The CAS PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components. It involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of provided patient radiological images with identifiable placement anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

The CAS PSI Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen CR, NexGen CR-Flex, Nexgen CR-Flex Gender, Nexgen LPS, Nexgen LPS-Flex, Nexgen LPS-Flex Gender, Persona CR, and Persona PS.

The patient specific guide components are intended for single-use only.

Device Description

The CAS PSI Knee is an orthopedic instrument system indicated to assist in the positioning of knee replacement components. It involves surgical planning software used pre-operatively, and surgical instrument components that include patient specific guides to precisely align and position the implant components intra-operatively relative to each patient's anatomical features per the surgical plan. The surgical planning software allows the review of patient joint models determined from radiological images upon which the surgical placement of the implant components is adjusted per anatomical landmarks. The patient specific guides are fabricated per the patient models to fit each patient's anatomy with features that set the relative placement of the implant components per the surgical plan. The system is compatible with given implant systems per its indications for use.

AI/ML Overview

The provided document describes the CAS PSI Knee System, an orthopedic instrument system designed to assist in the positioning of knee replacement components. It includes surgical planning software and patient-specific guides.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be within X mm" or "reproducibility must be within Y degrees"). Instead, it broadly describes the types of tests conducted and concludes with a statement of satisfactory performance for its intended use.

Acceptance Criteria Category	Specific Criteria (Implicit/General)	Reported Device Performance
Software System Tests	No hazardous anomalies present.	"Performed to ensure that no hazardous anomalies were present in the system software components. They consisted of testing software features and functionalities in correspondence to software design requirements." (Implies requirements were met.)
Software Performance Tests	Reproducibility and accuracy of algorithms (model meshing, segmentation, landmark assignment, planning, jig creation).	"Tests were performed to verify the reproducibility and accuracy of the software system algorithms. These included the accuracy and reproducibility of the software tools, the model meshing and segmentation methods, the assignment of surgical landmarks, the planning method, and the jig creation algorithms." (Implies verification of both reproducibility and accuracy.)
Guide Mechanical Resistance Tests	Mechanical performance (resistance to use/drop breakage, debris generation, aging stability, sterilization, extreme shipping).	"Tests were performed to verify the mechanical performance of the guides including resistance to use or drop breakage, debris generation, aging stability, sterilization, and extreme shipping conditions." (Implies successful verification of these mechanical properties.)
Full System Validation Tests	Overall system performance in terms of usage and instrument ergonomics.	"Full use simulations tests using cadaver specimens or sawbones were performed by multiple surgeons to verify and validate the overall system performance in terms of system usage and instrument ergonomics. The results demonstrated satisfactory performance per the intended use." (Indicates satisfactory performance as judged by multiple surgeons during simulations.)

The overall conclusion is that "The information and data provided ... established that the CAS PSI Knee System is substantially equivalent to the predicates." This is the ultimate "acceptance" for 510(k) clearance, rather than meeting specific quantitative performance thresholds.

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

The document mentions "full use simulations tests using cadaver specimens or sawbones."

Sample Size: The exact number of "cadaver specimens or sawbones" is not specified. It refers to generic plural forms.
Data Provenance: The document does not specify the country of origin. The data is presented as prospective simulation tests conducted for validation.

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

Number of Experts: "multiple surgeons." The exact number is not specified.
Qualifications of Experts: They are described as "surgeons," implying medical doctors specializing in surgery, likely orthopedic surgeons given the context of knee replacement. No specific experience level (e.g., "10 years of experience") is provided.

4. Adjudication Method for the Test Set:

The document mentions "Full use simulations tests... were performed by multiple surgeons to verify and validate the overall system performance..." It states that "The results demonstrated satisfactory performance per the intended use." This suggests a consensus-based or qualitative evaluation by the surgeons, but no specific adjudication method (e.g., 2+1, 3+1, none) is detailed. The assessment of "satisfactory performance" is the reported outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was NOT explicitly stated or described in the provided text. The "full system validation tests" involved "multiple surgeons" but focused on verifying the system's performance and ergonomics, rather than comparing human reader performance with and without AI assistance or quantifying an effect size of improvement.

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

Yes, standalone performance was assessed for the software components. The "Software Performance Tests" specifically focused on verifying "the reproducibility and accuracy of the software system algorithms. These included the accuracy and reproducibility of the software tools, the model meshing and segmentation methods, the assignment of surgical landmarks, the planning method, and the jig creation algorithms." This refers to the algorithm's performance without direct human intervention in the execution of the plan.

7. The Type of Ground Truth Used:

For the "Software Performance Tests," the ground truth likely involved pre-defined anatomical landmarks and surgical plans against which the algorithm's output (meshing, segmentation, landmark assignment, planning, jig creation) was compared for accuracy and reproducibility.
For the "Full System Validation Tests," the ground truth was effectively expert assessment/consensus ("satisfactory performance per the intended use") by multiple surgeons observing the system's usage and instrument ergonomics in simulation. It's an assessment of whether the system achieved the intended surgical outcome or allowed surgeons to achieve it.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set of the software. The software's capabilities are described (modeling patient anatomy from MRI scans, identifying landmarks, planning implant placement), but not the data used to develop or train these capabilities.

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

The document does not provide information on how the ground truth for the training set was established.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS CAS PSI KNEE SYSTEM

Applicant: Zimmer CAS 75 Queen Street, suite 3300 Montreal, Quebec Canada, H3C 2N6 Tel .: 514 861 4074 Fax: 514 866 2197

SEP 1 3 2013

Contact Person: Christopher McLean

Date Summary Prepared: August 15, 2013

Device Trade Name: CAS PSI Knee System

Device Name / Product Code, Regulation Classification Name / Number:

Knee Arthroplasty Implantation System / OOG, Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis / 21 CFR § 888.3560 2) Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer / JWH. Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis / 21 CFR § 888.3560 3) Prosthesis. Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous. Coated, Polymer/Metal / MBH, Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis / 21 CFR & 888.3565

Predicate Devices:

1. Zimmer Patient Specific Instruments System 5.0, Submitter: Materialise N.V., K121640
1. Zimmer Patient Specific Instruments System 2.5, Submitter: Materialise N.V., KI11492

Device Description:

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Indications for Use / Intended Use:

The patient specific guide components are intended for single-use only.

Technological Comparisons to the Predicates:

The main technology in the CAS PSI Knee system is the same as in the predicates. Both the CAS PSI Knee system and the predicates involve an equivalent software package to pre-operatively model the patients anatomy from MRI scans, identify surgical landmark on the patient models in accordance with the implant surgical technique to reference the placement of the implants, plan the placement of the implants upon the model and per the surgical landmarks, and to create corresponding models for Femoral and Tibial Guides with surfaces and elements to uniquely fit each patient topographical features and set or reference the placement of the implant system components per the plan.

While the Femoral and Tibial Guides provide the same functions in both the CAS PSI Knee system and the predicates, in the CAS PSI Knee system the tibial guide functions are provided by two guides as compared to one single guide in the predicates. The predicate Tibial Guide combines features to set both the location of the implant tibial cut guides as well as the location of the implant tibial component on the cut surface. In the CAS PSI Knee this is provided by one guide to set the location of the implant system's tibial cut guide, and a separate Tibial Rotational Guide to locate the implant's tibial component on the cut surface. While provided separately the approach is equivalent since the intended use to place the implant component is the same.

Another difference is that the system includes additional instrument accessories called Drop Rod Adaptors. These allow for the intra-operatively validation of the alignment provided by the Tibial Guide while the Tibial Guide is still set on the patient. In the predicates the user is similarly instructed to perform the verification of the alignment of the tibial cut with, however, the difference that it is done only once the cut guide is positioned on the patient after the predicate Tibial Guides have been removed, and also that it is by using the implant's system drop rod adaptors instruments as intended for this While the approach is different, the intended use to verify the alienment purpose. imparted by the Tibial Guides is equivalent.

A final difference is that the CAS PSI Knee system includes full scale 3-D reproductions of the bone models of each patient's distal femur and proximal tibia on which the locations of the guides and reference landmarks are depicted per the surgical planning. These allow the surgeon to visually gage intra-operatively the accuracy of the bone

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models relative to the actual patient's anatomy and the relative placement of the guides

Given their intent to provide more information for the user to gage the per the plan. accuracy of the planning and guides, these do not raise new safety or effectiveness concerns.

Performance Data:

Four different types of non-clinical tests to were conducted to verify and validate the performance of the system and assess that no new safety and efficacy issues were raised in the device.

. Software System Tests: They were performed to ensure that no hazardous anomalies were present in the system software components. They consisted of testing software features and functionalities in correspondence to software design requirements.
Software Performance Tests: Tests were performed to verify the reproducibility o and accuracy of the software system algorithms. These included the accuracy and reproducibility of the software tools, the model meshing and segmentation methods, the assignment of surgical landmarks, the planning method, and the jig creation algorithms.
Tests were performed to verify the Guide Mechanical Resistance Tests: . mechanical performance of the guides including resistance to use or drop breakage, debris generation, aging stability, sterilization, and extreme shipping conditions.
Full System Validation Tests: Full use simulations tests using cadaver specimens or . sawbones were performed by multiple surgeons to verify and validate the overall system performance in terms of system usage and instrument ergonomics. The results demonstrated satisfactory performance per the intended use.

Conclusion:

The information and data provided in the 510(k) Premarket Notification established that the CAS PSI Knee System is substantially equivalent to the predicates.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. To the left of the bird-like figure, there is a circular seal with text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

September 13, 2013

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

Zimmer CAS Mr. Christopher McLean Quality & Regulatory Affairs Associate Director 75 Queen Street, Suite 3300 Montreal, Quebec H3C 2N6 CANADA

Re: K131409 Trade/Device Name: CAS PSI Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: JWH, MBH, OOG Dated: August 15, 2013 Received: August 16, 2013

Dear Mr. McLean:

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

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Page 2 - Mr. Christopher McLcan

CFR Part 807); labeling (21 CFR Part 801); medical device 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 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/ResourcesforYou/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/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometries/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 -S

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

Enclosure

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510(k) Number: K131409

Device Name: CAS PSI Knee System

Indications for Use:

The patient specific guide components are intended for single-use only.

Prescription Use _ V (per 21CFR 801.109) OR

Over-the-Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey Hanley, PhD

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.