The ShapeMatch 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 provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The ShapeMatch 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 ShapeMatch 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 ShapeMatch Cutting Guides are intended for single use only.

Device Description

The ShapeMatch 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 ShapeMatch 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

The provided 510(k) summary for the ShapeMatch® Cutting Guides ([K122053](https://510k.innolitics.com/search/K122053)) does not include information about specific acceptance criteria or a clinical study designed to prove the device meets such criteria.

Instead, it relies on non-clinical testing and substantiates equivalence to a predicate device. Here's a breakdown based on the categories requested:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in terms of measurable performance thresholds.
Reported Device Performance: The document states "Detailed software verification and validation were performed per FDA Guidance, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff." This indicates that the software aspects of the device (likely related to generating the custom guides from imaging data) were tested for correctness and functionality, but specific performance metrics (e.g., accuracy of cuts, fit of components) are not quantified in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable for clinical efficacy. The document explicitly states "Clinical Testing: Not Applicable to validate changes." The software verification and validation would have involved various test cases, but details on sample size or data provenance for those tests are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable for clinical efficacy. Since clinical testing was deemed "not applicable," there's no mention of experts establishing a ground truth for a clinical test set.

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

Not applicable for clinical efficacy. No information on adjudication methods for a clinical test set.

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:

Not applicable. This device is a cutting guide, not an AI-assisted diagnostic tool for "human readers." No MRMC study was conducted or referenced.

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

The device's function is to generate physical cutting guides from imaging data. The "algorithm" here would be the software that processes the MRI/CT data and designs the guide. The "Detailed software verification and validation" would assess the standalone performance of this software in accurately translating image data into guide designs. However, no specific metrics or studies demonstrating this standalone performance (e.g., how precisely the software determines bone geometry or cut planes compared to a 'gold standard') are provided in this summary.

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

For the "software verification and validation," the ground truth would likely be established through engineering specifications, validated anatomical models, or potentially comparisons to manual measurements/designs. Specific details are not provided.

8. The sample size for the training set:

This information is not provided, as the summary focuses on software verification and validation rather than a deep learning machine learning model that would require a distinct training set. The device appears to be based on algorithmic design from patient imaging.

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

Not applicable as no specific training set for a machine learning model is described. The ground truth for the software development (if one considers the development data as a "training set" in a broader sense) would be based on established anatomical knowledge, engineering principles, and potentially measurements from cadaveric or synthetic models.

In summary: The 510(k) for the ShapeMatch® Cutting Guides relies on non-clinical software verification and validation for regulatory submission, asserting substantial equivalence to a predicate device. It explicitly states that clinical testing was "Not Applicable to validate changes." Therefore, many of the requested details regarding clinical study design, acceptance criteria, and ground truth establishment for clinical performance are not present in this document.

Summary

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

K122053 (1/2)

OCT
24
2012

510(k) Summary

Sponsor	Howmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430
Contact Person	Tammy WhartonSenior Regulatory Affairs SpecialistOtisMed, Stryker Orthopaedics1600 Harbor Bay Parkway, Suite 200Alameda, CA 94502Phone: (510) 995-4462
Date Prepared:	September 27, 2012
Proprietary Name:	ShapeMatch® Cutting Guides
Common Name:	Cutting Guide
Classification Name:	21 CFR §888.3560Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis21 CFR §888.3565Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis

Legally Marketed Device to Which Substantial Equivalence is Claimed: Stryker® Patient Specific Cutting Guides, K110533

Device Description: The ShapeMatch 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.

Intended Use: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components

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

intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Indications: The ShapeMatch 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 ShapeMatch 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 ShapeMatch 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:

Detailed software verification and validation were performed per FDA Guidance, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff.

Clinical Testing: Not Applicable to validate changes.

Conclusion: The ShapeMatch 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 address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-0609, Silver Spring, MD 20993-0002. The address is likely for a specific department or division within the FDA.

OCT 24 2012

Howmedia Osteonics Corp. c/o Ms. Tammy Wharton Senior Regulatory Affairs Specialist OtisMed, Stryker Orthopaedics 1600 Harbor Bay Parkway, Suite 200 Alameda, CA 94502

Re: K122053

Trade/Device Name: ShapeMatch® 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, OOG Dated: September 27, 2012 Received: October 3, 2012

Dear Ms. Wharton:

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.

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

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

Page 2 - Ms. Tammy Wharton

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 (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 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/ResourcesforYou/Industry/default.htm

Sincerely yours,

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): K122053

Device Name: ShapeMatch® 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 ShapeMatch Cutting Guides are intended for single use only.

Prescription Use(Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use(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)

Page 1 of 1	(Division Sign-Off)Division of Surgical, Orthopedic, and Restorative Devices
-------------	----------------------------------------------------------------------------------

510(k) Number	K122053
---------------	---------

Page 3

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.