Search Results

The subject Trident Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts.

Indications:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

The subject Trident Acetabular Shells are characterized by the following features:

• Shell substrate: Ti6Al4V alloy. .
• Surface coating: PS-HA. This coating is comprised of a rough layer of plasma-sprayed . CP Titanium beneath a thin layer of Hydroxylapatite (HA). This coating is similar to the AD-HA coating (a rough layer of arc-deposited CP Titanium beneath a thin layer of HA) featured on the predicate Trident Acetabular Shells , and identical to the coating found on the predicate Citation TMZF HA Hip Stems.
• Outer Shell Geometry: The subject series of Trident Acetabular Shells will include one version with the patented Dual Radius (PSL®) outer geometry and one version with a single-radius (hemispherical) outer geometry:
• Inner Shell Geometry: An interior geometry which accommodates the predicate Trident Polyethylene Acetabular Insert through a wireless locking mechanism.
• Apical Dome Hole: This dome hole (which is not intended to receive a bone screw) is featured on all subject shell versions, and allows for attachment of the shell to implantation/removal instrumentation.
• Screw Hole Configurations: The subject shells are available in all of the following screw hole configurations:
  • Solid Back: No Screw Holes.
  • 3-Hole: Three screw holes clustered on the dome of the shell. -
  • 5-Hole: Five screw holes clustered on the dome of the shell.
  • Multi-cluster: A number of screw holes (ranging from 4 to 16, depending on shell size) scattered across the dome of the shell.
  • X'tra Solid Back: Features screw holes around the periphery of the shell, but no dome screw holes.
  • X'tra Multi-cluster: Features screw holes around the periphery of the shell, and a number of screw holes (ranging from 4 to 16, depending on shell size) scattered across the dome of the shell.
  • A range of outer diameter (O.D.) sizes from 40 through 80mm, in 2mm increments

In addition, the following design feature is exclusive to the Dual Radius (PSL®) versions of the subject devices:

• Circumferential Normalizations: Normalizations are distinct steps which are machined into the exterior of the shells. The circumferential normalizations on the subject shells begin at the peripheral lip and progress approximately three fourths of the way up the face of the shells, decreasing gradually until the step profile is negated by the PS-HA coating.

The provided text is a 510(k) summary for a medical device called "Trident Acetabular Shells: PS-HA." This document describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. It is not a study that provides detailed device performance data or acceptance criteria in the manner requested.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the document does not contain this information.

Specifically, the document states under "Performance Data":
"Test data characterizing the PS-HA coating was provided in accordance with relevant FDA guidance documents. The shell-to-insert locking mechanism was tested to characterize fatigue strength, push-out resistance, and lever-out torque resistance. (This test data was incorporated by reference to a previous 510(k))."

This section indicates that some testing was performed and "test data was provided," but it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set.
3. Data provenance, number of experts, adjudication methods, or ground truth details.
4. Information about MRMC studies, standalone algorithm performance, or training set details.

The document merely states that tests were done and submitted, and implies that the results supported the claim of substantial equivalence. It does not present the results or the acceptance criteria themselves.

Ask a specific question about this device