Intended Use: The Stryker® Navigation System - iNfinitus Hip Resurfacing Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.
Indications for Use: The system is indicated for partial hip resurfacing, to assist in precise positioning of hip femoral resurfacing component. The system must be used within the operating room and should be operated only by trained personnel such as orthopedic surgeons and clinic staff.

Device Description

Stryker® Navigation System - iNfinitus Hip Resurfacing Module is part of the product series of the Stryker® Navigation System. The system comprises software for intraoperative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated hip resurfacing surgery. The Stryker® Navigation System - iNfinitus Hip Resurfacing Module is based on the previously cleared Stryker® Navigation System - Hip Module. The Hip Resurfacing module is tailored to the workflow of hip resurfacing procedures and consists of planning and preparing the acetabular side with depth to seat measurement for the cup and planning and preparation tasks for the femoral component.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Stryker Navigation System - iNfinitus Hip Resurfacing Module, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text for K072271 does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance. It primarily focuses on the device description, intended use, and indications for use, and a comparison to predicate devices, which implies the new device performs similarly or equivalently to the predicate to warrant substantial equivalence.

Stryker Navigation System - iNfinitus Hip Resurfacing Module is being cleared as substantially equivalent (SE) to the predicate devices K022365 Stryker Navigation - Hip Module and K063028 VectorVision Hip SR. Therefore, its performance is considered acceptable if it is comparable to these predicate devices. The submission and clearance focus on the safety and effectiveness being equivalent to these existing technologies for computer-assisted hip surgery navigation.

Key Study Information from K072271:

The provided 510(k) summary does not contain details of a specific performance study in the format requested. 510(k) clearances for navigation systems often rely heavily on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than extensive clinical efficacy studies with detailed performance metrics like sensitivity/specificity or reader studies.

The information provided is typical for a 510(k) submission where substantial equivalence is demonstrated through comparison to legally marketed predicate devices, focusing on:

Device Description: What the device is and how it functions.
Intended Use & Indications for Use: What the device is meant to do.
Technological Characteristics: How the device achieves its function.
Comparison to Predicate Devices: Demonstrating that the new device is as safe and effective as existing, legally marketed devices.

Therefore, the following points cannot be extracted directly from the provided text, as a detailed performance study report is not present:

Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
The type of ground truth used: Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Conclusion:

Based on the provided 510(k) summary for K072271, the clearance relies on demonstrating substantial equivalence to predicate devices (K022365 Stryker Navigation - Hip Module and K063028 VectorVision Hip SR) rather than presenting a detailed independent performance study with quantitative acceptance criteria and results for the new iNfinitus Hip Resurfacing Module. The document does not contain the specific study details or performance metrics you requested.

Summary

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K072271

4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 800 965 6505 www.stryker.com

stryker

Instruments

510(k) Summary
Device Sponsor:	Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412	DEC 1 8 2007
Registration No.:	1811755
Trade Name:	Stryker® Navigation System - iNfinitus Hip Resurfacing Module
Common Name:	Navigation System
Classification Name:	Stereotaxic Instruments
Equivalent to:	K022365 Stryker Navigation - Hip ModuleK063028 VectorVision Hip SR
Device Description:	Stryker® Navigation System - iNfinitus Hip Resurfacing Module is part of theproduct series of the Stryker® Navigation System. The system comprises software forintraoperative surgical planning and supports computer assisted surgery based on awireless optical tracking localization device for the use in navigated hip resurfacingsurgery.The Stryker® Navigation System - iNfinitus Hip Resurfacing Module is based on thepreviously cleared Stryker® Navigation System - Hip Module. The Hip Resurfacingmodule is tailored to the workflow of hip resurfacing procedures and consists ofplanning and preparing the acetabular side with depth to seat measurement for the cupand planning and preparation tasks for the femoral component.
Intended Use:	Stryker® Navigation System - iNfinitus Hip Resurfacing ModuleThe Stryker® Navigation System - iNfinitus Hip Resurfacing Module isintended as a planning and intraoperative guidance system to enable open orpercutaneous computer assisted surgery. The system is indicated for any medicalcondition in which the use of computer assisted surgery may be appropriate, andwhere a reference to a rigid anatomical structure such as but not limited to the pelvis,or femur, can be identified.
Indications for Use:	The system is indicated for partial hip resurfacing, to assist in precise positioning ofhip femoral resurfacing component.The system must be used within the operating room and should be operated only bytrained personnel such as orthopedic surgeons and clinic staff.Contraindications• An immobile hip due to an existing condition, such as rheumatoid arthritis,previous fracture, or fusion.

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Image /page/1/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 resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2007

Stryker Corporation % Ms. Becky Ditty Regulatory Affairs 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K072271

Trade/Device Name: Stryker Navigation System - iNfinitus Hip Resurfacing Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 12, 2007 Received: December 13, 2007

Dear Ms. Ditty:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Becky Ditty

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known):

Device Name: Stryker Navigation System - iNfinitus Hip Resurfacing Module

Intended Use

The Stryker Navigation System -- Nfinitus Hip Resurfacing Module is intended as a planning and intraoperalive guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical and tion in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical stuch as but not limited to the pelvis, or femur, can be identified.

Indications for Use

The system is indicated for partial hip resurfacing, to assist in precise positioning of the femoral resurfacing component.

The system should be operated only by trained personnel such as orthopedic surgeons and clinic staff.

Contraindication

· An immobile hip due to an existing condition, such as rheumatoid arthritis, previous fracture, or fusion.
· Surgical situation where increasing surgical time may be detrimental to the patient.

Prescription Use X (Part 21 CFR 801 Subpart D) and/or

Over-The-Counter Use (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)

R.N.

Division of General, Restorative. and Neurological Devices

510(k) Number K072271

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).