(89 days)
The ADVANCE® Ultra-Congruent Tibial Insert is indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques.
The ADVANCE® Ultra-Congruent tibial insert is part of a total system that is indicated for use only with cement.
The ADVANCE® Ultra-Congruent tibial insert is part of a total system that is indicated for use only with cement. The ADVANCE® Ultra-Congruent Tibial Insert is manufactured from ultra high molecular weight polyethylene.
This document is a 510(k) summary for a medical device called the ADVANCE® Ultra-Congruent Tibial Insert. It describes the device, its intended use, materials, and a summary of testing performed to demonstrate substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state "acceptance criteria" in a quantitative manner with pass/fail thresholds. Instead, it describes comparability to a predicate device and adherence to industry standards, which serve as an implicit form of acceptance criteria for this 510(k) submission.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Testing) |
|---|---|
| Femoral-tibial contact area comparability to predicate device. | "Submitted femoral-tibial contact area testing demonstrates that the ADVANCE® Ultra-Congruent Tibial Insert is comparable to the predicate device." |
| Stability and resistance to displacement under physiological loads (femoral-tibial constraint). | "Submitted femoral-tibial constraint testing (anterior shear, medial shear, medial shear, lateral shear, and rotation) demonstrates that the ADVANCE® Ultra-Congruent Tibial Insert is expected to remain stable and resist displacement when subjected to appropriate physiological loads." |
| UHMWPE properties meet or exceed minimal properties of ASTM F 648. | "Submitted ultra high molecular weight polyethylene (UHMWPE) properties demonstrate that the ADVANCE® polyethylene components meet or exceed minimal properties of ASTM F 648." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the contact area testing, constraint testing, or UHMWPE properties testing. It also does not provide information on the data provenance such as country of origin or whether the data was retrospective or prospective.
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 is a mechanical device, not an imaging or diagnostic device. Therefore, the concept of "ground truth" established by human experts in the context of diagnostic interpretation (e.g., radiologists) is not applicable here. The "truth" or performance is established through physical and material property testing against industry standards and predicate device benchmarks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or clinical 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
Not applicable. This document pertains to the 510(k) clearance of a mechanical knee implant, not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm. Performance is assessed through physical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the device's materials and mechanical properties is established by:
- Comparability to a legally marketed predicate device: The Intermedics Natural Knee Ultra-Congruent Tibial Insert.
- Adherence to established industry standards: Specifically, ASTM F 648 for Ultra High Molecular Weight Polyethylene.
- Expected physiological performance: Demonstrating stability and resistance to displacement under appropriate loads.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning model requiring training data.
9. How the ground truth for the training set was established
Not applicable. As this is a mechanical device, the concept of a "training set" and its "ground truth" in the context of predictive modeling does not apply.
§ 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.