(198 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). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial Augment are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.
The APEX PS Knee System includes a posterior stabilized Femur Component incorporating a proportionally sized box. The Femur Component has the same bone cuts as the Apex Knee™ System (K060192) with the addition of a cut for the Femur Component box. Femur Components will be available in both cemented and uncemented versions. Size ranges, high flex, and all other design features of the Apex Knee System are retained. The PS Insert has a medio-lateral constraint and utilizes the Apex Knee System Tibial Baseplate. For each PS Insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.
The acceptance criteria and study proving the device meets them for the Apex PS Knee™ System are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Apex PS Knee Flexion Range of Motion | Compliance with FDA Class II Special Controls Guidance Document (January 16, 2003) and ASTM F2083-08. Specific range of motion not explicitly stated as an acceptance criterion but implied to be sufficient for function up to 140 degrees (high flexion design feature). | All samples tested met the acceptance criteria. |
| Contact Area of the Apex PS Knee | Compliance with FDA Class II Special Controls Guidance Document (January 16, 2003) and ASTM F2083-08. | All samples tested met the acceptance criteria. |
| Tibio-Femoral Constraint of the Apex PS Knee, PS Insert | Compliance with ASTM F2083-08 and ASTM F1223-03. | All samples tested met the acceptance criteria. |
| Apex Knee PS Tibial Insert Post Strength Testing | Compliance with FDA Class II Special Controls Guidance Document (January 16, 2003). | All samples tested met the acceptance criteria. |
| Apex PS Knee Patello-Femoral Contact Area and Stability | Compliance with ASTM F2083-08 and FDA Class II Special Controls Guidance Document (January 16, 2003). | All samples tested met the acceptance criteria. |
| Apex PS Knee Lift-off Comparison to Predicate (DePuy P.F.C. Sigma) | Performance to be comparable or better than the predicate device (DePuy P.F.C. Sigma). | All samples tested met the acceptance criteria. |
| Apex PS Knee Wear Review | Compliance with ISO 14243-3, ISO 14243-2, and ASTM F1877. | All samples tested met the acceptance criteria. |
| Apex PS Insert Minimum PS Thickness | Compliance with FDA Class II Special Controls Guidance Document (section 5) and ISO 21536 (2007). | All samples tested met the acceptance criteria. |
| Apex PS Knee Component Surface Finish Review | Compliance with ISO 7207-2 (1998), ISO 21534 (2007), and ISO 21536 (1998). | All samples tested met the acceptance criteria. |
| Apex PS Knee Instrument Review | Implied to meet design and performance specifications for instruments. | All samples tested met the acceptance criteria. |
| Apex PS Knee Tibio-Femoral Conformity Ratios | Implied to meet design specifications. | All samples tested met the acceptance criteria. |
Study Proving Device Meets Acceptance Criteria:
The device's performance was evaluated through a series of non-clinical tests as listed above. The provided document states, "All samples tested met the acceptance criteria." This indicates that for each specific test, the Apex PS Knee™ System demonstrated performance within the predefined limits or adherence to the specified standards, thereby proving the device meets its acceptance criteria.
Detailed Information on the Study:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample size for each non-clinical test. It generally states, "All samples tested met the acceptance criteria," implying that a sufficient number of samples were tested to demonstrate compliance with the standards.
- Data Provenance: The tests are non-clinical, likely laboratory-based. The country of origin of the data is not explicitly stated, but given the submitter is OMNIlife science, Inc. in E. Taunton, MA, USA, the testing was likely conducted in the US or by US-affiliated labs. The nature of these tests makes them prospective in that they are conducted specifically to evaluate the new device against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable to this type of submission. The "ground truth" for non-clinical performance criteria of a medical device like a knee implant is established by recognized national and international engineering standards (e.g., ASTM, ISO) and FDA guidance documents, not by individual expert consensus on specific cases. The tests are designed to objectively measure physical and mechanical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as the evaluation involves objective physical and mechanical tests against predefined standards, not subjective clinical assessments requiring adjudication.
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
- This question is not applicable. The submission is for a knee implant, a physical medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This is a physical medical device, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests are the specified engineering and performance criteria established by national and international standards (ASTM F2083-08, ASTM F1223-03, ISO 14243-3, ISO 14243-2, ASTM F1877, ISO 21536, ISO 7207-2, ISO 21534) and relevant FDA Guidance Documents. These standards define acceptable ranges or behaviors for various mechanical and material properties of knee prostheses.
8. The sample size for the training set
- This question is not applicable. There is no "training set" in the context of this submission, as it's for a physical device undergoing non-clinical mechanical and material testing, not a machine learning model.
9. How the ground truth for the training set was established
- This question is not applicable for the reason stated above.
§ 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.