(152 days)
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or 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 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 purpose of the submission is a line extension of the Vanguard XP femoral component. The Vanguard XP femoral component is now compatible with the standard Vanguard bearings components when using Vanguard tibial trays.
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.
The Vanguard XP Knee System is made up of multiple components, including: instrumentation, femoral components, several types of bearings and tibial travs.
The provided text is a 510(k) summary for the Biomet Vanguard XP Knee System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study to prove safety and effectiveness from scratch. Therefore, the information provided aligns with what is typically found in a 510(k) submission and does not describe a study in the way one might expect for a novel AI device or a new drug.
Based on the provided information, I can answer your questions as follows:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and device performance in numerical terms as one might expect for an AI or software-based device with specific metrics like accuracy, sensitivity, or specificity. Instead, the performance is demonstrated through a series of non-clinical tests designed to show that the "line extension" modifications do not adversely affect safety and efficacy compared to the predicate devices. The acceptance criteria essentially were that the tests met or exceeded established standards for knee prostheses.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | The device's mechanical properties (e.g., wear, constraint, contact area, fatigue, range of motion, surface roughness) for the line extension should be comparable to or better than the predicate devices and meet established orthopedic device standards (e.g., ASTM standards, ISO standards, or internal design specifications for knee prostheses, although specific standard numbers are not given here). The modifications should not adversely affect safety and efficacy. Porous plasma spray coating characterization should be consistent with previously cleared data. Previously cleared P/F contact area and stability testing were used to support unchanged P/F articulating geometry. | "All testing met or exceeded the established acceptance criteria." |
"The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices."
"The technological characteristics of the Vanguard XP Knee System are the same as those of predicate devices... in terms of design, material, and principle of operation with the exception of slight modifications... The subject Vanguard XP femur modifications utilize the identical manufacturing processes as the predicates. The previously cleared, porous plasma spray characterization data on identical substrate was provided in K113550 and used in support of subject 510(k). Previous P/F contact area and stability testing were provided in support of unchanged P/F articulating geometry." |
| Material Composition | Materials used should be biocompatible and consistent with the predicate devices and established orthopedic standards (e.g., Co-Cr-Mo, E1 poly). | "composed of Co-Cr-Mo," "dual bearings machined of E1 poly." Implied consistency with predicates. |
| MRI Compatibility | The device should be compatible with MRI procedures, or a rationale for its compatibility established. | "MRI Compatibility Rationale" was performed, and the overall conclusion is that the device "did not raise any new safety and efficacy issues." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "non-clinical tests" which are typically laboratory-based mechanical or material tests. It does not specify sample sizes in the context of human subjects or clinical data. No human data (clinical or retrospective/prospective) was used for this 510(k) submission. Therefore, provenance such as "country of origin of the data" or "retrospective/prospective" is not applicable in this context.
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. The product is a physical medical device (knee prosthesis), not a diagnostic algorithm or AI system that requires expert interpretation to establish a ground truth for a test set. Evaluation relies on engineering and materials testing by qualified personnel, not medical experts establishing ground truth for diagnostic images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or studies involving human expert assessment where there might be disagreement that needs to be resolved. This submission relies on engineering and material testing, which typically have objective measurements against defined 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
This is not applicable. An MRMC study is designed for evaluating diagnostic tools, often involving AI, and comparing human performance with and without AI assistance. The Vanguard XP Knee System is a prosthetic implant, not a diagnostic tool or AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device like a knee prosthesis, "ground truth" for performance is typically established through:
- Engineering specifications and standards: Adherence to established ASTM (American Society for Testing and Materials) or ISO (International Organization for Standardization) standards for materials, fatigue life, wear, strength, etc.
- Bench testing: Direct measurement of physical properties and performance under simulated physiological conditions.
- Material characterization: Analysis of material composition, surface properties, and coatings.
In this case, the "ground truth" for the non-clinical tests was adherence to either established internal acceptance criteria based on validated methods or industry standards. The previously cleared predicate devices and their established performance also served as a "ground truth" for comparison for the line extension.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable (see point 8).
§ 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.