(232 days)
Physica total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or . avascular necrosis:
- 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.
Physica knee system is intended for cemented fixation
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:
- non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; ●
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- . treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods:
- revision of a failed primary implant;
- . cuff tear arthropathy (CTA Heads only);
- glenoid arthrosis without excessive glenoid bone loss: A1. A2 and B1 according to Walch . classification (SMR Hybrid Glenoid only).
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner, the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
The Physica System is a total knee system and the SMR Reverse is a reverse shoulder system.
The purpose of the Special 510(k) is to add an alternative sterilization method for the Physica KR Liner and SMR Reverse Humeral Liners. Both systems utilize conventional (non-crosslinked) UHMWPE liners (ISO 5834-2 ASTM F648). The liners can be sterilized using a minimum gamma radiation dose of 25 kGy.
The provided text is a 510(k) premarket notification for artificial joint components (knee and shoulder liners). It focuses on demonstrating substantial equivalence to previously cleared devices, primarily through preclinical testing and does not describe a clinical study or a study involving AI/software.
Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, expert involvement, and AI performance cannot be extracted from this document.
Here's what can be gathered, addressing the relevant parts of your request:
1. A table of acceptance criteria and the reported device performance:
The document states: "The Physica KR Liner and SMR Reverse Humeral Liner is substantially equivalent to the predicate devices cited on the previous page with respect to indications, design, function, and performance." It then lists the following preclinical tests:
| Acceptance Criteria Category | Reported Device Performance (Summary) | Details Provided in Document |
|---|---|---|
| Sterilization Validation | Met established sterilization requirements. | "Sterilization validation" was performed, indicating the new sterilization method (minimum gamma radiation dose of 25 kGy) was validated. Implies acceptance criteria related to sterility assurance level (SAL) were met. |
| UHMWPE Characterization | Materials meet industry standards. | "UHMWPE Characterization" was performed. This would involve tests to confirm material properties (e.g., molecular weight, density, mechanical properties) meet the specifications for conventional UHMWPE (ISO 5834-2 ASTM F648). Implies acceptance criteria related to material specifications were met. |
| Mechanical Testing | Device mechanically performs as intended and is comparable to predicate. | "Mechanical Testing" was performed. This would have involved tests such as wear, fatigue, static strength, etc., to demonstrate the device's mechanical integrity and performance is equivalent to the predicate devices under simulated physiological conditions. Implies acceptance criteria related to biomechanical performance were met. |
Important Note: The document does not provide specific numerical acceptance criteria (e.g., "wear rate must be
§ 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.