(56 days)
The LINK TrabecuLink Femoral and Tibial Cones are indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis and joint fractures which disallow an osteosynthetic reconstruction.
The LINK TrabecuLink Femoral and Tibial Cones are indicated for the following conditions:
- Surgeries which require implantation of a total knee endoprosthesis after severe degeneration or bone loss, traumata, or other pathologies.
The device is intended for uncemented use.
The LINK® TrabecuLink® Femoral Cones are an extension to the LINK® TrabecuLink® Tibial Cones (K200113). The femoral cones are designed to be used in conjunction with the LINK® Endo-Model® Knee System Standard / Modular / Porex® coated (K143179; K152431) and with the Endo-Model® SL® Knee System (K151008) femoral components. The subject device is intended to fill large bone defects and stabilize the femoral bone structure in a joint replacement.
The femoral cones are manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6AI4V). The femoral cones consist of a non-porous bulk interior surface and a trabecular structure made of titanium (LINK® TrabecuLink®) on the external surface. The LINK® TrabecuLink® Femoral Cones provide cementless fixation to the bone. The mating knee endoprosthesis is cemented to the femoral cone.
This document is a 510(k) Premarket Notification from the FDA for the LINK® TrabecuLink® Femoral Cones. It focuses on the substantial equivalence of this device to existing predicate devices.
Based on the provided document, there is NO information described about acceptance criteria relating to software or AI-driven medical devices, nor a study proving a device meets such criteria.
The document details the regulatory clearance process for a medical implant (femoral cones for knee replacement), which is a physical device, and its performance evaluation relies on non-clinical bench testing rather than clinical studies or artificial intelligence performance metrics.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving a device meets these criteria in the context of an AI/software device, as this document pertains to a physical orthopedic implant.
The sections below demonstrate what a response would look like if the provided text did contain information about AI/software device performance criteria.
Hypothetical Response (if the document were about an AI/Software device):
(Please note: The following information is entirely fabricated and for illustrative purposes, as the original document does not contain this content.)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint | |
| Area Under the Receiver Operating Characteristic Curve (AUC) > 0.90 for detecting disease X | AUC = 0.92 (95% CI: 0.90-0.94) |
| Sensitivity > 85% for disease X | Sensitivity = 88% (95% CI: 86-90%) |
| Specificity > 70% for disease X | Specificity = 75% (95% CI: 72-78%) |
| Secondary Endpoints | |
| F1-score > 0.80 for disease X | F1-score = 0.85 |
| Positive Predictive Value (PPV) > 60% | PPV = 65% |
| Negative Predictive Value (NPV) > 90% | NPV = 93% |
| Average processing time per image |
§ 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.