(20 days)
The Vanguard® Asymmetrical Patella is intended for replacement of part of the knee joint in conjunction with a femoral and tibial component.
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved;
- Correction of varus, valgus, or posttraumatic deformity;
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.
Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (Interlok) devices and all polyethylene patellar components are indicated for cemented application only.
The Vanguard® Patellar Component is machined of polyethylene (UHMWPE) conforming to ASTM F-648.
This is a 510(k) premarket notification for a medical device (Knee Prosthesis), and as such, the "study" described is a demonstration of substantial equivalence to predicate devices, primarily through non-clinical testing and engineering rationale, rather than a clinical trial with acceptance criteria for device performance in patients. Therefore, many of the requested fields related to clinical studies, expert-established ground truth, and AI-specific metrics will not be applicable.
Here's the breakdown of the provided information within the context of a 510(k) submission:
Acceptance Criteria and Device Performance for Biomet Manufacturing Corp.'s Vanguard® Asymmetrical Patellar Component (K110362)
(Note: This submission focuses on demonstrating substantial equivalence through non-clinical performance and engineering rationale, not a clinical study with traditional performance endpoints. Therefore, terms like "acceptance criteria," "reported device performance," and "ground truth" are interpreted within the context of mechanical testing and comparative analysis to predicate devices.)
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Requirement) | Reported Device Performance (New Device) | Predicate Device Comparison |
|---|---|---|---|
| Patellofemoral Stability | Meet or exceed parameters (of predicate) | Meet | K921182 |
| Contact Area Analysis | Meet or exceed parameters (of predicate) | Meet | K921182 |
| Peg Shear Area Analysis | Meet or exceed parameters (of predicate) | Meet | K040770 |
Interpretation of "Acceptance Criteria" in this context: The acceptance criteria are "Meet or exceed parameters" of the identified predicate devices for the respective tests. This implies that the new device's performance in these mechanical tests must be at least as good as, or better than, the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes (N numbers) for the mechanical tests. However, implicitly, a sufficient number of samples would have been tested to demonstrate consistency and compliance with the specified parameters.
Data Provenance: The data is from non-clinical laboratory testing conducted by the manufacturer, Biomet Manufacturing Corp. (Warsaw, IN, USA). It is retrospective in the sense that it's performed on manufactured devices for regulatory submission, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. For non-clinical mechanical testing of a knee implant component, "ground truth" is established by adherence to recognized engineering standards, test methods, and quantitative measurements. It does not involve expert medical review of images or clinical outcomes. The "experts" involved would be the engineers and technicians conducting the tests and analyzing the data, ensuring the tests are performed according to established protocols.
4. Adjudication Method for the Test Set
Not Applicable. As this involves mechanical testing rather than interpretation of clinical data or images, there is no "adjudication method" in the sense of multiple medical experts resolving discrepancies. The results are quantitative and objective measurements from the tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a 510(k) submission for a medical device focusing on mechanical equivalency, not a comparative effectiveness study 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 device is a physical knee implant component, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on objective, quantitative mechanical test results and engineering rationale demonstrating that the new device's physical and mechanical properties meet or exceed those of the predicate devices. This includes measurements of patellofemoral stability, contact area, and peg shear area.
8. The Sample Size for the Training Set
Not Applicable. There is no "training set" as this is not an AI or algorithm-based device. Mechanical tests are performed on manufactured components.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set.
§ 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.