Search Results

The hip prosthesis AMIS-K Long is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.

Total hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, rheumatoid 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, partial hip arthroplasty, hip resurfacing replacement, or total hip arthroplasty.

Partial hip arthroplasty is indicated in the following cases:
· Acute traumatic fracture of the femoral head or neck

• · Non-union of femoral neck fracture
• · Avascular necrosis of the femoral head.
• · Primary pathology involving the femoral head but with a non-deformed acetabulum.

The AMIS-K Long cemented stem is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.

The AMIS-K Long is a straight, double-tapered cemented stem whose primary stability is ensured by bone cement.

The AMIS-K Long implants in this submission are comprised of the following size: from #2 to #5 with 2 different stem body size for #2, #3 and #4, 1 different stem body size for #5. Stem length: 200 - 250 - 300 mm (for each size).

The AMIS-K Long implants are part of the Medacta Total Hip Prosthesis system.

The Medacta Total Hip Prosthesis system consists of femoral stemoral heads, and acetabular components.

The AMIS-K Long are cemented stems manufactured from high nitrogen stainless steel (ISO 5832-9) with a mirror polished surface.

The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high polyethylene (HXUHMWE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352, K120531 and K122911), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967).

The AMIS-K Long implants can be combined with the CoCr Ball Heads (K072857 and K080885). Endo Head (K111145), or MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).

The provided text is a 510(k) summary for a medical device (Amis K Long hip prosthesis), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance. Specifically:

• No acceptance criteria for AI/ML performance are listed. The acceptance criteria mentioned refer to non-clinical performance tests for the physical hip prosthesis (e.g., pull-off strength, fatigue testing).
• No study proving AI/ML device performance is described. The document explicitly states "No clinical studies were conducted." and describes non-clinical mechanical tests.
• The requested elements (sample size, data provenance, expert qualifications, etc.) are not applicable in this context as the document is about a physical implant, not an AI/ML diagnostic or assistive device.

The study described in the document primarily focuses on non-clinical mechanical tests to validate the physical properties of the hip prosthesis, such as pull-off strength, range of motion, and fatigue. These tests adhere to established international standards (ASTM, EN ISO, ISO).

In summary, the provided text does not contain the information necessary to answer the questions about acceptance criteria and a study proving device performance as they relate to AI/ML or diagnostic accuracy.

Ask a specific question about this device