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The Natural-Hip CoCr Offset Stern is intended for cemented use only in cases of hemi- or total hip replacement for treatment of the following:

1. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
2. Those patients with failed previous surgery where pain, deformity or dysfunction persists.
3. Revision of previously failed hip arthroplasty.

The Natural-Hip CoCr Offset Stem is a collared straight stem manufactured from forged CoCr alloy (ASTM F799). The design provides 6-7mm of offset to allow the surgeon to more closely approximate the normal femoral head center in cases where varus deformity may be present. The proximal one-third of the stem's surface is grit blasted and features normalization steps which enhance cement compression and bonding for optimal fixation of the hip stem in the femoral canal. The distal portion of the stem has a hole to allow the use of a distal centralizer for correct distal alignment. The stem also employs proximal PMMA centralizers which, along with the distal centralizer, provide for an even cement mantle. The stem employs a Sulzer 12/14 configured neck trunnion for attachment to either a metallic, Biolox, or Zirconia femoral head having a Sulzer 12/14 configured bore

The provided text is a 510(k) summary for a medical device called the "Sulzer Orthopedics Inc. Natural-Hip CoCr Offset Stem." This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing de novo performance criteria through a clinical study with acceptance criteria, test sets, and ground truth.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document.

This type of 510(k) submission typically relies on:

• Comparison of Technical Characteristics: Showing that the new device has similar materials, design, manufacturing processes, and intended use as already approved devices.
• Performance Benchmarking (often non-clinical): This might involve mechanical testing, biocompatibility testing, or other engineering assessments to demonstrate that the new device performs as safely and effectively as the predicate devices, without directly involving patient data or clinical endpoints that would require the specific details you've asked for.

Here's a summary of what can be extracted from the provided text, and where the requested information is absent:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in the format of pass/fail metrics for a clinical study. The "acceptance criteria" here implicitly revolve around demonstrating substantial equivalence to predicate devices in terms of design, materials, and intended use.
   • Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity, specificity, clinical outcome measures) are reported. The document describes the device's design features (e.g., offset, grit-blasted surface, centralizers) and its intended use, implying its performance is comparable to its predicates.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring ground truth is presented.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set 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-powered 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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for a clinical study is presented. The "ground truth" for this submission is demonstrating that the device is safe and effective because it is substantially equivalent to devices already on the market.

8. The sample size for the training set: Not applicable. No training set for an algorithm is presented.

9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for a training set is presented.

Key Substantial Equivalence Information Provided:

• Predicate Devices (Section {1}):
  • Sulzer Orthopedics Natural-Hip CoCr Stem
  • Howmedica Precision Strata Offset Stem
  • Johnson & Johnson PFC Offset Stem
  • DePuy Endurance Offset Stem
  • DePuy Stability Offset Stem
  • Osteonics Omnifit Enhanced Offset Stem
  • The basis for acceptance is demonstrating substantial equivalence to these devices in terms of design, materials (forged CoCr alloy, ASTM F799), indications for use, and mechanical performance (implicitly, as it's a hip stem).

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