(260 days)
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.
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (from "Performance Testing" section) |
|---|---|
| Mechanical Strength & Durability (comparable to predicate devices and standards) | Evaluated for: |
- 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.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.