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PROFEMUR® GLADIATOR® Cemented Classic Stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

The PROFEMUR® GLADIATOR® Cemented Classic Stems present a tapered-wedge design and a reduced distal stem tip, identical to the legally marketed modular PROFEMUR® GLADIATOR® Cemented Stem (K111910, SE 10/14/2011) with PROFEMUR® Cobalt Chrome Modular Necks (K091423, SE 08/25/2009; K100866, SE 04/28/2010). The subject stems are intended to be cemented and have a glass-beaded body, medial collar, proximal shoulder and neck region with a surface roughness identical to the legally marketed modular PROFEMUR® GLADIATOR® Cemented Stem (K111910, SE 10/14/2011) with PROFEMUR® Cobalt Chrome Modular Necks (K091423. SE 08/25/2009; K100866. SE 04/28/2010). The subject stems possess a proximal medial collar designed to assist rotational stability and offer protection against subsidence, identical to the cleared predicate PROFEMUR® GLADIATOR® Cemented Stem (K111910, SE 10/14/2011) with PROFEMUR® Cobalt Chrome Modular Necks (K091423, SE 08/25/2009; K100866, SE 04/28/2010). The trunnion is a MicroPort 12/14 SLT taper, with an as-machined geometry to form a taper lock with a mating femoral head implant. The trunnion is identical to the MicroPort femoral stem tapers of the predicate and reference devices. The subject stems possess an oval impaction feature on the proximal shoulder for proper femoral stem insertion into the femoral canal, identical to the cleared reference PROFEMUR® GLADIATOR® Thin HA Classic Stem w/ Collar (K200007, SE 04/25/2020). The subject PROFEMUR® GLADIATOR® Cemented Classic Stems are manufactured from forged cobalt chromium alloy (ASTM F799). The PROFEMUR® GLADIATOR® Cemented Classic Stems were designed to accommodate a wide range of patient anatomy and to provide an optimized fit to adequately restore the biomechanics of the respective hip (including restoration of the natural leg length and head center offset). The subject PROFEMUR® GLADIATOR® Cemented Classic Stems are offered in sizes 4, 6, 8, 10, and 12 with the stem length ranging from 125mm to 170mm, identical to the cleared reference PROFEMUR® GLADIATOR® Cemented Stems (K111910, SE 10/14/2011). The subject classic stem possesses two different neck options: standard (with a CCD neck angle of 135°) and extended/Varus 8° (with a CCD angle of 127°).

This document describes a 510(k) premarket notification for the "PROFEMUR® GLADIATOR® Cemented Classic Stem," a hip joint prosthesis. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence through mechanical testing and engineering analyses. The acceptance criteria are implicitly that the subject device performs equivalently to the predicate devices under standardized tests.

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

The document states that "worst-case constructs" were used for mechanical testing. However, it does not specify the exact sample size (e.g., number of stems tested per condition) for the mechanical tests.

The data provenance is not explicitly mentioned as "country of origin" or "retrospective/prospective." Given this is a 510(k) submission for a medical device (hip stem), the testing data is typically generated in a controlled laboratory environment by the manufacturer (MicroPort Orthopedics Inc., located in Arlington, Tennessee, USA). It is not clinical data but rather benchtop mechanical testing.

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

This information is not applicable to this document. The "ground truth" for the test set is established by industrial standards (e.g., ASTM, ISO) and engineering analysis, not by human expert consensus or clinical observation for this type of device submission. The performance is objectively measured against predefined criteria in these standards.

4. Adjudication Method for the Test Set:

This information is not applicable. As the evaluation is based on objective mechanical testing against engineering standards, an adjudication method for human interpretation is not relevant.

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:

This information is not applicable. This submission is for a hip replacement implant (a physical medical device) and does not involve AI, human readers, or image interpretation.

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

This information is not applicable. This submission is for a hip replacement implant and does not involve an algorithm.

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

The "ground truth" for the performance evaluation in this context is based on standardized mechanical testing protocols and design specifications compliant with recognized industry standards (ASTM, ISO). The performance is measured directly and objectively against these standards.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is a physical medical device and not an AI/machine learning model.

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

This information is not applicable for the same reason as point 8.

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