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The MobiliTTM Cup, for cemented and cementless use, are indicated for primary replacement of the hip joint:

• In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis
• -For patients who have a high risk of dislocation
• In cases of necrosis of the femoral head -
• In cases of fracture of the neck of the femur -
• In cases of congenital luxation -

The MobiliTTM Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup.

The cementless MobiliTTM standard Cup, with flanges and hook are indicated for cementless use only.

The cemented MobiliT™ Cup is indicated for cemented use only.

The MobiliT™ Cup is a modular system consisting of two articulating surfaces in the same joint space. The MobiliT™ Cup is a metal shell combined with a specific ECiMa™ insert. This system offers two articulating surfaces in the same joint space, one between the shell and the insert, the other between the insert and the femoral head. The shell is made of stainless with ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) insert. A Trinity™ femoral head 22mm or 28mm CoCr, or a 28mm BIOLOX® delta articulates within the ECiMa™ insert to allow for a second articulation. The MobiliTTM Cup is designed for use with any Corin 12/14 femoral stem.

The MobiliT™ Cup is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The MobiliT™ Cup is intended to be used with the following approved devices:

• 22mm and 28mm CoCr heads (K110087, K131647 and K170359) ●
• 28mm BIOLOX® delta Ceramic Heads (K103120) .

This is a medical device 510(k) clearance document for the MobiliT™ Cup, a hip prosthesis. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not contain a table of acceptance criteria with specific numerical targets and corresponding device performance metrics. Instead, it relies on non-clinical testing to demonstrate substantial equivalence to predicate devices. The acceptance is based on the new device performing comparably to the predicate devices in various required tests.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as "sample size." The testing is described as "Non-Clinical Testing and Analysis," which typically involves a set number of physical samples of the device being tested according to standardized methods. The specific number of devices or components tested for each experiment (e.g., how many cups were subjected to push-out tests) is not provided.
• Data Provenance: The data comes from non-clinical bench testing performed by the manufacturer (Corin USA Limited or its affiliates). There is no mention of country of origin for the testing data beyond the manufacturer's location. The tests are not retrospective or prospective in the clinical sense, as no human or animal subjects were involved.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable. For a medical device 510(k) clearance based solely on non-clinical (bench) testing, there are no "experts used to establish ground truth" in the way one would for clinical image interpretation or diagnosis. The "ground truth" for these engineering tests is established by adhering to recognized international and ASTM standards (e.g., ISO 7206-12, ASTM D570, ISO 14242-1/2, ASTM 2582-14). Compliance is assessed by engineers and regulatory bodies against these standards.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical endpoints. This document describes non-clinical engineering tests where the results are objective measurements against established standards, not subjective interpretations requiring adjudication.

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:

• No. An MRMC comparative effectiveness study was not conducted. This is a hip prosthesis, not an AI-powered diagnostic device designed to assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No. This is a physical medical implant (hip prosthesis), not an algorithm or AI device. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests is based on engineering standards and specifications (e.g., the force required to reach a specific deformation, wear rates within acceptable ranges as defined by ISO standards). The results are objective measurements against established pass/fail criteria derived from these standards and comparison to predicate device performance.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of this 510(k) submission. Training sets are relevant for machine learning algorithms, which is not what this device is. The development of the device likely involved engineering design, prototyping, and iterative testing, but this is distinct from an AI training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. (See point 8).

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