(65 days)
Indications for use of knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or 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, and 4) correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant intended for use with bone cement.
The Maxim Removable Molded Poly Tibia is intended to replace the tibial articulating surface in a total joint replacement with Maxim femoral components cleared in 510(k) K915132. This device is a CoCr tibial plate with a removable molded UHMWPE tibial bearing that can be used with previously cleared modular Maxim tibial bearings.
This document is a 510(k) summary for the Biomet, Inc. Maxim Removable Molded Poly Tibia Device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria. Therefore, the requested information about acceptance criteria and a study proving the device meets them cannot be fully provided from the given text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a table of acceptance criteria or reported device performance metrics in the way typically found in a clinical or performance study report (e.g., sensitivity, specificity, accuracy, mechanical failure rates, etc.).
Instead, the document details the intended use and potential risks of the device, and discusses its substantial equivalence to existing devices on the market. The FDA's letter further clarifies specific limitations and conditions for marketing the device.
| Acceptance Criteria (Not explicitly stated in the document as such) | Reported Device Performance (Implied by substantial equivalence and intended use) |
|---|---|
| Functional Equivalence to legally marketed predicate devices | "In function and overall design the Maxim Removable Molded Poly Tibia Prosthesis is equivalent to other commercially available tibial components currently on the market." |
| Safety Profile comparable to existing knee joint replacement prostheses | Potential risks "are the same as with any joint replacement device." (A list of potential risks is provided: Reaction to bone cement, Fracture of components, Cardiovascular disorders, Implant loosening/migration, Soft tissue imbalance, Deformity of the joint, Delayed wound healing, Fracture of the cement, Bone fracture, Hematoma, Blood vessel damage, Nerve damage, Excessive wear, Infection, Metal sensitivity, Dislocation). |
| Material Composition for tibial plate and bearing | Device is a "CoCr tibial plate with a removable molded UHMWPE tibial bearing." |
| Specific Design Features | "Removable Molded Poly Tibia" intended to "replace the tibial articulating surface in a total joint replacement with Maxim femoral components cleared in 510(k) K915132." |
| Cemented Use Only | Device is intended for "cemented use only." (This is a condition of clearance, not an "acceptance criterion" per se, but implies the device's performance relies on cemented fixation). |
| Minimum Polyethylene Thickness | The thinnest nominal 12mm insert has a minimum polyethylene thickness under the condyles of 6.6 mm. (This is a design specification, not a performance criterion). |
2. Sample size used for the test set and the data provenance
The document does not report on a specific "test set" or a clinical study with associated sample sizes to demonstrate performance against acceptance criteria. The 510(k) submission process for this type of device typically relies on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than extensive new clinical performance data unless a new technological claim or significant difference warrants it.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no such test set or ground truth establishment is described in the provided document.
4. Adjudication method for the test set
Not applicable, as no such test set or adjudication process is described in the provided document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done or reported in this 510(k) summary. This type of study is more common for diagnostic imaging AI devices assessing human-in-the-loop performance, not mechanical implants.
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 or relevant. This device is a physical knee joint implant, not an algorithm.
7. The type of ground truth used
Not applicable, as the document focuses on substantial equivalence based on design, materials, and intended use, rather than a performance study requiring a "ground truth."
8. The sample size for the training set
Not applicable. This device is a physical implant, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.