(40 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
- traumatic arthritis, and o
- avascular necrosis (not applicable to Physica TT Tibial Plate); o
- · 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, valgus, or flexion deformities.
In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated for: - · Absent or not-functioning posterior cruciate ligament;
- · Severe antero-posterior instability of the knee joint.
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 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 fixed to the femoral and tibial implants using bone cement. Tibial liners can be used with cemented or uncemented tibial or femoral components.
The Physica system is a total knee replacement system consisting of a Femoral component, a Tibial plate, a Tibial liner, a Tibial stem and a Patella component; the Tibial stem and the Patella component are optional to be used as required for each individual patient and as allowed in the Instructions for Use.
The Physica Porous Femoral components are made of CoCrMo alloy and the internal surface is PoroTi coated; they are intended to be used without bone cement; the components to be used in combination with (Tibial plate, TT Tibial plate, Tibial liner, Tibial stem, Patella) were previously cleared (K141934, K152008, K190911, K201084).
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Physica system," a knee replacement system. This document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML powered device, which typically involves performance metrics like sensitivity, specificity, accuracy, or other relevant statistically derived performance measures against a defined ground truth.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, as required for a 510(k) submission.
Here's why the requested information cannot be extracted:
- No AI/ML Component: The "Physica system" is a physical knee replacement prosthesis, not an AI or software-as-a-medical-device (SaMD). Therefore, the concept of "device performance" in this context refers to biomechanical properties, material compatibility, and overall safety and efficacy in a surgical setting, not diagnostic or predictive performance.
- No "Acceptance Criteria" for AI Performance: The document discusses conformity to FDA guidelines and referenced standards for mechanical safety and materials, which are the "acceptance criteria" for a physical implant. It does not define statistical performance thresholds for an AI algorithm.
- No "Study Proving Device Meets Acceptance Criteria" for AI: The "non-clinical testing" mentioned primarily involves mechanical comparisons and material testing, not studies comparing algorithmic output to ground truth. The document explicitly states "Clinical testing was not necessary to demonstrate substantial equivalence."
- No Ground Truth for AI: Since there's no AI component, there's no need for an "expert consensus," "pathology," or "outcomes data" to establish ground truth for algorithm training or testing.
- No Training or Test Set: Again, as there's no AI, there are no training or test datasets in the traditional sense.
Therefore, it is not possible to provide the requested table and information based on the provided PDF content.
The document's conclusion of "substantial equivalence" is based on:
- Comparison of intended use.
- Comparison of materials.
- Summary of technological characteristics.
- Preclinical (non-clinical) testing which primarily involved mechanical safety confirmation and material conformity.
§ 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.