(55 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, with the option of using a porous coated femoral component for uncemented or cemented fixation. 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; .
- Congenital dislocation; ●
- Revision procedures where other treatments or devices have failed. .
The Apex Knee System Porous Coated Femoral Components are part of the Apex Knee System for primary or revision total knee replacement. These cobalt chrome femoral components have a sintered porous coating (ASTM F1377). Fixation of the femoral component is achieved using either PMMA bone cement or by biological fixation via tissue ingrowth into the porous coating. The Apex Knee System consists of a range of sizes of 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 sizefor-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.
The provided text describes a 510(k) premarket notification for the Apex Knee System Porous Coated Femoral Components. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove performance against specific acceptance criteria. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details will not be explicitly found in this document.
However, I can extract the relevant information from the document that addresses the comparison to predicate devices, which is the basis for this 510(k) clearance.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is the claim of equivalence.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Claimed to be substantially equivalent to: |
- Apex Knee System (K060192) for cemented components
- Sigma Cruciate-Retaining Porocoat® Femoral Components (K062654) for porous coated components |
| Identical Intended Use | Indications for Use are identical to the predicate Apex Knee System, with the added option of uncemented fixation for the porous coated femoral component. |
| Similar Design Features | Similar design (asymmetric femur, anatomic patella groove, metal-backed UHMWPE tibial component, patella design) to predicate devices. The key difference is the addition of a porous coating. |
| Similar Materials | Femoral component: Cobalt chrome.
Porous coating: Sintered cobalt chrome (same as DePuy predicate and Sponsor's K031110) |
| Same Manufacturing, Packaging, Sterilization Methods | Identical to the predicate Apex Knee System (K060192). |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to existing predicate devices rather than new clinical testing against a specific test set. No new clinical study data or patient samples are presented for this purpose in the document. The 'test set' in this context would be the comparison against specifications and characteristics of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this is a 510(k) based on substantial equivalence, there is no "test set" in the sense of clinical data requiring expert review for ground truth. The evaluation is against the features and performance of predicate devices as described in their own 510(k)s or regulatory clearances.
4. Adjudication method for the test set:
- Not applicable. No clinical data test set requiring adjudication is presented.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a total knee replacement prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a total knee replacement prosthesis and does not involve an algorithm or AI component.
7. The type of ground truth used:
- Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) hinges on the established characteristics, performance, and regulatory clearances of the legally marketed predicate devices. The "truth" is that the new device is functionally and materially similar enough to the predicates to warrant substantial equivalence.
8. The sample size for the training set:
- Not applicable. This device is a physical medical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.