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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.

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.

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.

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.

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