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The Mpact implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, rheumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.

• · 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 where sufficient bone stock is present

The Mpact Extension implants are a line extension to Medacta's Mpact (K103721) and Mpact Extensions (K122641, K132879, K183582 and K200391) Systems and are designed to be used with the Medacta Total Hip Prosthesis System. Specifically, the devices subject of this submission are:

• Liners sizes 22/A and 28/A of each design type (flat, hooded, offset +4mm and face changing . +10°);
• Acetabular Shells size Ø44 of each design type (No-hole, Two-holes and Multi-holes); ●
• Acetabular Shells sizes from Ø42T to Ø58T of each design type (No-hole, Two-holes and Multi-● holes) allowing to be coupled with an increase size of liner.

The Mpact Extension implants are sterile implantable devices intended to be used during Total Hip Arthroplasty: the acetabular shells together with their respective liners are used to replace the acetabulum.

Analogously to the predicate devices, the subject acetabular shells are made of Ti6Al4V according to ASTM F136-13 and Ti coated according to ASTM F1580-18, while the subject liners are made of High-Cross ultra-high molecular weight polyethylene (UHMWPE).

The provided text does not describe an AI medical device, but rather an orthopedic implant (hip joint prosthesis). Therefore, the questions regarding acceptance criteria, study details, expert qualifications, adjudication methods, AI assistance, standalone performance, and training set information are not applicable to this submission.

The FDA 510(k) summary for the Medacta International S.A. Mpact Extension (K230011) outlines the device, its indications for use, comparison to predicate devices, and performance data for substantial equivalence.

Here's a summary of the information provided in relation to the device's performance, but not in the context of AI:

1. Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with corresponding device performance for an AI model. Instead, it lists the following non-clinical performance tests conducted to support substantial equivalence for the orthopedic implant:

   Acceptance Criteria (Implied by Test Type)	Reported Device Performance
   Acetabular cup fatigue assessment	Performed (Implicitly met industry standards for fatigue strength)
   Acetabular cup deformation assessment	Performed (Implicitly met industry standards for resistance to deformation)
   PE liners stability (Axial Disassembly Force) per ASTM F1820	Performed (Implicitly met ASTM F1820 standard)
   Evaluation of impingement risk	Performed (Rationale provided, implicitly acceptable risk)
   Evaluation of Range of Motion (ROM) per EN ISO 21535	Performed (Implicitly met EN ISO 21535 requirements)
   PE HC liner wear test	Rationale for wear test provided (This suggests either the wear characteristics were considered equivalent to predicates, or specific wear tests were deemed not necessary based on similarity to previously cleared devices, or a rationale was provided to explain why testing demonstrated acceptable wear. The document states "Rationale for wear test" which implies a justification was given, rather than a direct report of a wear rate.)
   Bacterial Endotoxin Test (LAL test) per European Pharmacopoeia §2.6.14	Performed (Implicitly met pyrogenicity standards)
   Pyrogen test per USP chapter	Performed (Implicitly met pyrogenicity standards; note that the devices are not labeled as non-pyrogenic or pyrogen-free)
   Biocompatibility	Assessed (Implicitly met biocompatibility standards)
   Shelf-Life evaluation	Performed (Implicitly demonstrated acceptable shelf-life)

2. Sample Size for Test Set and Data Provenance: Not applicable as this is not an AI device. The performance tests for the orthopedic implant are laboratory-based mechanical and biological tests, not statistical analyses using a test set of medical data.

3. Number of Experts and Qualifications: Not applicable. Ground truth for an AI device involves expert annotations; for an orthopedic implant, it's about meeting engineering and biological standards.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No clinical studies were conducted, and this is not a device that would typically involve human-in-the-loop AI assistance.

6. Standalone Performance Study: Not applicable. This refers to AI algorithm performance without human interaction. The device is a physical implant.

7. Type of Ground Truth Used: Not applicable in the AI sense. For the orthopedic implant, "ground truth" would be defined by established engineering standards (e.g., ASTM, ISO) for material properties, mechanical performance, and biocompatibility.

8. Training Set Sample Size: Not applicable. This device is not an AI algorithm requiring a training set.

9. Ground Truth for Training Set Establishment: Not applicable.

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