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· Hip components are indicated for 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 (NIDID) 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 rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; 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, or Girdlestone resection: fracture-dislocation of the hip; and correction of deformity.

The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.

The REDAPT Anteverted Cemented Liner is manufactured from highly cross-linked polyethylene (ASTM F648) via standard machining processes. The liners incorporate integral polyethylene spheres that create a 1.5 mm gap between the porous shell or natural acetabulum for a consistent bone cement mantle.

Here's an analysis of the provided text regarding the acceptance criteria and study for the REDAPT Anteverted Cemented Liner, structured to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining explicit, quantitative acceptance criteria for novel performance. However, it does mention various mechanical tests and their successful completion, which imply meeting internal or industry-standard acceptance criteria.

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

The document does not explicitly state the sample sizes for the mechanical tests. For medical devices like hip liners, samples often refer to the number of devices tested. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective, as these are in vitro mechanical tests.

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

Not applicable. This device is a mechanical implant, and the "ground truth" for its performance is established through objective engineering standards and mechanical testing, not expert clinical consensus or interpretation of images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication is typically relevant for studies involving human interpretation or clinical endpoints. Mechanical tests have pass/fail criteria based on engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a hip implant, not an AI diagnostic device. An MRMC study is not relevant here.

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

Not applicable. This is a medical device, not an algorithm. Its performance is assessed through its physical properties and mechanical behavior.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established through established engineering principles, material specifications (e.g., ASTM F648 for highly cross-linked polyethylene), and industry-standard mechanical testing protocols. These tests simulate in vivo conditions to assess properties like fatigue, push-out strength, lever-out resistance, torque-to-failure, range of motion, impingement, and wear. The success criteria are typically defined by these standards or comparative data from predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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