(90 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, postraumatic 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 present 510k submission is for a cruciate retaining (CR) version of the Progressive Orthopaedic Total Knee System and a line extension of HC PS tibial inserts. The main predicate device (K142649) is a posterior stabilized (PS) version of the Progressive Orthopaedic Total Knee System. All implant components are the same between the two versions, except for the tibial inserts and the femoral components. The posterior stabilized version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The cruciate retaining version of the Progressive Orthopaedic Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint.
The Progressive Orthopaedic Total Knee System is a Patellofemorotibia, polymer / metal / polymer, semi-constrained, cemented knee prosthesis, consisting of a femoral component, tibial insert, 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 the tibial baseplate component. 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 a range of sizes of the femoral component to be matched with up to one size up/down of the tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome and sombrero shape of each UHMWPE patellar component provides contact with the femoral component.
This FDA 510(k) K150783 document is for a medical device called the "Progressive Orthopaedic Total Knee System", specifically a cruiciate retaining (CR) version. It is a knee replacement system. The document does not describe an AI/ML device or an algorithm. As such, the information requested in your prompt (e.g., acceptance criteria for an AI model, sample sizes for test and training sets, number of experts for ground truth, MRMC studies, etc.) is not applicable to this document.
The document focuses on demonstrating that the new CR version of the knee system is substantially equivalent to a previously cleared posterior stabilized (PS) version and another predicate device. This is done through a comparison of technological characteristics and performance testing of mechanical aspects of the device.
Here's the information gleaned from the document that is somewhat related to your request, but adapted to the context of a physical medical device (a knee prosthesis):
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Contact area between femoral and tibial insert components | Femoral/Tibial Insert Contact Area Test results indicate substantial equivalence. |
| Interlocking mechanism strength (anterior shear) | Anterior Shear Test results indicate substantial equivalence. |
| Interlocking mechanism strength (posterior shear) | Posterior Shear Test results indicate substantial equivalence. |
| Interlocking mechanism strength (medial/lateral shear) | Medial/Lateral Shear Test results indicate substantial equivalence. |
| Material composition (for device components) | CR version is manufactured from the same materials as the PS version. |
| Range of sizes available | Range of sizes for CR version is the same as the PS version. |
| Design similarity to predicate device | CR version design is substantially similar to the PS version system design. |
Explanation: The "acceptance criteria" here are not explicitly stated as numerical thresholds in the document. Instead, the document demonstrates "substantial equivalence" to a predicate device. The performance tests were conducted to show that the CR version performs similarly to the predicate device in terms of these mechanical properties, implying that the performance of the CR version is "acceptable" if it is equivalent to a device already on the market.
2. Sample size used for the test set and the data provenance:
Due to this being a mechanical device and not an AI/ML model, there is no "test set" in the sense of medical images or patient data. The "tests" performed are mechanical engineering tests on the device components. The sample sizes for these specific mechanical tests are not provided in this summary document. The "data provenance" is derived from in-vitro mechanical testing of the physical device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on medical images) does not apply to the mechanical testing of a knee prosthesis. Device performance is measured through objective physical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This refers to consensus among human readers for medical image analysis, which is not relevant here.
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 is for AI/ML systems and their impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document pertains to a physical medical device, not an algorithm.
7. The type of ground truth used:
For the mechanical performance tests, the "ground truth" would be the objective measurements obtained from the mechanical testing, demonstrating the physical properties (e.g., contact area, shear strength) of the device components. The implicit "ground truth" for showing substantial equivalence is the established performance of the predicate devices.
8. The sample size for the training set:
Not applicable. This document is not about AI/ML.
9. How the ground truth for the training set was established:
Not applicable. This document is not about AI/ML.
§ 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.