(141 days)
The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. 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 Apex Knee System is a primary or revision total knee replacement. This knee replacement is intended for use with bone cement and single use implantation. This knee system consists of a range of sizes of cobalt chrome femoral components with a deep patellar groove, dome shaped UHMWPE patella resurfacing components, UHMWPE tibial inserts, cobalt chrome tibial trays, and a titanium alloy bolt for locking the tibial insert to the tibial tray. This modular configuration allows the surgeon user to choose a combination of femoral and tibial tray component sizes to appropriately fit the anatomy of the patient, and to use a tibial insert with a size-for-size match to the femoral component. There are two different articular geometries for the tibial insert, a cruciate retaining ("CR") design, which allows retention of the posterior cruciate ligament, and an ultra-congruent posterior cruciate substituting ("Ultra") design. For each tibial insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.
This document focuses on the Apex Knee System, a total knee replacement device. The provided text is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to predicate devices, rather than a study evaluating acceptance criteria of a novel device. Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory submission.
However, I can extract information related to the device's characteristics and its comparison to existing devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify "acceptance criteria" in the sense of performance metrics for a novel device, nor does it present "reported device performance" from a study. Instead, it demonstrates substantial equivalence to predicate devices. The table below summarizes the design and material characteristics of the Apex Knee system and compares them to two predicate devices. This comparison serves as the basis for claiming substantial equivalence, implying that if the predicate devices are "accepted," then a device with similar characteristics also meets the necessary safety and effectiveness profile.
| Characteristic | Apex Knee System (Reported) | Acceptance Criteria (Implied by Predicate Devices) |
|---|---|---|
| Intended Use | Primary and revision, 3-compartment, cemented | Primary and revision, 3-compartment, cemented |
| Porous coated | No | No |
| Asymmetric femur, anatomic patellar groove | Yes | Yes |
| Anatomic (asymmetric) tibial tray | Yes | Yes (for Natural-Knee® II), No (P.F.C. ® Sigma) |
| Metal-backed UHMWPE tibial component | Yes | Yes |
| Tibial insert designs | CR and Ultra | CR ("Curved") / CR ("Congruent") and Ultra ("Ultracongruent") |
| Tibial tray distal features | Central post and 2 keels | Central post and 2 short keels / Central post, 4 keels, and 4 pegs |
| Patella design | Round, single radius dome, 3 pegs | Round, single radius dome, 3 pegs / Round, partial dome, 3 pegs |
| Cobalt chrome femur | Yes | Yes |
| CoCr tibial tray | Yes | Yes (for Natural-Knee® II), No (ti alloy for P.F.C. ® Sigma) |
| All-poly patella | Yes | Yes |
| UHMWPE | Sheet molded GUR 1020 | Sheet molded GUR 1020 |
| Highly cross-linked UHMWPE (sterilization) | No (EtO) | No (y irradiation in vacuum / in nitrogen) |
Note: The "Acceptance Criteria" column above is an interpretation of the characteristics present in the predicate devices that the Apex Knee System is demonstrating equivalence to. The direct performance metrics for "acceptance" are not explicitly stated as they would be in a clinical trial or performance study report.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. This is a 510(k) submission, which relies on demonstrating substantial equivalence to legally marketed predicate devices, not on a separate "test set" of patients or data for a novel performance study. The "data" here refers to the design specifications and material properties of the Apex Knee System being compared.
- Data Provenance: Not applicable in the context of human data. The "data" consists of the design and material specifications of the Apex Knee System and the predicate devices. This information is typically generated through engineering design, material testing, and manufacturing processes. The document does not mention human data from trials or registries.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth for a clinical test set is not established in a 510(k) submission that relies on predicate device comparison. The "ground truth" for this submission is implicitly the established safety and effectiveness of the existing predicate devices.
4. Adjudication Method for the Test Set:
Not applicable. There is no "test set" in the context of clinical data for adjudication here. The comparison is against predicate device specifications, which is a regulatory review process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a knee prosthesis, not an imaging diagnostic device that would typically involve human readers for interpretation. Therefore, an MRMC study is not relevant to this submission.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device (total knee replacement), not an algorithm or AI system.
7. Type of Ground Truth Used:
The "ground truth," in the context of a 510(k) for a physical device, is effectively the established safety and effectiveness of the legally marketed predicate devices. The submission argues that because the Apex Knee System is substantially equivalent in its design, materials, and intended use to these predicates, it shares the same safety and effectiveness profile.
8. Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of developing this physical medical device. Device design and material selection are based on engineering principles, biomechanical testing, and historical clinical performance of similar devices, not machine learning training data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the machine learning sense.
§ 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.