The Stryker ENT Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to the following ENT procedures:

Transphenoidal access procedures;
Intranasal procedures;
Sinus procedures, such as maxillary antrostomies, sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies;
ENT related anterior skull based procedures.

Device Description

The Stryker ENT Navigation System is a computer-assisted image-guided surgery system. The system displays the position of navigated instruments on a model of the patient's anatomy based on preoperative images (CT or MRI) using electromagnetic tracking technology. The position of the instruments and the patient are localized within an electromagnetic field produced by a field generator. The navigation of instruments relative to the patient's anatomy is established via registration of the patient's anatomy to the preoperative images via anatomical landmarks, or surface matching. The position of navigated instruments is then displayed with respect to preoperative images.

The system comprises a computer platform, the software, patient trackers, pointers and suction tubes, instrument trackers, and a dedicated calibration body.

This submission is about the new version 3.6 of the Scopis software application, and the updated computer platform called Electromagnetic Navigation Unit with the new operating system version 3.6.A.

AI/ML Overview

The provided text describes the Stryker ENT Navigation System and its associated software, but it does not include a study that proves the device meets specific acceptance criteria in the way described in the prompt's request.

Instead, the document states:

"To ensure accuracy, subject devices are tested in accordance with ASTM F2554. The devices meet state-of-the-art acceptance criteria for point accuracy, precision, and distance accuracy."
"Scopis software applications were subject to verification and validation testing in compliance with IEC 62304 and FDA guidances. All testing criteria were met."

This indicates that internal testing was conducted against existing standards and internal acceptance criteria, but the specific results of such a study are not detailed in the provided K221098 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices, not on presenting a detailed clinical or performance study with specific metrics as requested.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here's what can be inferred or explicitly stated from the document, along with what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria Category	Specific Acceptance Criteria (as described in the document)	Reported Device Performance (as described in the document)
Accuracy	Adherence to ASTM F2554 standards for point accuracy, precision, and distance accuracy.	"The devices meet state-of-the-art acceptance criteria for point accuracy, precision, and distance accuracy."
Software	Compliance with IEC 62304 and FDA guidances for verification and validation testing.	"All testing criteria were met."
Electrical Safety & EMC	Compliance with ANSI/AAMI ES 60601-1 and IEC 60601-1-2.	"Applicable devices in scope were checked and certified for compliance."
Safety	Verification of risk controls in accordance with ISO 14971.	"Verification of risk controls...is in accordance with ISO 14971."
Security	Verification of operating system security with respect to NIST 800-53 and FDA Guidances; operating system updates.	"All testing criteria were met."

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

Not explicitly stated for accuracy testing. The document mentions "subject devices are tested," implying device-level testing rather than patient data.
The "Performance Data" section discusses non-clinical testing. Clinical testing was "deemed unnecessary."

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

Not applicable/Not stated. No clinical study involving expert ground truth establishment is described or referenced. The testing mentioned is non-clinical.

4. Adjudication method for the test set:

Not applicable/Not stated. No clinical study or expert review process is described.

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. The document explicitly states, "No clinical testing was deemed necessary for this Traditional 510(k) submission." This is not an AI-assisted diagnostic device for image interpretation by human readers. It's an image-guided surgery navigation system.

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

Yes, in spirit, for the non-clinical performance aspects. The accuracy, software, electrical safety, safety, and security tests can be considered "standalone" evaluations of the device's functional and safety characteristics without human-in-the-loop performance in a clinical context. However, this isn't a traditional "algorithm only" performance evaluation as one might see for an AI diagnostic device. It's about the technical performance of the navigation system components.

7. The type of ground truth used:

For the Accuracy testing (ASTM F2554), the ground truth would typically be established by highly accurate measurement systems and physical phantoms.
For Software testing (IEC 62304), the "ground truth" would be the specified software requirements and expected behavior, validated through testing protocols.
For Electrical Safety, EMC, Safety, and Security, the "ground truth" is adherence to the technical standards and regulations.

8. The sample size for the training set:

Not applicable/Not stated. This device is a navigation system, not a machine learning model that requires a "training set" in the traditional sense for medical image analysis. Its "training" is in its engineering design and software development, not in learning from a large dataset.

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

Not applicable/Not stated. As explained above, this isn't a machine learning model that involves a training set with established ground truth from data.

Summary

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July 12, 2022

Stryker Corporation Maya Schiel Senior Staff Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg, Baden-Wuerttemberg D-79111 Germany

Re: K221098

Trade/Device Name: Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: April 12, 2022 Received: April 14, 2022

Dear Maya Schiel:

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.

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

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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 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,

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K221098

Device Name

Stryker ENT Navigation System

with Scopis® ENT Software, Scopis® ENT Software with TGS®. Scopis® Planning Software and Electromagnetic Navigation Unit

Indications for Use (Describe)

Example procedures include, but are not limited to the following ENT procedures:

Transphenoidal access procedures;
Intranasal procedures;
Sinus procedures, such as maxillary antrostomies, sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies;
ENT related anterior skull based procedures.

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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st

510(k) Summary

Traditional 510(k): Scopis ENT Software 510(k) Number: K221098

Submitter Information

510(k) Submitter	Stryker Leibinger GmbH & Co. KGBoetzinger Strasse 4179111 Freiburg, Germany
FDA Establishment Number	8010177
Contact Person	Maya SchielSenior Staff Regulatory Affairs SpecialistPhone: +49 30 311 911 89Mail: maya.schiel@stryker.com
Date Submitted	April 12, 2022
Subject Device
Trade / Proprietary Name	Scopis ® ENT SoftwareScopis ® ENT Software with TGS ®Scopis ® Planning SoftwareElectromagnetic Navigation Unit
Common Name	Ear, Nose, And Throat Stereotaxic Instrument
Classification	Class II, 21 CFR 882.4560
Classification Product Code	PGW
Classification Name	Stereotaxic Instrument

Legally Marketed Predicate Device

Predicate Device Nameand 510(k) Number	TGS Guidewire and updated Scopis ENTSoftware (K193118)
	Scopis ENT SoftwareScopis ENT Software with TGS
	Scopis Hybrid Navigation System EM (K161491)

-Electromagnetic Navigation Unit

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The purpose of this Traditional 510(k) Submission is to gain clearance for the new version of the Scopis software variants and the updated Electromagnetic Navigation Unit as parts of the Stryker ENT Navigation System.

The initial clearance of this navigation system was achieved via K161491 in 2017 by Scopis GmbH. Scopis GmbH was acquired by Stryker in November 2017. In July 2018, the legal manufacturer for the devices was changed to Stryker Leibinger GmbH & Co. KG. Since October 2019, the devices have also been physically manufactured in Freiburg under the Stryker Leibinger Quality Management System. The 510(k) ownership was also transferred.

As part of the post-acquisition integration the Scopis name of the system was changed from Scopis Hybrid Navigation System to Stryker ENT Navigation System.

The Scopis software applications were most recently cleared under K193118 in 2020. The computer platform called Electromagnetic Navigation Unit was cleared within the first submission for the system with K161491.

Device Description

The system comprises a computer platform, the software, patient trackers, pointers and suction tubes, instrument trackers, and a dedicated calibration body.

This submission is about the new version 3.6 of the Scopis software application, and the updated computer platform called Electromagnetic Navigation Unit with the new operating system version 3.6.A.

Electromagnetic Navigation Unit

The Electromagnetic Navigation Unit serves as platform of the Stryker ENT Navigation System. This is the computer platform where the navigation software is installed on, and where the main components required for navigation are connected to, like Field Generator or electromagnetic instruments.

Optionally, the Electromagnetic Navigation Unit allows to display the output of external endoscopic imaging devices from Stryker or other manufacturers. Instrument trackers allow for navigation of corresponding endoscope optics. A dedicated calibration body is utilized to calibrate endoscopes and enable Augmented Reality overlay of endoscopic video images.

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Image /page/5/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and connected, giving the word a modern and sleek appearance. The color of the text is black, contrasting with the white background.

Scopis Software Application

The software application provides the functionality necessary to import the patient image data sets, build the image-based model of the anatomy, plan a surgical procedure, and display location of navigated instruments relative to the model of the anatomy.

There are two navigation software variants: Scopis ENT Software and Scopis ENT Software with TGS. In comparison to Scopis ENT Software, Scopis ENT Software with TGS offers the ability to create more advanced surgical plans such as target paths to anatomy and display these during navigation. Both Scopis navigations software variants are installed on the Electromagnetic Navigation Unit.

In addition, there will be one designated planning software called Scopis Planning Software. This variant offers identical functionality for creation of advanced surgical plans like Scopis ENT Software with TGS but does not include any navigation functionality. This software is intended to be used on a planning system, like a personal computer of the surgeon, to prepare the application of one of the navigation software variants. Accordingly, after planning the data are to be transferred to the Electromagnetic Navigation Unit for surgical navigation with one of the navigation software variants.

Intended Use

The Scopis ENT Software is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures together with the Stryker ENT Navigation System. The software application is indicated for any medical condition in which the use of computerassisted surgery may be appropriate

The Scopis ENT Software with TGS is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures together with the Stryker ENT Navigation System. The software application is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate.

The Scopis Planning Software is intended as an aid for precisely locating anatomical structures in preparation for either open or percutaneous procedures together with the Stryker ENT Navigation System. The software application is indicated for any medical condition in which the use of computer-assisted pre-operative planning may be appropriate.

The Electromagnetic Navigation Unit is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

Indications for Use

Example procedures include, but are not limited to the following ENT procedures:

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Traditional 510(k) K221098 Scopis Software Application

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-Transsphenoidal access procedures;
-Intranasal procedures;
-Sinus procedures, such as maxillary antrostomies, ethmoidectomies, sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies;
-ENT related anterior skull-based procedures

Comparison of Technological Characteristics

This submission is about the new version of the Scopis software application and the updated operating system running on the corresponding computer platform.

The general way the devices are used, and function has not been changed. So, the subject and predicate devices are identical in most characteristics, such as:

FDA product codes and regulation
Intended users and target patient population ●
Indications for Use ●
Application Area ●
Type of Use and type of Patient Contact
Intended Environment
Tracking Technology ●
Programming Language
Operating Principles
Modes of Operation ●
. Image Import
Reference Images ●
Patient Registration ●
Planning Objects .
Control Mechanism ●

The new software version has been developed to add some new features to the software. These new features include, but are not limited to:

Support tracking multiple instruments of the same kind ●
Improved guidance during patient registration ●
. Field generator alignment support
. Introducing a new software variant, the Scopis Planning Software
Cybersecurity improvements .

Further, the operating system running on the computer platform of the navigation system called Electromagnetic Navigation Unit has been updated to Windows 10 IoT Enterprise LTSC 2019.

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Performance Data

Non-Clinical Testing

Non-clinical design verification and validation activities were conducted to provide evidence that the subject devices successfully meet their requirements and perform according to their specifications and intended uses. Table 2 provides a summary of the performance data

Table 2: Summary of Performance Data

Test Item	Test summary
Accuracy	To ensure accuracy, subject devices are tested in accordancewith ASTM F2554. The devices meet state-of-the-artacceptance criteria for point accuracy, precision, and distanceaccuracy.
Software	Scopis software applications were subject to verification andvalidation testing in compliance with IEC 62304 and FDAguidances. All testing criteria were met.
Electrical Safety andElectromagnetic Compatibility	Applicable devices in scope were checked and certified forcompliance with ANSI/AAMI ES 60601-1 and IEC 60601-1-2.
Safety	Verification of risk controls specified in the corresponding riskanalysis is in accordance with ISO 14971.
Security	Verification of the security of the operating system with respectto technical requirements (NIST 800-53 and FDA Guidances)and operating system updates. All testing criteria were met.

Clinical Testing

No clinical testing was deemed necessary for this Traditional 510(k) submission.

Conclusion

The subject devices have the same main functionalities and follow the same operating principles as their predicates. The fundamental technological characteristics do not change. The only differences are caused by the introduction of additional features of the new software version and some improvements, e.g., for cybersecurity. The performance data demonstrate that the subject devices meet their specifications and the requirements on safety and effectiveness.

In conclusion, the information provided demonstrates that the Electromagnetic Navigation Unit and the three software variants are at least as safe and effective as their predicates (K161491, K193118) and do not raise different issues of safety or effectiveness, and therefore supports a determination of substantial equivalence.

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).