(178 days)
When a mechanical alignment approach is utilized, 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.
When a kinematic alignment approach is utilized, 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.
- Moderate valgus, varus, or flexion deformities.
The kinematic alignment (KA) surgical technique may only be used with Persona porous and cemented non-porous CR femoral components, Persona CR or UC articular surface components, and the cemented nonporous Persona Natural cemented 5 degree tibial components without a stem extension,
Porous coated components may be used cemented or uncemented (biological fixation), except for the Persona porous 0 degree OsseoTi Spiked Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
The purpose of this submission is to add three new components to the Persona Personalized Knee System. These components consist of a non-porous cemented stemmed tibial baseplate, a porous OsseoTiTM non-cemented tibial baseplate, and a porous plasma sprayed femur. The addition of these components do not change the intended use or fundamental scientific technology of the device system.
The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones. With this submission a new porous plasma sprayed femoral component will be added to the system. These femoral components articulate against tibial and patellar articular surface to form a total knee system. In addition, two new tibial plates will be added, a cemented non-porous stem tibial baseplate and a porous OsseoTiTM stemmed tibial baseplate. All of the new components come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use. To aid the implantation of these devices several new reusable instruments are also introduced.
The provided text is a 510(k) summary for the Zimmer® Persona™ Personalized Knee System. It is a regulatory document from the FDA, and it focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a performance study with detailed acceptance criteria and results for a novel AI/device.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria for an AI-based or similar novel medical device. The information requested (acceptance criteria table, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) is typically found in submissions for AI/ML-based devices or other novel technologies that require demonstrating performance against specific metrics.
This document describes a joint replacement system and its components, and the "Summary of Performance Data" section lists non-clinical tests (e.g., fatigue testing, material evaluations, Bacterial Endotoxin Test) and explicitly states "Clinical Tests: - None provided."
To directly answer your request based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not available. The document lists non-clinical tests (e.g., fatigue testing, material evaluations) but does not provide specific quantitative acceptance criteria or reported performance values for these tests.
- 2. Sample sized used for the test set and the data provenance: Not applicable. No test set in the context of an AI/ML algorithm evaluation is described. The non-clinical tests would have their own sample sizes for the materials or components tested, but these are not provided in this summary.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic or AI-based performance test is mentioned.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 document does not describe an AI-assisted device or an MRMC study.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. No training set is mentioned as this device is not an AI/ML product.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA 510(k) pertains to a knee prosthetic system and relies on demonstrating substantial equivalence through similar intended use, indications, materials, design features, and sterilization to predicate devices, along with non-clinical mechanical and material testing. It does not describe a performance study with acceptance criteria in the manner you've outlined for an AI/ML or diagnostic device.
§ 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.