(176 days)
The Vanquard® Cruciate Molded Poly Tibia is intended for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved; 2. Failure of a previous joint replacement procedure 3. Correction of varus, valgus, or post traumatic deformity; 4. Correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant intended for use with bone cement.
The Vanguard® Removable Molded Poly Tibia (also referred to as the Vanguard® Mono-Lock) is intended to replace the tibial articulating surface in a joint replacement and works in conjunction with previously cleared Vanguard® Knee Systems. There are three parts to the Vanguard® Removable Cruciate Molded Polyethylene Tibia component: the tibial plate (Co-Cr-Mo), tibial bearing (UHMWPE) and an insert (Ti-6AL-4V). The profile of the tibial plate is identical to that of the predicates. The stem geometry of the Vanguard® Removable Molded Poly Tibia is non modular and does not include the conical core geometry to house the female taper as the predicate K915132. The articulation surface is identical to the surface cleared in K060525.
This document describes a 510(k) premarket notification for a medical device, the Vanguard® Removable Molded Poly Tibia, which is a knee prosthesis. The submission seeks to demonstrate substantial equivalence to previously cleared predicate devices.
Acceptance Criteria and Device Performance:
The primary "acceptance criteria" in a 510(k) submission for a device like this are centered around demonstrating substantial equivalence to existing legally marketed predicate devices. This means proving that the new device is as safe and effective as a predicate device. For this specific device, the key performance aspects relate to the mechanical properties and design.
Since this is a knee prosthesis, "performance" is largely assessed through non-clinical mechanical testing and comparison to predicates. There are no clinical performance metrics in terms of patient outcomes or diagnostic accuracy in the same way one might have for an AI/ML device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Summary) |
|---|---|
| Material Composition Equivalence: Materials used are identical or equivalent to predicates. | The document explicitly states: "The technological characteristics (material, design, and sizing) of the Vanguard® Removable Molded Poly Tibia are identical to the predicate devices." (p.2/2) "The material... remain identical to the predicate devices." (p.2/2) |
| Design Equivalence (Articulation Surface): The articulating surface design is equivalent to predicates to ensure proper function and wear. | "The articulation surface is identical to the surface cleared in K060525." (p.1/2) |
| Tibial Plate Profile Equivalence: The overall profile of the tibial plate matches that of predicates. | "The profile of the tibial plate is identical to that of the predicates." (p.1/2) |
| Locking Mechanism Equivalence: The mechanism for securing the components is identical to predicates. | "The locking mechanism... remain identical to the predicate devices." (p.2/2) |
| Stem Design Performance (Fixed Cruciate vs. I-beam): The new fixed cruciate stem design performs equivalently to the predicate's fixed I-beam stem and other predicate designs. | The key change noted is the stem design: "the new device has a fixed cruciate stem whereas the predicate has a fixed I-beam stem." (p.2/2) To address this, "The CoCr Cruciate Plate 80/20 Fatigue Test Report is also provided to further indicate the devices are functional within its intended use." (p.2/2) This suggests the acceptance criterion was mechanical equivalence in fatigue performance for the new stem design. |
| Mechanical Strength and Durability: The device withstands forces and fatigue for its intended lifespan, demonstrated through relevant mechanical tests. | "Mechanical testing was previously performed to determine substantial equivalence and the following test reports were provided in the predicate 510(k): CoCr I-Beam Tray 80/20 Fatique Test Report, Removable Molded Tibia PS Post Fatigue Strength, 10mm PS Component - Intercondylar Polyethylene Thickness Analysis, Vanguard Removable Retention Test. The CoCr Cruciate Plate 80/20 Fatigue Test Report is also provided to further indicate the devices are functional within its intended use." (p.2/2) |
| Sizing Equivalence: Additional sizes are consistent with existing predicate sizing and performance. | "Additional sizes to the tibial plate and bearing include 59mm, 87mm and 91mm, which are identical to the predicate devices in K915132." (p.2/2) This implies that the performance of these additional sizes is inherently covered by the existing predicate's characterization. |
| Intended Use Compatibility: The device is appropriate for the stated indications for use. | The intended uses are listed on p.1/2 and p.4/5, aligning with typical knee replacement indications. The substantial equivalence argument supports that the device is safe and effective for these uses given its similarity to predicates. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is primarily non-clinical mechanical testing and a demonstration of design and material equivalence to predicate devices.
Specific Information Requested:
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Sample sizes used for the test set and the data provenance:
- This submission relies on non-clinical mechanical testing rather than clinical data from human subjects. The "test set" would consist of physical device samples.
- The document lists several "test reports" such as "CoCr I-Beam Tray 80/20 Fatique Test Report," "Removable Molded Tibia PS Post Fatigue Strength," etc.
- The sample sizes for these specific mechanical tests are not explicitly stated in the provided text.
- Data Provenance: The tests are indicated as having been "previously performed" (for predicates) and some new tests (e.g., CoCr Cruciate Plate 80/20 Fatigue Test Report) were "provided to further indicate the devices are functional within its intended use." This implies the testing was likely conducted in a lab setting by the manufacturer, Biomet Manufacturing Corp., or a contract lab. The country of origin for the testing data is not specified but would presumably be related to Biomet's operations (USA, given the address in Indiana). The data is retrospective in the sense that many tests leverage previous data from predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is less applicable to a mechanical device 510(k) submission based on substantial equivalence and non-clinical testing.
- There is no "ground truth" in the clinical diagnostic sense established by human experts for a test set of patient data.
- The "ground truth" for mechanical testing is established by engineering standards and specifications (e.g., ISO, ASTM standards for medical device mechanically), often with verification by qualified engineers and testing technicians. The number and qualifications of these individuals are not specified in the document.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a concept used in clinical trials or studies with human reader performance assessment, not for mechanical device testing for substantial equivalence. The "adjudication" of mechanical test results would typically refer to review by quality control/engineering personnel to ensure adherence to protocols and standards.
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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 mechanical device, not an AI/ML diagnostic tool. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an AI/ML algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is based on engineering specifications, mechanical performance standards (e.g., fatigue strength, retention strength), and comparison to the proven performance of predicate devices. It's about demonstrating mechanical integrity and functional equivalence, not clinical diagnostic accuracy or patient outcomes data directly.
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The sample size for the training set:
- Not applicable in the context of an AI/ML device. For a traditional mechanical device, there isn't a "training set" in the machine learning sense. The "training" for such devices involves design iterations, material selection, and internal testing to optimize the product before formal verification tests.
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How the ground truth for the training set was established:
- Not applicable for the reasons stated above. Design and R&D involve iterative testing, but not a formally defined "training set" with ground truth in the AI/ML context.
§ 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.