Navigation Enabled Instruments are reusable instruments intended 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 intended; and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
• the use of EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® SAI, EXPEDIUM VERSE®. VIPER PRIME® (without stylet control) or SYMPHONYTM OCT system is indicated,
· 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.
These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with Synthes Small Battery Drive II System 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® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® 2, VIPER® SAI, VIPER PRIME®, EXPEDIUM VERSE®, and SYMPHONYTM OCT 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 of these instruments is achieved using the Medtronic StealthStation navigation system and associated tracking arrays.

AI/ML Overview

The provided FDA 510(k) summary for the "Navigation Enabled Instruments" (K200791) describes the device, its intended use, and a performance study. However, it does not contain the detailed acceptance criteria or the specific results in a format that would allow for a direct numerical comparison as requested in your prompt.

Specifically, the document states that "Simulated Use testing was performed" and lists what this testing aimed to demonstrate, but it does not provide:

A table of quantitative acceptance criteria (e.g., specific accuracy thresholds)
The reported device performance against those criteria (e.g., measured accuracy values)
Sample sizes for test sets (it mentions "clinically relevant anatomical specimen / model" but not the number)
Data provenance (country of origin, retrospective/prospective)
Number/qualifications of experts for ground truth
Adjudication method
MRMC study information
Standalone performance data
Type of ground truth used (beyond "anatomical specimen / model")
Sample size for training set
How ground truth for the training set was established

Key information that can be extracted from the provided text, related to the performance study, is as follows:

1. Acceptance Criteria and Reported Device Performance:

The document describes the objectives of the simulated use evaluation, which implicitly define the areas for which performance must be acceptable. However, it does not state specific numerical acceptance criteria or the reported device performance against them.

Acceptance Criteria (Implicit from study objectives)	Reported Device Performance (as stated in document)
Navigation Enabled Instruments can be rigidly connected to the NavLock tracker.	The Simulated Use Evaluation allows to show that: - Navigation Enabled Instruments can be rigidly connected to the NavLock tracker (rigidity).
Navigation Enabled Instruments can be adequately verified on the StealthStation Medtronic.	The Simulated Use Evaluation allows to show that: - Navigation Enabled Instruments can be adequately verified on the StealthStation Medtronic (instrument verification).
Navigation Enabled Instruments can be accurately navigated, and screws accurately placed.	The Simulated Use Evaluation allows to show that: - Navigation Enabled Instruments can be accurately navigated, and screws accurately placed (accuracy verification).

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

Sample Size: The document mentions "a clinically relevant anatomical specimen / model." It does not specify the number of specimens/models used or the number of trials/measurements performed.
Data Provenance: The study was a "Simulated Use testing," implying it was conducted in a controlled environment, likely at the manufacturer's facility. No information on country of origin of data, or whether it's retrospective or prospective is provided, though based on "simulated use," it's prospective testing.

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 in the document. The ground truth would likely be established by the physical properties of the "anatomical specimen / model" and the known dimensions/placement attempts, but expert involvement for ground truth definition is not mentioned.

4. Adjudication method for the test set:

This information is not provided in the document. Given it's a simulated use test on a model, formal adjudication as seen in clinical trials with human data is unlikely to be described here.

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 comparative effectiveness study is mentioned. The device is a navigation system for surgical instruments, not an AI-assisted diagnostic or interpretive tool that would typically involve "human readers" in this context. The evaluation focuses on the instrument's performance, not human reader improvement.

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

The device inherently involves human-in-the-loop, as they are "Navigation Enabled Instruments" intended to "assist the surgeon." Therefore, a "standalone algorithm only" performance study is not applicable or described for this type of device. The simulated use testing inherently includes the human (or simulated human interaction) with the system.

7. The type of ground truth used:

"Clinically relevant anatomical specimen / model." This typically refers to cadaveric specimens or realistic physical models that mimic human anatomy. The ground truth for accuracy would be based on the known anatomical landmarks or pre-defined target locations within these models.

8. The sample size for the training set:

This information is not provided. This device is largely mechanical and optical (for navigation) rather than a machine learning/AI device that typically requires a discrete "training set" in the conventional sense. Its "training" would be through engineering design, calibration, and predicate device experience.

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

This information is not provided, and as noted above, a formal "training set" and its ground truth establishment, as understood in AI/ML contexts, is not explicitly documented for this type of medical device in this summary.

Summary

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July 31, 2020

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

Re: K200791

Trade/Device Name: Navigation Enabled Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 25, 2020 Received: March 26, 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.

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542 of the Act); 21 CFR 1000-1050.

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-

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, 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) K200791

Device Name

Navigation Enabled Instruments

Indications for Use (Describe)

• the use of EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® SAI, EXPEDIUM VERSE®. VIPER PRIME® (without stylet control) or SYMPHONYTM OCT system is indicated,

· 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.

These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with Synthes Small Battery Drive II System 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)

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:	Daria Bochenek, Senior Regulatory Affairs SpecialistEimattstrasse 34436 OberdorfSwitzerland
	Telephone:	+41 61 965 61 54
	Fax:	+41 61 965 66 16
	Email:	dbochene@its.jnj.com
B.	Date Prepared	March 25, 2020
C.	Device Name
	Trade/Proprietary Name:	Navigation Enabled Instruments
	Common/Usual Name:	Orthopedic stereotaxic instrument
	Device Classification and Regulation:	Class II per 21 CFR § 882.4560
	Classification Product and Panel Code:	OLO; Orthopedic
D.	Predicate Device Names
	Primary Predicate Device:
	Navigated CD HORIZON® SOLERA® Screwdrivers and Taps (K140454)
	Secondary Predicate Device:
	Navigated INFINITY™ Instruments (K173338)
	Reference Devices:
	Medtronic StealthStation S8 Spine Hardware and Software (K162309 and K170011)

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Expedium Spine System, Viper System, Viper 2 System (K111136)

Expedium Verse Spine System (K142185)

Expedium Spine System. Viper and Viper 2 Systems (K160904)

SYMPHONYTM OCT System (K181949)

E. Device Description

F. Indications for Use

the use of EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, 0 VIPER® 2, VIPER® SAI, EXPEDIUM VERSE®, VIPER PRIME® (without stylet control) or SYMPHONY™ OCT system is indicated,
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.

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

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

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

Materials H.

The subject devices are manufactured from stainless steels, titanium alloy and titanium nitride coating.

I. Performance Data

Simulated Use testing was performed with a Medtronic StealthStation navigation system. The testing consisted of assembly of the Navigation Enabled Instruments with the Medtronic NavLock trackers, verification and navigated insertion (manual and under power) of Navigation Enabled Instruments and DePuy Synthes screws into a clinically relevant anatomical specimen / model.

The Simulated Use Evaluation allows to show that:

o Navigation Enabled Instruments can be rigidly connected to the NavLock tracker (rigidity),
o Navigation Enabled Instruments can be adequately verified on the StealthStation Medtronic (instrument verification),
o Navigation Enabled Instruments can be accurately navigated, and screws accurately placed (accuracy verification).

J. Conclusion

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