(75 days)
The Apex Knee ™ Modular Tibia System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:
• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Revision procedures where other treatments or devices have failed
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only. The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.
The Modular Tibial Baseplate is offered in sizes 1 thru 6 and is a symmetrical design. It is 5mm thick, and accepts Tibial Stems and Augment Blocks on its inferior surface. Modular Tibia Stems are available from 9-17mm diameter in lengths of 75,100 or 150mm. The stem mates to the Modular Tibial Baseplate via a Morse taper connection, secured by a Locking Bolt. Modular Tibia Augments are available in, size 1 thru 6. Each Augment is 4mm thick, and may be placed on either the medial or lateral side of the baseplate. They may be stacked up to three high in equal or descending sizes to create either a uniform or stepped lateral profile. Bone cement should not be used between stacked augments. Once stacked the augments must be secured to the tibial tray using a locking bolt of appropriate length to match the height of the augment stack. The Tibial tray (tibial baseplate) - augment assembly is then cemented to the prepared tibia.
Here's a breakdown of the acceptance criteria and study information for the Apex Knee ™ Modular Tibia System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details non-clinical performance testing rather than clinical performance (e.g., diagnostic accuracy metrics). The acceptance criteria are implicit in that the samples must meet the standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Augment Attachment Strength (per ASTM F1814-97AR03) | "All samples tested met the acceptance criteria." |
| Fretting Analysis (per ASTM F1800-07) | "All samples tested met the acceptance criteria." |
| Stem Attachment and Tray/Augment Attachment Strength (per ASTM F1814-97) | "All samples tested met the acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for each non-clinical test (Augment Attachment Strength, Fretting Analysis, Stem Attachment, and Tray/Augment Attachment Strength).
The data provenance is from non-clinical bench testing, not human subjects. Therefore, details like country of origin for data or retrospective/prospective classification are not applicable.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This information is not applicable. The ground truth for this device (a knee implant system) is established through adherence to engineering standards and physical properties as assessed by bench testing, not expert interpretation of diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to resolving discrepancies in human expert assessments, which is not relevant for non-clinical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This type of study would involve human readers and is relevant for diagnostic or AI-assisted medical devices, not for assessing the mechanical properties of an orthopedic implant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The Apex Knee ™ Modular Tibia System is a physical orthopedic implant, not a software algorithm or AI device. Therefore, a "standalone algorithm performance" study is irrelevant in this context. The standalone performance relates to the mechanical integrity and functionality of the implant itself, which was assessed through the non-clinical tests.
7. Type of Ground Truth Used
The ground truth used for this device's evaluation was adherence to specified ASTM (American Society for Testing and Materials) standards for mechanical and material properties. This is a type of engineering and material science ground truth, not clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
This information is not applicable. As a physical orthopedic implant, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles, material science, and prior successful designs.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. There is no "training set" for physical implant devices in the way there is for AI/ML algorithms. The design and manufacturing are based on established engineering principles, material properties, and successful predicate device designs, all of which are validated through non-clinical testing.
§ 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.