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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 (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 rheumatoid arthritis, arthritis 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.

Smith & Nephew SMF° Hip Stem components are intended for single use only and are to be implanted without bone cement.

The Smith & Nephew SMP Hip Stem is a straight, tapered, proximally loaded stem designed to match the geometry of the femur. The subject monoblock SMF° femoral stem line additions are offered in sizes 1 - 9. The subject devices have fixed, non-modular necks with a 12/14 neck taper to accept currently available Smith & Nephew femoral heads, and are available in standard and high offset. The SMF® monoblock femoral stems are manufactured from titanium alloy (Ti-6Al-4V) and are proximally coated with Smith & Nephew's Stiktite porous coating.

The provided text describes the Smith & Nephew SMF® Hip Stem line additions, a medical device for hip replacement. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, addressing your specific points:

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

The document does not explicitly state numerical "acceptance criteria" in the way one might see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a previously cleared predicate device (K103256).

The "performance" is primarily demonstrated through the similarity of features and material attributes, and a review of performance testing.

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

The document primarily refers to "performance testing" of the device, not a "test set" in the context of diagnostic algorithm validation. The testing appears to be bench testing or mechanical testing of the physical hip stem components. The specific sample sizes for these tests (e.g., number of stems tested for fatigue strength) are not provided. Similarly, the data provenance (country of origin, retrospective/prospective) is not applicable as it's not a clinical study involving patient data.

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)

This information is not applicable to this type of device submission. The "ground truth" for a hip stem is its mechanical integrity and biocompatibility, which are evaluated through engineering tests and material science, not through expert review of clinical cases.

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

This is not applicable to the submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or diagnosis. The performance evaluation here focuses on the physical properties of the device.

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

An MRMC study is not applicable as this is a physical implant device, not an AI or diagnostic tool requiring human reader interpretation. No such study was performed or described.

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

This is not applicable as the device is a physical hip stem, not an algorithm or AI.

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

The "ground truth" for this device's performance is established through compliance with recognized standards and guidance documents for orthopedic implants, material specifications (Ti-6Al-4V), and mechanical testing results (e.g., fatigue strength). The goal is to demonstrate that the expanded sizes of the hip stem maintain the safety and effectiveness characteristics proven for the predicate device.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI or machine learning model that requires a "training set."

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

This is not applicable for the reasons stated in point 8.

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