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Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• Certain cases of ankylosis.
  The DePuy Solution System Hip System is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement.

The DePuy Solution System Hip Prosthesis is manufactured from ASTM F-75 Cobalt Chromium-Molybdenum alloy and has a sintered cobalt-chrome-molybdenum alloy bead porous coating (Porocoat®) applied to the stem. The porous coating is applied to the entire stem with the exception of the polished neck and tapered stem tip region. The DePuy Solution System Hip Prosthesis is a single use device.

The regulatory submission K030979 for the DePuy Solution System Hip Prosthesis does not contain acceptance criteria or a study proving the device meets said criteria in the way typically expected for AI/ML-driven medical devices.

Instead, this submission is a traditional 510(k) premarket notification for a medical device (a hip prosthesis) that falls under the "substantial equivalence" pathway. This means the device's clearance is based on its similarity to previously cleared predicate devices, rather than a performance study against predefined acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone performance for an AI/ML device is not applicable to this submission.

Here's an breakdown based on the provided text, specifically addressing why the requested information isn't present:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the Study That Proves the Device Meets Acceptance Criteria:

The "study" presented here is a substantiation of substantial equivalence rather than a performance study against acceptance criteria.

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

• Sample Size for Test Set: Not applicable. There was no "test set" in the context of evaluating an AI/ML algorithm's performance. The basis for equivalence relies on comparing the device's attributes (design, materials, intended use) to predicate devices, not on clinical data demonstrating performance in a "test set."
• Data Provenance: Not applicable. No clinical data or image data set was analyzed to demonstrate performance. The submission refers to the characteristics of the device itself and its predicates.

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

• Number of Experts: Not applicable. No ground truth was established by experts for a test set, as no performance study was conducted.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was utilized.

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

• MRMC Study: No. This submission pertains to a physical orthopedic implant, not an AI/ML diagnostic or assistive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or discussed.

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

• Standalone Performance: No. This is not an algorithm; it is a physical medical device.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. The concept of "ground truth" as used in AI/ML performance evaluation (e.g., pathology, expert consensus, outcomes data) is not relevant to a substantial equivalence determination for a hip prosthesis. The "truth" in this context is whether the new device's characteristics are sufficiently similar to legally marketed predicate devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.

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

• How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.

Summary for K030979:

The DePuy Solution System Hip Prosthesis received 510(k) clearance based on its substantial equivalence to two predicate devices: the DePuy Vision Hip Prosthesis (K953703) and the DePuy AML Hip Prosthesis (K012364). The basis for this determination was "similarities of design, same materials, identical sterilization processes, and the same intended use." This regulatory pathway does not require clinical performance trials demonstrating effectiveness against predetermined acceptance criteria in the manner expected for AI/ML devices. Therefore, the submission does not contain the types of data (e.g., test sets, ground truth, expert adjudication, MRMC studies) typically associated with evaluating AI/ML device performance.

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