(49 days)
This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
- Previously failed hip surgery.
- Proximal femoral neck fractures or dislocation.
- Idiopathic avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures.
- Treatment of fractures that are unmanageable using other forms of therapy.
- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
The subject device is a set of smaller stems that extends the size range of the previously cleared Trivicta® stems (K233758).
Trivicta® is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta® is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating.
The size range of the subject device is: lengths (97-101mm), horizontal offsets (36-43mm), vertical offsets (27-29mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.
Trivicta® is compatible with the following Ortho Development® devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.
The provided text is an FDA 510(k) clearance letter and associated summary for a hip stem device. This type of document describes the device, its indications for use, and a comparison to predicate devices, along with performance data to demonstrate substantial equivalence.
However, the information requested in your prompt regarding acceptance criteria for a software device, specifically around AI performance metrics like sensitivity, specificity, MRMC studies, ground truth establishment, training data, etc., is not contained within this FDA clearance document.
The document states under "Clinical Testing" (Page 7): "No clinical testing is required to establish the safety and effectiveness of Trivicta." This indicates that the clearance was based on non-clinical performance data (sterilization, shelf life, biocompatibility, mechanical testing) and comparison to predicate devices, not on a study involving AI performance or human-in-the-loop assessments as would be typical for medical AI devices.
Therefore, I cannot fulfill your request for the specific AI-related acceptance criteria and study details because the provided document is for a mechanical orthopedic implant, not an AI-powered diagnostic or therapeutic device.
§ 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.