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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 BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects of hip joint or proximal femur, which cannot be treated by conservative or osteosynthetic procedures.

The BiMobile Dual Mobility System is indicated for the following conditions:

• · Primary and secondary coxarthrosis
• Rheumatoid arthritis
• · Correction of functional deformities
• · Avascular Necrosis
• · Femoral neck fractures
• · Revision after implant loosening dependent on bone mass and quality
• · Dislocation risks

The device is intended for cemented and cementless use.

The BiMobile instruments are considered a line extension to the instrument system cleared in 510(k) K171273 and K190535 with the BiMobile Dual Mobility System. Like the original instruments, the additional BiMobile instruments are manual orthopedic surgical reusable instruments offered to aid the implantation of the BiMobile Dual Mobility System (K171273 and K190535). The BiMobile Instruments incorporate design changes for simplicity of use. The modifications do not significantly alter the surgical workflow or technique, the intended use, or involve any change in technology.

The provided text is a 510(k) summary for the BiMobile Instruments (for use with Dual Mobility System), an accessory to hip joint prostheses. This document describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

This document does not describe a study involving an AI/Machine Learning device or an algorithm-only standalone performance study.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or training set details, as these are not relevant to the content of the provided 510(k) summary.

The document discusses the substantial equivalence of modified accessory instruments to predicate instruments based on non-clinical testing and evaluations. These evaluations are focused on ensuring the modified instruments function as intended and are safe, not on the performance of a diagnostic or predictive algorithm.

The listed "non-clinical testing and evaluations" are:

• Simulated transport testing
• Biocompatibility assessment
• Interface analysis, functional testing, biolab evaluation, application risk analysis
• Durability testing
• Validation of reprocessing and sterilization instructions

These tests are standard for mechanical medical devices and accessories to ensure their physical integrity, material safety, and functional reliability. They do not involve "device performance" in the sense of accuracy, sensitivity, or specificity as would be relevant for an AI/ML diagnostic.

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General indications:

The MobileLink(0) 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(8) Dual Mobility Insert is additionally indicated for:

• 7. Dislocation risks
     The MobileLink(8) Acetabular Shells are intended for cementless fixation.

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.
Dual Mobility Inserts: The Dual Mobility Inserts are manufactured from CoCrMo alloy. They assemble by taper lock to any MobileLink® Acetabular Shell (either the PlasmaLink or TiCaP versions cleared in K182321) and mate with polyethylene Dual Mobility Liners (from the BiMobile System cleared in K171273 and K190535.

Shell/Insert Adapters ("face changers"): These are optional components that can be used as an interface between the MobileLink® Acetabular metal shells (either the PlasmaLink or TiCaP versions cleared in K182321) and the neutral and shouldered polyethylene inserts to adjust the center of rotation and anteversion angles. They are manufactured from Ti6Al4V alloy, and come in various designs: neutral, offset, offset with 10° inclination, and offset with 20° inclination. The neutral version assembles to the mating shell by taper lock only, while the other versions assemble by taper lock plus an assembly screw.

The provided document is a 510(k) summary for the LINK MobileLink® Acetabular Cup System. This document describes the device and its indications for use, but does not contain any information regarding specific acceptance criteria, device performance metrics, or study results that would allow for the completion of the requested table and detailed study description.

The "Performance Testing" section states that non-clinical performance testing and analysis were provided, including:

• Acetabular construct disassembly testing (Push-out, lever-out, torque out for all acetabular modular connections)
• Fretting/Corrosion testing
• Impingement testing
• Range of Motion analysis according to ISO 21535
• Biocompatibility evaluation

However, it does not report the acceptance criteria for these tests or the actual device performance values achieved. It only concludes that "The results of non-clinical performance testing demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent."

The document also explicitly states: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." This confirms that there was no study involving human subjects or a comparison of AI-assisted vs. non-AI assisted performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance, number of experts, adjudication methods for ground truth, MRMC studies, or standalone performance.
3. Details on ground truth types or training set information.

This information would typically be found in a more detailed technical report or study protocol, which are not included in this 510(k) summary.

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The BiMobile Dual Mobility 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. The BiMobile Dual Mobility System is indicated for the following conditions:

• · 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
• · Dislocation risks
  The device is intended for cemented and cementless use.

The BiMobile cup system is a dual mobility acetabular implant system. The system is consisting of wrought cobalt chromium molybdenum alloy (CoCrMo acc. to ISO 5832-12) metal shells with a highly polished inner surface, which are available in three different outer surface modifications. There is the cemented version with a glass blasted surface of concentric grooves, and two cementless versions where a pressfit generating macrostructure is covered by either a PlasmaLink (titanium plasma spray acc. to ISO 5832-2/ASTM F1580) or TiCaP (titanium plasma spray and calcium phosphate acc. to ISO 5832-2/ASTM F1580 and F1609) coating. For each size, from 42 to 70, a dedicated liner made of Ultra-high-molecular-weight polyethylene (conventional UHMWPE acc. to ISO 5834-2/ASTM F648) is available. These can be combined with ceramic or CoCr alloy femoral heads of sizes 22 mm (for Size 42-46) and 28 mm (for size 48-70). The purpose of this submission is to add acetabular liners in Vitamin E highly crosslinked UHMWPE (E-Dur) acc. to ASTM F2695, ASTM F2565 to the BiMobile Dual Mobility System. This premarket notification does not include the femoral components. The BiMobile Dual Mobility System is compatible with previously cleared femoral heads (K171273, K161840, K953653, K931571, and K920756), femoral stems and neck segments (K183141, K161840, K151008, K142187, and K953653,) of Waldemar Link GmbH & Co. KG.

The provided text describes a 510(k) premarket notification for a medical device called the "BiMobile Dual Mobility System - E-Dur Inserts." It outlines the device, its intended use, and its comparison to predicate devices, focusing on the justification for substantial equivalence.

However, the document does not contain the specific information required to answer your request about acceptance criteria and the study that proves the device meets them, especially in the context of AI/ML or diagnostic performance. The provided text details non-clinical performance testing for a hip implant system, which involves material characterization, biocompatibility testing, wear analysis, and mechanical testing. These are typical assessments for orthopedic implants to demonstrate their safety and effectiveness in a mechanical and biological sense, not for evaluating a diagnostic or AI-driven system's performance.

Therefore, many of your specific questions cannot be answered from the provided text.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document mentions several types of non-clinical performance testing. While it states that the results "demonstrate that the device is as safe, as effective, and substantially equivalent to the predicate devices," it does not provide specific numerical acceptance criteria or reported performance values for each test (e.g., a specific wear rate limit or a minimum axial disassembly force). It only lists the types of tests performed.

Regarding questions 2-9 about test sets, ground truth, expert adjudication, MRMC studies, and training sets, the document does not provide any relevant information. This is because the submission is for a physical medical implant, not a diagnostic device or an AI/ML system.

Here's why these questions are not applicable based on the provided text:

• 2. Sample sized used for the test set and the data provenance: Not applicable. The tests performed are non-clinical (material, wear, mechanical) and do not involve patient data or diagnostic test sets.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic or AI performance, is not relevant for this type of device.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical mechanical/material testing.
• 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 a hip implant, not a diagnostic or AI-assisted interpretation device.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

In summary: The provided FDA 510(k) clearance letter and summary are for a mechanical medical device (a hip implant system). The "performance testing" described is non-clinical, mechanical, and material-based, aimed at demonstrating the physical properties and durability of the implant. It does not involve AI/ML performance, diagnostic accuracy, human readers, or patient-specific ground truth data in the way your questions are framed.

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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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