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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, internal fixation, arthrodesis, 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 MasterLoc® 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 describes a 510(k) premarket notification for a hip prosthesis called the "MasterLoc Stem." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria for a novel AI/software medical device.

Therefore, the information required to answer your prompt, which is tailored for an AI/software medical device (e.g., acceptance criteria for model performance, training/test set details, expert ground truth establishment, MRMC studies), is not present in the provided document.

The document details:

• Device Name: MasterLoc Stem
• Regulation Number/Name: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
• Regulatory Class: Class II
• Product Codes: LZO, LPH, MEH, KWY, LZY
• Indications for Use: Cementless use in total or partial hip arthroplasty in primary or revision surgery for conditions like arthritis, avascular necrosis, femoral head/neck fracture, or failure of previous hip surgery.
• Predicate Devices: K052792 ANTHOLOGY Hip Stem (Smith & Nephew, Inc.) and K072857 Medacta Total Hip Prosthesis (Medacta International).
• Performance Testing: Mechanical testing (e.g., ISO 7206-4, ISO 7206-6, EN ISO 21535, ASTM F2009-00) for risks like breakage, limited range of motion, coating adhesion, and modular connection instability. These are physical product performance tests against engineering standards, not AI/software performance criteria.

In summary, this document does not contain the information needed to fill out your requested table and details for an AI/software medical device.

If you have a document describing the validation of an AI/software medical device, please provide that, and I would be happy to help.

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