(107 days)
The hip prosthesis MasterLoc® is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia:
· Avascular necrosis of the femoral head;
· Acute traumatic fracture of the femoral head or neck;
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
A hip prosthesis consists of a femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The acetabular components consists of a metal cup, and a liner that is made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components can be: Versafitcup, Versafitcup CC Trio, Mpact, Medacta Bipolar Head.
All the auxiliary components of the prosthesis are supplied in single-use individual packages.
The MasterLoo® stems can be combined with the CoCr ball heads, Endo Head or with the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads. Refer to the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads package insert and to CoCr heads package insert for more information about ball heads.
The provided text is a 510(k) summary for the Medacta MasterLoc Stem, a hip prosthesis. It describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device, which is what your request implies by questions about sample sizes for test/training sets, ground truth, experts, and MRMCs.
This document describes the regulatory clearance process for a physical medical device (hip implant) based on its similarity to existing, legally marketed predicate devices. The "performance testing" section refers to mechanical and material testing, not the performance of an AI algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance (for an AI/ML device): The document refers to mechanical engineering standards (e.g., ISO 7206-4, ISO 7206-6, ASTM F2009-00) for testing the physical implant's strength, durability, and stability. It states that "The new test successfully met acceptance criteria" without detailing the specific criteria or exact performance values, as these are related to the mechanical properties of the implant, not diagnostic accuracy of an AI.
- Sample size used for the test set and data provenance: Not applicable, as this is not an AI/ML study.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not applicable.
- If a standalone performance study was done: The document describes "Performance Testing" for the physical implant, which is a standalone evaluation of its mechanical properties against standards, not an AI algorithm's performance.
- The type of ground truth used: For a physical implant, "ground truth" would be established by engineering standards and validated physical testing against those standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a physical hip implant, not an AI/ML medical device. Therefore, the specific questions you asked regarding AI/ML device validation and ground truth establishment are not addressed by this text.
§ 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.