The Stryker® Patient Specific Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.

The Stryker Patient Specific Cutting Guides are intended for use with the CR, PS and CS components of the Triathlon® Knee System. The indications for use of the Triathlon Knee System when used with the Stryker Patient Specific Cutting Guides are:

General Total Knee Arthroplasty (TKR) Indications:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
Post-traumatic loss of knee joint configuration and function.
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Failed reconstruction procedures which did not involve the implantation of hardware on the condylar surfaces

Additional Indications for Posterior Stabilized (PS):

Ligamentous instability requiring implant bearing surface geometries with increased constraint.
Absent or non-functioning posterior cruciate ligament.
Severe anteroposterior instability of the knee joint.

The Stryker Patient Specific Cutting Guides are intended for single use only.

Device Description

The Stryker® Patient Specific Cutting Guides are single-use, disposable, cutting guides designed and manufactured from patient imaging data (MRI/CT). The cutting guides are used to aid the surgeon intra-operatively in making the initial distal femoral and the initial proximal tibial bone cuts during a total knee arthroplasty surgery. The cutting guides also establish the references for component orientations. The cutting guides are manufactured from polyoxymethylene per ASTM F1855.

The Stryker Patient Specific Cutting Guides are intended for use with the Triathlon® Knee System (Cruciate Retaining (CR), Posterior Stabilized (PS) and Condylar Stabilizing (CS)) determined substantially equivalent via the following 510(k)s K031729, K040267, K042993, K051146, K051380, K053514, K062037, K061251, K063423, and K072575.

The accessory Triathlon® Extra-medullary (EM) Universal Goniometer is available for the surgeon to use intra-operatively to check the position of the femoral and tibial components. The goniometer mates with the saw slots on both the femoral and tibial guides for use in referencing the cuts with anatomic landmarks prior to resection of the bone. The accessory Triathlon® EM Universal Goniometer is made from Stainless Steel per ASTM A564.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Stryker Patient Specific Cutting Guides, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria. Instead, the non-clinical testing aimed to demonstrate comparable accuracy to conventional jig-based instrumentation, and the clinical testing aimed to show a strong co-relationship between MRI and long-standing radiograph measurements.

Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical (Accuracy of Cutting Guides): Accuracy relative to pre-operative plan. Placement accuracy comparable to conventional jig-based instrumentation.	Accuracy quantified in a cadaveric model. Placement accuracy achieved with the Stryker Patient Specific Knee Cutting Guides is comparable to conventional jig-based instrumentation.
Clinical (Accuracy of MRI Protocol): Accuracy and repeatability of measurements from a new MRI protocol. Strong co-relationship between MRI and long-leg radiograph for mechanical alignment.	Accuracy and repeatability of MRI measurements were quantified. A strong co-relationship between the long leg x-ray and augmented MRI scanning was demonstrated.

2. Sample Size and Data Provenance

Non-Clinical (Cadaveric Assessment):
- Sample Size (Test Set): Not explicitly stated, described as "a cadaveric model."
- Data Provenance: Cadaveric data; implicitly from a controlled laboratory setting (likely within the US, but not specified). It is a prospective study as it involved active experimentation.
Clinical Research Study:
- Sample Size (Test Set): Not explicitly stated.
- Data Provenance: Not specified (e.g., country of origin). Described as a "clinical research study," implying prospective data collection on human subjects.

3. Number and Qualifications of Experts for Ground Truth

The document does not provide information on the number or qualifications of experts used to establish ground truth for either the non-clinical or clinical studies.

4. Adjudication Method for the Test Set

The document does not provide any information regarding an adjudication method for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is reported that details the effect size of human readers improving with AI vs. without AI assistance. The non-clinical study compared the device's accuracy to conventional jig-based instrumentation, which is a different type of comparison.

6. Standalone Performance Study

The studies conducted describe the performance of the "Stryker Patient Specific Cutting Guides" which are patient-specific surgical instruments generated from patient imaging data (MRI/CT). The studies assess the accuracy of these guides and the MRI protocol used to generate the data for the guides. This can be considered a standalone performance assessment of the device's ability to facilitate accurate cuts and the accuracy of the imaging protocol that informs the device. However, it's not "algorithm-only" in the sense of a diagnostic AI, as the device itself is a physical cutting guide. The software component mentioned (detailed software verification and validation) relates to the generation of these guides.

7. Type of Ground Truth Used

Non-Clinical (Cadaveric Assessment): The ground truth was based on the "pre-operative plan" for bone cuts, which would have been established by a surgeon or planning software. The success was measured by comparing the actual cuts made using the guides to this plan.
Clinical Research Study: The ground truth for knee alignment was established by "long standing radiograph images," which are a standard clinical method for assessing mechanical alignment.

8. Sample Size for the Training Set

The document makes no mention of a training set sample size. The device is generated from individual patient MRI/CT data, so it's a patient-specific design rather than an AI model trained on a large dataset in the conventional sense. The "software verification and validation" would be a separate process from a training set for a machine learning model.

9. How Ground Truth for Training Set was Established

As no training set is described for an AI model, there is no information on how its ground truth would have been established. The core of the device relies on patient-specific imaging data translated into a physical guide, not on a machine learning model trained on a general dataset.

Summary

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

KI10533(1/2)

510(k) Summary

MAY 1 9 2011

Sponsor	Howmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430
Contact Person	Karen AriemmaProject Manager, Regulatory Affairs/Regulatory ComplianceHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5718
Date Prepared:	February 23, 2011
Proprietary Name:	Stryker® Patient Specific Cutting Guides
Common Name:	Cutting Guide
Classification Name:	21 CFR §888.3560Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-ConstrainedCemented Prosthesis21 CFR §888.3565Knee joint patellofemorotibial metal/polymer porous-coated uncementedprosthesis

Legally Marketed Device to Which Substantial Equivalence is Claimed: Smith & Nephew Visionaire System, K082358

Device Description: The Stryker® Patient Specific Cutting Guides are single-use, disposable, cutting guides designed and manufactured from patient imaging data (MRI/CT). The cutting guides are used to aid the surgeon intra-operatively in making the initial distal femoral and the initial proximal tibial bone cuts during a total knee arthroplasty surgery. The cutting guides also establish the references for component orientations. The cutting guides are manufactured from polyoxymethylene per ASTM F1855.

{1}------------------------------------------------

Intended Use: The Stryker® Patient Specific Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.

Indications: The Stryker® Patient Specific Cutting Guides are intended for use with the CR, PS and CS components of the Triathlon® Knee System. The indications for use of the Triathlon Knee System when used with the Stryker Patient Specific Cutting Guides are:

General Total Knee Arthroplasty (TKR) Indications:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid . arthritis or post-traumatic arthritis.
� Post-traumatic loss of knee joint configuration and function.
. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
. Failed reconstruction procedures which did not involve the implantation of hardware on the condylar surfaces

Additional Indications for Posterior Stabilized (PS):

. Ligamentous instability requiring implant bearing surface geometries with increased constraint.
Absent or non-functioning posterior cruciate ligament. .
Severe anteroposterior instability of the knee ioint. .

The Stryker Patient Specific Cutting Guides are intended for single use only.

Summary of Technologies: Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the predicate device.

Non-Clinical Testing: A cadaveric assessment was undertaken to quantify the accuracy of the Stryker Patient Specific Knee Cutting Guides relative to the pre-operative plan in a cadaveric model and compare the placement accuracy achieved with the use of Stryker Patient Specific Knee Cutting Guides is comparable to conventional jig based instrumentation. The verification utilized cadaveric data and all investigations were conducted in conformity with ethical principles of research.

Detailed software verification and validation were performed per FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Clinical Testing: A clinical research study was performed to quantify the accuracy and the repeatability of measurements obtained from a new magnetic resonance imaging (MRI) protocol. The study also measured and compared the mechanical alignment angle of the knee obtained through MRI scans and long standing radiograph images. A strong co-relationship between the long leg x-ray and augmented MRI scanning was demonstrated.

Conclusion: The Stryker Patient Specific Cutting Guides are substantially equivalent to the predicate device identified in this premarket notification.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

Howmedia Osteonics Corp. % Ms. Karen Ariemma Project Manager, Regulatory Affairs/Regulatory Compliance 325 Corporate Drive Mahwah, New Jersey 07430

MAY 1 9 2011

Re: K110533

Trade/Device Name: Stryker® Patient Specific Cutting Guides Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH, QOG Dated: February 23, 2011 Received: February 24, 2011

Dear Ms. Ariemma:

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 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.

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

Page 2 - Ms. Karen Ariemma

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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,

AS. B. M h
fen.

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

Enclosure

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

Indications for Use

510(k) Number (if known): K | 10533

Device Name: Stryker 8 Patient Specific Cutting Guides

Indications for Use:

General Total Knee Arthroplasty (TKR) Indications:

. Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
Post-traumatic loss of knee joint configuration and function. .
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability.
Failed reconstruction procedures which did not involve the implantation of hardware on the . condylar surfaces

Additional Indications for Posterior Stabilized (PS):

Ligamentous instability requiring implant bearing surface geometries with increased ● constraint.
Absent or non-functioning posterior cruciate ligament. .
. Severe anteroposterior instability of the knee joint.

The Stryker Patient Specific Cutting Guides are intended for single use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off)
Division of Surgical, Orthopedic,

Division of Imaging
and Restorative Devices

K4653?

Miller an

510(k) Number

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.