(214 days)
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treat, the devices are indicated for:
- · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
- · Inflammatory joint disease including rheumatoid arthritis
- · Correction of functional deformity including congenital hip dysplasia
- · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
- · Failed previous hip surgery including internal fixation, reconstruction, hemiatthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan, World and Encore femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.
Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.
Signature Orthopaedics' SignaSure Insert is indicated for use with the cementless Signature Orthopaedics' Logical Acetabular Cup to provide dual mobility articulation.
Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- · Acute femoral head or neck fracture
- · Fracture dislocation of the hip
- · Avascular necrosis of the femoral head
- · Non-union of femoral neck fractures
- · Certain high subcapital and femoral neck fractures in the elderly
- · Degenerative arthritis involving only the femoral head
The SignaSure Dual Mobility System consists of cementless and cemented shells, and a poly component. The SignaSure Poly is manufactured from crosslinked polyethylene and is spherical in geometry with outer and inner spherical conforming articular surfaces. The inner articular surface mates and retains a femoral head. The outer articular surface articulates within the highly polished inner diameter of the SignaSure Cementless or Cemented Cup. The SignaSure Cementless Cup is manufactured from CoCr alloy and is sequentially plasma sprayed with titanium coating and hydroxyapatite to gain cementless fixation. The SignaSure Cemented Cup is manufactured from CoCr alloy and is grit blasted and macro textured to aid in fixation via bone cement.
This document is a 510(k) premarket notification for a medical device called the SignaSure Dual Mobility System, which is a hip replacement prosthesis. The document does not describe specific acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML algorithm or a diagnostic device.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the cornerstone of the 510(k) pathway for medical devices. The performance testing mentioned is for the physical device itself (a hip implant), not for an AI algorithm.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, sample sizes, ground truth establishment, or human reader effectiveness improvement, as these concepts are not applicable to the content of the provided document.
The document does mention:
- Performance Testing: Non-clinical testing and engineering evaluations were conducted to verify that the performance of the SignaSure Dual Mobility System is adequate for anticipated in-vivo use. The specific tests performed were:
- Head assembly/disassembly/lever out testing
- Range of motion analysis
- Coating adhesion
- Articular surface wear
- Impingement testing
- Post impingement lever out testing
These tests are typical for mechanical hip implants to assess their durability, functionality, and structural integrity. The document states that these results support the substantial equivalence claim, meaning the device's performance is comparable to marketed predicate devices.
However, none of the other requested information (related to AI acceptance criteria, clinical study design for AI, training/test sets, expert adjudication, MRMC studies) is present in this FDA 510(k) document.
§ 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.