(56 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 treatment, the devices are indicated for:
· Non-inflammatory degenerative ioint 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 or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics' World Cup components are intended for cementless fixation only.
The primary purpose of this Special 510(k) Device Modification to devices cleared as part of the World Cup System (K201278 and K241690) is to notify the FDA of additional geometrical variants of the World liner available in crosslinked UHMWPE (XLPE) and Vitamin-E Stabilized, 100kGy crosslinked UHMWPE (Vit-E HXLPE) material options.
The World Liners are compatible with World Acetabular Cups and are available in neutral, and hooded, lateralised, high wall, face changing and eccentric variants. The liners are designed to sit within an acetabular shell and articulate with a femoral head.
The provided document is an FDA 510(k) clearance letter for a medical device called "World Liner," which is a component of a hip replacement system. It primarily details the regulatory clearance process, the device's indications for use, and a comparison to predicate devices, emphasizing that the new "World Liner" variants are substantially equivalent to previously cleared versions.
However, this document does not contain any information about acceptance criteria, specific study designs (like MRMC or standalone performance studies), sample sizes for test or training sets, expert qualifications, or ground truth establishment methods as would be expected for an AI/ML-based device submission.
The "Performance Testing" section is extremely brief and only mentions "Engineering evaluations" and "Range of Motion assessment per ISO 21535." These are typical for mechanical devices to demonstrate physical performance and compatibility, not for evaluating the performance of an AI/ML algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance: This information is not present.
- Sample sizes used for the test set and data provenance: Not mentioned.
- Number of experts used to establish ground truth and qualifications: Not mentioned, as there is no apparent AI/ML ground truth evaluation.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study details: Not mentioned.
- Standalone performance details: Not mentioned.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
This document is for a mechanical medical device (hip liner), not an AI/ML-driven device. As such, the type of performance data and evaluation criteria you are asking about (which are relevant for AI/ML) are not applicable or present in this context.
§ 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.