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The indications for use of the total 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. Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   Additional indication specific to use of Accolade II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:

1. When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
   Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

The Accolade II Femoral Hip Stem, a tapered non-porous coated femoral stem intended for cementless, press-fit application. Accolade II has a variable medial curvature which increases with each stem size in order to facilitate press fit stability and load transmission in the proximal region of the stem geometry is designed to address variations in patient femoral morphology. The overall stem length has been reduced, compared to the Accolade TMZF hip stem, to facilitate intra-operative stem insertion.
The stem is manufactured from a Ti-6A1-4V substrate materially Pure (CP) Titanium coating and Purefix hydroxylapatite (HA) coating identical to the previously cleared 2 Piece Modular Hip Stem (K013106). The Accolade II Femoral Hip Stem is available in 12 sizes ranging from size 0 through 11 with two neck angles (127° and 132°) that provide dual head offsets. The stem is designed for use with the currently available compatible Howmedica Osteonics' femoral heads and their compatible acetabular components. The Accolade II Femoral Hip Stem is a sterile, single-use device intended for use in primary and revision total and hemi hip arthroplasty to alleviate pain and restore function. The subject hip stem is compatible with V40 heads, C-taper heads when used with the V40/C-Taper Adaptor Sleeve, Universal Heads when used with the V40/Universal Adaptor Sleeve and Unitrax Heads.

The provided text describes a 510(k) submission for the "Accolade II Hip Stem," which is a hip prosthesis. This submission is focused on demonstrating substantial equivalence to previously cleared predicate devices, rather than showcasing performance against specific acceptance criteria through a clinical study.

Therefore, many of the questions related to acceptance criteria, device performance, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable in the context of this 510(k) summary. The FDA's 510(k) clearance process for devices like this typically relies on non-clinical testing (e.g., mechanical, material characterization) and comparison to predicate devices, rather than human clinical trials demonstrating a specific performance metric.

Here's how the provided information maps to your requests:

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

• Not Applicable. The submission states "Clinical testing was not required for this submission." The basis for clearance is demonstrating substantial equivalence to predicate devices through engineering and risk analysis, not meeting pre-defined performance acceptance criteria from a clinical study. The "performance" here refers to material and mechanical characteristics, which are implicitly acceptable if they match or are superior to the predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No clinical test set data was used. The evaluation was based on engineering and risk analysis compared to predicate devices.

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 clinical test set with expert-established ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set requiring adjudication was used.

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. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a hip implant. Standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. As no clinical testing was performed to establish performance metrics, no ground truth as typically defined for clinical studies was established. The "ground truth" for this 510(k) is essentially the established safety and effectiveness of the predicate devices based on their materials, design, and intended use, and the demonstration that the modified device is substantially equivalent to these predicates.

8. The sample size for the training set

• Not Applicable. There was no "training set" in the context of machine learning or an AI algorithm. The device's design and materials were developed and evaluated through engineering principles.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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