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The Instruments for LINK® MEGASYSTEM-C® Family are intended to aid in intra-operative implantation of the LINK® MEGASYSTEM-C® (K151008), which can be integrated with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for knee replacement, and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement. The LINK® MEGASYSTEM-C® (K151008), has the following indications:

The LINK® MEGASYSTEM-C® is intended to be used with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) which can be integrated for knee joint replacement and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement.

The LINK MEGASYSTEM-C® is indicated for treatment of any of the following Limb salvage/Oncology procedures:

1. Revision for loosened femoral prosthesis components involving extensive bone loss;
2. Surgical intervention for severe trauma;
3. Oncology cases where extensive resection and replacement of bone is required from tibia to hip area;

The device is to be used with bone cement unless a proximal femur or a modular stem is indicated for use.

For the use of the LINK® Endo-Model® SL® Rotating Hinge Knee System additional indications should be noted:

1. Bone necroses.
2. Bicondylar arthrosis by partly damaged collateral ligaments.
3. Revision surgery after primary total knee replacement.
4. Revision surgery after rotating or non-rotating hinged knee replacement.
5. Revision surgery by insufficient / inadequate bone mass.
6. Arthrosis of patella flange.
7. Valgus/Varus deformities

The LINK® MEGASYSTEM-C® is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187).

This is a duplicate 510k and line extension in Link Bio Corp.'s name for the accessory instrument system previously cleared in K151008 by Waldemar Link GmbH & Co KG for use with/as accessories to the LINK® MEGASYSTEM-C® and in conjunction with components of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187). It includes the same instruments as in K151008, and additional accessory instruments (line extension).

The provided text describes a 510(k) premarket notification for surgical instruments used in knee and hip replacement (Trade/Device Name: Instruments for LINK® MEGASYSTEM-C® Family). This submission is a duplicate 510(k) and line extension for accessory instruments previously cleared under K151008.

Based on the provided document, the device in question is a set of manual reusable surgical instruments, not an AI/ML-driven device or a device that generates diagnostic data that would typically have acceptance criteria related to sensitivity, specificity, or similar performance metrics. The document explicitly states:

"Extensive performance testing was provided in K151008 for the implant system, but is not required for the accessory instruments."

And regarding technological characteristics:

"The accessory instruments presented in K151008 are exactly replicated in this duplicate 510k. Additional reusable manual surgical instruments included as a line extension are for the same purpose (to support implantation of the same Waldemar Link GmbH implant systems) as the existing instrument system, with no significant differences in technological features, materials, or intended use."

Therefore, the following information cannot be extracted from this document as it pertains to AI/ML or data-driven diagnostic devices, which this product is not:

• Acceptance criteria and reported device performance (in terms of diagnostic accuracy or similar metrics)
• Sample size for the test set and data provenance
• Number of experts and their qualifications for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to a predicate device (K151008) based on the instruments being identical or having minor design modifications that do not change their intended use or function. No "study" in the sense of a clinical trial or performance evaluation against specific diagnostic metrics is mentioned for these instruments.

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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 ® MP® Monoblock 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 LINK® MP® Monoblock is indicated for the following conditions:

• Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone the fixation of a new standard prosthesis is not possible

• Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture

The device is intended for cementless use.

The LINK® MP® Monoblock Hip Prosthesis is a straight hip prosthesis stem. The hip prosthesis is made of Titanium Aluminum Vanadium alloy (Ti-6Al-4V). The prosthesis stems are available in a range of sizes, lengths, CCD angles and offsets. Additional features include a tapered stem with a microporous glass-blasted surface.

The LINK® MP® Monoblock Hip Prosthesis is designed to be used in conjunction with femoral heads that are manufactured from Cobalt Chromium Molybdenum casting alloy (CoCrMo) or ceramic (BIOLOX® forte and BIOLOX® delta) via 12/14 morse taper (K161840). In total joint use, the femoral head articulates aqainst LINK® BiMobile Cup System (K171273). The LINK® MP® Monoblock Hip Prosthesis provides cementless fixation to the bone.

The provided text is related to an FDA 510(k) premarket notification for a medical device, the "LINK® MP® Monoblock Hip Prosthesis." This document concerns the regulatory clearance of a physical medical device (an orthopedic implant), not an AI/ML software.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies related to AI/ML performance is not applicable to this document.

The document states:

• "Non-clinical performance testing and analysis were provided, including bench testing." This refers to physical tests on the implant, not a study involving data or AI.
• "There was no clinical performance testing required for this device." This explicitly states that human clinical trials were not part of this submission for demonstrating substantial equivalence.

In summary, the provided content does not contain the information requested about AI/ML device performance or the study details typically associated with it.

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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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The LINK® MEGASYSTEM-C® is intended to be used with the components of the Endo-Model® SL® Rotating and Non-Rotating Hinge Knee or Endo-Model® Knee System (#K143179) which can be integrated for knee joint replacement and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement.

The LINK® MEGASYSTEM-C® is indicated for treatment of any of the following Limb salvage/Oncology procedures:

1. Revision for loosened femoral prosthesis components involving extensive bone loss;

2. Surgical intervention for severe trauma;

3. Oncology cases where extensive resection and replacement of bone is required from tibia to hip area;
   The device is to be used with bone cement unless a proximal femur or a modular stem is indicated for use.

For the use of the LINK® Endo-Model® SL® Rotating and Non-Rotating Hinge Knee System additional indications should be noted:

1. Bone necroses.

2. Bicondylar arthrosis by partly damaged collateral ligaments.

3. Revision after primary total knee replacement.

4. Revision surgery after hinge knee or rotational knee joint.

5. Revision surgery by insufficient / inadequate bone mass.

6. Arthrosis of patella flange.

7. Valgus/Varus deformities

The LINK® MEGASYSTEM-C® is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187)

There are three (3) modules of the MEGASYSTEM-C®:

• Proximal Femur
• Distal Femur / Proximal Tibia
• Total Femur

The system allows partial bone replacements both in the proximal and distal femur in small increments as well as a total replacement of the femur. For the knee joint components, the Endo-Model® SL® Rotating Hinge Knee is used in the MEGASYSTEM-C®.

The LINK® MEGASYSTEM-C® is produced of Cobalt Chromium Molybdenum casting alloy (CoCrMo) and Ultra high molecular weight polyethylene (UHMWPE/noncrosslinked). The Modular Stems (cemented) and the Pushthrough stems are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials. The Modular Stems (cementless) are made of Titanium-Aluminum-Vanadium alloy (Ti-6A1-4V) materials.

Stem Segments, Coupling for diaphyseal spacer and Support Ring are produced of Titanium-Aluminum-Vanadium alloy (Ti-6Al-4V). Coupling components and the knee fusion nail are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials.

Femoral Segments and Proximal Tibial Spacers are produced of Titanium-Aluminum-Vanadium alloy (Ti-6Al-4V) and respectively of Ultra high molecular weight polyethylene (UHMWPE/non-crosslinked).

This document describes a 510(k) premarket notification for the LINK® MEGASYSTEM-C® total knee and hip revision prosthesis. It asserts substantial equivalence to a predicate device, the GMRS™ Global Modular Replacement System.

Here's a breakdown of the requested information based on the provided text, focusing on the device's performance given that it is a physical implant and not an AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a medical device (prosthesis) and not an AI/ML system, the "acceptance criteria" pertain to mechanical and material performance rather than typical AI metrics like accuracy, sensitivity, or specificity. The document references specific ISO and ASTM standards and then reports that the device passed these tests.

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

The document refers to "test samples" for mechanical testing, but does not specify a numerical sample size for each test. For example, it states "All Endo-Model® SL® Knee System test samples completed the 10 million cycles Tibial Baseplate Fatigue Strength testing." It does not specify if "all" means 3, 5, or more samples.

• Sample Size: Not explicitly stated numerically for each test; refers to "test samples."
• Data Provenance: Non-clinical (laboratory/mechanical testing). No mention of country of origin for the "data" itself, beyond the device manufacturer being from Germany. The tests are based on international (ISO) and US (ASTM) standards.

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

This concept is not applicable to the submitted document. This review is for a physical medical device (prosthesis) that undergoes mechanical and material testing, not an AI/ML diagnostic or predictive system that requires expert consensus for ground truth. The "ground truth" for these tests is defined by the physical behavior of the materials and constructs under controlled laboratory conditions as per the standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study assessing interpretations or diagnoses where adjudication would be necessary. The tests are objective mechanical measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This is a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" is established by adherence to recognized international and national standards for material science and biomechanical testing (e.g., ISO 14243-1, ISO 14243-2, ISO 14879, ASTM F1800, ISO 7206-6, ISO 7206-4, ASTM F2580, ASTM F1875-98). The physical properties and performance under specified test conditions are the objective "ground truth."

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.

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