Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated; and with the VELYS Spine System as well as the with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:

• the use of EXPEDIUM, VIPER, SYMPHONY OCT and the TriALTIS Spine System is indicated,

· the use of stereotactic surgery may be appropriate, and
· 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.

These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.

The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

Device Description

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™, VIPER™, SYMPHONY™ OCT and TriALTISTM screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation Enabled Instruments also include the CROSSNAV™ Adaptor to facilitate navigation of the Navigation Enabled Instruments with the VELYS Spine System. Navigation of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine as well as the Medtronic StealthStation navigation system and associated tracking arrays.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "CROSSNAV Navigation Enabled Instruments," which are reusable instruments used in spinal surgery. The documentation focuses on demonstrating substantial equivalence to previously cleared predicate devices. While it lists various performance data evaluations, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or accuracy thresholds with reported device performance metrics.

The document primarily states that the device's technological characteristics, design, materials, performance, and intended use are consistent with those of the predicate devices, and that testing was conducted to confirm this consistency. It mentions "Accuracy Verification through engineering analysis" and "Fulfillment of navigation systems instrument accuracy requirements," but it does not provide the specific acceptance criteria for these, nor the actual measured performance data.

Therefore, I cannot fully answer your request for a table of acceptance criteria and reported device performance with the specific details requested (sample size, expert qualifications, etc.) because that information is not present in the provided document.

However, I can extract the information that is present and indicate what is missing based on your request.

Acceptance Criteria and Device Performance (Information Available in Document)

The document implies that the acceptance criteria revolved around demonstrating substantial equivalence to predicate devices in terms of design, materials, performance characteristics, and intended use. The performance data listed are categories of evaluation rather than specific numerical acceptance criteria.

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied from the document's Conclusion)
Consistency in design and materials with predicate devices	"The technological characteristics of the CROSSNAV Navigation Enabled Instruments in terms of design, materials and performance are consistent with those of the predicate devices."
Accuracy verification	"Accuracy Verification through engineering analysis" was performed. (No specific numerical results or criteria provided)
Fulfillment of navigation system instrument accuracy requirements	"Fulfillment of navigation systems instrument accuracy requirements as stated by the navigation manufacturer" was performed. (No specific numerical results or criteria provided)
CAD Model Evaluation	"CAD Model Evaluation" was performed. (No specific outcomes provided)
Simulated Use Evaluation	"Simulated Use Evaluation" was performed. (No specific outcomes provided)
No new questions of safety and effectiveness	"This does not raise new questions of safety and effectiveness based on application of recognized consensus standards and design controls."

Missing Information (Based on your Request and Not Present in the Document)

Specific numerical acceptance criteria: The document does not provide a table with quantitative acceptance thresholds (e.g., accuracy within X mm, a certain pass/fail rate for a simulated use).
Reported device performance (quantified): While it states tests were performed (e.g., "Accuracy Verification"), it does not report the actual measured performance data against specific criteria.
Sample size used for the test set: Not mentioned.
Data provenance (country of origin, retrospective/prospective): Not mentioned.
Number of experts used to establish ground truth: Not applicable for the type of engineering/design validation described.
Qualifications of experts: Not applicable.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned and typically not relevant for surgical instruments unless they involve AI for image interpretation or diagnosis. The device is a "Navigation Enabled Instrument," suggesting it assists human surgeons, but the document doesn't detail a study comparing human performance with and without the device.
Standalone (algorithm only) performance: Not applicable as this is a physical instrument, not a standalone algorithm.
Type of ground truth used: For the engineering evaluations mentioned (accuracy, simulated use), the ground truth would likely be based on engineering specifications, physical measurements, and perhaps surgical standards, but is not detailed.
Sample size for the training set: Not applicable and not mentioned, as this is a physical instrument, not an AI model that requires a training set in the typical sense.
How ground truth for the training set was established: Not applicable.

Summary of what the document provides regarding validation:

The validation approach for the CROSSNAV Navigation Enabled Instruments, as presented in the 510(k) summary, primarily relies on:

Engineering Analysis: To verify accuracy and adherence to design specifications.
Fulfillment of Navigation System Accuracy Requirements: Ensuring compatibility and performance within existing navigation systems (VELYS Spine System and Medtronic StealthStation® System).
CAD Model Evaluation: likely for design integrity and fit.
Simulated Use Evaluation: To assess performance in a representative environment.

The absence of detailed quantitative performance results and specific acceptance criteria in this public 510(k) summary is common, as these details are typically found in the full submission, which is proprietary. The FDA's clearance implies that the submitted data (which includes the detailed study reports) was sufficient to demonstrate substantial equivalence to the predicate devices.

Summary

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June 14, 2024

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

Depuy Synthes Daniel Meyer Regulatory Affairs Manager Eimattstrasse 3 Oberdorf, 4436 Switzerland

Re: K233255

Trade/Device Name: CROSSNAV Navigation Enabled Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 12, 2023 Received: June 10, 2024

Dear Daniel Meyer:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Image /page/1/Picture/6 description: The image shows a digital signature. The signature is from Jesse Muir. The date of the signature is 2024.06.17 and the time is 10:48:44 -04'00'.

For 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

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Indications for Use

Submission Number (if known)

K233255

Device Name

CROSSNAV Navigation Enabled Instruments

Indications for Use (Describe)

• the use of EXPEDIUM, VIPER, SYMPHONY OCT and the TriALTIS Spine System is indicated,

· the use of stereotactic surgery may be appropriate, and
· 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.

These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.

The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

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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510(k) Summary

A.	Submitter Information
	510(k) Sponsor:	Medos International, SARL
	Contact Person:	Daniel MeyerRegulatory Affairs ManagerEimattstrasse 34436 Oberdorf BLSwitzerland
	Telephone:	+41-61-9656856
	Email:	dmeyer1@its.jnj.com
B.	Date Prepared	12 October 2023
C.	Device Name
	Trade/Proprietary Name:	CROSSNAV Navigation Enabled Instruments
	Common/Usual Name:	Orthopedic Stereotaxic Instrument
	Device Classification andRegulation:	Class IIOLO – 21 CFR §882.4560
	Classification Product andPanel Code	OLO – Neurology
D.	Predicate Device Names
	Primary Predicate Device:
	Navigation Enabled Instruments (K200791) – OLO
	Additional Predicate Device:
	TriALTIS Navigation Enabled Instruments (K231527) -OLO

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E. Device Description

Indications for Use F.

the use of EXPEDIUM™, VIPER™, SYMPHONY™ OCT and the TriALTISTM Spine . System is indicated,
. the use of stereotactic surgery may be appropriate, and
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.

These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.

The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

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

The technological characteristics, including design, material and performance as well as intended use of the CROSSNAV Navigation Enabled Instruments are consistent with those of the predicate devices.

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Compared to the predicate devices, the subject devices expand the scope of the Navigation Enabled Instruments for compatibility with an additional Navigation System, the VELYS Spine System. Similarly to predicate devices, CROSSNAV Navigation Enabled Instruments include drills, taps and screwdrivers and are indicated for use when implanting DePuy Synthes screws. This does not raise new questions of safety and effectiveness based on application of recognized consensus standards and design controls.

H. Materials

The subject devices are manufactured from stainless steel alloys and titanium alloys (Ti-6Al-4V). Several of the devices have coatings including AlTiN (Aluminum Titanium Nitride Coating), TiN (Titanium Nitride Coating) and Tungsten Carbide coating.

I. Performance Data

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

. Accuracy Verification through engineering analysis,
Fulfillment of navigation systems instrument accuracy requirements as stated by . the navigation manufacturer,
. CAD Model Evaluation,
. Simulated Use Evaluation.

J. Conclusion

The indications for use of the CROSSNAV Navigation Enabled Instruments are consistent with those of the predicate devices. The technological characteristics of the CROSSNAV Navigation Enabled Instruments in terms of design, materials and performance are consistent with those of the predicate devices. The CROSSNAV Navigation Enabled Instruments 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).