The Zimmer® PSI Shoulder is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Bigliani/Flatow® Complete Shoulder Solution, Zimmer® Trabecular Metal™ Glenoid, and Zimmer® Trabecular Metal™ Reverse Shoulder.

The Zimmer® PSI Shoulder instrument guides and bone model are intended for single use only.

Device Description

The Zimmer PSI Shoulder System is an orthopedic instrument system indicated to assist in the positioning of shoulder 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 and the applicable shoulder arthroplasty surgical techniques. 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 is a 510(k) premarket notification for the Zimmer PSI Shoulder System. It describes the device, its intended use, and a summary of safety and effectiveness, including performance data.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., "accuracy must be > 95%"). Instead, it focuses on demonstrating that the system's performance is maintained from the predicate device and that no new safety and efficacy issues arise from the modifications. The performance is assessed qualitatively.

Acceptance Criteria (Implied)	Reported Device Performance
Software changes function as required	Software System Tests verified functional changes and no impact on existing functions.
No new safety and efficacy issues	Full System Validation Tests using cadaver specimens or sawbones demonstrated "satisfactory performance per the intended use as in the predicate."
Overall system performance maintained from predicate	Predicate Component Test Validity Analysis confirmed continued adequacy of hardware components after modifications for sterilization, biocompatibility, and mechanical safety (drop resistance, use resistance, stability, packaging effects).
Accuracy within acceptable limits for intended use	"Satisfactory performance per the intended use as in the predicate" was demonstrated, implying acceptable accuracy, though no specific numerical metrics are provided.
System usage and instrument ergonomics are satisfactory	Full System Validation Tests demonstrated "satisfactory performance" in terms of system usage and instrument ergonomics.
Compatibility with additional implant systems	The core of the submission is to extend compatibility. The tests demonstrated satisfactory performance with the added implant systems.

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

Test Set Sample Size: The document mentions "cadaver specimens or sawbones" for Full System Validation Tests. However, it does not specify the exact number of cadavers or sawbones used.
Data Provenance: The tests are described as "non-clinical tests or analyses." The text does not specify the country of origin but implies these were conducted by Zimmer CAS. The tests are prospective in nature, as they involve testing the modified device to verify its performance.

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

Number of Experts: The document states that Full System Validation Tests were performed by "multiple surgeons." It does not specify the exact number of surgeons.
Qualifications of Experts: The experts are identified as "surgeons," implying they are qualified medical professionals with experience in shoulder replacement surgical procedures. No further details on their years of experience or specific titles (e.g., orthopedic surgeon) are provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus). It states that the Full System Validation Tests were performed by "multiple surgeons" and the "results demonstrated satisfactory performance." This suggests a qualitative assessment by these surgeons, but the method for reconciling any potential discrepancies or arriving at a collective "satisfactory performance" judgment is not detailed.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done or reported in this document.

The Zimmer PSI Shoulder System is described as a device to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement. It involves "surgical planning software" and "surgical instrument components that include patient specific guides." This suggests an AI-assisted workflow, but the evaluation focuses on the safety and effectiveness of this system rather than a comparative effectiveness study against unassisted human performance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

The document does not explicitly describe a standalone performance study where the algorithm performs without human intervention. The system is designed to "assist in pre-operative planning and/or intra-operative guiding," indicating that a human (surgeon) is always in the loop. The "Software System Tests" verify the software changes, but this is an internal functional verification, not a standalone clinical performance assessment.

7. Type of Ground Truth Used for the Test Set

The "ground truth" for the Full System Validation Tests appears to be expert assessment/judgment by "multiple surgeons." They assess the "overall system performance in terms of system usage, instrument ergonomics, and accuracy" during simulations using cadaver specimens or sawbones. This is a practical, functional ground truth based on surgeon experience and observation in a simulated surgical environment. There is no mention of pathology, long-term outcomes data, or an independent, objective standard beyond the surgeons' collective judgment.

8. Sample Size for the Training Set

The document describes the Zimmer PSI Shoulder System as using "patient-specific radiological images" and "surgical planning software." While the system involves processing patient data, the text does not mention a "training set" in the context of machine learning model development. This seems to be a rules-based or image processing system that generates patient-specific guides rather than a system trained on a large dataset in the conventional sense of deep learning or advanced AI. Therefore, no training set sample size is provided.

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

As there is no mention of a "training set" in the context of machine learning, there is no information on how its ground truth was established. The system appears to be deterministic, based on anatomical landmarks and surgical planning logic rather than learning from labeled data.

Summary

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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

June 16, 2015

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

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

Re: K150730

Zimmer

Canada

Trade/Device Name: Zimmer PSI Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT, KWS, PHX Dated: March 18, 2015 Received: March 20, 2015

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

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Page 2 - Mr. Christopher McLean

(21 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 (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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 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) K150730

Device Name

Zimmer PSI Shoulder System

Indications for Use (Describe)

The Zimmer® 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 precluded from being radiologically scanned. The Zimmer® PSI Shoulder is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Bigliani/Flatow® Complete Shoulder Solution, Zimmer® Trabecular Metal™ Glenoid, and Zimmer® Trabecular Metal™ Reverse Shoulder. The Zimmer® PSI Shoulder instrument guides and bone model are intended for single use only.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Zimmer PSI Shoulder 510(k)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ZIMMER PSI SHOULDER SYSTEM

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

Contact Person: Christopher McLean

Date Summary Prepared: March 18, 2015

Device Trade Name: Zimmer PSI Shoulder System (previously called CAS PSI Shoulder)

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

1. Code KWS / prosthesis, shoulder, semi-constrained, metal/polymer cemented, under 21 CFR § 888.3660 (Shoulder joint metal/polymer semi-constrained cemented prosthesis)
1. Code PHX / shoulder prosthesis, reverse configuration, under regulation 21 CFR § 888.3660 (Shoulder joint metal/polymer semi-constrained cemented prosthesis)
1. Code KWT / prosthesis, shoulder, non-constrained, metal/polymer cemented, under regulation 21 CFR § 888.3650 (Shoulder joint metal/polymer nonconstrained cemented prosthesis)

Predicate Devices: CAS PSI Shoulder System, from Zimmer CAS, 510(k) # K131129, cleared Aug. 20th, 2013

Device Description:

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Zimmer PSI Shoulder 510(k)

Indications for Use / Intended Use:

The Zimmer® PSI Shoulder instrument guides and bone model are intended for single use only.

Technological Comparisons to the Predicates:

The change is to extend the compatibility for use to assist in the placement of the glenoid components of two additional shoulder implant systems: the Zimmer® Bigliani/Flatow Complete Shoulder Solution and the Zimmer® Trabecular Metal™ Glenoid. The predicate was compatible with the Zimmer Trabecular Metal™ Reverse Shoulder implant system.

The system is composed of the following two main components involving the same main technology and methods as in the predicate:

Software to perform the planning per the patient's CT scans and in accordance with the given implant system,
Hardware that includes surgical Guides (or Jigs as called in the predicate) adjusted to fit the individual patients' anatomy and transfer the pre-operative plan, and a bone model of the patient's glenoid to provide the surgeon with an intra-operative visual reference of the planned location of the Guides.

The predicate system software was modified and additional guides were added to the current ones to accommodate the added implant techniques. This included:

Implementing models in the software of the new implant components to allow the related planning steps as in the predicate,
-Adding two new sizes, 20 & 21 mm, of Pin Guides and Reamer Guides to the current range of sizes,
Adding a new non-cannulated type of Reamer Guide, -
-Implementing in the planning software the placement of the drill guide instrument of the added implant systems.

In addition other general improvement unrelated to the above compatibility changes were also included: automatic generation of the pre-operative report, implementation of a new DICOM header reader, and improvements in the slice distance calculation and thresholding algorithms.

Performance Data:

Three different types of non-clinical tests or analyses were conducted to verify and validate that the performance of the system was maintained from the predicate and that no new safety and efficacy issues were raised in the device:

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Zimmer PSI Shoulder 510(k)

Software System Tests: These were performed to verify that the software changes function as required and that they did not impact the existing software functions.
-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, instrument ergonomics, and accuracy when used with the added implant systems. The results demonstrated satisfactory performance per the intended use as in the predicate.
-Predicate Component Test Validity Analysis: The predicate hardware component tests were reviewed to assess that they were still applicable for the modifications to the PSI guides and to confirm their continued adequacy in terms of sterilization by the user, biocompatibility, and mechanical safety tests including drop resistance, use resistance, stability, and packaging effects.

Conclusion:

The information and data provided in the 510(k) Premarket Notification established that the Zimmer PSI Shoulder System is substantially equivalent to the predicate.

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”