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The Restoration® Modular Hip System is indicated for use in:

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

Additional indications specific to the Restoration Modular Hip System:

The Restoration® Modular Hip System is intended to be used for primary and 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.

The Restoration Modular Hip System is a modular femoral replacement system. It is comprised of a proximal femoral body, a distal stem, and a locking bolt. The system is assembled utilizing a male/female taper, and a locking bolt to lock the proximal femoral body and distal stem. Many of the components are available in a wide variety of sizes, lengths and geometries to satisfy anatomical requirements and surgeon needs. The implants are fabricated from Titanium alloy (Ti-6AI-4V-ELI);some implants feature a plasma sprayed titanium and plasma sprayed Hydroxyapatite coating. The implants are intended for cementless use.

PROXIMAL FEMORAL BODIES
The proximal femoral bodies are available in three different styles: Cone, Broached, and Calcar, in a range of sizes. Each proximal femoral body features a plasma-sprayed Hydroxyapatite coating over plasmasprayed Titanium.

DISTAL STEMS
The stems are available in a range of diameters and lengths, straight or curved, to fit various patient anatomical requirements. The distal stems are available in two different styles: Plasma Distal Stems and Conical Distal Stems. The Plasma Distal Stems are fabricated from Titanium alloy (Ti-6Al-4V-ELI) and feature a plasma-sprayed Hydroxyapatite coating over plasma-sprayed Titanium. The Conical Distal Stems are fabricated from Titanium alloy (Ti-6Al-4V-ELI) and are grit blasted, fluted components with a taper extending the length of the stem. The Conical Distal Stems do not have a plasma sprayed Titanium or plasma sprayed Hydroxyapatite coating.

This document describes a 510(k) premarket notification for the Restoration® Modular Hip System, primarily focused on modifying the labeling to add MR Conditional language. It does not involve an AI/ML medical device. Therefore, the information required to answer your specific questions about acceptance criteria and a study proving device meets these criteria (especially in the context of AI/ML) is not present in this document.

The provided text from the FDA 510(k) submission states: "Clinical testing was not required as a basis for substantial equivalence." This is a crucial piece of information indicating that no clinical study (including MRMC or standalone performance studies, or ground truth establishment relevant to AI/ML) was performed or submitted for this particular 510(k). The device is a physical implant, not a software algorithm.

Therefore, I cannot fulfill your request for the following information based on the provided document:

1. A table of acceptance criteria and the reported device performance: Not applicable for an AI/ML device, and no performance criteria/results beyond MR compatibility testing are provided for this physical device.
2. Sample sized used for the test set and the data provenance: No clinical test set data or provenance is provided.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable, as there's no AI/ML ground truth establishment.
4. Adjudication method: Not applicable.
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 MRMC study was done, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable, as there's no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical orthopedic implant, specifically addressing MR compatibility. The "Non-Clinical Testing" section describes in-vitro tests performed according to ASTM standards to characterize the device's compatibility in the MR environment. These tests involved:

• Magnetically Induced Displacement Force Test (per ASTM F2052-15)
• Magnetically Induced Torque Test (per ASTM F2213-17)
• Image Artifact Test (per ASTM F2119-07)
• Heating by RF Fields Test (per ASTM F2182-19e1)

The "acceptance criteria" here would be the successful demonstration that the device's magnetic properties, torque, image artifacts, and heating during MR scans are within acceptable limits as defined by these ASTM standards, allowing for "MR Conditional" labeling. The specific numerical results of these tests (e.g., precise temperature rise, displacement force) are not provided in this summary, only the methods used.

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