(139 days)
The Apex Knee™ 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 Apex Knee Revision Femur system augments are intended to be bolted to the femoral component and cemented to the prepared femur.
The Apex Knee™ Modular Tibia System is composed of a tibial baseplate that mates with a cap, keel or a stem. Additionally the baseplate may be used with tibial augments and pegs. The components are used together to form a prosthesis for implantation.
This document is a 510(k) summary for the Apex Knee™ Modular Tibia System. It outlines the device's description, indications for use, comparison to predicate devices, and non-clinical test summaries. It explicitly states that no clinical studies were performed for this submission.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for clinical studies cannot be provided, as none were conducted.
The acceptance criteria and study information provided in this document pertain exclusively to non-clinical testing.
Here's the information about the non-clinical tests mentioned:
Acceptance Criteria and Study Information for Non-Clinical Testing:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Packaging Seal per ASTM F1929 | Pass (Seal integrity maintained) | Device successfully met the criteria (implied by "The following tests were conducted") |
| Tray Fatigue Strength Testing per ASTM F1800-07 | Pass (Maintain structural integrity under fatigue loading) | Device successfully met the criteria (implied by "The following tests were conducted") |
| Tray-Augment Fret Testing per ASTM F1800-07 | Pass (Minimize micromotion and wear at the interface) | Device successfully met the criteria (implied by "The following tests were conducted") |
| Tray-Augment Attachment Strength per ASTM F1814-Shear | Pass (Maintain secure attachment under shear forces) | Device successfully met the criteria (implied by "The following tests were conducted") |
| Tray-Stem Attachment Testing per ASTM F1814: Axial, F1814: Torsion | Pass (Maintain secure attachment under axial and torsional forces) | Device successfully met the criteria (implied by "The following tests were conducted") |
| Stem and Augment Bolt Retention Testing | Pass (Maintain bolt integrity and retention) | Device successfully met the criteria (implied by "The following tests were conducted") |
| Modular Stem Femur vs Tibia Loading Comparison per ASTM F1800-07 | Pass (Comparable loading characteristics between components) | Device successfully met the criteria (implied by "The following tests were conducted") |
Note: The specific quantitative acceptance criteria for each test are not detailed in this summary but are standard for the cited ASTM methods.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided summary for any of the non-clinical tests.
- Data Provenance: The tests are described as being conducted "internally" or by a certified lab for the manufacturer, OMNI life science, Inc., based in East Taunton, MA, USA. The data is thus considered prospective as it was generated specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. These are engineering/mechanical tests, not clinical evaluations requiring expert interpretation of ground truth data. The "ground truth" is determined by the physical properties and performance measured against the ASTM standard specifications.
4. Adjudication Method for the Test Set
- Not applicable, as these are technical performance tests, not clinical evaluations requiring human adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The document explicitly states: "No clinical studies were performed."
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This is a medical device (knee implant), not an algorithm or AI system.
7. Type of Ground Truth Used (Non-Clinical)
- Engineering specifications and recognized industry standards (ASTM): The "ground truth" for these non-clinical tests is adherence to the performance requirements outlined in the specified ASTM standards (e.g., F1929, F1800-07, F1814).
8. Sample Size for the Training Set
- Not applicable. This refers to a medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This refers to a medical device, not a machine learning model.
§ 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.