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Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Smith & Nephew Hip System components with HA are intended for single use only and are intended to be implanted without bone cement.

This 510/k) submission seeks FDA clearance to have the calcium phosphate coating (plasma sprayed from hydroxyapatite (HA) powder) on the subject hip components applied by an alternate coating supplier. The calcium phosphate coating is referred to as "HA coating." The hip system components included in this premarket notification are:

• . Porous Synergy Hip Stems
• . Non-Porous Synergy Stems
• Porous Anthology Hip Stems .
• . Porous Reflection Acetabular Shells

The Smith & Nephew Hip Stems with HA coating have been cleared for market by FDA via K052792, K002996 and K970337. The Reflection Acetabular cups with HA coating have been cleared for market by FDA via K990666 and K022556. The design, principle of operation, type of substrate materials, dimensional characteristics and indications for use will not change as a result of the implementation of an alternate HA coating supplier.

The provided document is a 510(k) summary for a medical device seeking FDA clearance. It focuses on demonstrating substantial equivalence to previously cleared devices, rather than establishing de novo safety and effectiveness through clinical trials with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested elements regarding acceptance criteria, study design, statistical details, and ground truth establishment are not applicable or available in this type of regulatory submission. The document primarily describes how the new HA coating supplier's product matches the characteristics and performance of the predicate device's coating.

Here's a breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to the successful demonstration of substantial equivalence to predicate devices. This is achieved by showing that the new HA coating produced by the alternate supplier is chemically and physically comparable to the original, and that the HA-coated components maintain the equivalent performance characteristics.

Study Details (Applicable to 510(k) Substantial Equivalence, Not Clinical Studies)

1. Sample size used for the test set and the data provenance:

   • Test Set: Not a traditional "test set" in the sense of clinical samples. The "test set" here refers to the actual device components and HA coating samples produced by the alternate supplier, which were subjected to various material and coating characterization tests. The specific number of samples for each test (e.g., how many HA powder lots, how many coated implants) is not specified in this summary.
   • Data Provenance: The tests were conducted on components manufactured by Smith & Nephew using the alternate HA coating supplier. The testing described appears to be laboratory-based (e.g., material characterization, physical property testing), not clinical data from patients. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject HA coated devices."

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

   • Not applicable. This submission relies on objective material and physical property testing, not expert interpretation of results to establish "ground truth" in a diagnostic sense. The "ground truth" (or benchmark) for comparison was the characteristics of the predicate device's HA coating and accepted industry standards/guidance documents.

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

   • Not applicable. Adjudication methods are used for interpreting subjective data (e.g., image reads, clinical endpoints). The data here are quantitative material and coating characteristics, which are objectively measured and compared to predefined specifications or predicate device characteristics.

4. 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 is a hardware/material modification submission, not an AI/software device. No human reader studies were conducted or are relevant to this type of device.

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

   • Not applicable. This is a hardware/material modification submission, not an algorithm.

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

   • The "ground truth" for demonstrating substantial equivalence was a combination of:
     • Specifications and characteristics of the legally marketed predicate devices.
     • Relevant guidance documents (e.g., "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants," "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement").
     • Industry standards and established test methods (e.g., comparing to NIST SRM 2910|a) for certain parameters).
     • Regulatory definitions (e.g., 21 CFR 888.3358 for porosity).

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for the device would be the manufacturing process development and quality control of the alternate coating supplier.

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

   • Not applicable. As above, no training set in the AI sense was used. The manufacturing process for the HA coating would have established its own internal quality control standards and specifications based on the desired material properties comparable to the predicate device.

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