(140 days)
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Painful and disabled knee joint resulting from osteoarthritis 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.
Femoral components and tibial tray components with porous coatings are indicated for cemented biological fixation application. Non-coated (interlok®) devices and all polyethylene patellar components are indicated for cemented application only.
The Vanguard® Complete Knee System is a total knee replacement system for either primary or revision knee arthroplasty. It is modular in design consisting of five components: a cobalt-chromium-molybdenum (Co-Cr-Mo) or Titanium (Ti) alloy femoral component, with either a porous plasma spray (PPS) or Interlok® surface finish; a cobalt-chromium-molybdenum (Co-Cr-Mo) or Titanium (Ti) alloy tibial tray; a patellar component, manufactured from polyethylene (UHMWPE); a locking bar, manufactured from a Titanium (Ti) alloy; and tibial bearings, manufactured from a Vitamin-E Highly Crosslinked polyethylene (VEHXPE).
This is a 510(k) premarket notification for the Vanguard Complete Knee System, a medical device. This document focuses on the claim of substantial equivalence to predicate devices rather than providing a study where the device meets specific acceptance criteria in the way an AI/software device would.
Therefore, the requested information elements related to algorithms, ground truth, expert adjudication, MRMC studies, and sample sizes for training/test sets are not applicable to this type of medical device submission.
Here's a breakdown of what is available in the document regarding the device's characteristics and the basis for its clearance:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria or reported device performance in the format of a clinical study with metrics like sensitivity, specificity, or accuracy. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices.
The "performance data" provided relates to non-clinical engineering analysis and material characteristics to show that modifications do not adversely affect safety and efficacy.
| Characteristic | Predicate Comparison | Result/Finding |
|---|---|---|
| Materials | Identical to Persona® Personalized Knee System | Vivacit-E material characteristics presented in MAF-1868. Material and dimensional comparison of Vivacit-E to E1 tibial bearings was performed. |
| Design Features | Similar to Vanguard® Complete Knee System | Evaluation of stress in manufacturing slots of Vivacit-E tibial bearings using finite element analysis (FEA). |
| Intended Use | Identical to predicates | Met |
| Indications for Use | Identical to Vanguard® Complete Knee System | Met |
| Sterilization | Identical to Persona® Personalized Knee System | Laser etching of Vanguard Vivacit-E material. Pyrogenicity Testing. |
| Safety & Effectiveness | - | Engineering analysis conducted to demonstrate modifications did not adversely affect safety and efficacy. Magnetic resonance imaging (MRI) compatibility testing performed. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes a physical medical device (knee implant components) and its clearance is based on substantial equivalence, primarily through non-clinical bench testing and material comparisons, not AI/software performance studies.
- The "test reports" mentioned (e.g., Vivacit-E material characteristics, FEA evaluation, MRI compatibility, Pyrogenicity Testing) refer to engineering and biocompatibility evaluations, not clinical trials with human subjects.
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)
- Not applicable. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 2.
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. See point 2.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. See point 2.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for this device's clearance is established through engineering principles, material science standards, and comparison to existing, legally marketed predicate devices. For example, material strength might be compared to industry standards or predicate device specifications, which serves as the "ground truth" for material performance.
8. The sample size for the training set
- Not applicable. See point 2.
9. How the ground truth for the training set was established
- Not applicable. See point 2.
Summary of the K183583 Submission:
- Device: Vanguard® Complete Knee System (specifically, modifications to the tibial bearings).
- Purpose of Submission: To introduce a modification to the tibial bearings within the existing Vanguard® Complete Knee System.
- Basis for Clearance: Substantial Equivalence to legally marketed predicate devices.
- Key Argument for Substantial Equivalence:
- Identical Intended Use and Indications for Use as predicates.
- Similar Technological Characteristics to predicates (materials, design features, sterilization).
- Non-Clinical Testing: Engineering analyses, material characteristic evaluations (Vivacit-E material characteristics, material and dimensional comparison, FEA for stress evaluation), laser etching analysis, MRI compatibility, and pyrogenicity testing were conducted.
- Clinical Testing: "Clinical data was not deemed necessary for the subject device." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means.
The document concludes that the differences introduced by the modification "do not raise new questions of safety and effectiveness" and that "the proposed device is at least as safe and effective as the legally marketed predicate devices."
§ 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.