used with UNAS, can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

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

{7}------------------------------------------------

The technological characteristics, including material, design and performance as well as intended use of the SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set are consistent with those of the predicate devices.

H. Materials

The subject devices are manufactured from stainless steel, titanium alloy (Ti-6Al-4V), anodized aluminum, TiN (Titanium Nitride Coating), TiAlN (Titanium Aluminum Nitride Coating), RADEL and silicone rubber.

I. Performance Data

The performance data for the subject devices consists of the following evaluations:

Accuracy Verification: ●
- o Fulfillment of navigation systems instrument accuracy requirements
- Instrument Length Comparison to Predicate Device O
- Array Characteristics Comparison to Predicate Device O
- Confirmation of Array Recognition by Brainlab Navigation System о
Implant/instrument mating conditions ●
Navigation Connection Repeatability for Pre-Calibrated Instruments ●
CAD Model Evaluation ●
Simulated Use Evaluation ●

J. Conclusion

The indications for use of the SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set are consistent with those of the predicate devices. The technological characteristics of the SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set in terms of design, materials and performance are consistent with those of the predicate devices. The SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set are substantially equivalent to the predicate devices.

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).