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The metaphyseal sleeve is intended for use in primary and revision knee joint replacement and in oncology cases. The metaphyseal sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral component with an intramedullary stem. The sleeve may be used across several product lines: the Limb Preservation System (LPS), the S-ROM system, and the fixed platform portion of the P.F.C. Sigma system. The previously cleared indications for use for these systems:

The LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

• malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) . requiring extensive resection and replacement:
• · patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid drithritis, requiring extensive resection and replacement;
• · revision cases for a failed previous prosthesis requiring extensive resection and replacement;
• · severe trauma requiring extensive resection and replacement.

The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The metaphyseal sleeve, the distal femoral component, the tibial components, and the nonporous coated straight and bowed stems are intended for cemented use only.

The S-ROM Modular Total Knee System was cleared as the "NOILES Posterior Stabilized Knee."

The NOILES Posterior Stabilized Knee is indicated for use with PMMA bone cement in primary or revised cases in patients:

• who have reached skeletal maturity and .
• for whom the surgeon has decided to resect both cruciate ligaments or whose cruciate . ligaments are absent or incompetent due to the following conditions: rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to a variety of diseases and anomalies, failure of a previous knee reconstruction procedure, trauma.

The P.F.C. Sigma Knee System is indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout.

This damage may also be a result of trauma or failed prior surgical intervention.

The P.F.C. Sigma Knee System is indicated for use with polymethylmethacrylate (PMMA) bone cement.

The metaphyseal sleeve is a component to the previously cleared Limb Preservation System (LPS). The titanium sleeve is used to fill metaphyseal defects in the distal femur and joins a knee femoral component with an intramedullary stem. The sleeve is cone-shaped, with an outer stepped anatomical taper to fill the metaphyseal region of the distal femur. All but the final four steps of the sleeve are porous coated. The sleeve ranges in size from 31 to 46mm, as measured at the widest (M/L width) portion of the sleeve.

Through the use of adapters, the sleeve is compatible on its proximal and distal ends with femoral stems and distal femoral components. The femoral stems and distal femoral components are from previously cleared DePuy knee systems such as the Limb Preservation System, the S-ROM® NOILES Total Knee System and the fixed platform of the P.F.C. Σ System.

On the distal end, the sleeves either mate directly with the posts on previously cleared femoral components (e.g., the S-ROM femoral) or, through the use of one of the two wrought cobalt chrome femoral to sleeve adapters, mate with previously cleared femoral components that do not have posts (e.g., the LPS femoral, the P.F.C. Σ TC3 or the P.F.C. Σ PS femoral). These adapters will be available in 3 offsets: +0, +5 and +10 millimeters.

On the proximal side, the sleeves mate with previously cleared stems, either directly (when using an S-ROM stem) or through the use of the titanium LPS P.F.C. Stem to Sleeve Adapter (when using a P.F.C. type fluted or cemented stem).

The provided document is a 510(k) summary for the LPS Metaphyseal Sleeve, a medical device. It describes the device, its indications for use, and establishes substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

Regulatory documents like 510(k) summaries focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against specific acceptance criteria. These types of performance studies are typically found in design validation documentation, which is not publicly available in a 510(k) summary.

Therefore, I cannot fulfill your request for the tables and information based on the provided text, as the necessary details are absent.

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