(74 days)
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® Saddle Shaped Patella is for use with bone cement only.
The ADVANCE® Saddle Shaped Patella is manufactured from UHMWPE (ASTM F 648). The patella is designed to be a product line extension to the existing ADVANCE® Knee System.
It is designed to articulate with the surface geomery of the medial pivot femoral component. The design of the subject device provides better articulation and increased surface area. The patella is available in 3 sizes, that match the articulating geometry of the femoral component. All three patellae have the same diameter of 25mm.
The provided text describes a 510(k) submission for the ADVANCE® Saddle Shaped Patella, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed acceptance criteria and standalone clinical study results in the same way a PMA (Premarket Approval) or a more recent 510(k) summary might.
Based on the provided text, here's what can be extracted and what cannot be:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Contact Area (Superiority) | "exceeds the requirements" |
| Lateral Stability (Superiority) | "exceeds the requirements" |
| Substantial Equivalence to Predicate Device | Declared substantially equivalent |
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 primarily describes mechanical test data. It does not mention a test set of patients, nor does it provide details on sample size, country of origin, or whether the study 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 information is not provided. The study appears to be focused on mechanical performance data rather than clinical performance requiring expert ground truth for interpretation of patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided, as the "test set" in the context of the available information refers to mechanical tests, not patient data 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
There is no mention of an MRMC study, human readers, AI, or comparative effectiveness with human readers. This document is from 1999 and describes a knee implant, making such a study highly unlikely for this type of device at that time.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of an algorithm or standalone performance, as this relates to a physical medical implant, not a software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance claims ("exceeds the requirements for contact area and lateral stability") is based on mechanical testing standards and comparisons to currently available knees, not clinical outcomes, pathology, or expert consensus on patient data. The ground truth for the overall submission is substantial equivalence to a predicate device based on design, materials, and mechanical performance.
8. The sample size for the training set
There is no mention of a training set. This is a medical device and the "study" referenced is mechanical testing, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or relevant to the information provided.
§ 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.