(87 days)
The subject Trident Acetabular Shells are single-use devices intended for cemented or 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: a rough layer of plasina-sprayed CP Titanium.
- 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 any 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 one third of the way up the face of the shells, decreasing gradually until the step profile is negated by the PS coating.
The provided text is a 510(k) summary for the Trident Acetabular Shells. It describes a medical device and its predicate devices, not a study involving a device with acceptance criteria in the sense of a performance evaluation against specific metrics by a machine learning model.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document because it pertains to the regulatory submission for a physical medical implant, not a diagnostic or AI-driven device being evaluated against performance metrics.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on materials, indications for use, and design.
The "Performance Data" section states:
Test data characterizing the plasma-sprayed Titanium 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. (All test data was incorporated by reference to previous 510(k)s).
This indicates that specific mechanical tests were performed for the physical components, but it does not detail the acceptance criteria for these tests or the results in a manner that aligns with the questions posed for an AI/diagnostic device.
In summary, none of the requested information regarding acceptance criteria and performance against those criteria in the context of an AI/diagnostic study is present in the provided text.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.