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The MAKO Surgical Corp. Patellofemoral Knee Implant System II is intended to be used in cemented patello-femoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

This device consists of a CoCrMo patellofemoral component and an ultra-high molecular weight polyethylene patella components are intended for cemented, one-time use only. The anterior surface of the patellofemoral component is polished and features a trochlear groove. The posterior surface of the patellofemoral and patella component employ features such as cement pockets and pegs for enhanced stability of the prosthesis when cemented onto the femur and patella, respectively.

The provided text describes the MAKO Surgical Corp. Patellofemoral Knee Implant System II and its regulatory clearance, but it does not contain information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or comparative effectiveness studies).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about the study design elements you requested, as this information is not present in the provided document.

This document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed clinical study results or performance metrics against specific acceptance criteria for a new AI/software-based medical device.

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The MAKO Surgical Corp. Patellofemoral Knee Implant System is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

This device consists of a CoCrMo patellofemoral component and an ultra-high molecular weight polyethylene patella components are intended for cemented, one-time use only. The anterior surface of the patellofemoral component is polished and features a trochlear groove. The posterior surface of the patellofemoral and patella component employ features such as cement pockets and pegs for enhanced stability of the prosthesis when cemented onto the femur and patella, respectively.

The provided text describes a submission for a 510(k) premarket notification for the "MAKO Surgical Corp. Patellofemoral Knee Implant System." This document establishes substantial equivalence to a predicate device, which is a regulatory pathway for medical devices rather than a study demonstrating performance against acceptance criteria in the context of an AI/software device.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text because the document describes a medical device, not a software or AI product.

The document primarily focuses on:

• Device Identification: Name, submitter, contact, date.
• Classification: Common name, classification name/number, product code.
• Substantial Equivalence: Comparison to a predicate device (Stryker Corporation's Avon Patello-femoral Joint - K051948).
• Intended Use/Indications for Use: Specifies the conditions for which the implant is used (degenerative arthritis, patellar dislocation/fracture, failed previous surgery).
• Device Description: Components (Patellofemoral component - CoCr, Patella component - UHMWPE, radiographic o-ring), sizes, materials, instrumentation.
• Sterilization and Packaging: Methods for sterilizing components and instrumentation, and packaging details.
• Biocompatibility: Stating materials meet ASTM standards.
• Regulatory Correspondence: FDA's letter of review and determination of substantial equivalence.

This is a predicatye-based clearance for a physical implant, not a software or AI-based diagnostic/prognostic tool that would typically have the kind of performance metrics and study designs you've asked about.

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