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The ZENITH Hip System is designed for total hip arthroplasty and is intended to be used with compatible components (femoral heads and acetabular cups) of the Helicon Hip System.

The indications for use are:

• A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• C. Proximal femoral fractures.
• D. Avascular necrosis of the femoral head.
• E. Non-union of proximal femoral neck fractures.
• F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

The un-coated stem in the ZENITH Hip System is indicated for cemented use while the porous coated stem is indicated for non-cemented use.

The ZENITH Hip System (ZHS) offers a proximally porous and nonporous femoral stem component each compatible with all femoral heads, acetabular components, and cancellous bone screws of the Helicon Hip System (HHS). The porous ZHS stems are manufactured from forged Titanium (Ti) alloy, and employ a porous-coating made from commercially pure Ti (CPTi) beads. The nonporous ZHS stems are manufactured from forged cobalt chrome (CoCr) alloy. The porous Ti stem is a straight, collarless design available in 6 sizes ranging from 10 to 15mm. The nonporous CoCr stem is a straight, collared design available in 8 sizes ranging from 8 to 15mm. Both stems feature a neck-shaft angle of 128°, a 12/14 Morse taper trunnion, neck relief, and a cylindrical fluted shaft. A distal centralizer manufactured from polymethylmethacrylate (PMMA) is available for cemented applications of the CoCr stem.

The ZHS also includes 36mm femoral heads and acetabular cups. The heads are manufactured from forged or wrought CoCr alloy. The 36mm inserts are manufactured from conventional UHMWPE. The heads are highly polished and are available in four neck offsets (-5mm, Neutral, +5mm, +10mm). The heads incorporate an identical female 12/14 Morse taper used on all predicate HHS CoCr heads. The 36mm inserts are compatible with predicate HHS acetabular shells ranging in size from 56 to 68mm. Refer to the compatibility table (new Attachment 1 of the September 12, 2012 Al response/Supplement 1 ). The 36mm inserts are offered in neutral or 10 degree hooded configurations. Hooded inserts include an X-ray marker manufactured from wrought Ti alloy. The 36mm heads and mating inserts are also compatible with the Helicon Hip System.

Here's a breakdown of the acceptance criteria and study information for the ZENITH Hip System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (hip implant), which focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not describe a study involving an AI algorithm or human-in-the-loop performance. The "acceptance criteria" here refer to meeting performance standards for mechanical integrity and design equivalence, not for diagnostic accuracy or human performance with AI.

The "study" in this context is a series of non-clinical bench tests and a comparative analysis of specifications to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in terms of a numerical sample size of devices tested. The testing involved "worst-case stem/head configurations," implying a selection of representative components that would experience the highest stresses or potential failure modes.
• Data Provenance: The testing was "nonclinical bench testing" and involved a "Failure Modes and Effects Analysis (FMEA)." This indicates laboratory testing, rather than human clinical data. The data provenance is from the manufacturer's (or its licensee's) internal testing. Country of origin for the data is not specified beyond being generated for a U.S. FDA submission. The data is retrospective in the sense that it evaluates manufactured components against predefined criteria; it is not a prospective clinical trial.

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

• This question is not applicable in the context of this device and documentation. "Ground truth" in this context refers to the defined engineering specifications and performance standards against which the device's mechanical properties were measured. These standards are established by engineering principles, regulatory guidelines (e.g., ISO standards for implants, not detailed here), and comparison to predicate devices, rather than expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to a process of resolving discrepancies among human readers in interpreting clinical data. For bench testing of mechanical properties, results are typically measured objectively against predefined engineering thresholds.

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, an MRMC comparative effectiveness study was not done. This document pertains to a hip implant (hardware), not an AI algorithm for diagnostic imaging or decision support. Therefore, there is no AI component or human reader performance to evaluate.

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

• No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on:
  • Engineering Specifications and Performance Standards: Established mechanical testing methodologies (e.g., fatigue testing, bond strength, fretting corrosion, range of motion) used to ensure the device meets required functional and safety thresholds.
  • Predicate Device Performance: The primary "ground truth" for substantial equivalence is the established safety and effectiveness of legally marketed predicate devices. The ZENITH Hip System is shown to perform "at least as safely and effectively" as these predicates.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of a physical hip implant. The principles of substantial equivalence and bench testing do not involve machine learning training sets.

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

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

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