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• Versafitcup CC TRIO

The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole 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, post-traumatic 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

• Quadra-P and Quadra-P Collared

The hip prosthesis Quadra-P and Quadra-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The Quadra-P Cemented is designed for cemented 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, traumatic 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• AMIStem-H, AMIStem-H Collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared

The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The AMIStem-C is designed for cemented 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, traumatic 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• MiniMAX

The MiniMax 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, traumatic 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• Quadra-H and Quadra-R

The hip prosthesis Quadra -S, Quadra-H and Quadra-R is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The hip prosthesis Quadra-C is designed for cemented 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, traumatic 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The Quadra-C size 0 implant should not be implanted in patients with a mass of 65 kg or greater.

• SMS and SMS Collared

The hip prosthesis SMS and SMS Collared are 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, traumatic 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• Mpres

The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.

Total Hip Arthroplasty with the Mpres stem is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head.
• Failure of previous hip surgery:
  • Conservative hip surgery,
  • Internal fixation,
  • Arthrodesis,
  • Hip resurfacing replacement.

Partial hip arthroplasty with the Mpres stem is indicated in the following cases:

• Acute traumatic fracture of the femoral head.
• Avascular necrosis of the femoral head.
• Primary pathology involving the femoral head but with a non-deformed acetabulum.

• Mpact Acetabular Shell

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, post-traumatic 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The aim of this submission is to seek clearance for the addition of a new coating supplier for the following coatings:

• Titanium + Hydroxyapatite coating;
• Hydroxyapatite coating;
• Porous Titanium coating for Mpact devices; and
• Titanium coating for Mpact T sizes devices.

The already FDA cleared devices affected by the change are listed in Table 1 below.

N/A

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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 <151>	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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The MPACT Extension 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, post-traumatic 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, hemiarthrodesis, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present

The MPACT implants subject of this submission are comprised of the following products:

• 33 sizes of Offset +4mm PE liners; and
• 32 sizes of Face-changing +10° PE liners.

These liners are a component of a total hip joint prosthesis that is used to replace the acetabulum. The component is an inner liner made of High-Cross ultra-high molecular weight polyethylene (UHMWPE); which is inserted in the Acetabular shell.

They are all a line extension to Medacta's MPACT (K103721), and MPACT Extensions (K122641 and K132879) Systems and are designed to be used with the Medacta Total Hip Prosthesis System. In detail, the Liners subject of the current submission are compatible with the MPACT No-Hole and Two-Hole (K132879), MPACT Multi-Hole and Rim-Hole (K132879); and the Mpact 3D Metal Acetabular Shells (K171966).

As regards to the femoral head components, the MPACT Extension Liners can be combined with the CoCr Ball Heads (K072857 and K080885), MectaCer Biolox Option Heads (K131518), or with the MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).

The provided text describes the regulatory clearance for a medical device called "MPACT Extension" and details the non-clinical performance data used to demonstrate its substantial equivalence to predicate devices. It explicitly states that no clinical studies were conducted. Therefore, the acceptance criteria and study information related to human performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to this submission.

Here's a breakdown of the relevant information from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that testing was conducted according to written protocols with acceptance criteria based on standards. The specific numerical acceptance values or individual performance results are not explicitly listed in this summary, but the general statement "device passed the tests, supporting substantial equivalence" implies that the acceptance criteria were met for all listed non-clinical tests.

2. Sample size used for the test set and the data provenance
Not applicable. No human test set was used as this was a non-clinical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No human test set was used.

4. Adjudication method for the test set
Not applicable. No human test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "No clinical studies were conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical implant (hip joint component), not an algorithm or AI software for which standalone performance would be relevant.

7. The type of ground truth used
For the non-clinical performance tests, the "ground truth" was established by the specified industry standards (ASTM F1820-13, EN ISO 21535, European Pharmacopoeia §2.6.14, USP chapter <85>, USP chapter <151>). These standards define the methodologies and acceptable performance limits for mechanical properties and biocompatibility.

8. The sample size for the training set
Not applicable. No human training set was used. "Training set" typically refers to data used to train AI models; this device is a physical implant.

9. How the ground truth for the training set was established
Not applicable. No human training set was used.

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The hip prosthesis is 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, posttraumatic . 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, internal fixation, arthrodesis, ● hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Mpact Extension components are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Extension consists of the following components:

Revised dimensions and labeling of the acetabular shells (Ti-6AI-4V, ASTM F136 and Ti, ASTM F1580 porous coating) cleared under K103721 and K122641 to correlate to the actual external diameter including the porous coating.

Modified design of the hooded acetabular liners (UHMWPE ISO 5834-2 Type1 and HighCross® HXUHMWPE) cleared under K103721 and K122641. The modification of the hooded liner is specific to the external side of the anti-luxation shoulder, creating a chamfer in order to reduce the risk of psoas irritation.

Additional sizes of the cancellous bone screws (flat head, 6.5mm diameter, Ti-6Al-4V ISO 5832-3) cleared under K103721 with lengths of 50, 55, 60, 65, and 70mm.

The provided text describes a 510(k) premarket notification for the "Mpact Extension" hip prosthesis. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data a new device might require. Therefore, the information typically requested in your prompt (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) is largely not applicable or not provided in this specific document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that performance testing was conducted "in accordance with various international standards and FDA guidance documents" and "as part of design verification to written protocols with pre-defined acceptance criteria." However, it does not explicitly list the specific numerical acceptance criteria for each test or the detailed, quantitative results against those criteria. It only provides a high-level summary that the results "met the acceptance criteria."

2. Sample size used for the test set and the data provenance

The document mentions that testing was conducted on the "worst case component size and option/design" for the Mpact Extension. It does not specify a numerical sample size for any of the tests, nor does it refer to a "test set" in the context of clinical data for a device performance study. The testing described is design verification, typically conducted on physical prototypes or simulations. Data provenance (country, retrospective/prospective) is not applicable here as it refers to a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device underwent design verification testing against established engineering standards and internal protocols, not a clinical study requiring expert ground truth for interpretation of patient data.

4. Adjudication method for the test set

Not applicable, as this refers to a clinical study with image or data interpretation, which is not described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a hip prosthesis, not an AI-powered diagnostic tool, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This refers to AI algorithms, and this device is a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the design verification tests, the "ground truth" would be the engineering specifications, material properties, and performance requirements defined by relevant international standards (e.g., ASTM, ISO) and the manufacturer's internal design controls. The device was tested to ensure it met these pre-defined physical and mechanical properties.

8. The sample size for the training set

Not applicable. This refers to the training of an AI algorithm, which is not relevant to this device.

9. How the ground truth for the training set was established

Not applicable. This refers to the training of an AI algorithm, which is not relevant to this device.

In summary:

This 510(k) submission for the Mpact Extension focused on demonstrating substantial equivalence to predicate devices through design verification testing based on engineering standards and internal protocols. It does not include clinical trial data, AI performance metrics, or information typically associated with studies involving human data interpretation or AI algorithms. The "study" referenced is the series of design verification tests, which confirmed the device's physical and mechanical properties met established criteria.

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