Search Results

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 and is intended for cemented application only.

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 is a 510(k) premarket notification for a medical device (Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis), not a study evaluating software or an AI device. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI device performance metrics (like sensitivity, specificity, or reader improvement) is not applicable here.

The document discusses the substantial equivalence of the "Maxim Removable Molded Poly Tibia" prosthesis to other commercially available tibial components based on its function and overall design. The FDA's letter states that they have "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976."

Therefore, I cannot provide the requested information as it pertains to a different type of device assessment than what is presented in the provided text.

Ask a specific question about this device

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.

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.

Ask a specific question about this device