The CAS PSI Shoulder is intended to be used as a surgical instrument to construct and transfer a pre-surgical plan to orthopaedic surgical procedures. The CAS PSI Shoulder is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not otherwise precluded from being radiologically scanned.

The CAS PSI Shoulder is to be used with the Zimmer® Trabecular Metal™ Reverse Shoulder Baseplate in accordance with the implant system's indications and contraindications.

The CAS PSI Shoulder hardware components (jigs and bone model) are intended for single use only.

Device Description

The CAS PSI Shoulder consists of both software and hardware components and requires the patient to be radiologically scanned. The CAS PSI Shoulder has been developed with the fundamental goals to assist in pre-operative planning (using the CAS PSI Shoulder Software) and to accurately construct and transfer a pre-operative plan to orthopedic surgical procedures (using the CAS PSI Shoulder Hardware). The hardware (jigs and bone model) have features designed to mate with legally marketed instruments to aid in the implantation of legally marketed Class II implant devices. The hardware components are designed to mate with legally marketed instruments and thus indirectly aid in the placement of legally marketed implants. The software is developed in C++ programming language for a windows operating system. The hardware (jigs and bone guide) are made from biocompatible polyamide (Duraform) with press-fit 304 and 17-4 Stainless Steel components.

AI/ML Overview

The provided text describes the "CAS PSI Shoulder" device, a surgical planning and instrument guidance system for shoulder replacement procedures. However, the document does not contain the level of detail requested in the prompt regarding acceptance criteria and a specific study proving the device meets those criteria.

Instead, it provides a general overview of non-clinical performance studies and a high-level conclusion.

Here's a breakdown of what can and cannot be extracted from the given text based on your request:

What can be extracted:

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

The document states: "Non-clinical testing demonstrated that the CAS PSI Shoulder meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy."

However, it does not provide a specific table of acceptance criteria nor quantified device performance metrics from these tests. It only lists the types of non-clinical studies conducted.

Acceptance Criteria	Reported Device Performance
Not specified in detail. The document generally indicates meeting "performance requirements as defined by Design Control activities" and achieving "substantial equivalence."	"Meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy."

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

Sample Size for Test Set: Not specified for any of the listed non-clinical studies.
Data Provenance: Not specified for any of the listed non-clinical studies (e.g., country of origin, retrospective/prospective). The studies are listed as "Simulated Use Testing," "Cadaveric Testing," etc., implying laboratory or cadaver-based testing rather than clinical patient data.

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):

This information is not provided in the document. The non-clinical studies (Simulated Use, Cadaveric) would likely involve internal experts or engineers evaluating performance, but their number and qualifications are not detailed.

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

This information is not provided in the document.

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:

No, an MRMC comparative effectiveness study was not done or reported. The document focuses on non-clinical testing and states that "clinical data and conclusions were not needed to demonstrate substantial equivalence." The device assists in planning but the studies listed are not designed to measure human reader improvement with or without AI.

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

The document describes "Software Verification and Validation" as one of the non-clinical studies. This would likely involve evaluating the algorithm's performance in a standalone capacity internally. However, specific metrics of its standalone performance (e.g., accuracy, precision) are not reported.

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

For the non-clinical studies:
- Simulated Use Testing & Cadaveric Testing: The ground truth would likely be based on established anatomical landmarks, surgical protocols, engineering specifications, and possibly measurements of implant or instrument placement accuracy against a predefined ideal.
- Software Verification and Validation: Ground truth would be based on expected software output given specific inputs, adherence to design specifications, and computational accuracy.
Specific methodologies for establishing ground truth are not detailed.

8. The sample size for the training set:

Not applicable/Not provided. The document describes a "Software Verification and Validation" study and does not mention machine learning or AI in a way that suggests a distinct training set for an AI model. The software component aids in pre-operative planning, which is a rules-based or computational task rather than a traditional machine learning model requiring a training set in the context of this document.

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

Not applicable/Not provided for the same reasons as point 8.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence through non-clinical performance studies (simulated use, cadaveric, biocompatibility, sterilization, dimensional stability, drop testing, and software verification/validation). It explicitly states that clinical data and conclusions were not needed. As such, it lacks the detailed performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment methods typically found in studies evaluating AI diagnostic or prognostic devices against specific acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the letter 'Z' inside of a circle. The letter 'Z' is bold and black, and the circle is a thin black line. Below the circle is the word 'zimmer' in a lowercase, sans-serif font. The word 'zimmer' is also black.

Applicant:

Contact Person:

K131129

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

AUG 2 0 2013

510(k) Summary

Christopher McLean Zimmer CAS 75 Queen Street, Suite 3300 Montreal, Canada, Quebec H3C 2N6

Jason Heckaman Zimmer, Inc. 1800 West Center Street Warsaw, IN 46580 Telephone: (574) 371-8675 Fax: (574) 372-4605

Patient Specific Instruments

20 August 2013

CAS PSI Shoulder

Date:

Trade Name:

Common Name:

Product Code / Device:

Classification Name:

Predicate Devices:

KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

PBF - Orthopaedic Surgical Planning and Instrument Guides

21 CFR § 888.3660 - Shoulder joint metal/polymer semiconstrained cemented prosthesis

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides, manufactured by Materialise N.V. and cleared under K112389 on 20 July 2012. Zimmer Patient Specific Instruments System 5.0, manufactured by Materialise N.V. and cleared under K121640 on 5 Dec 2012. Glenoid Intelligent Reusable Instrument System (Glenoid IRIS), manufactured by Custom Orthopaedic Solutions, Inc. and cleared under K123122 on 5 April 2013.

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The CAS PSI Shoulder consists of both software and Device Description: hardware components and requires the patient to be radiologically scanned. Device Function, Scientific Concepts, Design Features and Physical Properties that form the Basis for the Device: The CAS PSI Shoulder has been developed with the fundamental goals to assist in pre-operative planning (using the CAS PSI Shoulder Software) and to accurately construct and transfer a pre-operative plan to orthopedic surgical procedures (using the CAS PSI Shoulder Hardware). The hardware (jigs and bone model) have features designed to mate with legally marketed instruments to aid in the implantation of legally marketed Class II implant devices. Significant Physical Characteristics: Device Design: The hardware components are designed to mate with legally marketed instruments and thus indirectly aid in the placement of legally marketed implants. Materials Used: The software is developed in C++ programming language for a windows operating system. The hardware (jigs and bone guide) are made from biocompatible polyamide (Duraform) with press-fit 304 and 17-4 Stainless Steel components. Comparison to the Predicate: The subject and predicate devices have similar indications for use and are all intended to aid (either directly or indirectly ) in the placement of Class II orthopedic devices. The subject and predicate devices have the same intended use, functioning, patient-specific template design, and use a selective laser sintering manufacturing process for hardware components. Intended Use: The CAS PSI Shoulder is intended to be used as a surgical instrument to construct and transfer a pre-surgical plan to orthopaedic surgical procedures. The CAS PSI Shoulder is indicated, based on patient-Indications for Use: specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not otherwise precluded from being radiologically scanned.

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The CAS PSI Shoulder is to be used with the Zimmer® Trabecular Metal™ Reverse Shoulder Baseplate in accordance with the implant system's indications and contraindications.

The CAS PSI Shoulder hardware components (jigs and bone model) are intended for single use only.

Performance Data:

Non-Clinical Performance Studies Conducted:

1. Simulated Use Testing
1. Cadaveric Testing
1. Biocompatibility Rationale
1. Sterilization Rationale
1. Dimensional Stability Testing
1. Drop Testing
1. Software Verification and Validation

Non-Clinical Performance Testing Conclusions: Non-clinical testing demonstrated that the CAS PSI Shoulder meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy.

In this case, clinical data and conclusions were not needed to demonstrate substantial equivalence.

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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare.

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

August 20, 2013

Zimmer CAS % Mr. Jason Heckaman Manager, Regulatory Affairs Zimmer, Incorporated 1800 West Center Street Warsaw, Indiana 46580

Re: K131129

Trade/Device Name: CAS PSI Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, PBF Dated: July 19, 2013 Received: July 22, 2013

Dear Mr. Heckaman:

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. Drue, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Jason Heckaman

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/Resourcesfor You/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/ReportalProblem/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,

Laurence D. Coyne -S

For

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

Enclosure

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Indications for Use

510(k) Number (if known):

K131129

Device Name:

CAS PSI Shoulder

Indications for Use:

The CAS PSI Shoulder is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intraoperative guiding of surgical instruments for shoulder replacement surgical procedures on patients not otherwise precluded from being radiologically scanned.

The CAS PSI Shoulder is to be used with the Zimmer® Trabecular Metal™ Reverse Shoulder Baseplate in accordance with the implant system's indications and contraindications.

The CAS PSI Shoulder hardware components (jigs and bone model) are intended for single use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/14 description: The image shows the text "Casey L. Hanley, Ph.D" on the top line and "Division of Orthopedic Devices" on the second line. There is a horizontal line separating the two lines of text. The text is black and the background is white.

(Division Sign-Off) Division of Orthopedic Devices 510 (k) Number: K131129

Page 1 of 1

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”