Search Results

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

The AcuMatch A-Series Porous Coated Acetabular Components are indicated for pressfit and cemented applications.

The A-Series acetabular component is a two piece device consisting of a porous metal acetabular shell and a mating polyethylene liner. The metal component is machined from titanium alloy (Ti-6A1-4V) conforming to ASTM F136-96. Three layers of chemically pure titanium beads conforming to ASTM F67-95, grade 2, are sintered to the outer surface of the metal shell to produce the porous coating.

There are three basic shell designs, each of which is available in 14 sizes. Each shell type is available with and without a hydroxyapatite (HA) coating on the beaded surface. The HA coating characteristics are defined in FDA Master File MAF 339 (BioCoat, Inc.).

The A-Series cups are intended for press-fit applications. Components without the HA coating may also be used in cemented applications. Instrumentation is used to prepare the cavity of the acetabulum for implanting of the shell. The A-Series shells are designed such that an interference condition is created between the prepared acetabulum and the rim diameter of the porous coated shell. Instrumentation is used to impact the shell into the bone for a secure fit. The cluster and multi-hole designs allow for use of Ti-6Al-4V bone screws to supplement fixation if desired.

The A-Series acetabular liner is composed of ultra-high-molecular-weight polyethylene (UHMWPE) as called out in ASTM F648-98. There are five primary liner designs with various sizes having the ability to accept 22, 26, 28, and 32 mm diameter femoral heads. The minimum bearing thickness for each liner type is greater than 6 mm.

The A-Series has an apical hole locking mechanism and a 12-tab anti-rotational indexing system at the rim of the cup.

The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device, specifically the Exactech® AcuMatch A-Series Porous Coated Acetabular Component. This document is a premarket notification to the FDA, demonstrating substantial equivalence to legally marketed predicate devices, rather than a study proving new acceptance criteria for the device's performance.

Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as it relates to performance metrics typically found in AI/ML medical device evaluations (e.g., sensitivity, specificity, F1 score, effect size from MRMC studies).

Here's why the requested information isn't present in this document type:

• Acceptance Criteria and Reported Device Performance: This document establishes "substantial equivalence" based on similar materials, design, intended use, and technological features to previously approved devices. It does not define new, specific performance acceptance criteria (like diagnostic accuracy metrics) for the A-Series acetabular component itself. The "performance" discussed is primarily related to mechanical properties and design aspects compared to predicate devices.
• Sample Size and Data Provenance: This is not applicable as it's not an AI/ML study with a test set of data.
• Number of Experts and Qualifications: Not applicable for this type of device submission.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable as it's not an algorithm.
• Type of Ground Truth: Not applicable, as there's no diagnostic task or "ground truth" in the AI/ML sense.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does provide in relation to "performance":

The document focuses on demonstrating that the A-Series component is substantially equivalent to existing, legally marketed hip prosthesis acetabular components. This equivalence is shown through:

• Material Equivalence: Identical material specifications (titanium alloy for the shell, UHMWPE for the liner) as predicate devices.
• Design Equivalence (with variations and comparative testing):
  • Similar hemispherical outside geometries.
  • Similar surface coatings (three uniform layers of titanium beads, optional HA coating).
  • Differences in shell hole configurations (no-hole, multi-hole, cluster hole) and liner designs (extended coverage, lateralized options) compared to the MCS line.
  • Mechanical Testing for Design Differences: "Tests were performed to determine the torsional strength of the proposed A-Series system in comparison to Exactech's MCS cup. The torsional study shows that the locking mechanism on the A-Series is stronger than the same size MCS component. Another engineering evaluation shows that the force required to disengage an A-Series liner from its shell exceeds the force required to disassemble the MCS component."
  • Clearance Modeling: An "engineering report modeling the clearance between the spherical radius of the A-Series shell and liner shows a 0.008 inch difference for the least material condition and 0.001 inch difference for the maximum material condition."
  • Lever Out Torque Analysis: "Lever out torque analysis of the new Exactech A-Series component places the strength of the locking mechanism in the range of other legally marketed devices."

Essentially, the "study" demonstrating performance here is an engineering evaluation and comparative mechanical testing (torsional strength, disengagement force, lever out torque) against predicate devices to show that any design changes do not negatively impact safety and effectiveness or, in some cases, show improvement. However, these are not quantified in terms of specific acceptance criteria or an AI/ML study format.

Ask a specific question about this device