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The NEO™ PS Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with excised posterior cruciate ligament, undergoing surgery for total knee replacement due to:
. Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
. Failed osteotomies, partial knee replacement, or failed prior total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.
. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
. Moderate valgus, varus, or flexion deformities.
NEO™ PS Total Knee System components are indicated for use only with cement and are single use devices.

The NEO PS Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation:
The Neo PS Knee System femoral component, when used with the Neo PS articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

The provided text describes a medical device, the NEO PS Knee System, and its clearance process through the FDA's 510(k) pathway. This pathway establishes substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials with defined acceptance criteria. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of diagnostic accuracy or performance, is not directly applicable to this submission.

However, based on the provided document, we can infer the "acceptance criteria" and "study" in the context of a 510(k) submission as demonstrating substantial equivalence to predicate devices through various performance tests.

Here's an analysis of the information that can be extracted or reasonably inferred from the document:

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

Since this is a 510(k) submission for a knee implant, the "acceptance criteria" are not reported as specific statistical thresholds for diagnostic accuracy (e.g., sensitivity, specificity). Instead, they are implied to be achieving comparable or acceptable performance in mechanical and functional tests as benchmarked against predicate devices and relevant industry standards.

• Tibial tray fatigue strength
• Insert locking mechanism strength
• PS post strength |
  | Functional Range of Motion (comparable to predicate devices and patient needs) | Evaluated for:
• Femorotibial range of motion
• Femorotibial range of constraint
• Patellofemoral range of constraint |
  | Contact Mechanics (comparable to predicate devices to minimize wear and stress) | Evaluated for:
• Femorotibial contact areas/contact stress
• Patellofemoral contact area and contact stress |
  | Material Compliance (meeting established biomedical standards) | "The metals and standard UHMWPE material from which the components are manufactured are the same materials used in the predicate knee systems and comply with applicable implantable materials standards." |
  | Overall Substantial Equivalence | "All evaluations determined that the NEO PS Knee System is substantially equivalent to the predicate devices." |

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable in the context of a clinical test set for diagnostic performance. The "test set" here refers to the physical devices undergoing various mechanical and material tests. The specific number of physical samples tested for each mechanical test is not disclosed in this summary.
• Data Provenance: The tests are likely conducted in a controlled laboratory environment by the manufacturer (Pipeline Orthopedics) or a contract testing laboratory. The country of origin for these tests is not specified but is presumably the US, where the company is based. The data would be considered prospective in the sense that the tests are designed and performed to evaluate the new device's characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of submission. "Ground truth" in the context of a 510(k) for a medical implant refers to established engineering principles, material standards, and the performance characteristics of legally marketed predicate devices. The "experts" involved are likely biomechanical engineers, material scientists, and regulatory experts who interpret test results against these standards and predicate device data. The document does not specify the number or detailed qualifications of such experts involved in the testing or the substantial equivalence determination beyond the general regulatory process.

4. Adjudication method for the test set:

This concept is not applicable here. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies in expert interpretations of medical data (e.g., image readings). For a medical implant's mechanical testing, the "adjudication" is inherent in the test protocols themselves, the calculation of results, and the comparison against predefined acceptance criteria or predicate device performance. Any discrepancies would relate to test execution or interpretation which would be resolved through standard engineering and quality control procedures.

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:

This is not applicable. An MRMC study is relevant for diagnostic devices (e.g., imaging software) where human interpretation is involved and improved with AI assistance. The NEO PS Knee System is a joint implant, not a diagnostic tool.

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

This is not applicable. This question pertains to AI/algorithm performance. The NEO PS Knee System is a physical knee implant.

7. The type of ground truth used:

The "ground truth" for this 510(k) submission is primarily established through:

• Predicate Device Performance: Benchmarking against the mechanical and functional characteristics of the legally marketed predicate devices (NEO CR Knee System, NexGen® LPS-Flex Knee System, Triathlon PS Knee System).
• Industry Standards: Compliance with "applicable implantable materials standards" (e.g., ASTM, ISO standards for biocompatibility, mechanical properties, etc., though not explicitly named).
• Engineering Principles: The tests conducted (fatigue, strength, ROM, contact stress) are based on established biomechanical and engineering principles to ensure the device can withstand anticipated physiological conditions.

8. The sample size for the training set:

This is not applicable. A "training set" refers to data used to train an AI algorithm. The NEO PS Knee System is a physical implant.

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

This is not applicable for the same reason as point 8.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

The Zimmer Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces. The addition of the Constrained Posterior Stabilized (CPS) Vivacit-E® articular surface components will provide surgeons with the ability to obtain moderate varus/valgus and/or internal/external rotation constraint compared to the existing Persona PS articular surfaces. CPS articular surfaces are for use with cemented nonporous tibial and femoral components only.

The Zimmer Persona Personalized Knee System is a medical device. Clinical data and conclusions were explicitly stated as NOT needed for this device. Therefore, the information provided focuses on non-clinical performance (bench testing).

1. Table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not explicitly stated in the provided text for individual bench tests. The description refers to "testing" which implies a sample size appropriate for engineering validation (e.g., usually 3-6 samples per test).
• Data Provenance: The data is from "bench testing" conducted by Zimmer, Inc. This is non-clinical, laboratory-based data. No information about country of origin for data or retrospective/prospective nature is applicable as it's not human or animal study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The ground truth for this device is based on engineering specifications and validated bench test methodologies, not expert interpretation of clinical data.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or imaging data. For bench testing, results are typically analyzed against predefined engineering specifications or industry 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 device is a knee prosthesis, not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study involving human readers and AI assistance was conducted.

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

• Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

• The ground truth for this device's performance is based on engineering specifications, established industry standards for orthopaedic implants, and the performance characteristics of predicate devices. Bench tests are designed to simulate in-vivo conditions and measure physical properties against these predetermined criteria.

8. The sample size for the training set:

• Not applicable. This device is a knee prosthesis, not a machine learning model. There is no "training set" in the context of an algorithm.

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

• Not applicable, as there is no training set for this device.

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