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The REFLECTION 3-Hole Shell with Asymmetric Porous Coating is individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, cr Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The REFLECTION 3-Hole Shell with Asymmetric Porous Coating is for single use only.

The REFLECTION 3-Hole Shell with Asymmetric Porous Coating is manufactured from titanium allov and has a titanium porous coating. The design of the shell is based upon the REFLECTION Acetabular Shell.

The provided text is a 510(k) summary for a medical device called the "REFLECTION 3-Hole Shell with Asymmetric Porous Coating". A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate medical device) that is not subject to PMA.

Based on the provided document, the device does not include any AI/ML components or software. It is a physical orthopedic implant. Therefore, the questions related to AI/ML specific acceptance criteria, studies, and data provenance are not applicable to this device.

The document demonstrates substantial equivalence to a predicate device, the "REFLECTION Acetabular Shell", based on similarities in intended use, design features, and material composition. No clinical studies or performance data, in the sense of acceptance criteria involving specific numerical thresholds for accuracy, sensitivity, or specificity, are presented for this device.

The relevant information from the document can be summarized as follows:

1. Acceptance Criteria and Reported Device Performance: Not applicable for an AI/ML device. The "acceptance criteria" here is substantial equivalence to a predicate device based on design, materials, and intended use.

   • Acceptance Criteria: Substantial equivalence to the REFLECTION Acetabular Shell regarding intended use, design, and materials.
   • Reported Device Performance: The document states that the new device shares "similarities in design features, overall indications, and material composition" with the predicate device. No specific performance metrics (e.g., accuracy, sensitivity, specificity) are reported as they are not relevant for demonstrating equivalence of a physical implant.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical implant, not a software/AI device evaluated on a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: 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: Not applicable.

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: Not applicable. For a physical device, the "ground truth" for substantial equivalence lies in comparing its physical and functional characteristics to a known, legally marketed predicate device.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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