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Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Femoral neck fractures.

Correction of functional deformities.

The Vario-Cup System consists of an UHMWPE component encased in an ultra-smooth polished EndoDur (CoCrMo) outer metal casing, for articulation in the bony acetabulum. It is to be used in conjunction with femoral components of the LINK Total Hip Systems. The 22 mm inner diameter Vario-Cup Prostheses are available in outer diameters ranging from 39-43 mm in 1 mm increments. Vario-Cups are self-centering which provides for a functional view of their position in post-op X-rays. An anti-luxation feature resists dislocation: an UHMWPE Safety Ring is placed in a groove at the entrance of the polyethylene insert after assembly of Vario-Cup and femoral components.

This FDA submission focuses on a medical device, the Vario-Cup System, and does not involve AI/ML performance evaluation. Therefore, the requested information about acceptance criteria for AI models, study design for AI models, and related AI-specific details cannot be extracted from the provided text.

The document primarily addresses the substantial equivalence of the Vario-Cup System to predicate devices based on non-clinical performance data, material characterization, and design similarities. It explicitly states that no clinical performance testing was required for this device.

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The LINK® TrabecuLink® Tibial Cones are indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis and joint fractures which disallow an osteosynthetic reconstruction.

The LINK® TrabecuLink® Tibial Cones are indicated for the following conditions:

· Surgeries which require implantation of a total knee endoprosthesis after severe degeneration or bone loss, traumata or other pathologies.

The device is intended for uncemented use.

The LINK® TrabecuLink® Tibial Cones are designed to be used in conjunction with the LINK® Endo-Model® Knee System Standard / Modular / Porex® coated (K143179; K152431) and with the Endo- Model® SL® Knee System (K151008) tibial components. The subject device is intended to fill small to medium bone defects and provide a stable platform for the tibial articulating components.
The tibial cones are manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6Al4V, ISO 5832-3). The tibial cones consist of a non-porous bulk interior surface and a trabecular structure made of titanium (LINK® TrabecuLink®) on the external surface.
The LINK® TrabecuLink® Tibial Cones provide cementless fixation to the bone. The subsequently implanted knee endoprosthesis is cemented to the tibial cone.

This document describes the LINK® TrabecuLink® Tibial Cones, a medical device used in total knee replacement surgeries. It does not describe an AI/ML device, and therefore, the information typically requested about AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for training sets) is not applicable here.

The document focuses on demonstrating the substantial equivalence of the device to legally marketed predicate devices through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter and 510(k) summary do not present formal "acceptance criteria" for performance in a table format with specific numerical targets. Instead, they refer to "non-clinical performance testing and analysis" which demonstrate that the device is "as safe, as effective and substantially equivalent to the predicate device." The "acceptance" is implicitly that the device performs comparably to the predicate devices in these tests.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. This refers to non-clinical bench testing, not a dataset of patient cases.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this was non-clinical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as this was non-clinical bench testing. Performance was assessed against engineering and material science standards and comparison to predicate devices, not expert human interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable, as this was non-clinical bench 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 not an AI/ML device, and no MRMC study was conducted.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For non-clinical performance, the "ground truth" or reference for assessment would be established engineering and material science standards, specifications, and direct comparison to the performance characteristics of the predicate devices. There is no biological "ground truth" (like pathology or outcomes data) established for these specific tests, as they are mechanical and material characterizations.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, and no training set was used.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device.

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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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The LINK® BiMobile™ Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.

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

• · Primary and secondary coxarthrosis
• · Osteoarthritis
• Necrosis of the femoral head
• Femoral neck fractures
• · Revision after implant loosening
• · Acetabular dysplasia

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).

This premarket notification does not include the femoral components. The LINK® BiMobile™ Dual Mobility System is compatible with the FDA cleared LINK® femoral stems of the SP-CL® / LCU® (K161840); and the Lubinus SPII® (K953653) hip systems, with the MP® Reconstruction Prosthesis (K142187) and MEGASYSTEM-C® (K151008) neck segments and with the femoral heads made of cobaltchromium and ceramic.

The provided text is related to a 510(k) premarket notification for a medical device called the LINK® BiMobile™ Dual Mobility System, which is an acetabular cup for hip replacement.

Based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific performance criteria in the context of typical AI/ML device evaluations (e.g., sensitivity, specificity, accuracy). This document is a regulatory submission for a traditional medical device, not a software as a medical device (SaMD) or an AI/ML-powered device.

The "Performance Data" section explicitly states:

• "Non-clinical performance testing and analysis were provided including bench testing, coating characterization and endotoxin testing."
• "Bench testing included: Wear test per ISO 14242-1 and -2; Particles Analyses per ISO 17853 and ASTM F1877; Liner Press-in testing; Lever-out testing, Axial Disassembly testing and Range of Motion analyses of the LINK® BiMobile™ Dual Mobility System."
• "The coating was evaluated per FDA Guidance Documents entitled "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarked Surveillance Requirements" and "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants"."
• "Coating characterization included: Microstructural analysis; Mechanical testing and Metallurgical analysis."
• "The results of non-clinical performance testing demonstrate that the device is as safe, as effective, and substantially equivalent to the predicate devices."
• "There was no clinical performance testing required for this device."

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, AI/ML performance metrics, sample sizes for test/training sets, expert consensus, or MRMC studies, as these aspects are not present in the provided document. The device's "acceptance criteria" were met through non-clinical testing demonstrating substantial equivalence to predicate devices, rather than a clinical trial or AI/ML performance study.

Summary of available information regarding the "study" for this device:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of AI/ML metrics. The performance data focuses on mechanical and material integrity (wear, particle analysis, press-in, lever-out, axial disassembly, range of motion, coating characteristics).
2. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. The "test set" refers to physical samples of the device and its components used for bench testing. The specific number of physical units tested is not detailed, nor is general "data provenance" as would be relevant for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on objective measurements against engineering specifications and international standards (ISO, ASTM).
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this was not done as it's a physical implant, not an AI assistance tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not an algorithm-only device.
7. The type of ground truth used: For physical performance tests, the "ground truth" refers to established engineering standards (ISO, ASTM) and material specifications.
8. The sample size for the training set: Not applicable; there is no training set for this type of device.
9. How the ground truth for the training set was established: Not applicable.

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