(29 days)
The VEGA Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
The VEGA Knee System is designed for use with bone cement.
The VEGA Knee System is a semi-constrained cemented prosthesis with a Posterior Stabilization (PS) design. The femoral component, tibial plateau and extension stem are manufactured from Cobalt Chromium Molybdenum alloy (CoCrMo) with a Zirconium nitride (ZrN) coating. The tibial "gliding surfaces" (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and the tibial plug is made of PEEK. The system is made up of numerous components available in various sizes. All components are sterile and for single use only.
The provided document is a 510(k) summary for the VEGA Knee System, specifically addressing a modification to the wrench size for 10mm extension stems. This document is a premarket notification for a medical device that aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical acceptance criteria through a study with human subjects.
Therefore, many of the requested data points (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable to this type of submission for this particular device modification. The submission focuses on mechanical testing to ensure the modification does not negatively impact the device's performance compared to the predicate.
Here's the information that can be extracted from the provided text, alongside an explanation of why other points are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for mechanical testing) | Reported Device Performance |
|---|---|
| Performance similar to legally marketed VEGA Knee System (K101281) | "The results were found to be similar to the legally marketed VEGA Knee System." |
- Explanation: For this type of modification (wrench size for extension stems), the "acceptance criteria" are implied to be that the modified component, when subjected to mechanical testing, performs comparably to the previously cleared design. The document doesn't specify numerical thresholds for success, but rather a qualitative comparison.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Mechanical testing... was performed," but does not provide the number of samples or specimens tested.
- Data Provenance: The testing was performed internally by the manufacturer (Aesculap Implant Systems, LLC). The nature of the testing is "mechanical testing," implying laboratory-based testing rather than clinical data from a country of origin.
- Retrospective/Prospective: Not applicable. Mechanical testing is a laboratory-based evaluation of physical properties, not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This was mechanical testing of a physical component (extension stem), not an evaluation of a diagnosis or outcome that would require expert human judgment or "ground truth."
4. Adjudication Method
- Not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This type of study investigates human reader performance (e.g., radiologists, pathologists) often in the context of diagnostic AI. The submission is for a knee implant modification and involves mechanical testing.
6. If a Standalone (Algorithm Only) Performance Study was Done
- Not applicable. This is a medical device (knee implant), not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for mechanical testing is typically established by engineering specifications, material properties, and comparison to the performance of the predicate device under similar testing conditions. It's not "expert consensus," "pathology," or "outcomes data" in the traditional sense for diagnostic or prognostic studies. The implied ground truth is the established performance of the original VEGA Knee System (K101281) through its own mechanical testing.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable for the same reasons as #8.
Study that Proves the Device Meets the Acceptance Criteria:
The document states: "Mechanical testing of the Aesculap Implant Systems VEGA 10mm extension stems was performed as a result of the risk assessment. The results were found to be similar to the legally marketed VEGA Knee System."
This "mechanical testing" is the study referenced. No further details are provided in this summary regarding the specific tests conducted (e.g., fatigue testing, static strength testing), the number of samples, or the quantitative results. The conclusion provided is that the performance was "similar" to the predicate device, indicating it met the implicit acceptance criterion of not degrading performance due to the modification.
§ 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.