(141 days)
The Vanguard XP Knee System is intended for replacement of a total knee joint and the preservation of the anterior and/or posterior cruciate ligament (ACL/PCL) when used in conjunction with a femoral, tibial and patellar component.
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic 1. 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 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 components* are intended only for uncemented biologic fixation application.
*where available
The subject Vanguard XP Knee System line extension introduces the 59mm XP-XP Tibial Tray, modifications to corresponding 59mm XP-XP and XP-AS bearings, implant-specific instrumentation, differential bearing (thickness and/or articulation) compatibility and MR conditional labeling for the system.
The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of Co-Cr-Mo, two styles of tibial trays manufactured of Co-Cr-Mo (with locking bar), and dual bearings machined of E1 poly. Biomet patellae can be used with the Vanguard XP Knee System. The subject Vanguard XP-XP tibial components are available in Biomet's Interlok coarse blasted finish for cemented fixation.
This document is a 510(k) premarket notification for the "Vanguard XP Knee System". It focuses on a line extension, specifically the introduction of a 59mm XP-XP Tibial Tray and related components. The document describes the device, its intended use, and provides a summary of performance data (non-clinical tests) used to demonstrate substantial equivalence to existing predicate devices.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics in the way one might expect for a new artificial intelligence (AI) device. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the performance of the new device (Vanguard XP Knee System line extension) is comparable or equivalent to the predicate devices.
| Test Category | Specific Test | Implied Acceptance Criteria (relative to predicate) | Reported Device Performance (Summary) |
|---|---|---|---|
| Mechanical Performance | Wear | Comparable wear characteristics | Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary) |
| Contact Area | Comparable contact area | Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary) | |
| Constraint | Comparable constraint characteristics | Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary) | |
| Tibiofemoral Stability Locking mechanism test | Acceptable locking mechanism stability | Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary) | |
| Tibial Tray fatigue Test | Acceptable fatigue life | Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary) | |
| Bearing Micromotion Analysis/Cyclic Locking Mechanism Test | Acceptable micromotion and locking mechanism performance | Non-clinical performance testing completed to support substantial equivalence. (Specific results not detailed in this summary) | |
| Magnetic Resonance (MR) Compatibility | RF heating (ASTM F2182-11a) | Meet MR Conditional requirements | Determined to be MR Conditional in accordance with ASTM F2503-13. (CEM43 analysis also mentioned) |
| Image Distortion (ASTM F2119-07) | Meet MR Conditional requirements | Determined to be MR Conditional in accordance with ASTM F2503-13. | |
| Magnetically Induced Displacement Force (ASTM 2052-14) | Meet MR Conditional requirements | Determined to be MR Conditional in accordance with ASTM F2503-13. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study or a study involving a "test set" of patient data in the context of an AI device. The "tests" described are non-clinical (mechanical and MR compatibility) and would involve physical devices or components, not a patient data set. Therefore, sample sizes for a test set and data provenance (country, retrospective/prospective) are not applicable or provided in this document as it pertains to a traditional medical device, not an AI/software device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a knee implant, not an AI diagnostic or prognostic tool. "Ground truth" in the context of expert consensus on patient data is not relevant to the non-clinical mechanical testing and MR compatibility testing described.
4. Adjudication Method
Not applicable, as this is not a study involving expert review or a patient data test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a traditional medical device (knee implant) premarket notification, not an AI device. An MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance Study
No. This document is for a physical medical device (knee implant), not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests described would be based on established engineering principles, material science standards (e.g., ASTM standards for MR compatibility, fatigue testing), and comparison to the performance of legally marketed predicate devices. The "truth" is determined by whether the device meets specific physical and performance characteristics as defined by these standards and comparison.
8. Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
§ 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.