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-Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint;
-The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation);
-History of patellar dislocation or patella fracture;
-Dysplasia-induced degeneration
This device is intended for cemented use only.

The Zimmer Patellofemoral Joint (PFJ) Prosthesis is designed to closely replicate the anatomic features of the patellar groove on the femur. The implant's articulating surface incorporates the NexGen® knee system's frontal profile geometry for optimal patella tracking for both resurfaced and unresurfaced patellas. The construct of the PFJ prosthesis accommodates a wide range of patients, both female and male. Five sizes in left and right configurations are being offered for this implant.

Here's an analysis of the provided text regarding the Zimmer® Patellofemoral Joint Prosthesis:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided document is a 510(k) Summary for the Zimmer® Patellofemoral Joint Prosthesis (K070695). For this type of device, a 510(k) clearance is typically based on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit "acceptance criteria" and a detailed "study" in the sense of a clinical trial proving specific performance metrics against those criteria.

The acceptance criteria here would be understood as the device being as safe and effective as the predicate devices. The "study" demonstrating this involves non-clinical performance data and a comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing, which typically involves laboratory or benchtop tests on components or the complete device itself, not a patient-based "test set" in the traditional clinical trial sense.
• Data Provenance: Not applicable for a "test set" as described above. The "non-clinical testing" would have been conducted by Zimmer, Inc., likely at their facilities or by contracted testing laboratories.

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

• Not applicable. As this is a non-clinical submission, ground truth related to patient outcomes or diagnoses is not established by clinical experts for a test set. The "ground truth" relates to engineering and material specifications, and the functionality of the device as tested in a lab setting.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of a human-read test set or any adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study is a type of clinical comparative study involving multiple human readers interpreting medical images, typically with and without AI assistance, across multiple patient cases. This submission is for a prosthetic device, not an imaging diagnostic tool, and the data presented is non-clinical.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

• Not applicable in the context of imaging algorithms. This device is a physical implant. The "standalone performance" is essentially the device's mechanical and functional performance demonstrated through non-clinical bench testing.

7. The Type of Ground Truth Used

• The "ground truth" for non-clinical testing refers to established engineering standards, biomechanical principles, material specifications, and performance targets derived from the predicate devices and general orthopedic requirements. It's based on engineering specifications and established mechanical/material properties, rather than clinical outcomes or pathology.

8. The Sample Size for the Training Set

• Not applicable. In the context of medical devices like prostheses, there isn't a "training set" in the sense of machine learning. The design and development of the device would involve iterative engineering, simulations, and prototype testing, but not a dataset used to "train" an algorithm.

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

• Not applicable. See point 8. The design process is guided by anatomical studies, engineering principles, and experience with previous successful knee prosthesis designs (including the predicate devices).

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The general indications associated with the use of Patellofemoral Joint Prosthesis in patellofemoral arthroplasty include:

• 1. Patients with osteoarthritis in the distal femur and patella.
• Patients with a history of patellar dislocation or patellar 2. fracture.
• 3. Those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The design of the Patellofemoral Joint Prosthesis closely replicates the anatomic features of the patellar groove on a femur. In addition, the design of the highly polished concave gliding anterior surface of the Patellofemoral Joint Prosthesis is identical to the proximal anterior surface of the articulating geometry of the Natural Knee II System's femoral component which has been determined substantially equivalent by the FDA via 510(k) K936159. The highly polished concave gliding surface of the Patellofemoral Joint Prosthesis complements the design of the articulating geometry of the IOI's patella components for optimal patellar tracking.

The posterior surface of the Patellofemoral Joint Prosthesis employs two fixation pegs for enhanced stability of the prosthesis when cemented into the femur. In addition, the posterior surface of the Patellofemoral Joint Prosthesis employs a grit blasted roughened surface to facilitate interdigitation with bone cement. The roughness of the grit blasted surface ranges from 175 - 225 uinch.

The Patellofemoral Joint Prosthesis is an asymmetrically designed component and, therefore, is available in both left and right configurations.

This document is a 510(k) premarket notification for a medical device submitted in 1996. It outlines the device's characteristics and compares them to predicate devices to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) notice explicitly states that the device's safety and effectiveness are established through substantial equivalence to predicate devices, rather than through specific performance metrics and acceptance criteria from a clinical study. The "performance" here refers to the device's features and materials matching or being similar to those of previously approved devices.

Study Proving Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) is the 510(k) Premarket Notification itself, which acts as a regulatory submission. It does not describe a clinical performance study with specific acceptance criteria that were met with statistical significance. Instead, it argues that the device is "substantially equivalent" to legally marketed predicate devices based on design, materials, and intended use.

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

This document does not describe a clinical test set with human subjects. The "test" is a comparison of the device's specifications and design features against those of predicate devices. There is no sample size of patients or data provenance in the context of a clinical study.

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

Not applicable. The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and market presence of the predicate devices. There were no experts used to establish ground truth for a clinical test set in this context.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This submission focuses on engineering and design comparisons for substantial equivalence, not clinical effectiveness studies comparing human readers or AI.

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

Not applicable. This is a physical medical device (prosthesis), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" used in this context is the existence and regulatory approval of the predicate devices. The argument for the new device's safety and effectiveness is based on its similarity to these already-approved devices, assuming their safety and effectiveness are established. There is no pathology, expert consensus (in the context of clinical outcomes), or outcomes data presented for the new device itself to establish ground truth.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device requiring a training set. The "training" for this device's development would be engineering design principles and knowledge of existing prostheses.

9. How the Ground Truth for the Training Set was Established:

Not applicable as there is no training set mentioned for this type of device.

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