(193 days)
The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
This document is a 510(k) premarket notification for a medical device: Zirconia ceramic femoral heads for use with specific hip stems. The content is primarily a summary of safety and effectiveness used to demonstrate substantial equivalence to predicate devices, rather than a detailed study report with acceptance criteria and performance data.
Therefore, the requested information regarding acceptance criteria, device performance, study details, and ground truth cannot be fully extracted from the provided text. The document focuses on demonstrating that the new Zirconia ceramic heads are comparable in material, design, and clinical indications to existing, cleared devices.
Based on the provided text, the following information can be stated:
- Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in the document. The filing is a 510(k) premarket notification, which relies on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo acceptance criteria with detailed performance metrics.
- Sample Size Used for the Test Set and Data Provenance: Not applicable. This document is not a report of a clinical trial or a test set evaluation. It's a regulatory submission demonstrating equivalence.
- Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: Not applicable. This document does not describe a ground truth establishment process for a test set.
- Adjudication Method for the Test Set: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (femoral head), not an algorithm or AI system.
- The type of ground truth used: Not applicable in the context of an AI/algorithm. For a physical device, "ground truth" would relate to material properties, wear performance, or clinical outcomes, which are not detailed as a "ground truth" for a specific test set in this document. The "truth" in this context is established through a body of evidence including material testing and comparable clinical performance of predicate devices.
- Sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary of the document's relevance to the request:
The document outlines an intention to market Zirconia ceramic heads for hip replacement prostheses. The core of the submission is to establish substantial equivalence to predicate devices. This means that instead of presenting a new study with explicit acceptance criteria for performance, the submission argues that the device is "equivalent in material, design and clinical indications" to already cleared devices. This equivalency is the "proof" that the device meets regulatory requirements.
The predicate devices mentioned are Zirconia heads manufactured by Demarquest for Zimmer (K944601), DuPuy (K926395), and Smith and Nephew Richards, Inc. (K935921). The "acceptance criteria" are effectively that the new device performs sufficiently similar to these cleared predicate devices according to established material and design standards for hip prostheses.
§ 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.