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The Avon Patello-femoral Joint Prosthesis 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 submission covers the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. The femoral components are manufactured from Cobalt Chrome (CoCr) and the patellar components are manufactured from Ultra-high Molecular Weight Polyethylene (UHMWPE) materials.

The purpose of this submission is to add Magnetic Resonance (MR) Conditional labeling to the labeling of the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. Additionally, minor labeling and packaging updates, as detailed in the respective sections, are also included in this submission.

The provided text is a 510(k) Summary for a medical device (Avon Patello-femoral Joint Prosthesis) seeking clearance for minor labeling and packaging updates, specifically to add Magnetic Resonance (MR) Conditional labeling. This submission does not describe a study to prove the device meets acceptance criteria related to its clinical effectiveness or performance in a patient.

Instead, it describes non-clinical testing to demonstrate that the device is "MR Conditional" as per relevant ASTM standards. Therefore, many of the requested categories are not applicable to the information provided.

Here's the breakdown of what can be extracted:

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

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

This information is not provided. The testing was non-clinical (laboratory testing of the device components), not involving human subjects or 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)

Not applicable. The ground truth for the MR Conditional testing is established by the ASTM standards themselves, which define methodologies and criteria for measurement. No human experts were involved in establishing "ground truth" for this non-clinical testing.

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

Not applicable. This was non-clinical, objective testing against predefined engineering standards.

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

Not applicable. This document is not about AI or diagnostic imaging interpretation. It is for a joint prosthesis and its MR compatibility.

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

Not applicable. This document is not about an algorithm, but a physical medical device.

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

The "ground truth" for the non-clinical testing was defined by adherence to published ASTM standards for MR compatibility. These are objective engineering and physics standards.

8. The sample size for the training set

Not applicable. This was non-clinical testing, not a machine learning study.

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

Not applicable. This was non-clinical testing, not a machine learning study.

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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 Avon® Patello-femoral Joint Prosthesis 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 arc intended for implantation with bone cement.

The Avon® Patello-femoral Joint (PFJ) Prosthesis was cleared for marketing in K010100. K020841 and K041160. The current system consists of cobalt-chromium femoral components available in four sizes (extra small, small, medium, and large), and all-polyethylene components available in various sizes (small, medium. and large) and styles. This 510(k) submission is a line extension to the Avon "Patello-femoral Joint Prosthesis to add additional styles of patellar components to the system and update the labeling.

The provided text describes a 510(k) Premarket Notification for the Avon® PFJ Prosthesis, focusing on its substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the format requested.

The document is a summary of safety and effectiveness, and subsequently, the FDA's letter of substantial equivalence. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, largely through comparison of design, materials, indications, and operational principles, often supported by bench testing where relevant. It does not typically involve clinical studies with human subjects that would generate acceptance criteria and performance data in the context of sensitivity, specificity, or similar metrics for diagnostic devices.

Therefore, many of the requested categories concerning acceptance criteria and study details cannot be directly answered from the provided text.

Based on the provided information, here's what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy per se. The "performance" assessment is based on the claim of substantial equivalence to a predicate device.

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

Not applicable. The document describes a 510(k) submission for a medical device (prosthesis), which typically relies on bench testing and comparison to a predicate device, rather than patient-based test sets with a specific sample size. The "testing" mentioned refers to compatibility testing, not a clinical trial or performance study on 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)

Not applicable. There is no mention of a ground truth established by experts as this is not a diagnostic device or a study involving human-in-the-loop assessment of images or clinical findings.

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

Not applicable. No test set or expert adjudication is described in the context of this device submission.

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

Not applicable. This device is a prosthesis, not an AI-powered diagnostic tool, so an MRMC study is not relevant here.

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

Not applicable. This is a physical implantable device, not an algorithm.

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

Not applicable in the sense of a clinical or diagnostic study. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, and the demonstrating that the new device meets the same standards through design, material, and functional equivalence, often supported by bench testing.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning or AI device.

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

Not applicable.

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