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The DYNASTY® Dual Mobility Inserts and Liners, when used with compatible acetabular shells and femoral heads, are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. In revision arthroplasties, all devices associated with the wear couple must be removed and replaced.

Indications for Use:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and;

4. revision procedures where other treatments or devices have failed;

5. dislocation risks;

6. treatment of non-union, femoral neck fractures of the proximal femur with head involvement which are unmanageable by other techniques

Dual Mobility Inserts and Liners are single use implants intended for uncemented arthroplasty.

The Dual Mobility (DM) Inserts and Liners are designed for use with compatible DYNASTY® acetabular shells, MicroPort Orthopedics non-skirted femoral heads and PROFEMUR® femoral stems, to create a system with two articulating interfaces in the acetabular joint space of the hip.

The E-CLASS® DUAL MOBILITY INSERTS are manufactured from Vitamin E cross linked polyethylene conforming to ASTM F2695 and are available with an inner diameter of 28 mm and outer diameters from 38 mm to 56 mm in 2 mm increments. The E-Class® DM Inserts are compatible with and provide a primary articulating surface for all 28 mm, non-skirted femoral heads.

DM CoCr Liners are manufactured from cobalt chrome (CoCr) alloy conforming to ASTM F1537 (Type 1) and are available with inner diameters from 38 mm in 2 mm increments. The DM CoCr Liners are designed to mate with all DYNASTY® acetabular shells via a taper locking mechanism and provide the secondary articulating surface for the E-Class® DM Inserts.

This document is a 510(k) Premarket Notification from MicroPort Orthopedics, Inc. to the FDA regarding their E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS. The document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document describes mechanical testing to demonstrate substantial equivalence, rather than a clinical study evaluating human-in-the-loop performance of an AI device. Therefore, the "acceptance criteria" discussed are for the mechanical properties of the orthopedic implants, not for an AI algorithm's diagnostic performance.

Tabla de criterios de aceptación y rendimiento informado del dispositivo:

Study Information (Mechanical Testing)

This document describes a premarket notification for an orthopedic implant, not an AI/software device. Therefore, the questions related to AI device performance evaluation (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone performance) are not directly applicable to the type of study described.

However, based on the provided text, we can infer some details about the mechanical testing study:

1. Sample size used for the test set and the data provenance:

   • The sample size for each mechanical test is not explicitly stated (e.g., "n="). Instead, it mentions "MicroPort has evaluated the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS and data demonstrates substantial equivalence..." This implies multiple samples were tested for each specified mechanical test to comply with the relevant ASTM/ISO standards.
   • Data Provenance: The testing was "performed for the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS" by MicroPort. The location is implied to be within MicroPort's testing facilities, likely in the US (Arlington, Tennessee, is mentioned as their address). It is inherently a prospective execution of validated test methods on newly manufactured devices.

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

   • Not applicable in the context of mechanical testing. "Ground truth" here refers to the precise measurements and evaluations against established engineering standards (ASTM, ISO). The "expertise" involved would be mechanical engineers and technicians conducting the tests and interpreting the results according to the specified standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. Mechanical testing involves objective measurements rather than subjective expert consensus. Results are compared directly to numerical acceptance criteria defined by the standards.

4. 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 is not an AI device or a human-in-the-loop study.

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

   • Not applicable. This is not an AI algorithm. The performance evaluation is inherently "standalone" in the sense that it's testing the physical properties of the device itself, not an algorithm's output.

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

   • The "ground truth" for mechanical testing is defined by the acceptance criteria specified in the referenced ASTM and ISO international standards. These standards provide the validated methodologies and performance thresholds for assessing the safety and efficacy of orthopedic implants.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning study requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for mechanical testing.

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