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The POLARSTEM Cemented Femoral Stem is indicated for advanced degeneration of the hip joint as a result of degenerative, post-traumatic or theumatoid arthritis; fracture or avascular necrosis of the femoral head; failure of previous hip surgery, such as joint reconstruction, arthrodesis, hemiarthoplasty, surface replacement arthoplasty, or total hip replacement.

The POLARSTEM Cemented Femoral Stem is intended for single use only and is to be implanted with bone cement.

The subject of this traditional 510(k) is the POLARSTEM Cemented Femoral Stems. The POLARSTEM Cemented are manufactured from stainless steel according to ISO 5832-9. These subject POLARSTEM hip stems include same design features as the POLARSTEM Standard and Lateral Femoral Stem cleared under K130728.

The POLARSTEM cemented is suitable for partial or total replacement of the hip joint to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in skeletally mature individuals.

The POLARSTEM is available for cemented use in 9 sizes of standard stems (125.5mm to 159.5mm), and 8 sizes of lateral stems (131.5mm to 159.5mm).

This document does not contain information about the acceptance criteria and study that proves a device meets given acceptance criteria. It is a 510(k) premarket notification for a medical device (POLARSTEM Cemented Femoral Stem) and primarily discusses its substantial equivalence to a legally marketed predicate device.

The content focuses on:

• Device Description and Indications for Use: What the device is, its material, sizes, and what it's used for (hip joint replacement).
• Substantial Equivalence: Comparing the subject device to a predicate device (POLARSTEM Standard and Lateral Femoral Stems - K130728) in terms of intended use, indications for use, design, material, and performance.
• Performance Testing (Non-Clinical): Listing various ISO and ASTM standards applied for mechanical, biocompatibility, and other physical tests (e.g., Finite Element Analysis, Neck Fatigue, Corrosion Analysis).
• Clinical Performance: A brief mention of "Clinical evidence of the subject POLARSTEM SS Cemented Femoral Stem from their outside United States (OUS) use has been provided to support the safety and effectiveness of the subject device."

It explicitly states: "To further support a determination of substantial equivalence, mechanical testing was conducted on the POLARSTEM Cemented femoral stem." and "A review of the mechanical data and the technical memo, indicates that the subject POLARSTEM SS Cemented femoral stem is substantially equivalent to predicate device listed in the table above."

Therefore, the document does not provide the specific details requested in your prompt regarding acceptance criteria, target performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for either training or test sets. These types of detailed studies are more commonly found in PMA (Premarket Approval) applications or more extensive clinical trial reports, rather than a 510(k) summary focused on demonstrating substantial equivalence to a predicate.

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