Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.

Use of this prosthesis is generally only indicated in skeletally mature patients.

The ic-Bipolar Heads is for uncemented use in conjunction with the EcoFit® Hip System for the following indications:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Device Description

The ic-Bipolar Head System consists of a bipolar liner, retaining ring, and femoral head. The system is used for hip replacements in which the femur requires replacement but the acetabulum does not (i.e. hemi-arthroplasty) The ic-Bipolar Head System articulates directly with the natural (non-replaced) acetabulum on the outer side and with a femoral head on the inner side. The ic-Bipolar Head System is manufactured of CoCrMo and UHMWPE. The ic-Bipolar Head System is used in conjunction with the EcoFit® Hip System (K163577) and MUTARS® Proximal Femur Replacement System (K181778).

AI/ML Overview

The provided FDA 510(k) summary (K191569 for the implantcast ic-Bipolar Head System) outlines performance testing but does not specify numerical acceptance criteria or provide detailed study results for those criteria. Instead, it generally states that testing was performed to assure substantial equivalence and demonstrate performance as intended.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
UHMWPE Characterization	"Performed" (Specific metrics and criteria not provided)
Taper Disassembly	"Performed" (Specific metrics and criteria not provided)
Modular Disassembly	"Performed" (Specific metrics and criteria not provided)
Range of Motion	"Performed" (Specific metrics and criteria not provided)
Endotoxin Testing	"Performed" (Specific metrics and criteria not provided)

Missing Information: The document states that "All necessary testing has been performed... to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended." However, it does not explicitly list quantitative acceptance criteria for each test (e.g., "Taper Disassembly Force > X N" or "Range of Motion > Y degrees") nor does it provide the specific results obtained during these tests.

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

Sample Size for Test Set: Not specified. The document mentions "test units representative of finished devices" were used for performance testing, but the number of units tested per performance test is not provided.
Data Provenance: Not specified. Performance testing is generally conducted in a laboratory setting by the manufacturer (Implantcast GmbH) or a contracted testing facility. The document doesn't specify if any data used for testing was derived from clinical sources (e.g., country of origin, retrospective/prospective). Given the nature of mechanical and material tests, it's highly likely to be prospective laboratory testing.

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

Not applicable / Not specified. This type of information (expert review for ground truth) is typically relevant for AI/ML device submissions where clinical images or data require expert interpretation. For a physical medical device like a hip implant, ground truth is established through standardized engineering and material testing methods, often against international standards (e.g., ISO, ASTM, which are not explicitly cited here but are implied by "Performance Testing").

4. Adjudication Method for the Test Set

Not applicable. See point 3. Mechanical and material tests do not involve expert adjudication in the way clinical diagnostic studies do. The "adjudication" is determined by whether the test results meet pre-defined performance specifications derived from standards or predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, not done. An MRMC study is not relevant for this type of device (bipolar head system). This is a physical implant, not a diagnostic AI device requiring human reader interaction.

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

No, not applicable. This device is a physical implant, not an algorithm or AI product. "Standalone performance" in this context would refer to the device's mechanical and material performance, which is what the "Performance Testing" section generally describes.

7. The Type of Ground Truth Used

Engineering and Material Specifications / Predicate Device Performance: The "ground truth" for the performance measures described would be established by:
- Industry standards: Conformance to relevant ISO or ASTM standards for implant materials and mechanical properties (e.g., fatigue strength, wear resistance, dimensional accuracy).
- Predicate device characteristics: Demonstrating that the device performs "substantially equivalently" to the predicate device (Aesculap Bipolar Acetabular Cup K060707) in terms of mechanical and material properties. This usually involves showing that test results fall within an acceptable range or meet specific thresholds generally accepted for such devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 28, 2019

Implantcast, GmbH % Dave Mcgurl Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K191569

Trade/Device Name: Implantcast ic-Bipolar Head System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY Dated: June 13, 2019 Received: June 13, 2019

Dear Dave Mcgurl:

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) K191569

Device Name ic-Bipolar Head System

Indications for Use (Describe)

The ic-Bipolar Heads is for uncemented use in conjunction with the MUTARS® Proximal Femoral Replacement System for the following indications:

Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.

Use of this prosthesis is generally only indicated in skeletally mature patients.

The ic-Bipolar Heads is for uncemented use in conjunction with the EcoFit® Hip System for the following indications:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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1. 510(K) SUMMARY

Device Trade Name:	ic-Bipolar Head System
Manufacturer:	implantcast GmbHLueneburger Schanze 2621614 BuxtehudeGermany
Contact:	Ms. Juliane HöppnerPhone: +49 4161 744-135Fax: +49 4161 744-200j.hoeppner@implantcast.de
Prepared by:	Mr. Dave McGurlDirector, Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: 202.552.5797Fax: 202.552.5798dmcgurl@mcra.com
Date Prepared:	August 14, 2019
Classification:	21 CFR §888.3390
Class:	II
Product Codes:	KWY
Primary Predicate Device:	Aesculap Bipolar Acetabular Cup (K060707)
Common Name:	Bipolar Hip
Reference Devices:	MUTARS® Proximal Femur Replacement System (K181778)Ecofit Hip System (K163577)

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Indications for Use:

The ic-Bipolar Heads is for uncemented use in conjunction with the MUTARS® Proximal Femoral Replacement System for the following indications:

Proximal femur replacement in oncology cases where radical resection and replacement । of bone is required.
Limb salvage procedures including surgical intervention for severe trauma, failed । previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.

Use of this prosthesis is generally only indicated in skeletally mature patients.

The ic-Bipolar Heads is for uncemented use in conjunction with the EcoFit® Hip System for the following indications:

। Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis --
| Correction of functional deformity
-Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Device Description:

Performance Testing:

All necessary testing has been performed for the worst-case configuration of the ic-Bipolar Head System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the ic-Bipolar Head System was characterized through the following tests:

UHMWPE Characterization ●
o Taper Disassemblv
Modular Disassembly
Range of Motion
Endotoxin Testing

Substantial Equivalence:

Like the ic-Bipolar Head System, the Aesculap BiPolar Acetabular Cup predicate incorporates nearly identical geometry, similar or identical sizes (28mm), and corresponding indications for use. Like the ic-Bipolar Head System, the predicate is also manufactured from medical grade

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CoCrMo Alloy and UHMWPE. Both components are intended to be used with a hip stem and articulate against the natural acetabulum. The ic-Bipolar Head System is substantially equivalent with respect to materials, indications, function and performance to Aesculap Bipolar Acetabular Cup (K060707).

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.