(243 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.
Specific indications are as follows:
- 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 total joint replacement procedure.
Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application.
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/plates 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. Both the XP femoral and the XP-CR tibial components are available with a previously cleared porous plasma spray (PPS) coating of titanium alloy and Biomet's Interlok® coarse blasted finishes. The Vanguard XP-XP tibial components are available in Biomet's Interlok® coarse blasted finish. Porous coated femoral and tibial components are indicated for cemented and uncemented biological fixation application. Non-coated coarse blasted (Interlok®) femoral and tibial components are indicated for cemented application only. Accessory components are available including removable femoral pegs and femoral augments.
This document is a 510(k) summary for the Vanguard™ XP Knee System, a knee replacement device. It establishes substantial equivalence to previously cleared predicate devices through non-clinical performance testing.
Here's an analysis of the provided information, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside performance data with specific numerical values or success/failure metrics. Instead, it lists various non-clinical tests performed and states:
"All testing met or exceeded the established acceptance criteria."
This indicates that acceptance criteria were internally defined and met, but the specific thresholds and quantitative results are not disclosed in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document relates to non-clinical (mechanical) testing of a medical device (knee implant components). These types of tests typically do not involve human subjects or retrospective/prospective data from patients.
- Sample size for the test set: Not explicitly stated but implied to be sufficient for mechanical testing according to established standards. The tests mentioned (e.g., Tibiofemoral Mechanical Stability, Cyclic Fatigue of Tibial Tray, Wear Test) would involve multiple samples of the components under various load conditions.
- Data provenance: Not applicable in the context of human data. The tests were performed on the device components themselves.
- Retrospective or prospective: Not applicable.
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)
This is not applicable as the study involves non-clinical mechanical testing of an orthopedic implant, not medical image analysis or clinical diagnosis. Ground truth would be defined by engineering specifications and physical measurements, rather than expert clinical consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept applies to clinical studies or studies where human expert review is required to establish ground truth or evaluate outcomes, typically in image analysis or diagnostic contexts. For mechanical testing, outcomes are determined by physical measurements against predefined engineering standards.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation systems, which is not the nature of this medical device (a knee implant). The submission focuses on demonstrating the physical and mechanical performance of the implant components.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance study was not done. This is not an AI/software device. The product is a physical knee implant system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this type of non-clinical performance data is based on engineering specifications, established industry standards (e.g., ASTM standards for medical devices), and predefined physical and mechanical thresholds. For example, a wear test would have an acceptance criterion for maximum allowable material loss after a certain number of cycles, and the "ground truth" is measured wear, compared against this criterion. Similarly, fatigue tests would have criteria for the number of cycles to failure at a given load.
8. The sample size for the training set
Not applicable. This device is a physical implant, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.