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The POLARCUP® Dual Mobility System is 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 dislocation .
• . Femoral neck fracture or proximal fracture to hip joint

The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement. The POLARCUP® Dual Mobility System is intended for single use only.

The POLARCUP Dual Mobility System consists of a metal shell and plastic liner (or insert). The inside of the metal shell is polished, and the outside of the plastic liner is able to articulate against this polished surface. This dual mobility design results in higher intra-prosthetic stability to address the treatment of patients with a high risk of dislocation (especially for elderly patients) or patients with recurrent dislocation. The subject of this premarket notification is the addition of an outer hydroxylapatite coating to the currently available acetabular shell.

The provided text is a 510(k) summary for the POLARCUP® Dual Mobility System, a medical device. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/software validation.

Instead, this document describes:

• The device (POLARCUP® Dual Mobility System) and its components (metal shell, plastic liner).
• Its intended use (treatment of advanced degeneration of the hip joint, fractures, failures of previous hip surgery, osteoarthritis, and patients at high risk of dislocation).
• Its classification and regulatory information.
• Its technological characteristics, specifically noting that mechanical data indicates it can withstand in vivo loading.
• Its substantial equivalence to predicate devices (other hip prostheses from Smith & Nephew).
• A brief conclusion that, based on similarities to predicates and mechanical testing, the device is substantially equivalent.

Therefore, I cannot provide the requested information because the document does not describe acceptance criteria for an AI/software device, nor does it detail a study that proves such a device meets acceptance criteria.

The questions you've asked (about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are all highly relevant to the validation of AI/Software as a Medical Device (SaMD) or AI-enabled medical devices. This document, however, is for a physical orthopedic implant and does not involve AI or software in the way your questions imply.

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The POLARCUP® Dual Mobility System is 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 dislocation
• Femoral neck fracture or proximal fracture to hip joint .

The POLARCUP® Dual Mobility System is intended for single use only and depending on its version is to be implanted either with or without bone cement.

The POLARCUP Dual Mobility System consists of a metal shell and plastic liner (or insert). The inside of the metal shell is polished, and the outside of the plastic liner is able to articulate against this polished surface. This dual mobility design results in higher intra-prosthetic stability to address the treatment of patients with a high risk of dislocation (especially for elderly patients) or patients with recurrent dislocation. The subject device is identical to the previously cleared POLARCUP® Dual Mobility System with the exception of an increase in the size range and the addition of Highly Crosslinked Polyethylene Liners.

Here's the analysis of the provided text regarding the acceptance criteria and study for the POLARCUP® Dual Mobility System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, K110135, is a 510(k) premarket notification for a medical device. For such devices, "acceptance criteria" and "device performance" are typically established through bench testing and comparison to predicate devices rather than clinical study outcomes with specific metrics like sensitivity or specificity.

Therefore, the "acceptance criteria" here relate to demonstrating substantial equivalence through mechanical testing and material characterization, and the "reported device performance" is the conclusion that these tests met the requirements for substantial equivalence.

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

This is a physical medical device (implantable hip component), not a diagnostic algorithm or software. Therefore, the concept of a "test set" and "data provenance" in the context of clinical images or patient data does not apply in the same way.

• Sample Size for Test Set: Not applicable in the traditional sense of patient data. The "test set" would refer to the number of devices or components used in mechanical and material testing. The document does not specify the exact number of units tested for each mechanical evaluation (Wear Testing, Coating Characterization, Range of Motion Testing, Stress Analysis, and Fatigue Properties).
• Data Provenance: The data comes from in vitro mechanical and material testing conducted by Smith & Nephew, Inc. There is no information regarding country of origin for the data or whether it's retrospective or prospective, as these terms are relevant for clinical studies, not bench testing.

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

Not applicable. "Ground truth" in this context would be scientifically established standards for material and mechanical performance testing, as well as regulatory standards for demonstrating substantial equivalence. The document does not mention the use of experts to establish a "ground truth" for the test data itself. The interpretation and assessment of the test results would be conducted by qualified engineers and regulatory affairs personnel within Smith & Nephew, and ultimately reviewed by FDA experts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations of clinical data, particularly in diagnostic studies. This document describes a submission for a physical implant, where performance is assessed through objective mechanical and material tests.

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-assisted diagnostic device, nor is it a device that involves human "readers" interpreting clinical cases. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on established engineering and material science principles and regulatory standards for mechanical and material performance of hip prosthetic components. This includes:

• Industry standards for wear testing (e.g., ISO standards for orthopedic implants).
• Material property specifications for titanium alloys, polyethylene, and porous coatings.
• Biomechanical principles for stress analysis and fatigue life.
• The performance characteristics of the predicate devices (K070278 POLARCUP Dual Mobility System and K083116 VERSAFIT Double Mobility System) against which the subject device is being compared for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable, as there is no training set for this type of medical device submission.

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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.

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 .

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:

• 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.

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