(337 days)
The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
- · Rheumatoid arthritis;
- · Post-traumatic arthritis.
- · Correction of functional deformity;
- · Fractures, dislocation of the hip and unsuccessful cup arthroplasty.
- · Revisions in cases of good remaining bone stock.
Delta TT cup is intended for cementless use.
The Delta Dual Mobility System is intended to be used with Delta TT Acetabular System.
The subject Delta Dual Mobility System represents a dual mobility option for Delta TT acetabular system.
The Delta Dual Mobility System is intended for cementless use in total hip arthroplasty. The system is composed of an acetabular cup shell (previously cleared in K112898, K141395), a fixed liner, a mobile liner and a femoral head (previously cleared in K112158, K141327, K143509). Only femoral heads with offset S, M and L are intended to be used with Delta Dual Mobility System. The femoral head can be coupled with the previously cleared femoral stems. Bone screws that can optionally be used for additional fixation were cleared in K112898, K141395 and K172456.
The previously cleared acetabular cup shells are manufactured in titanium alloy: 14 cup shell sizes are intended to be used with dual mobility option. The CoCrMo fixed liners and the UHMWPE mobile liners are both available in 2 sizes. The previously cleared femoral heads are available in CoCrMo and Biolox Delta versions. Bone screws are provided for optional use to provide further primary fixation.
The provided document is a 510(k) premarket notification for a medical device, the Delta Dual Mobility System, and NOT a study report proving a device meets acceptance criteria. A 510(k) notification aims to establish substantial equivalence to a previously legally marketed device (predicate device), not necessarily to demonstrate performance against specific, pre-defined acceptance criteria through a clinical trial or extensive standalone performance study in the way an AI/ML device would be evaluated.
Therefore, the requested information regarding acceptance criteria, specific study design for proving performance, sample sizes, expert involvement, and ground truth establishment is not present in this document.
The document explicitly states:
- "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Dual Mobility System to the predicate devices." (Page 5)
Instead, the submission relied on:
- Comparison of intended use, indications, technical characteristics, materials, sizes, device usage, sterility, and expiration/shelf life to predicate devices.
- Non-clinical (mechanical) testing and engineering analysis to demonstrate substantial equivalence. These tests included:
- Pull-out and Lever-out of mobile liner
- Fixed liner push-out, lever-out and torque-out
- Fatigue-fretting off-axis
- Fatigue rim impingement
- Wear
- Simulation of Range of Motion
- LAL testing (bacterial endotoxin)
Since no clinical testing or performance study of the nature typically conducted for an AI/ML device was performed, I cannot provide the requested details. The information about the Delta Dual Mobility System pertains to a hip prosthesis, which is a physical medical device, not a software or AI/ML product.
§ 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.