(188 days)
The Progressive Orthopaedic Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.
The Progressive Orthopaedic Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The Progressive Orthopaedic Total Knee System is designed for cemented use only.
The Progressive Orthopaedic Total Knee System is of the fixed bearing type with a posterior stabilized design. It is a Patellofemorotibia, polymer/metal/polymer, semi-constrained, cemented knee prosthesis, that consists of a femoral component, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotation.
The provided text does not contain detailed acceptance criteria or extensive study data for the Progressive Orthopaedic Total Knee System. The document is essentially a 510(k) summary for a medical device, which focuses on establishing substantial equivalence to a predicate device rather than presenting a comprehensive performance study with specific acceptance criteria and detailed results.
However, based on the information provided, here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance: | |
| - Fatigue performance of tibial tray (to withstand expected in vivo loading without failure) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies the fatigue performance criteria were met, likely by demonstrating equivalence to the predicate's known performance or by meeting industry standards). |
| - Interlock mechanism strength (between tibial insert and tibial baseplate) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies the interlock strength criteria were met, likely by demonstrating equivalence to the predicate). |
| - Shear fatigue strength of tibial insert post (to withstand expected in vivo loading without failure) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies the shear fatigue strength criteria were met, likely by demonstrating equivalence to the predicate). |
| - Contact pressures and areas (to be comparable to predicate for proper articulation) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies acceptable contact pressures and areas, likely comparable to the predicate). |
| Functional Performance: | |
| - Lateral subluxation of patellar component (to ensure stability) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies lateral subluxation was within acceptable limits, likely comparable to the predicate). |
| - Range of motion performance (to ensure adequate knee movement) | "Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure." (Implies acceptable range of motion, likely comparable to the predicate). |
| Substantial Equivalence: | |
| - Same intended use and indications for use as predicate | Met: The document explicitly states, "The Progressive Orthopaedic Total Knee System has the same intended use and indications as the U2 Total Knee system." |
| - Manufactured from the same materials as predicate | Met: "The Progressive Orthopaedic Total Knee System is manufactured from the same materials as the U2 Total Knee system." |
| - Same range of sizes as predicate | Met: "The range of sizes available for the Progressive Orthopaedic Total Knee System is the same as the range of sizes cleared for the U2 Total Knee system." |
| - Design substantially similar to predicate | Met: "The Progressive Orthopaedic Total Knee System design is substantially similar to the U2 Total Knee system design." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for mechanical testing or details on the test set. It mentions "Performance Testing" which is typically conducted on device prototypes or specific components, not clinical data. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) does not apply in the context of this 510(k) summary, as it's not a clinical study report.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable. The 510(k) summary describes mechanical performance testing of the device components, not a clinical study involving diagnosis or interpretation by experts to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable, as it pertains to clinical studies often involving expert interpretation, which is not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through design, materials, and mechanical performance testing, not clinical effectiveness studies comparing human readers with and without AI assistance. This device is a physical knee implant, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a physical knee implant and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical performance tests would be established through engineering standards, material specifications, and validated biomechanical testing methods. For example, for fatigue performance, the ground truth is the point at which the component fails or exceeds a predefined deformation limit, which is then often compared to the expected in-vivo loads. It's not based on expert consensus, pathology, or outcomes data in the traditional clinical sense.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical implant and does not involve a "training set" in the context of machine learning or algorithm development.
9. How the Ground Truth for the Training Set Was Established
This information 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.