(49 days)
The Osteonics® Anterior Femoral Blocks, because they are accessory components to an existing total knee replacement system, are subject to the general indications and contraindications of their mating knee femoral components, as follows:
General Indications for Total Knee Replacement Components
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration 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.
- Indications Specific to the Femoral Wedges
- Painful, disabling joint disease of the knee secondary to degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
Polymethyl methacrylate (PMMA) bone cement will be used to affix a selected femoral block to its mating knee femoral component. The assembled block-to-femoral component construct is intended for cemented fixation to the prepared distal femur.
The Osteonics® Series 7000 Total Knee Anterior Femoral Blocks are characterized by the following design features.
- Basic Anterior Femoral Shape: The Osteonics® Series 7000 Total Knee Anterior Femoral Blocks conform to the outline of the proximal anterior aspect of the mating femoral component.
- Size range: The Osteonics® Series 7000 Total Knee Anterior Femoral Blocks are available in a range of sizes that correspond with mating femoral components.
- Thickness: The Osteonics® Series 7000 Total Knee Anterior Femoral Blocks are 3mm thick.
- Surface finish: The Osteonics® Series 7000 Total Knee Anterior Femoral Blocks feature an area roughened via a grit blast operation. The grit blasted surface provides a stronger bone cement/prosthesis interface than would a smooth or satin-finished surface.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Osteonics® Series 7000 Total Knee Anterior Femoral Blocks:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Withstand anticipated in-vivo loading conditions for the block-to-femoral component construct. | All specimens successfully endured 10 million cycles of physiologically relevant loading, with no signs of impending wedge/femoral component interface failure. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document doesn't specify the exact number of "specimens" tested, only stating "All specimens."
- Data Provenance: The document does not provide information about the country of origin of the data or whether the study was retrospective or prospective. It is an in-vitro mechanical test, not related to patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "ground truth" for this device's performance is based on defined engineering standards for mechanical durability and simulated physiological loading, not expert human assessment of images or patient outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. There was no human adjudication process described for the mechanical performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or implied. The study described is a mechanical performance test, not a clinical study involving human readers or patient cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. This device is a mechanical knee implant component, not an algorithm or AI system. The "standalone" performance refers to the device itself performing as intended under simulated conditions.
7. Type of Ground Truth Used
The "ground truth" in this context is the mechanical integrity and durability of the device under simulated physiological loading. The acceptance criterion is the ability to withstand 10 million cycles without failure, suggesting a predefined engineering standard for durability in orthopedic implants.
8. Sample Size for the Training Set
This information is not applicable. This device is a mechanical knee implant component, not an AI system. There is no concept of a "training set" in the context of its performance testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.