(114 days)
- 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 joint replacement procedure.
The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.
The Regenerex tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.
Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex and OsseoTi components are intended only for uncemented biologic fixation application.
The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral components. The Vanguard DA 360 components are not approved for sale in the United States.
The Vanguard 360 OsseoTi Tibial Sleeve Augments are porous, modular augment sleeves that have been designed to address a wide range of defects in cases of severe bone loss in both primary and revision cases. The subject augments are constructed from a previously cleared materials/additive manufacturing process known as OsseoTi. The OsseoTi process results in a fully integrated part with solid and porous regions. This structure leads to a highly interconnected volume of porosity and promotes biological fixation.
The subject OsseoTi Tibial Sleeve Augments mount directly onto the previously cleared Vanguard 360 Tibial Tray boss via Morse tapers. The subject augments are available in half and full sleeve configurations and multiple sizes.
The medical device in question is the Vanguard® 360 OsseoTi™ Tibial Sleeve Augments.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Construct Testing | Static Axial (Pull Off) Force | Met established criteria | Met or exceeded criteria |
| Torque Resistance | Met established criteria | Met or exceeded criteria | |
| Fatigue | Met established criteria | Met or exceeded criteria | |
| Fretting | Met established criteria | Met or exceeded criteria | |
| MRI Compatibility Justification | Met established criteria | Met or exceeded criteria | |
| OsseoTi Material Characterization | Interconnecting Porosity | Met established criteria | Met or exceeded criteria |
| Micrographs | Met established criteria | Met or exceeded criteria | |
| Porosity and Pore Size | Met established criteria | Met or exceeded criteria | |
| Roughness | Met established criteria | Met or exceeded criteria | |
| Abrasion Resistance | Met established criteria | Met or exceeded criteria | |
| Mechanical Strength | Met established criteria | Met or exceeded criteria | |
| Chemical Composition | Met established criteria | Met or exceeded criteria | |
| Shear Fatigue | Met established criteria | Met or exceeded criteria | |
| Static Shear | Met established criteria | Met or exceeded criteria | |
| Static Tensile | Met established criteria | Met or exceeded criteria | |
| Animal Data | (Not explicitly named, but conducted) | Met established criteria | Met or exceeded criteria |
Note: The document states "All testing met or exceeded the established acceptance criteria," but does not explicitly list the quantitative values of these criteria. The implicit acceptance criteria for each test are that the device performed within the intended use and did not raise new safety or efficacy issues, aligning with the performance of predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical tests (material characterization and construct testing) and "animal data." It explicitly states:
- Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
Therefore, there is no human clinical test set for this submission. The tests performed were laboratory-based and animal studies. The sample sizes for these tests are not specified in the document.
- Data Provenance: The tests are described as non-clinical (laboratory-based material and mechanical testing) and animal data. No country of origin is specified for these studies, nor is it explicitly stated if they were retrospective or prospective, though non-clinical and animal studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As there was no human clinical test set for a performance evaluation, the concept of "ground truth" derived from expert consensus on patient data (e.g., radiology reports) is not applicable here. The "ground truth" for the non-clinical tests would be defined by engineering specifications, material science standards, and established biomechanical testing protocols. The qualifications of the engineers/scientists conducting these tests are not provided.
4. Adjudication Method for the Test Set
Not applicable, as there was no human clinical test set requiring adjudication of findings (e.g., medical image interpretations).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Data/Information: None provided as a basis for substantial equivalence." This submission relies on non-clinical and animal data to establish substantial equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the device described. The device is a physical knee implant component, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the non-clinical testing and animal data, the "ground truth" would be established by:
- Engineering specifications and standards: For mechanical properties, fatigue, fretting, static axial force, torque resistance.
- Material science standards: For interconnecting porosity, micrographs, porosity and pore size, roughness, abrasion resistance, mechanical strength, chemical composition, shear fatigue, static shear, static tensile.
- Animal study endpoints: For biocompatibility, bone ingrowth, or other relevant biological responses (details not provided).
There was no "expert consensus," "pathology," or "outcomes data" from human subjects used to establish ground truth for this 510(k) submission.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set for a physical medical implant.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.