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.

D.0 Premarket Notification 510(k) Summary

D.1 Submitter Information

Company Name and Address:

PLUS ORTHOPEDICS AG Erlenstraße 4a CH-6343 Rotkreuz Switzerland

Contact Name:

Pamela J. Weagraff, Principal Consultant Quintiles Consulting 18 Bridie Lane Norfolk, MA 02056

Telephone: 508-528-1745 Facsimile: 978-752-1225 E-mail: pamela.weagraff@quintiles.com

Date Prepared: January 23, 2007

D.2 Name of Device

2.1 Trade Name: POLARCUP® Dual Mobility System
2.2 Common Name: Acetabular Component
2.3 Classification Name and Reference:

Title 21 Code of Federal Regulation (CFR), Part 888.3358, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Product Code: LPH Title 21, CFR, Part 888.3390, Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis; Product Code: KWY

Substantial Equivalence Claimed to Predicate Device D.3

Biomet® Tri-Polar Systems, K991990

Traditional 510(k) - POLARCUP® Dual Mobility System January 23, 2007

{1}------------------------------------------------

D.4 Device Description

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

4.1 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.

4.2 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.

{2}------------------------------------------------

4.3 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 .

D.5 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

D.6 Predicate Device Comparison of Indications for Use / Intended Use and Technical Characteristics

The comparison of the POLARCUP® Dual Mobility System was based on a review of the Design Control documentation, relevant aspects of which are included in the company's 510(k) Premarket Notification, and information concerning the predicate device that was obtained from the predicate device manufacturer's web site. The comparison considered technical characteristics and the indications for use / intended use.

Traditional 510(k) - POLARCUP® Dual Mobility System January 23, 2007

{3}------------------------------------------------

D.7 Performance Data

7.1 Performance Standards (Section 514 Compliance): no applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act, for either hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis or hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
7.2 The POLARCUP® Dual Mobility System does conform to the following FDA recognized standards:

7.2.1 Sterility

ISO 11137-1:2006, Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11137-2, 2006, Sterilization of health care products --Radiation -- Part 2: Establishing the sterilization dose

7.2.2 Materials

ISO 5832-9:1992, Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel

ISO 5832-2:1999, Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium

ISO 5832-1:1997, Implants for surgery -- Metallic materials -- Part 9: Wrought Stainless Steel

ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2 : Moulded Forms

7.3 Performance Testing: Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.

D.8 Conclusion:

The information and data provided in this 510(k) Premarket Notification establish that the POLARCUP® Dual Mobility System is substantially equivalent to the afore-mentioned predicate device with respect to indications for use/intended use, and technical characteristics.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Plus Orthopedics AG % Quintiles Consulting Ms. Pamela J. Weagraff, MBA, RAC 18 Bridie Lane Norfolk, Massachusetts 02056

APR 1 6 2007

Re: K070278

Trade/Device Name: POLARCUP® Dual Mobility System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, KWY Dated: January 23, 2007 Received: January 29, 2007

Dear Ms. Weagraff:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

Page 2 - Ms. Pamela J. Weagraff

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Brye Kup

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ODE Indications Statement

510(k) Number (if known): Unknown

Device Name: POLARCUP® Dual Mobility System

Indications for 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

Prescription Use: X (21 CFR 801 Subpart D) Over-the-Counter Use: (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michale Buchman

Division Sign-up),
Division of Ger. vol. Restorative,

and A

510(k, ...K070278

Traditional 510(k) - POLARCUP® Dual Mobility System January 23, 2007

Company Confidential Page 9 of 77

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.