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The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific indications for use of the Restoration® Modular System include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Revision procedures where other treatments or devices have failed, and Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Restoration® Modular Hip System is a modular hip system comprised of different proximal body styles and three distal stem designs, which are affixed with the use of a locking bolt. These individual components are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem to better fit the patient. This submission modifies the existing Restoration® Modular Cone Body to create a new style of proximal body called the Restoration® Modular Calcar Body for use with the previously cleared Restoration® Modular Distal Stem components.

The provided document is a 510(k) Premarket Notification for a line extension to a modular hip system. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices based on similarities in intended use, materials, and design, and confirmed by mechanical testing and analysis.

However, the document does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of algorithm performance or clinical outcomes. The "study" mentioned refers to mechanical testing for demonstrating substantial equivalence of the new components to predicate devices. There is no mention of any AI or software-based device, nor any performance metrics, sample sizes for test/training sets, expert ground truth, or adjudication methods typically associated with studies for such devices.

Therefore, the requested information cannot be extracted from this document in the format provided.

Specifically, none of the requested information points 1 through 9 can be addressed as they pertain to the evaluation of an algorithm or software device, which is not the subject of this 510(k) filing.

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The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific indications for use of the Restorations Modular System include:

• . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• Rheumatoid arthritis, .
• Correction of functional deformity, .
• Revision procedures where other treatments or devices have failed, and
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

The Restoration® Modular Hip System is a modular hip system comprise of different proximal body styles and three distal stem designs, which are affixed with the use of a locking bolt. These individual components are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem to better fit the patient. This submission modifies the existing 19mm Cone Body and adds a new style of proximal body called the MT3 body for use with the previously cleared distal stem components

The provided document is a 510(k) summary for the Restoration® Modular System, a medical device for hip arthroplasty. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details (like MRMC or standalone performance), because a 510(k) for device modifications typically relies on mechanical testing and comparison to predicates, not extensive clinical trials with human readers or AI algorithms.

The document primarily focuses on:

• Device Description: The Restoration® Modular System is a modular hip system comprising different proximal body styles and three distal stem designs, assembled by the surgeon. This submission modifies an existing 19mm Cone Body and adds a new MT3 body.
• Intended Use: For primary or revision total hip arthroplasty, and in the presence of severe proximal bone loss. Indications include non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, correction of functional deformity, revision procedures, and treatment of nonunion, femoral neck, and trochanteric fractures.
• Substantial Equivalence: The new components are deemed substantially equivalent to a predicate device in intended use, materials, and design. Mechanical testing was conducted to prove mechanical strength equivalence. Manufacturing methods, packaging, and sterilization are identical to the predicate.

In summary, none of your requested information (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is available in this 510(k) submission, as it pertains to a physical orthopedic implant modification and not an AI/software device that would undergo such evaluation.

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