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The POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are indicated for:

· Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.

· Fracture or avascular necrosis of the femoral head

· Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement

• All forms of osteoarthritis

· Patients with hips at risk of distocation

· Femoral neck fracture or proximal fracture to hip joint

The POLARSTEM Standard and Lateral Femoral Stem with Ti/HA is intended for single use only and is to be implanted without bone cement.

The POLARSTEM Standard and Lateral Stems with Ti/HA are similar to the SL-PLUS Standard and Lateral Femoral Stems with TilHA cleared via K120211 and the Anthology Hip Stems cleared via K052792. The subject stems are made from forged titanium alloy Ti-6AI-4V with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite.

The provided document is a 510(k) premarket notification for a medical device, specifically the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA, which are components of a total hip joint replacement system.

Based on the nature of this document, it describes a
medical device, not an AI/ML algorithm or a diagnostic tool.

Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details does not apply to this type of submission.

The document discusses mechanical testing to demonstrate the device's capability to withstand in vivo loading without failure, and it leverages equivalence to previously cleared predicate devices.

Here's the relevant information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a table format for mechanical performance or directly report numerical performance data for the POLARSTEM stems beyond general statements. Instead, it relies on demonstrating substantial equivalence to predicate devices through mechanical testing.

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

This information is not applicable in the context of an AI/ML algorithm. For mechanical testing of medical devices, "sample size" refers to the number of physical devices tested. The document does not specify the exact number of stems subjected to fatigue testing, but standard practice involves testing multiple samples to statistical significance. The data provenance would be from laboratory mechanical testing, not human patient data in the typical sense of AI/ML.

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

This is not applicable. For this type of device, ground truth is established through engineering and material science principles, laboratory testing under controlled conditions, and compliance with recognized standards (e.g., ISO standards for orthopedic implants). There are no "experts" in the sense of clinical reviewers establishing ground truth for individual 'cases' in the way it would apply to an AI diagnostic.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication is a process typically used for human review of data, often in clinical trials or for establishing ground truth labels in AI. Mechanical tests have objective pass/fail criteria.

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

This is not applicable. MRMC studies are used to evaluate the performance of diagnostic tools (often AI) with and without human assistance. This document describes a physical implantable device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable as it concerns a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established through:

• Mechanical Engineering Standards: Compliance with industry-recognized standards for orthopedic implants regarding fatigue, strength, and material properties.
• Material Science Principles: Verification of the properties of the Ti-6Al-4V alloy and the Ti/HA coating.
• Predicate Device Performance: The primary method for proving substantial equivalence involves demonstrating that the new device performs comparably to legally marketed predicate devices, which have a track record of safe and effective use.

8. The Sample Size for the Training Set:

This is not applicable. The device is not an AI/ML algorithm, so there is no "training set."

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

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

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