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The subject hip stems are single-use devices intended for use in total hip replacement. They are designed for cementless fixation. They are intended for mechanical assembly to mating Howmedica V40™ Femoral Heads (excluding size +16mm (XX Long) V40 Femoral Heads).

Indications:
The indications for use of total hip replacement prostheses include:

• Osteoarthritis and avascular necrosis,
• Rheumatoid arthritis,
• Correction of functional deformity,
• Revision procedures where other treatments or devices have failed, and
• Revision procedures where other treatments or devices have failed, including neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The subject devices are single-use components intended for cementless fixation within the prepared canals of patients requiring hip arthroplasty. Unlike the predicate devices, however, the subject devices feature a V40™ Taper, and are therefore intended only for assembly to mating, commercially available Howmedica V40™ Femoral Heads. Note, also, that the subject hip stems are not recommended for use with size +16mm V40TM Femoral Heads.

The provided document describes a Special 510(k) for modifications to existing hip stems, focusing on the "Super Secur-Fit™ HA Hip Stems and Super Secur-Fit™ Plus HA Hip Stems." This type of submission is a declaration of substantial equivalence to a predicate device, based on the principle that the modifications do not raise new questions of safety or effectiveness. As such, it primarily relies on performance testing to demonstrate that the modified device is as safe and effective as the predicate.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. For mechanical testing like fatigue, the sample size is typically determined by relevant ISO standards (e.g., ISO 7206-6) and statistical power analysis to demonstrate reliability.
• Data Provenance: Not explicitly stated, but assumed to be prospective laboratory testing conducted by Howmedica Osteonics Corp. within the context of their device development and regulatory submission. The country of origin would likely be the USA, where Howmedica Osteonics Corp. is based.

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

• Not Applicable. This submission is for mechanical device modifications, not an AI/Software as a Medical Device (SaMD) that relies on expert interpretation of output. The "ground truth" for mechanical performance is established through physical testing and adherence to engineering specifications and international standards (like ISO 7206-6).

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation of data, typically in AI/SaMD performance evaluations. For mechanical testing, the "adjudication" is inherent in the objective measurement and interpretation of physical test results against predetermined criteria set by industry standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. MRMC studies are specific to evaluating the impact of AI on human reader performance, common in diagnostic imaging. This submission deals with mechanical modifications to a hip stem.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not Applicable. This is a hardware modification, not an algorithm or software. The "standalone performance" is the mechanical performance of the hip stem itself under simulated physiological conditions.

7. The Type of Ground Truth Used:

• Engineering Standards and Predicate Device Performance. The ground truth for this mechanical device is established by:
  • ISO 7206-6 Standard: This international standard defines the methods for fatigue testing of femoral components with a prosthesis head and neck. Compliance with this standard ensures the device meets recognized performance benchmarks for durability.
  • Predicate Device Performance: The underlying assumption of a 510(k) Special is that the modified device performs at least as well as the legally marketed predicate device (Secur-Fit™ HA Hip Stems and Secur-Fit™ Plus HA Hip Stems) in terms of safety and effectiveness, including mechanical strength. The new modifications (V40™ Taper, trimmed neck, modular collar slot) would have been tested to ensure they did not degrade performance.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is not an AI/Machine Learning device.

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

• Not Applicable. Since there is no training set, this question is not relevant.

In summary:

This 510(k) submission for mechanical hip stem modifications relies entirely on demonstrating that the revised design maintains the safety and effectiveness profile of its predicate device, primarily through physical performance testing (specifically neck fatigue testing per ISO 7206-6). The acceptance criteria are implicitly met by demonstrating compliance with this standard and showing that the new design performs comparably to the predicate, which is a fundamental requirement for 510(k) clearance. The document, typical for a Special 510(k) of this nature, describes the modifications and references the standard used for testing without delving into specific numerical test results, which would be contained in a more detailed technical report.

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