(90 days)
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Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved;
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Correction of varus, valgus, or posttraumatic deformity;
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Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.
The Vanguard® Complete Knee System is a total knee replacement system for either primary or revision knee arthroplasty. It consists of femoral components composed of cast Co-Cr-Mo per ASTM F-75 with either a porous plasma spray (PPS) or Interlok® surface finish, tibial bearings molded of polyethylene (UHMWPE) conforming to ASTM F-648 or machined of polyethylene (UHMWPE or UHMWPE with a-tocopherol) conforming to ASTM F-648, tibial trays (not part of this submission) and patellar components machined of polvethylene (UHMWPE) conforming to ASTM F-648.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device:
Important Note: The provided document is a 510(k) summary for a Vanguard® Complete Knee System (Knee Prosthesis). For this type of medical device, the "acceptance criteria" and "study" described are primarily related to mechanical and physical testing to demonstrate substantial equivalence to previously cleared devices, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested fields regarding expert adjudication, effect size of human readers with AI assistance, and training set information are not applicable (N/A) in this context.
Acceptance Criteria and Study for the Vanguard® Complete Knee System
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Parameter | How Performance Was Measured/Reported | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Tibial-femoral Contact Area | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." |
| Patello-femoral Contact Area | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Patellofemoral Mechanical Stability | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Tibialfemoral Constraint | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Tibialfemoral Mechanical Stability | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Posterior Stabilized Fatigue | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Posterior Stabilized Static Load | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Range of Motion Analysis | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| 80/20 Femoral Fatigue | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Vanguard® PS Open Box Tensile Stress | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Constraint testing of AS and CR-L | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Contact Area Analysis (AS bearing) | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Static Rotational Strength Test (PS+) | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Varus/Valgus Constraint (PS+) | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Tensile Strength E-poly | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Wear Testing E-poly | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Contact Areas Analysis (patellar) | Mechanical testing per established protocols. | "All testing met or exceeded the established acceptance criteria." | |
| Overall Conclusion | Substantial equivalence to predicate knee systems | Evaluation of technological characteristics and safety/efficacy implications of modifications. | "The Vanguard® Complete Knee System is substantially equivalent to previously cleared Biomet knee systems and do not raise any new issues of safety or efficacy." |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a number of "samples" in a clinical sense. The "test set" here refers to the collection of mechanical tests performed on the device components.
- Data Provenance: The tests were "previously performed" and the "test reports were provided in the predicate 510(k)s," suggesting that new, independent tests specifically for this submission were not all conducted, but rather existing data from predicate devices or previous versions demonstrating the performance of similar components. The tests themselves are non-clinical, laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. For mechanical testing, "ground truth" is typically established by engineering specifications, accepted industry standards (e.g., ASTM F-75, F-648), and internal quality control criteria, rather than expert human consensus in the way it's used for AI/diagnostic devices. The "experts" would be the engineers and technicians performing and verifying the tests against these established standards.
4. Adjudication method for the test set
- N/A. Given this is mechanical testing against defined specifications, there is no direct "adjudication method" involving multiple human readers as would be found in clinical imaging studies. The results are quantitative measurements compared against predefined pass/fail criteria.
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
- No. This is a mechanical device, not an AI/software diagnostic device. An MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a mechanical device, not an algorithm.
7. The type of ground truth used
- Engineering Specifications and Industry Standards: The ground truth for this device's performance is based on established engineering specifications, mechanical test standards (e.g., ASTM F-75, F-648), and internal acceptance criteria developed to ensure the safety and efficacy of knee prostheses. The goal is to demonstrate that the device performs within these acceptable mechanical limits.
8. The sample size for the training set
- N/A. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- N/A. 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.