Stryker® Orthopaedics RFID Instrumentation is intended for use as accessories to the Stryker® Navigation System's Hip and Knee Modules during orthopedic surgery.

Device Description

Stryker® Orthopaedics RFID Instrumentation are navigational compatible manual surgical instruments which contain radio-frequency identification (RFID) technology. The RFID tags on the instruments are passive and will not operate without the navigation system. These instruments will be used during orthopedic surgery in conjunction with the Stryker" Navigation System. The instrumentation will be maintained and distributed by Stryker® Orthopaedics, while the navigation system will be maintained and distributed by Stryker® Instruments.

AI/ML Overview

This 510(k) submission for Stryker® Orthopaedics RFID Instrumentation is a submission for Class II medical devices and as such does not contain acceptance criteria and performance study data in the same way a PMA submission for Class III devices would. For 510(k) devices, the primary demonstration is "substantial equivalence" to a predicate device, rather than detailed performance studies against specific acceptance criteria. The information you are requesting is typically not included in a 510(k) summary for this type of device.

Here's why and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable: This type of table is not present because a 510(k) primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The submission asserts "The Stryker® Orthopaedics RFID Instrumentation is substantially equivalent to other navigational compatible instruments in regards to intended use, design, materials, and operational principles." There are no specific performance criteria or reported results in this summary as would be found in a clinical trial report.

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

Not Applicable: No test set or associated data provenance (country of origin, retrospective/prospective) is described. The submission is based on a comparison to predicate devices, not on a new clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable: There is no mention of experts establishing ground truth because no new clinical test data requiring such assessment is provided or required for this type of 510(k).

4. Adjudication Method:

Not Applicable: As there's no test set or ground truth establishment by experts, there's no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not Applicable: An MRMC study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance. This device is a surgical instrument accessory with RFID capability. The 510(k) does not describe any MRMC studies, nor would they typically be relevant for this type of device.

6. Standalone (Algorithm Only) Performance:

Not Applicable: This device is a physical surgical instrument with RFID tags, not a standalone algorithm. Its function is to be used with a navigation system. Its "performance" would be related to its RFID readability and mechanical integrity, which are assessed through engineering verification and validation, not typically through standalone performance studies like an algorithm.

7. Type of Ground Truth Used:

Not Applicable: There is no ground truth, expert consensus, pathology, or outcomes data presented because no new clinical study requiring these elements was performed or required for this 510(k). Equivalence is established through comparison of design, materials, and operational principles to predicate devices.

8. Sample Size for the Training Set:

Not Applicable: This device is not an AI/ML algorithm that requires a training set. Physical product testing would involve engineering and durability tests on a small sample of manufactured instruments, not a "training set" in the context of data science.

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

Not Applicable: As there's no training set, there's no ground truth established for one.

In summary: This 510(k) submission relies on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices (K022365, K010204, K033341, K043223) rather than presenting new clinical study data with acceptance criteria, test sets, or ground truth establishment. The nature of the device (orthopedic manual surgical instruments with RFID capability) does not typically necessitate the types of performance studies and data analyses you've asked about, which are more common for diagnostic devices, software algorithms, or higher-risk devices.

Summary

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053348

510(k) Summary of Safety and Effectiveness . Stryker® Orthopaedics RFID Instrumentation Proprietary Name: Stryker® Orthopaedics RFID Instrumentation Common Name: Orthopedic Manual Surgical Instruments with RFID capability Classification Name and Reference: Stereotaxic instrument (Title 21 CFR §882.4560) Device Panel/Product Code: 84 HAW Proposed Regulatory Class: Class II For Information contact: Vivian Kelly, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5581 Fax: (201) 831-6038 Date Summary Prepared: November 30, 2005

Description

Indications:

Stryker® Orthopaedics RFID Instrumentation is intended for use as accessories to the Stryker Navigation System's Hip and Knee Modules during orthopedic surgery.

Substantial Equivalence:

The Stryker® Orthopaedics RFID Instrumentation is substantially equivalent to other navigational compatible instruments in regards to intended use, design, materials, and operational principles. The following devices are examples of predicate devices: 1) Hip and Knee Modules of the Stryker® Navigation System (K022365 and K010204), 2) Smith and Nephew Image Guided Surgical Instruments (K033341) and 3) DePuy CAS Knee Instrumentation (K043223).

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized depiction of a human figure, represented by three curved lines, suggesting a sense of care and support. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2006

Howmedica Osteonics Corporation % Ms. Vivian Kelly, RAC Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430

Re: K053348

Trade/Device Name: Stryker® Orthopaedics RFID Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 27, 2006 Received: July 28, 2006

Dear Ms. Kelly:

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. Vivian Kelly, RAC

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

sincerely yours,

Hubert Lemmens

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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s3348

Indications for Use

510(k) Number (if known):

Device Name: Stryker® Orthopaedics RFID Instrumentation

Indications

Stryker® Orthopaedics RFID Instrumentation is intended for use as accessories to the Stryker® Navigation System's Hip and Knee Modules during orthopedic surgery.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut Lunn

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(Division Sign-( Division of General, Restorative, and Neurological Devices

510(k) Number K053348

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).