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The hip system devices included in this submission are sterile, single-use devices intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function.

The overall indications for use for the subject total and hemi hip replacement prostheses include:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Rejuvenate Hip System is intended for cementless use only.

Additional indications specific to the Hipstar Stem:
The Hipstar Femoral Stem is intended for cementless use only.

When mated with a constrained acetabular liner the Hipstar Stem is indicated for use in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Additional indications specific to the Restoration Modular Hip System:
The Restoration Modular Hip System is intended 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 devices included in this submission are femoral heads, acetabular shells, acetabular inserts, modular necks, modular stems and accessory components used in hip arthroplasty procedures. All devices have been previously deemed substantially equivalent in prior 510(k) submissions and are commercially available. The purpose of this submission is to modify the labeling of these devices to include safety information in the Instructions for Use (IFUs) regarding modular hip stem junctions. In addition to this specific update, general revisions have been made to the IFUs to harmonize the language between the Howmedica Osteonics' hip stem labeling

This K121308 submission is for a modification to the labeling of existing hip system devices, not for a new device requiring performance testing against specific acceptance criteria. The submission states: "The subject hip system devices have been deemed substantially equivalent to other commercially available hip arthroplasty systems based upon an evaluation of intended use, design, materials, and operational principles in prior 510(k) submissions. The purpose of this submission is solely to revise the labeling to add safety information regarding modular hip stem taper junctions."

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them is not applicable to this specific 510(k) submission.

To address the prompt directly based on the provided text, the relevant section is "Substantial Equivalence," which implies that the performance of the device has already been established and accepted in prior submissions.

Here's a breakdown of why the requested information cannot be provided from the given document:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. This submission is for a labeling change, not a new device requiring performance criteria to be met. The substantial equivalence is based on prior 510(k)s.
• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No performance study data is presented in this submission.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No performance study data where ground truth is established is presented.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance study requiring adjudication is presented.
• 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: Not applicable. This device is a hip implant, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hip implant, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is established for this submission.
• 8. The sample size for the training set: Not applicable. No AI/machine learning training set is relevant to this device.
• 9. How the ground truth for the training set was established: Not applicable. No AI/machine learning training set is relevant to this device.

Conclusion based on the provided text:

The device's performance and acceptance criteria were established in previous 510(k) submissions, which deemed them "substantially equivalent to other commercially available hip arthroplasty systems based upon an evaluation of intended use, design, materials, and operational principles." This specific submission (K121308) does not provide details on the acceptance criteria or a study proving those criteria are met, as its sole purpose is to "revise the labeling to add safety information regarding modular hip stem taper junctions."

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