LINK® BiMobile(TM) Dual Mobility System

• K Number: K171273
• Device Name: LINK® BiMobile(TM) Dual Mobility System
• Manufacturer: Waldemar Link Gmbh & Co. KG
• Date Cleared: 2018-01-19 ( 263 days)
• Product Code: MEH , LZO
• Regulation Number: 888.3353
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K161840 , K953653 , K142187 , K151008 , K072020 , K093472 , K111572

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.