The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon 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:

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 base procedures.

Device Description

The Fiagon Navigation System displays position instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. The position of the instrument with integrated sensor and the patient equipped with localizers are localized within an electromagnetic field generated by a field generator. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field.

The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by fiducial marker, anatomical landmark or surface matching. Thereafter the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the Fiagon Navigation System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for establishing novel performance or clinical efficacy through the types of detailed studies typically associated with AI/ML model validation. Therefore, the document does not contain the information required to answer all parts of your request, particularly those related to AI/ML specific evaluations (like training set details, expert consensus for ground truth, MRMC studies, etc.).

However, I can extract the relevant information regarding acceptance criteria and performance data for this device as presented in the submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission focuses on bench testing to demonstrate that the modified device (with WiFi connectivity and iPad remote control with automatic registration) performs as intended and is substantially equivalent to its predicate. The "acceptance criteria" are implied by the types of tests conducted and their successful completion.

1. Table of Acceptance Criteria and the Reported Device Performance:

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Positioning Accuracy	Must perform comparably to the predicate device in locating anatomical structures precisely for navigation.	"Positioning accuracy test for target registration" was conducted. The device "functioned as intended and similar to the predicate."
Wireless Coexistence	Must not interfere with other wireless devices and must maintain functionality when coexisting with them.	"Wireless coexisting testing" was conducted. The device "functioned as intended and similar to the predicate."
Software Functionality	Software must operate without defects and perform all intended functions (e.g., displaying navigation information, updating at specified rates, handling registration).	"Software testing" was conducted. The device "functioned as intended and similar to the predicate."
Overall Performance & Equivalence	The modified system must perform as intended and in a similar manner compared to the predicate, and not raise new safety or effectiveness questions.	"In all instances, the device functioned as intended and similar to the predicate, supporting the substantial equivalence to the predicate device." "The modified device does not present any new issues of safety or effectiveness."

Study Details (as inferable from the document)

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

The document mentions "bench testing" but does not specify sample sizes (e.g., number of tests, number of targets, number of wireless interferences) or data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically not required for a 510(k) submission focused on substantial equivalence of a modified hardware/software system.

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 testing appears to be quantitative bench testing of accuracy and functionality, not a study requiring expert interpretation of medical images or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable to the type of bench testing 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, an MRMC study was not done. This device is a navigation system that displays instrument position relative to pre-operative scans, not an AI/ML diagnostic or assistive tool that would involve "human readers" interpreting images.

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

The tests described ("Positioning accuracy test for target registration", "Wireless coexisting testing", "Software testing") are essentially standalone performance evaluations of the device's capabilities. However, this is not an AI algorithm in the contemporary sense. The "algorithm" here refers to the underlying calculations for electromagnetic tracking and image-to-patient registration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For positioning accuracy, the ground truth would likely be established by a precisely measured physical reference (e.g., a known target position in a phantom) rather than clinical expert consensus or pathology. For wireless coexistence and software testing, the ground truth is whether the system performs according to specifications.

8. The sample size for the training set:

This is not applicable and not provided. This device is not described as an AI/ML system requiring a distinct "training set" in the context of deep learning.

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

This is not applicable, as there's no mention of a "training set" for an AI/ML model for this device.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or head in profile, composed of flowing lines.

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

December 1, 2016

Fiagon Gmbh % Ms. Yarmela Pavlovic Regulatory Counsel Hogan Lovells US LLP 3 Embarcadero Center, Suite 1500 San Francisco, CA 94111

Re: K162176

Trade/Device Name: Fiagon Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: November 1, 2016 Received: November 1, 2016

Dear Ms. Pavlovic:

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. 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 (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K162176

Device Name

Fiagon Navigation System

Indications for Use (Describe)

Example procedures include, but are not limited to:

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 Druq 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."

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

SECTION 6 - 510(k) Summary

August 3, 2016

1. Submitter Information/ 510(k) Holder

Submitter:	Fiagon GmbH
Address:	Neuendorfstrasse 23b16761 Hennigsdorf, Germany

	Telephone:	+49 3302 201 21 10
Telefax:	+49 3302 201 21 15

Mr. Dirk Mucha, CTO Contact:

Device Information 2.

Trade Name:	Fiagon Navigation System
Common Name:	Image guided surgery system
Classification:	Class II per 21 CFR 882.4560
Device:	Ear, Nose, and Throat Stereotaxic Instrument
Product Code:	PGW

Purpose of Submission 3.

The purpose of this submission is to gain clearance for a modified version of the previously cleared Fiagon Navigation System (K133573).

Predicate Device Information 4.

Fiagon Navigation System (K133573)

ട. Device Description

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

6. Intended Use

Example procedures include, but are not limited to:

ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures

7. Comparison of Technological Characteristics

The device is a modified version of the previously cleared Fiagon Navigation System (K133573). The reason for this Special 510(k) is to describe the addition of WiFi connectivity to the navigation system and the addition of an iPad remote control with automatic registration feature. The changes do not raise new types of safety or effectiveness questions. Bench testing has been conducted to evaluate the modified system, and results confirm that the device performs as intended and in a similar manner compared to the predicate.

Performance Data 8.

The following nonclinical performance testing was conducted to support the substantial equivalence of the device to the predicate.

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

Positioning accuracy test for target registration .
Wireless coexisting testing ●
Software testing ●

In all instances, the device functioned as intended and similar to the predicate, supporting the substantial equivalence to the predicate device.

9. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate, the Fiagon Navigation System has been shown to be substantially equivalent to the cleared predicate and the modified device does not present any new issues of safety or effectiveness.

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).