(31 days)
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.
This device is intended for cemented use only.
The Persona Natural Tibia Baseplate is designed to replace the proximal portion of the tibia via cemented fixation as part of the Persona Personalized Knee System.
The provided document is a 510(k) premarket notification for a medical device, specifically the Persona™ Natural Tibia™ Baseplates. It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data.
Therefore, the following information needed to describe the acceptance criteria and the study that proves the device meets the acceptance criteria is not applicable in this document:
- Acceptance criteria table and reported device performance (in terms of clinical metrics like sensitivity, specificity, etc.)
- Sample size for the test set and data provenance
- Number of experts and their qualifications for ground truth establishment
- Adjudication method
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study information
- Standalone algorithm performance study information
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How ground truth for the training set was established
Explanation:
The document explicitly states under "Clinical Performance and Conclusions": "Clinical data and conclusions were not needed for this device." This indicates that the regulatory submission was based on non-clinical evidence (bench testing) to demonstrate substantial equivalence to previously cleared devices.
Non-Clinical Performance and Conclusions:
The document lists the following non-clinical tests that were completed in support of the changes to the Persona Natural Tibia Baseplate:
- Fixation Testing: This likely assesses the stability and strength of the baseplate's attachment to the bone.
- Cantilever Fatigue Testing: This tests the device's ability to withstand repeated bending forces, simulating physiological loads.
- Bending Fatigue Testing of the keel and stem extension junction: This specifically evaluates the durability of critical structural components under bending stress.
- Cortical Impingement and Perforation Analysis using a database of computed tomography (CT) segmented tibial bones: This analysis likely ensures that the device design (size J baseplates) does not unduly impinge on or perforate the cortical bone of the tibia across a range of anatomical variations, using computational modeling based on CT data.
Comparison to Predicate Device:
The core of this 510(k) submission is to demonstrate that the new Persona™ Natural Tibia™ Baseplates (specifically Size J) are "similar or identical in intended use, material, sterility, and performance characteristics to the predicate devices." The predicates are listed as Persona™ Natural Tibia™ Baseplate and Instrumentation (K113369, cleared March 27, 2012, and K122765, cleared November 9, 2012). The non-clinical tests mentioned above would have been used to show that the performance of the new sizes/modifications is comparable to or meets the established performance of the predicate devices. The acceptance criteria for these non-clinical tests would typically be benchmarks derived from the performance of the predicate devices or relevant industry standards. However, the specific quantitative acceptance criteria and the detailed results demonstrating those criteria are met are not included in this summary document. They would be part of the more extensive 510(k) submission itself.
§ 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.