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General Indications:
The MobileLink® Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• 1. Primary and secondary osteoarthritis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformities
• 4. Avascular necrosis
• 5. Femoral neck fractures

6. Revision after implant loosening dependent on bone mass and quality

The MobileLink® Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. The cup system consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either plasma sprayed coating (PlasmaLink®) or a double coating consisting of plasma spray plus calcium phosphate coating (TiCaP®). All shells are implanted cementless. The acetabular inserts are manufactured from conventional UHMWPE or Vitamin E highly crosslinked UHMWPE (E-Dur®). The inserts are available in six designs, neutral, offset, shouldered, offset/shouldered, 10° and 20° inclination. This premarket notification does not include the femoral components. The MobileLink® Acetabular Cup System is compatible with previously cleared femoral heads (K161840, K953653) and hip stems and neck segments (K161840, K151008, K142187, K953653) of Waldemar Link GmbH & Co. KG.

The provided text describes a 510(k) premarket notification for the "MobileLink Acetabular Cup System". This notification is a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a study proving the device meets specific acceptance criteria in the same way a novel device might.

Instead, the submission relies on non-clinical performance testing and analysis to demonstrate substantial equivalence to predicate devices. There is no mention of specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria with statistical significance.

Here's an breakdown of the information based on your request, structured to reflect what is actually present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence based on non-clinical testing, there isn't a table of specific, quantitative "acceptance criteria" for clinical performance. The "performance" is demonstrated through various bench tests and characterizations, aiming to show similarity to predicate devices.

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

• Test Set Sample Size: Not explicitly stated in the document. The testing described is bench testing, involving mechanical specimens rather than patient data.
• Data Provenance: Not applicable in the context of clinical data. The tests are bench tests conducted in a laboratory setting for the purpose of a 510(k) submission.

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

• Number of Experts & Qualifications: Not applicable. For bench testing, "ground truth" is typically established by engineering specifications, material standards (e.g., ASTM, ISO), and regulatory guidelines rather than expert clinical consensus.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a clinical study involving human interpretation of data where adjudication would be necessary. The tests are objective measurements against engineering standards.

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

• MRMC Study: No. This device is a physical implant (acetabular cup system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.

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

• Standalone Performance: Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

• Ground Truth: For bench testing, the "ground truth" refers to established engineering standards (e.g., ASTM, ISO), mechanical properties, material specifications, and performance expectations derived from predicate devices. The goal is to demonstrate that the device meets these engineering and material requirements.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set of data.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

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The subject femoral heads are single-use devices intended for use in cemented or cementless total hip arthroplasty with various Howmedica Osteonics hip stems featuring the PCA® taper (2° 52') that are manufactured from CoCr alloy. They are not intended for use with any stem manufactured from Stainless Steel or Titanium alloy. They are also intended for use with any compatible, currently available Howmedica Osteonics acetabular component featuring a polyethylene bearing surface.

Indications for Use:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
2. rheumatoid arthritis (excepting the Osteolock" HA Acetabular Cup and Peri-Apatite coated prostheses):
3. correction of functional deformity:
4. revision procedures where other treatments or devices have failed; and,
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Peri-Apatite coated prostheses are indicated only for primary uncemented total hip arthroplasty for items 1, 3, & 5 above when offered for sale in the USA.

Femoral head prostheses are indicated for use in cementless total hip arthroplasty, depending upon the indications of the acetabular and femoral stem components chosen.

PCA® taper (2° 52') femoral heads manufactured from Alumina ceramic (ASTM F603) with a Ti-6Al-4V alloy sleeves (ASTM F136) will be available in 32mm diameters. The femoral heads will be available with 0 (standard) and +5 offsets. The PCA® taper femoral heads are compatible with a range of CoCr alloy Howmedica Osteonics PCA® taper femoral stems. The subject components are also compatible for use with a wide range of acetabular components (shells and polyethylene inserts).

The provided text is a 510(k) summary for a medical device, specifically PCA® Alumina 32mm Femoral Heads. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics in the way a diagnostic AI device would.

Therefore, the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, and MRMC/standalone studies is not present in this document. This document describes a physical orthopedic implant, not an AI or diagnostic software.

Here's why the requested information isn't available and what the document does provide:

• Acceptance Criteria and Reported Device Performance (Table): This document does not present quantitative performance metrics for the device. Instead, it asserts substantial equivalence based on material composition, design principles, and intended use as compared to existing devices.
• Sample size for the test set and data provenance: Not applicable. This is a physical device, not an algorithm tested on a dataset of patient information.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device does not have "ground truth" established by experts in the context of diagnostic interpretation.
• Adjudication method for the test set: Not applicable.
• 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 tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does describe and implies about how the device meets requirements:

The document focuses on demonstrating substantial equivalence to predicate devices already on the market. This is the primary "proof" for a 510(k) submission for this type of device.

Substantial Equivalence Section:
The PCA® Alumina Femoral Heads are deemed substantially equivalent to:

• Alumina V40™ Femoral Heads (K023901)
• PCA Total Hip System - Cementless Use (K920831)
• V40™/C-Taper Adapter Sleeve (K003379)

The inference is that because the new device is substantially equivalent in terms of materials (Alumina ceramic with Ti-6Al-4V alloy sleeves, 32mm diameter, 0 and +5 offsets for PCA® taper), intended use, and indications for use to these already cleared devices, it meets the safety and effectiveness requirements without the need for a new clinical trial generating performance data against specific acceptance criteria. The materials (ASTM F603 for Alumina, ASTM F136 for Ti-6Al-4V alloy) imply adherence to established material standards, which are a form of "acceptance criteria" for material properties.

In summary, for medical devices like the PCA® Alumina Femoral Heads, the "study that proves the device meets the acceptance criteria" is the comparison to legally marketed predicate devices under the 510(k) pathway, demonstrating that its features, intended use, and performance characteristics are similar to those already deemed safe and effective by the FDA.

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