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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, 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.

Total hip systems may be indicated for use (i) without bone cement, or (ii) for use with or without bone cement. Refer to the product labeling and literature for specific applications.

The Anthology Hip System, CPCS Cemented Hip System, and Synergy Hip System are for primary surgeries only.

The TANDEM Unipolar and Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.

Acetabular Hip Components are individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, congenital dysplasia. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocations of the hip.

The Constrained Liners are indicated for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

The purpose of this Traditional 510(k) is the following:

• 1. To add the MR safety information to the product labels and update the MR information within the package insert for the Smith & Nephew Hip Systems included within the scope of this 510(k), and
• 2. To address several iterative legacy design changes made to the subject hip system components.

This document is a 510(k) premarket notification for hip system components and does not describe an AI medical device. Therefore, I cannot provide information on acceptance criteria or studies related to AI algorithms.

The document primarily focuses on demonstrating substantial equivalence of the described hip system components to previously cleared predicate devices. The "Performance Data" section specifically mentions Magnetic Resonance Imaging (MRI) compatibility testing and "additional testing [...] to assess the modifications made to the subject Smith & Nephew Hip Systems devices against their predicates." This indicates performance data related to physical device properties, not AI performance.

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The ANTHOLOGY Hip Stem is 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; 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, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The ANTHOLOGY Hip Stem is for single use only.

The ANTHOLOGY Hip Stem is manufactured from titanium alloy. The design of the stem is based upon the SYNERGY Hip Stem.

The provided 510(k) summary for the ANTHOLOGY Hip Stem does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, statistical analysis, or comparison metrics.

Instead, this submission is a Premarket Notification (510(k)) which demonstrates substantial equivalence to a predicate device already legally marketed. For orthopedic implants like hip stems, substantial equivalence is typically established through a comparison of design features, material composition, intended use, and sometimes extensive bench testing and mechanical studies, rather than clinical efficacy studies with predefined acceptance criteria.

Here's how to address the requested information based on the provided text:

Acceptance Criteria and Device Performance

• No specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, or other quantitative performance indicators) are reported in this 510(k) summary. The "acceptance criteria" for a 510(k) in this context is primarily demonstrating that the new device is as safe and effective as a legally marketed predicate device.
• The reported "device performance" relies on demonstrating substantial equivalence to the SYNERGY Hip Stem. This means the ANTHOLOGY Hip Stem is expected to perform similarly to the SYNERGY Hip Stem because of shared design, materials, and intended use. The "Design Control Activities" mentioned are internal processes to ensure the device meets its design specifications and is safe and effective, but the specific results or metrics are not detailed in this public summary.

Study Information (Based on Substantial Equivalence and lack of clinical trial)

Given that this is a 510(k) based on substantial equivalence, and no clinical performance study is described, most of the requested fields are not applicable or the information is not provided.

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

   Acceptance Criteria (Stated or Implied for 510(k))	Reported Device Performance
   Substantial Equivalence to predicate device (SYNERGY Hip Stem) in:	"The intended use, design, and materials of the ANTHOLOGY Hip Stem are substantially equivalent to the SYNERGY Hip Stem."
   * Design Features	"similarities in design features"
   * Overall Indications	"overall indications"
   * Material Composition	"material composition"
   Safety and Effectiveness (implied through Design Control Activities)	"Design Control Activities have been completed and the results indicate that the subject device is safe and effective."

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

   • Not applicable / Not provided. The summary does not describe a "test set" in the context of a performance study with human subjects or a dataset for AI. The "test set" here would refer to the characteristics of the ANTHOLOGY Hip Stem itself and its comparison to the predicate. Data provenance is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not provided. Ground truth establishment by experts is typically for diagnostic devices or AI algorithms, not for mechanical orthopedic implants demonstrating substantial equivalence.

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

   • Not applicable / None specified. No adjudication method is described as there is no clinical performance test set.

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:

   • No. This is an orthopedic implant, not an AI-assisted diagnostic device. MRMC studies are not relevant here.

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

   • Not applicable. This is a physical medical device (hip stem), not an algorithm.

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

   • Not applicable in the conventional sense. For this 510(k), the "ground truth" for substantial equivalence is the existing, legally marketed predicate device (SYNERGY Hip Stem) and its established safety and effectiveness. The ANTHOLOGY Hip Stem is deemed safe and effective if it performs as well as the predicate without raising new questions of safety or effectiveness.

8. The sample size for the training set:

   • Not applicable / Not provided. No training set is described for a performance study.

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

   • Not applicable / Not provided. No training set is described.

In summary, this 510(k) submission establishes substantial equivalence through direct comparison to a predicate device, focusing on design, materials, and intended use. It does not involve clinical performance studies with specific acceptance criteria that would typically be described with metrics like sensitivity, specificity, or reader studies.

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