POLARCUP DUAL MOBILITY SYSTEM

• K Number: K070278
• Device Name: POLARCUP DUAL MOBILITY SYSTEM
• Manufacturer: PLUS ORTHOPEDICS AG
• Date Cleared: 2007-04-16 ( 77 days)
• Product Code: LPH , KWY
• Regulation Number: 888.3358
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K991990

Intended Use

The POLARCUP® Dual Mobility System is indicated for:

• All forms of osteoarthritis .
• Dislocation risks .
• Progressive loss of function of the hip joint as a result of a degenerative post-. traumatic or inflammatory / rheumatic destruction of the joint
• . Femoral head necrosis
• Proximal femoral fractures (especially femoral neck) .
• . Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement

The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

Device Description

The POLARCUP® Dual Mobility System consists of two components: a thin press fit shell and a liner component.

Shell Component: The POLARCUP® shell, is manufactured from stainless steel INOX M30NW according to ISO 5832-9:1992, Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel, and is available in three configurations:

• Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, with pegs and two flanges, uncemented use: allows for implantation with no pegs and no flanges, with no pegs and contoured flanges, screws in flanges but with no pegs, and two impacted pegs and two screws in flanges
• . Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, without pegs and flanges, uncemented use)
• . Stainless steel, mirror polished, without pegs and flanges, cemented use

Note: the pure Titanium coating found in the uncemented versions is a Titanium alloy according to ISO 5832-2:1999. Implants for Surgery -Metallic Materials - Part 2: Unalloyed Titanium.

The POLARCUP® shell is available in 13 sizes for each of the titaniumcoated versions for uncemented use, ranging in diameter from 43 mm to 67 mm. The mirror-polished version for cemented use is available in 11 sizes, ranging in diameter from 43 mm to 63 mm.

Cortical Screws and Impacted Pegs: Cortical screws and impacted pegs, both made of stainless steel INOX 316LVM according to ISO 5832-1:1997, Implants for surgery -- Metallic materials -- Part 9: Wrought Stainless Steel, are available for use with the POLARCUP® shell version with pegs and flanges for uncemented use. The cortical screws are 4.5 mm in diameter and available in 6 different lengths ranging from 40 mm to 60 mm. The impacted pegs are available in a single length of 13 mm.

Liner Component: The POLARCUP® liner component is a polyethylene insert, specifically Ultra-High Molecular Weight Polyethylene (UHMW PE) according to ISO 5834-2:1998, Implants for Surgery -- Ultra-High-Molecular-Weight Polyethylene - Part 2 : Moulded Forms, that retains the femoral head and moves freely in the POLARCUP® shell, allowing increased mobility and stability. The liner component is available in two internal joint diameters. 22 mm and 28 mm. The 22 mm diameter liner is available in 13 different sizes of spherical external radius of curvature whereas the 28 mm diameter liner is available in 11 different sizes of spherical external radius of curvature (to ensure a minimal thickness of 6.5 mm according to EN 12563).

The POLARCUP® Dual Mobility System may be used with the following components provided that they are legally marketed in the US and meet these specifications:

• Ball Heads: made of CoCrMo, ceramic or stainless steel, with diameters . of 22 or 28 mm
• Femoral Stems: polished or electro-polished necks .

AI/ML Overview

This looks like a submission for a medical device (POLARCUP® Dual Mobility System) to the FDA, seeking 510(k) clearance based on substantial equivalence to a predicate device. The document primarily describes the device, its components, materials, intended use, and a comparison to a predicate device. It also lists performance standards and testing performed in accordance with FDA design control requirements.

However, the provided text does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic or AI-driven performance metrics.

Here's why and what's missing:

• This is a mechanical implant: The POLARCUP® Dual Mobility System is a hip joint prosthesis, a mechanical device. Its performance is evaluated through material science tests, biocompatibility, and mechanical integrity, not typically through diagnostic accuracy metrics like sensitivity, specificity, or reader studies common for AI or diagnostic imaging devices.
• "Acceptance criteria" here refer to regulatory compliance and mechanical performance standards, not diagnostic performance: The document implicitly states its acceptance criteria through its adherence to ISO standards for materials and sterilization, and compliance with FDA's Design Control Requirements (Title 21 Code of Federal Regulations, Part 820.30). These ensure the device is safe and effective for its mechanical and biological function as an implant.
• No "study that proves the device meets acceptance criteria" in the requested format: The document mentions "Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements." This is the general statement about how its performance was verified, but it doesn't detail specific acceptance criteria values (e.g., "X% accuracy," "Y mm deviation") or the results of those specific tests in a table, as would be expected for a diagnostic device.
• Missing all AI/diagnostic specific questions: Because this is a mechanical implant, there's no information about sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or type of ground truth (e.g., pathology, outcomes data). These are relevant for AI/diagnostic devices, not for an orthopedic implant.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving performance in the context requested. The document does not provide the type of information that aligns with those questions.

To illustrate the type of information this document does provide, here's a summary of its performance-related content:

Summary of Performance-Related Information from the Provided Text:

Category	Description
Acceptance Criteria (Implied by Regulatory Compliance)	- Sterility: Conformance to ISO 11137-1:2006, ISO 11137-2:2006.

• Materials: Conformance to ISO 5832-9:1992 (Stainless Steel INOX M30NW), ISO 5832-2:1999 (Unalloyed Titanium), ISO 5832-1:1997 (Stainless Steel INOX 316LVM), ISO 5834-2:1998 (UHMW PE).
• Design and Manufacturing: Compliance with FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.
• Mechanical Integrity: Not explicitly quantified in this summary, but implied by "Design verification and design validation, e.g., bench testing." (Specific thresholds and results for wear, fatigue, etc., would be in the full submission). |
  | Reported Device Performance | - "Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements."
• The document concludes that the device is "substantially equivalent to the afore-mentioned predicate device with respect to indications for use/intended use, and technical characteristics." This implies that its performance (mechanical, material, etc.) is comparable and acceptable given its design and predicate. |

Answers to Specific Questions (Based on Lack of Relevant Information):

1. A table of acceptance criteria and the reported device performance: See table above, but note that the specific numerical acceptance criteria and corresponding numerical performance results for mechanical properties are not detailed in this summary.
2. Sample sized used for the test set and the data provenance: Not applicable/Provided. The tests are bench tests on device components/assemblies, not observational data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth for mechanical testing is based on engineering specifications and physical measurements, not expert review.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. Ground truth for material and mechanical tests is based on established engineering principles and measurement standards.
8. The sample size for the training set: Not applicable. This device does not use a "training set" in the AI sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (a hip implant), and thus the questions pertinent to AI or diagnostic device performance evaluation cannot be answered from this text.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.