(366 days)
The indications for the Vanguard™ 360 Revision Knee System 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 joint replacement procedure.
These devices are single-use implants intended for cemented use only.
The Vanguard™ 360 Revision Knee System is a series of femoral, tibial and offset adapter components designed to work in conjunction with femoral stems, bearings, trays, augments and patella components of Biomet's previously cleared Maxim® and Vanguard™ SSK knee systems. These components can be used for either primary or revision procedures, but are specifically designed for use where there is inadequate bone stock. Biomet has developed this system in order to expand its product line for its currently marketed Vanguard™ [SSK] Knee System (K042757).
The Vanguard™ 360 femoral components are made of Co-Cr-Mo alloy and incorporate the validation features as the predicate Vanguard SSK femoral components. The tibial components incorporate the same tibial tray profile as the current Biomet Tibial Trays and the predicate Offset Tibial Tray design and are made of Ti-6A1-4V titanium alloy. The femoral and tibial components are designed for use with the Biomet knee stems cleared in the predicate MCK (Maxim ) System. A series of tibial and femoral augments made of Ti-6A1-4V titanium alloy, allow for the modularity to accommodate bone defects that may be present during revision surgeries. The Ti-6Al-4V titanium alloy Offset Adapter components in this system, allow the surgeon to offset the centerline between the stem and the femoral or tibial components throughout 360 degrees in the transverse axis. Titanium alloy Ti-6A1-4V bone screws can be used if additional screw fixation is warranted.
The provided document describes a 510(k) premarket notification for the "Vanguard™ 360 Revision Knee System." This submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish novel performance claims through clinical studies. Therefore, much of the information requested, such as sample sizes for test and training sets, expert qualifications, ground truth methods for AI, MRMC studies, and standalone algorithm performance, is not applicable to this type of regulatory submission.
Here's an breakdown of the relevant information provided and an explanation of why other requested details are absent:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are typically met through non-clinical testing demonstrating that the new device is as safe and effective as the predicate devices. The "performance" is shown by verifying that the device meets safety and functionality standards comparable to existing, legally marketed devices.
| Acceptance Criteria (Non-Clinical Test Type) | Reported Device Performance |
|---|---|
| Resisting in-vivo torque: Engineering Justification regarding cylindrical Boss geometry. | Demonstrated capability to resist in-vivo torque. |
| Femoral Boss alignment tab removal: Engineering Justification. | Addressed the removal of the alignment tab. |
| 80/20 Fatigue Strength: Verification testing. | All components passed testing. |
| Cantilever Beam Fatigue: Verification testing. | All components passed testing. |
| MRI Distortion: Testing according to ASTM F2119-07. | Satisfied ASTM F2119-07. |
| RF Heating: Testing according to ASTM F2182-09. | Satisfied ASTM F2182-09. |
| Magnetically Induced Displacement Force/Torque Deflection: Testing according to ASTM F2052-06e1. | Measured 5° or less in 3.0T MRI System, passed testing. |
| Overall MRI Compatibility: Determined according to ASTM F2503-08. | Components are MR Conditional within ASTM F2503-08 definition. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This submission relies on non-clinical engineering and laboratory testing, not a clinical test set with patient data. The "test sets" here refer to test specimens or setups for mechanical and material property evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. Ground truth in the context of this 510(k) refers to established engineering standards, material specifications, and mechanical performance requirements, not expert clinical interpretations of diagnostic data. The "experts" would be the engineers and scientists conducting the described non-clinical tests.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods are typically for clinical studies involving human interpretation or uncertain outcomes. For engineering tests, results are typically determined by established test protocols and predefined acceptance limits.
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. This is a medical device (knee implant) submission, not an AI/software device. No MRMC studies were performed, and AI assistance is not involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For this 510(k) submission, the "ground truth" for non-clinical testing is based on:
- Established engineering principles and calculations (e.g., for resisting in-vivo torque, and addressing the femoral boss alignment tab removal).
- Industry standards and specifications (e.g., ASTM standards for MRI compatibility tests: ASTM F2119-07, ASTM F2182-09, ASTM F2052-06e1, ASTM F2503-08).
- Pre-defined acceptance criteria for mechanical strength and fatigue tests (80/20 Fatigue Strength, Cantilever Beam Fatigue).
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device. No "training set" was used.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As no training set was used, no ground truth needed to be established for it.
§ 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.