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.

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). 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.

AI/ML Overview

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.

Acceptance Criteria	Reported Device Performance
Not specified in the document for individual tests.	The results of non-clinical performance testing demonstrate that the device is as safe, as effective, and substantially equivalent to the predicate devices. (Specific performance values not provided)

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.

Summary

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August 6, 2019

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Waldemar Link GmbH & Co. KG Stefanie Fuchs Regulatory Affairs Manager Oststraße 4-10 Norderstedt, Germany 22844

Re: K190535

Trade/Device Name: BiMobile Dual Mobility System - E-Dur Inserts Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, MEH Dated: July 8, 2019 Received: July 11, 2019

Dear Stefanie Fuchs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190535

Device Name

BiMobile Dual Mobility System - E-Dur Inserts

Indications for Use (Describe)

· 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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

510(k) Submitter:	Waldemar Link GmbH & Co. KGBarkhausenweg 1022339 Hamburg, GermanyPhone: +49-40-539950Facility Registration #:3004371426 (Oststraße 4-10)Facility Registration #:3007118403 (Harckesheyde 95)
Contact Person:	Waldemar Link GmbH & Co. KGStefanie Fuchs (Regulatory Affairs)Oststraße 4-10Norderstedt, GERMANY 22844Phone: +49-40 53995-530Fax: +49-40 53995-174E-Mail: st.fuchs@linkhh.de
Date Prepared:	July 07, 2019
Trade Name:	BiMobile Dual Mobility System – E-Dur Inserts
Common Name:	Acetabular Cup
Classification Name:	Prosthesis, hip, semi-constrained, metal/ceramic/polymer,cemented or non-porous; 21 CFR §888.3353, product codeLZOProsthesis, hip, semi-constrained, uncemented,metal/polymer, non-porous, calcium-phosphate; 21 CFR§888.3353, product code MEH
Classification and Panel:	Class II, Orthopedic / 87
Predicate Devices:	LINK BiMobile Dual Mobility System, K171273,cleared January 19, 2018
	Trinity Dual Mobility System with ECiMa Liners by Corin,K170359, cleared October 31, 2017
	EXp Acetabular Shell Liner by Stelkast, Inc., K094035,cleared March 24, 2011
	MobileLink Acetabular Cup System, K182321, cleared May24, 2019
Device Description:	The BiMobile cup system is a dual mobility acetabularimplant system. The system is consisting of wrought cobaltchromium molybdenum alloy (CoCrMo acc. to ISO 5832-12)

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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. Indications for Use: 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: 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 7) Dislocation risks The device is intended for cemented and cementless use. The additional components of the BiMobile Dual Mobility Comparison to Predicate Device:

System are similar to the predicate devices in terms of intended use and indications, materials, sizes, designs and performance.

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Based on these similarities, the additional components of the BiMobile Dual Mobility System are believed to be substantially equivalent to the predicate device.

Performance Testing:	Non-Clinical Performance and Conclusions:
	The following material characterization, biocompatibilitytesting/analysis, wear analyses, mechanical testing wereperformed to demonstrate that the BiMobile E-Dur® Inserts
	perform as intended and are substantially equivalent to theidentified devices:
	- Material Characterization- Biocompatibility Testing and Analysis- Axial Disassembly Testing- Lever-out Testing- Standard and Adverse Wear Anaylses including ParticlesAnalyses- Range of Motion Analysis
	The results of non-clinical performance testing demonstratethat the device is as safe, as effective, and substantiallyequivalent to the predicate devices.
Clinical Testing:	Clinical performance Testing was not required to demonstratethe substantial equivalence of this device.
Conclusion:	The subject device BiMobile E-Dur inserts is substantiallyequivalent to the predicate devices identified in this premarketnotification.

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.