(67 days)
The Optimotion Implants Porous Metal-Backed Patella is intended or cementless applications when resurfacing the surgically prepared patella as part of primary Total Knee Arthroplasty (TKR). The Optimotion Implants Metal-Backed Patella is compatible for use with components of the Optimotion™ Blue Total Knee System components (K191084).
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from; noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic loss of knee joint configurations and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
· Fracture of the distal femur and/or proximal tibia that cannot be standard fracture-management techniques.
- · Optimotion porous tibial tray and porous CR femoral components are indicated for cemented or cementless use.
- · Optimotion cemented CR Femoral and cemented tibial tray components are indicated for cemented use only.
The Optimotion Implants Porous Metal-Backed Patella is an extension of The Optimotion™ Blue Total Knee System (K191084) product line for use in primary Total Knee arthroplasty. The Optimotion Porous Metal-Backed Patella will come in two variations Onset styles. It is a sterile, single use, non-modular porous metal-backed patella that is manufactured from UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). The device is offered in a symmetric design that is available in multiple sizes. The metal backing features an additive manufactured porous posterior surface and three additive manufactured porous pegs to provide cemented or cementless fixation to bone.
The provided document is a 510(k) summary for the Optimotion Implants Porous Metal-Backed Patella. It describes the device and its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or adjudication methods that would typically be found in a clinical study report for an AI/ML medical device.
The "Performance Testing" section (6.8) states that the device utilizes the performance testing of a previously cleared device (Optimotion™ Blue Total Knee System K191084) and refers to Appendix E-1 for the completed testing. It mentions tests for "Additive Titanium Porous Structure" including "Percent Porosity and Average Pore Size" and "Shear Static and Fatigue." These are engineering and material performance tests, not clinical or AI/ML performance studies.
Therefore, many of the requested items cannot be extracted from this document, as the device is a medical implant (patella) and not an AI/ML-based diagnostic or prognostic tool.
Here's a breakdown based on the information available in the document:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Specific Criteria (if available) | Reported Device Performance / Assessment |
|---|---|---|
| Material Properties | Percent Porosity | Tested (details in Appendix E-1) |
| Average Pore Size | Tested (details in Appendix E-1) | |
| Mechanical Properties | Shear Static | Tested (details in Appendix E-1) |
| Shear Fatigue | Tested (details in Appendix E-1) | |
| Substantial Equivalence | Design | Similar to predicate |
| Materials | Similar to predicate | |
| Indications | Similar to predicate | |
| Performance Characteristics | Similar to predicate | |
| Operational Principles | Similar to predicate |
Note: The document states that the device "utilizes the Performance testing of the Optimotion™ Blue Total Knee System (K191084)." To see the detailed acceptance criteria and reported performance for these mechanical and material tests, one would need to refer to Appendix E-1 of the original submission or the 510(k) for K191084. The current document only lists the types of tests performed.
2. Sample size used for the test set and the data provenance: Not applicable. This device is a physical implant, not an AI/ML diagnostic. The performance testing mentioned refers to material and mechanical property tests, not a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device requiring expert ground truth for classification or diagnosis. "Consultations with professionals at testing centers, Optimotion™ Implants' surgeon advisors, and engineering consultants" are mentioned in general for the previous device's testing, but not for establishing ground truth in an AI/ML context.
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 device is a physical implant, not an AI-assisted diagnostic tool for human readers.
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.): For the physical properties of the implant, the "ground truth" would be the established engineering standards for parameters like porosity, pore size, and shear strength.
8. The sample size for the training set: Not applicable. This device is a physical implant, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 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.