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General Indications:
The MobileLink Acetabular Cup System is indicated for mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• Primary and secondary osteoarthritis
• Rheumatoid arthritis
• Correction of functional deformities
• Avascular necrosis
• Femoral neck fractures
• Revision after implant loosening dependent on bone mass and quality

Dual Mobility Insert (in addition to the indications and general indications):

• Dislocation risk

The MobileLink Acetabular Shells are intended for cementless fixation.

The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

Additional indications specific to the TrabecuLink Augments:

• Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system.

MobileLink PlasmaLink and TiCaP Shells: The MobileLink 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 titanium plasma sprayed (TPS) coating (brand name: PlasmaLink) or a double coating consisting of titanium plasma spray coating plus calcium phosphate (CaP) coating (brand name: TiCaP). The MobileLink PlasmaLink and TiCaP Shells are compatible with polyethylene liners (K182321, K241636), acetabular bone screws (K192559), Dual Mobility Inserts (K200607) with BiMobile Dual Mobility Liners (K171273, K190535), Shell/Insert Adapters ("Face Changers", K200607), and TrabecuLink Augments (K241636).

This FDA 510(k) clearance letter is for a medical device called the "MobileLink Acetabular Cup System - inhouse coatings." It does not involve AI software and therefore does not have the acceptance criteria and study information typically associated with AI/ML-based devices.

The submission is specifically for a change in the coating supplier for an existing device from an external vendor to an in-house process. This means the core design and function of the acetabular cup system are already established and cleared.

Therefore, the requested information elements (acceptance criteria table, sample size for test set, experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, how training ground truth was established) are not applicable to this specific 510(k) submission.

Here's why and what information is provided:

• Device Type: This is a physical orthopedic implant (hip replacement component), not an AI/ML software device.
• Reason for Submission: The primary reason for this 510(k) is to notify the FDA of a change in the manufacturing process (in-house coating application instead of external). This is a manufacturing/materials change, not a new device with new performance claims requiring extensive clinical or AI performance studies.
• Performance Testing: The document states:
  • "Non-clinical performance testing and analysis were provided, including: Characterization of the TPS and TiCaP inhouse coatings."
  • "Biocompatibility evaluation."
  • "The results of non-clinical performance testing demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent."
  • "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

This means the acceptance criteria and supporting studies were focused on material characterization and biocompatibility to ensure the new in-house coating process yields a product that is equivalent to the predicate device in terms of safety and performance (e.g., adhesion, wear resistance, biological response), rather than diagnostic accuracy or human-AI interaction.

In summary, there is no information in this document to answer the questions about acceptance criteria related to AI/ML performance studies, as this is not an AI/ML device submission.

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The MobileLink Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur 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 Dual Mobility Insert is additionally indicated for:
7) Dislocation risks

Additional indications specific to the TrabecuLink Augments:
Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Shells are intended for cementless fixation. The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. This 510k adds several system components to the MobileLink Acetabular Cup System previously cleared in K182321, K192559, K200607, and K222066.

X-LINKed Inserts: The X-LINKed Inserts are manufactured from highly crosslinked polyethylene material. The inserts are available in the same sizes and designs as the previously cleared E-Dur inserts (K182321). The design variants include a neutral variant with or without offset, a shouldered variant with or without offset and 10° and 20° inclining variants with an offset. The inserts are fixed using a clamping system consisting of a combination of snap mechanism and conical clamping. Notches (tabs/recesses) at the rim further contribute to the rotational stability of the PE inserts.

TrabecuLink Augments: The TrabecuLink Metal Acetabular Augments are wedgeshaped components that conform to the shape of the acetabular shell. They are additively manufactured Ti6A14V alloy per ISO 5832-3 (chemistry and mechanical properties) and feature a porous structure (TrabecuLink) on the bone interfacing surface. They mate with the same MobileLink (TrabecuLink) Shells as previously cleared in K182321 and K222066 and they can be used with the same 6.5mm diameter bone screws cleared in K192559, or with new smaller diameter (4.5mm) bone screws introduced in this submission.

Bone Screws: The MobileLink Bone Screws are Ø 4.5mm in lengths from 15 -60mm (by 5mm increments). They feature the same head size/design as the previously cleared Ø 6.5mm screws and are made of the same wrought Ti6A14V alloy per ISO 5832-3 and ASTM F136 as the previously cleared Ø 6.5mm screws.

This document is a 510(k) Premarket Notification from Waldemar Link GmbH & Co. KG for their MobileLink Acetabular Cup System - Line Extension (Multiple). It's a submission to the FDA regarding new components for an existing hip replacement system.

The document does not describe a study involving acceptance criteria for a device's performance in a diagnostic or AI context. Instead, it is a regulatory filing for a medical device (hip replacement components). The "performance testing" section refers to non-clinical tests to ensure the mechanical and material integrity of the new components are comparable to existing, cleared devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as it is not relevant to the type of device or study described.

Here's an attempt to fill in the table and address the relevant points based on the provided text, while noting where information is not applicable or available:

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance:
See the table above. The acceptance criteria essentially boil down to demonstrating "substantial equivalence" to predicate devices through various non-clinical performance tests. The reported performance for each test is that "The results... demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent." Specific numerical thresholds for acceptance are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The tests are non-clinical, likely bench testing on prototypes or manufactured samples, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a non-clinical device performance study, not a diagnostic study requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a non-clinical device performance study, not a diagnostic study requiring adjudication.

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/Software device, nor is it a diagnostic device where MRMC studies would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/Software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical performance tests, the "ground truth" would be the established engineering standards, material specifications (e.g., ISO 5832-3, ASTM F136, ASTM F543), and the performance characteristics of the predicate devices. The new components are tested to meet these established benchmarks.

8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device.

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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 subject devices are 6.5mm diameter acetabular bone screws in various lengths manufactured from Ti6Al4V alloy. They are accessories to the predicate MobileLink® Acetabular Cup System (K182321).

This document (K192559) describes the 510(k) premarket notification for "Acetabular Bone Screws (for MobileLink Acetabular Cup System)". It's important to note that this document is for a medical device (bone screws), not an AI or software device. Therefore, the requested information regarding acceptance criteria and studies for an AI/software device does not apply to this submission.

The document discusses the substantial equivalence of the bone screws to predicate devices based on:

• Device Description: 6.5mm diameter acetabular bone screws in various lengths manufactured from Ti6Al4V alloy. They are accessories to the MobileLink® Acetabular Cup System.
• Intended Use: The MobileLink® Acetabular Cup System (with which these screws are used) is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures, including primary and secondary osteoarthritis, rheumatoid arthritis, correction of functional deformities, avascular necrosis, femoral neck fractures, and revision after implant loosening.
• Comparison to Predicate Device: The subject screws provide supplemental screw fixation for acetabular shells, are manufactured from the same Ti6Al4V alloy as the predicate, are available in Ø 6.5mm and various lengths, and minor technological differences do not raise new questions of safety or effectiveness.
• Performance Testing (Non-Clinical):
  • Bone screw testing according to ASTM F543.
  • Endotoxin testing.
  • Biocompatibility evaluation.
• Clinical Testing: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

Therefore, I cannot provide the requested information related to AI/software device acceptance criteria and study details because this document does not pertain to such a device.

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