The XPS/IPC System is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

Device Description

The navigated Quadcut® is a sterile, single use surgical instrument intended for the incision and removal of soft and hard tissue or bone in general otothinolaryngology, head and neck and otoneurological surgery. Quadcut® is an accessory component of the StraightShot M4 handpiece, which is an integral part of the XPS and IPC Systems. The XPS and IPC systems provide power to drive the blades during ENT procedures.

Quadcut® is intended for attachment to the M4 hand piece for use in conjunction with Fusion ENT software on a Medtronic computer-assisted surgery system. Each blade has a tracker mounted on it to allow for navigation during the ENT surgical procedure. The system's mobile emitter generates a low-energy magnetic field to locate the tracker mounted on the blade. Then, the software displays the location of the blade's tip within multiple patient image planes and other anatomical renderings.

AI/ML Overview

The provided text describes the 510(k) summary for the Medtronic Navigated Quadcut®. It includes details about the device, its intended use, and comparison to predicate devices, but it does not contain information related to software performance, AI algorithms, or clinical studies involving human readers or ground truth determination in the context of AI. The performance testing mentioned is for the device's functionality and compatibility, specifically navigational accuracy, and appears to be benchtop and simulated environment testing.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment for AI/software performance cannot be extracted from this document.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
System Accuracy Requirement: 95% confidence / 99.5% reliability, of <= 3.00 mm (Benchtop and simulated environment)	Testing was conducted to ensure acceptable navigational accuracy, specifically ensuring functionality and compatibility with Medtronic Navigation systems and Fusion software. The text indicates that these tests were sufficient to conclude substantial equivalence to the predicate device, which also likely met similar accuracy requirements.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set in the context of software or AI performance. The performance testing described is for "functionality and compatibility with the identified Medtronic products" and "navigational accuracy" using "benchtop and simulated real-life use conditions." This suggests physical device testing rather than a software-specific test set with individual cases. The data provenance (country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not available in the provided document. The study described focuses on the device's functional and navigational accuracy in a simulated/benchtop environment, not on human interpretation or expert-derived ground truth for diagnostic or image analysis tasks.

4. Adjudication Method for the Test Set

This information is not available in the provided document. As the testing pertains to device functionality and navigational accuracy, adjudication by human experts in the context of diagnostic interpretation is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted according to this document. The device in question is a surgical instrument (Quadcut®) with navigation capabilities, not an AI diagnostic or assistance tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a navigated surgical instrument. Its "performance" in terms of navigational accuracy is likely evaluated as a standalone system (the algorithm/system itself determining position) but it's used in conjunction with "human-in-the-loop" during surgery. The document does not describe the navigational algorithm as an "AI" in the modern sense but rather as a system that uses a tracker and magnetic field to display the blade's tip. There is no mention of a standalone AI algorithm evaluation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the navigational accuracy testing, the "ground truth" would likely be the actual physical position of the instrument's tip, measured by highly precise metrology equipment or a known reference standard in the benchtop and simulated environments. The document does not explicitly state the method for establishing this ground truth, but it would involve objective, measurable physical parameters. It's not related to medical expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.

8. The Sample Size for the Training Set

This information is not available as the document does not describe an AI/ML system that requires a "training set." The device is a surgical instrument with navigation capabilities based on electromagnetic tracking, not a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not available as there is no mention of a training set for an AI/ML algorithm within this document.

Summary

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<130608

510(k) Summary

February 27, 2012

I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville. Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
- Contact: Sharon McDermott Senior Regulatory Affairs Specialist

Proprietary Trade Name:

Quadcut®, 3.0 mm x 13 cm Quadcut®, 3.4 mm x 13 cm Quadcut®, 4.3 mm x 13 cm

II. Common Name: Stereotaxic Instrument
III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
IV. Classification: Class II (21 CFR 882.4560)
V. Product Code: HAW

VI. Product Description:

AUG 07 2013

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VII. Indications for Use:

The XPS/IPC System is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT - or MR-based model, or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

VIII. Identification of Legally Marketing Devices (Predicate Devices)

Description	510(k) Number	ClearanceDate
StealthStation Golden Eye Micro-Magnetic Tracking System Option	K001284	06/12/2000
Quadcut® (non-navigated), Class I(Product code: EQJ)	Exempt	NA

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Item	Subject Devices	Predicate Devices
Quadcut BladesIndications for Use	The XPS/IPC System is intended for the incision and removalof soft and hard tissue or bone in general otorhinolaryngology,head and neck, and otoneurological surgery.The Medtronic computer-assisted surgery system and itsassociated applications are intended as an aid for preciselylocating anatomical structures in either open or percutaneousprocedures. Their use is indicated for any medical condition inwhich the use of stereotactic surgery may be appropriate, andwhere reference to a rigid anatomical structure, such as theskull, can be identified relative to a CT- or MR-based model,or digitized landmarks of the anatomy.The system and its associated applications should be usedonly as an adjunct for surgical guidance. They do not replacethe surgeon's knowledge, expertise, or judgment.	Medtronic Xomed QuadcutBlades (non-navigated)Class I, 510(k) ExemptSame intended useStealthStation Golden EyeMicro-magentic System.K001284Same intended use
Establishment ofStereotacticCoordinates(Tracking Method)	Electromagnetic	StealthStation Golden EyeMicro-magentic System.K001284Same
System AccuracyRequirement	Benchtop and simulated environment:95% confidence / 99.5% reliability, as dictated by risk analysis,of $<=$ 3.00 mm.	StealthStation Golden EyeMicro-magentic System.K001284Equivalent
Materials - blade	304L stainless steel	Medtronic Xomed QuadcutBlades (non-navigated)Class 1, 510(k) ExemptSame material
M4 Hub	ABS hub	Medtronic Xomed QuadcutBlades (non-navigated)Class I, 510(k) ExemptSame materials
Sterilization Method	Ethylene Oxide sterilization	Medtronic Xomed QuadcutBlades (non-navigated)Class 1, 510(k) ExemptSame sterilization method

IX. Comparison of the Technological Characteristics:

The subject devices have the same intended use and technological characteristics as the predicate devices.

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X. Discussion of the Performance Testing

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. Specifically, testing with Medtronic Navigation systems and Fusion software was conducted to ensure acceptable navigational accuracy. Test samples were subjected to simulated real-life use conditions during functional testing.

XI. Conclusions

The navigated Quadcut® has been shown through comparison and testing to be substantially equivalent to the identified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

August 7, 2013

Medtronic Navigation % Ms. Sharon McDermott Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, CO 80027

Re: K130608

Trade/Device Name: Quadcut Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: June 25, 2013 Received: June 25, 2013

Dear Ms. McDermott:

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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Sharon McDermott

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalTroblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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

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Indications for Use

510(k) Number: K130608

Device Name:

Quadcut®, 3.0 mm x 13 cm Quadcut®, 3.4 mm x 13 cm Quadcut®, 4.3 mm x 13 cm

Quadcut® is an accessory component of the StraightShot M4 handpiece, which is an integral part of the XPS and IPC Systems.

Indications for Use:

The XPS/IPC System is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

Prescription Use X	AND/OR	Over-The-Counter Use
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eric A. Mann -S

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number_

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).