(26 days)
Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease including
o osteoarthritis
o traumatic arthritis, and
o avascular necrosis (not applicable to Physica TT Tibial Plate); - · Inflammatory degenerative joint disease including rheumatoid arthritis;
- · Correction of functional deformity:
- · Revision procedures where other treatments or devices have failed; and
- · Treatment of fractures that are unmanageable using other techniques.
Additional indications for Physica LMC component are:
- · Moderate varus, valqus, or flexion deformities.
In patients with preserved and well functioning collateral ligaments, Physica PS, PS Pro and HPS components are also indicated for: - · Absent or not-functioning posterior cruciate ligament;
- · Severe antero-posterior instability of the knee joint.
Additional indications for Physica HPS component are:
· Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- · 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.
- · Collagen disorders, and/or avascular necrosis of the femoral condyle.
- · Moderate varus, valgus, or flexion deformities.
AMF Revision TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon.
Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.
Tibial liners can be used with cemented or uncemented tibial or femoral components.
Physica Porous Femoral Components have been cleared via K210554 with a Porous coating performed by a supplier. With this 510(k) submission, Limacorporate intends to add an additional coating vendor for these components. No other change is introduced on the Physica Porous Femoral Components: Intended use, design, material, sterilization, packaging and principle of operation are unchanged compared to the information approved in K210554.
The provided text is a 510(k) premarket notification for a medical device called "Physica Porous Femoral Components." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific performance acceptance criteria via a clinical study with a detailed test set, ground truth, or expert review.
Therefore, the document does not contain the information requested regarding acceptance criteria met by a study that proves the device meets them. Specifically:
- No table of acceptance criteria and reported device performance: The document does not define specific performance metrics or acceptance thresholds that the device was tested against in a clinical setting.
- No sample size used for the test set or data provenance: There is no clinical test set described.
- No number of experts or their qualifications for ground truth: Since no clinical test set is described, there's no mention of experts establishing ground truth for it.
- No adjudication method for the test set: Not applicable as there's no clinical test set.
- No multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical testing was not necessary to demonstrate substantial equivalence of the new Physica Porous Femoral components to the predicate devices." This means no human-in-the-loop study was conducted.
- No standalone (algorithm only) performance study: This is not an AI/algorithm-based device; it's a knee prosthesis component.
- No type of ground truth used: Not applicable as there's no clinical test.
- No sample size for the training set: Not applicable as this is a physical device and not an AI/ML model.
- No description of how ground truth for the training set was established: Not applicable.
What the document does state regarding demonstrating equivalence:
The submission for the Physica Porous Femoral Components focuses on demonstrating substantial equivalence primarily through non-clinical testing and comparison of technological characteristics.
- Non-clinical testing: "Mechanical and morphological characteristics of the coating of the subject cementless Physica Porous Femoral components were confirmed through a comparison with previously cleared (K210554) cementless Physica Porous Femoral components. The PoroTi coating of subject Porous Femoral components fulfills the conformity to the FDA guidelines and referenced standards and the analysis was performed on worst case components or constructs."
- Comparison of technological characteristics: The document asserts that "The intended use, design, and materials of the subject Physica Porous Femoral components (part of Physica system) are substantially equivalent to those of the predicate devices."
In essence, the "study" proving the device meets requirements for market clearance in this case is a non-clinical bench testing and design control process to ensure the new manufacturing of the porous coating is equivalent to a previously cleared version, which itself would have established safety and effectiveness through its own predicate or data. No new clinical or human performance data was required for this specific 510(k) submission.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.