Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis,
-Avascular necrosis of the femoral head,
Correction of functional deformity. ー
-Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques,
Revision procedures where other treatment or devices have failed. -

AND/OR

The IBS is indicated for cementless use only.

Device Description

The IntraBlock™ BioBall™ Hip System (IBS) is composed of femoral stems, heads. taper adapter sleeves and acetabulum cups. The System is designed for uncemented use for either primary or revision hip arthroplasty.

The IBS stem is straight, collarless, and flat with a tapered design. The stem is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a proximal titanium plasma spray (TPS) coating. The stems are proportionally sized and shaped in sizes 6.25 mm to 15.00 mm to match the geometry of the femur. A lateralized version of the device is available. Both versions have a neck shaft angle of 135° and a 12/14 morse taper trunion. The Ceramic Head is made of Biolox® delta (Alumina Matrix Composite ISO 6474-2) and available in diameter 28 mm.

The taper adapter sleeves are made from titanium alloy (Ti-6AI-4V ELI) with a 12/14 morse taper trunion in the four neck lengths S, M, L and XL.

The cementless MultiCup Locking PressFit is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a titanium plasma spray (TPS) coating on the outer surface. It is used with a UHMWPE inlay sized for Ø28 mm heads. 5 holes with threaded plugs give the option for an additional fixation with locking screws. The MultiCup is available in 9 different sizes ranged from 48mm up to 62mm outer diameter.

AI/ML Overview

This document describes the 510(k) summary for the IntraBlock™ BioBall™ Hip System (IBS), a total hip replacement device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state specific acceptance criteria with numerical targets for device performance that would traditionally be found in a clinical study result table (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it describes a series of non-clinical tests conducted to demonstrate the device's mechanical integrity and material properties, aligning with established FDA guidance documents for orthopedic implants.

Acceptance Criteria Category	Reported Device Performance Summary (from text)
Mechanical Testing	- Distal and proximal fatigue testing of the worst case performed, consistent with "Guidance for Industry and FDA staff Non-Clinical Information for Femoral Stem Prostheses." - Static compression testing performed, consistent with "Guidance document for the preparation of premarket notifications for ceramic ball hip systems." - Connections between the stem, the adapter, and the head, as well as the liner locking mechanism, were tested. - Range of Motion analysis was performed.
Coating Characterization	- TPS coating underwent characterization per FDA's "Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopaedic Implants to support reconsideration of Post Market Surveillance Requirements."
Modular Connection Analysis	- Fretting and corrosion analysis performed.

It's important to note that the document states these tests were performed and were consistent with guidance documents, which implies they met the inherent "acceptance criteria" defined within those guidances for demonstrating safety and efficacy for substantial equivalence, rather than detailing the specific numerical outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: The document refers to "non-clinical testing and analysis" which typically involves physical samples or prototypes of the device, rather than patient data. No specific sample sizes (e.g., number of stems, cups, or heads tested) are explicitly mentioned for each mechanical test.
Data Provenance: The tests are non-clinical (laboratory-based). There is no patient data, so "country of origin" or "retrospective/prospective" are not applicable in the human data sense. The manufacturer is Merete Medical GmbH, based in Berlin, Germany.

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

Not applicable. This is a submission for a mechanical implant based on non-clinical testing, not a diagnostic or prognostic device requiring expert-established ground truth from medical images or patient data. The "ground truth" here is the adherence to mechanical and material standards established by recognized guidance documents.

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

Not applicable. As noted above, this involves non-clinical mechanical testing against predefined standards, not a review of clinical cases by experts.

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 device is a total hip replacement system, an implantable medical device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance.

6. If a standalone (i.e. 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 (expert concensus, pathology, outcomes data, etc):

The "ground truth" for this submission are the established mechanical and material standards and performance requirements outlined in referenced FDA guidance documents (e.g., "Guidance for Industry and FDA staff Non-Clinical Information for femoral Stem Prostheses", "Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopaedic Implants", "Guidance document for the preparation of premarket notifications for ceramic ball hip systems"). The device's performance in battery of non-clinical tests is compared against these engineering standards.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI/ML algorithm for this type of device. The design and manufacturing processes are developed based on engineering principles and existing knowledge of materials science and biomechanics, not machine learning training.

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

Not applicable, as there is no training set for this device.

Summary

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MAY 2 4 2013

2. 510(k) Summary of Safety and Effectiveness Information

Date Prepared:	November 2012
Submitted by:	Merete Medical GmbH
	Alt Lankwitz 102
	12247 Berlin, Germany

FDA Registration Number: 3002949614

Contact Person:

:: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

Rüdiger Hilken Merete Medical, Inc. 4 Crotty Lane - Suite 118 New York International Plaza New Windsor, NY 12553 Phone: 914 967 1532

Device Name: IntraBlock™ BioBall™ Hip System (IBS)

Common Name: Total hip replacement device

Classification Names: Hip Joint metal/ceramic/polymer semi-constrained. cemented or nonporous uncemented prosthesis (21 CFR 888.3353)

Product Code: LZO

Proposed Regulatory Class: Class II

K073567 - Biolox® delta Option Ceramic Heads Predicate Devices: K043537 - Taperloc® 12/14 Taper Femoral Components K121563 - Corin Trift TS Hip K001534 - Pinnacle™ Acetabular Cup K000306 - Pinnacle™ Acetabular Cup K093472 - Trinity Acetabular System

Device Description:

The taper adapter sleeves are made from titanium alloy (Ti-6AI-4V ELI) with a 12/14 morse taper trunion in the four neck lengths S, M, L and XL.

Merete Medical GmbH

Submission Date: 2012-11-16 Rev. 2: 2013-04-18_Rev.3: 2013-05-17

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510(k) Submission - IntraBlock™ BioBall™ Hip System (IBS)

Indications for Use

The IntraBlock™ BioBall™ Hip System (IBS) is intended for use in total hip arthroplasty.

The IBS is indicated for:

Patients suffering from severe hip pain and disability due to rheumatoid l arthritis, osteoarthritis, traumatic arthritis
Avascular necrosis of the femoral head
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric . fractures of the proximal femur with head involvement, unmanageable by other techniques
Revision procedures where other treatment or devices have failed ﺳ

The IBS is indicated for cementless use only.

Substantial Equivalence:

The IntraBlock™ BioBall™ Stems, MultiCup™ Locking PressFit, Femoral Heads and Titanium Taper Adapter Sleeves are technologically similar to the predicate devices.

Legally marketed Devices to which substantial Equivalence is claimed

K073567 - Biolox® delta Option Ceramic Heads

K043537 - Taperioc® 12/14 Taper Femoral Components

K121563 Corin Trift TS Hip
K001534 - Pinnacle™ Acetabular Cup

K000306 - Pinnacle™ Acetabular Cup

K093472 - Trinity Acetabular System

Non-Clinical Performance Data:

Non-clinical testing and analysis were provided, including mechanical testing and coating characterization. Mechanical testing included distal and proximal fatique testing of the worst case consistent with the "Guidance for Industry and FDA staff Non-Clinical Information for femoral Stem Prostheses". Range of Motion analysis was also performed. The TPS coating underwent characterization per FDA´s .Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopaedic Implants to support reconsideration of Post Market Surveillance Requirements". The Modular connection analysis including fretting and corrosion were also performed as well as static compression testing consistent with the "Guidance document for the preparation of premarket notifications for ceramic ball hip systems". Furthermore the connections between the stem, the adapter and the head, as well as the liner locking mechanism were tested.

Merete Medical GmbH

Submission Date: 2012-11-16 Rev. 2: 2013-04-18 Rev.3: 2013-05-17

Page 15 of 75

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2013

Merete Medical GmbH % Mr. Emanuel Anapliotis President Alt-Lankwitz 102 Berlin 12247 Germany

Re: K123619

Trade/Device Name: IntraBlock™ BioBall™ Hip System (IBS) 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 Dated: April 18, 2013 Received: April 24, 2013

Dear Mr. Anapliotis:

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. 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 (reporting of medical

{3}------------------------------------------------

Page 2 - Mr. Emanuel Anapliotis

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/8 description: The image shows the name "Erin DKeith" in a bold, sans-serif font. The letters "E", "r", "i", "n", "e", "i", "t", and "h" are solid black, while the letters "D" and "K" have a patterned design. The name appears to be a logo or a stylized signature.

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1. Indications for Use Statement

Indications for Use

510(k)·Number (if known): K123619

Device Name: IntraBlock™ BioBall™ Hip System (IBS)

Indications for Use:

The IntraBlock™ BioBall™ Hip System (IBS) is intended for use in total hip arthroplasty.

The IBS is indicated for:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis,
-Avascular necrosis of the femoral head,
Correction of functional deformity. ー
-Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques,
Revision procedures where other treatment or devices have failed. -

AND/OR

The IBS is indicated for cementless use only.

Prescription Use
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth Frank -S

Division of Orthopedic Devices

Merete Medical GmbH

Submission Date: 2012-11-16 Rev. 2: 2013-04-18_Rev.3: 2013-05-17

Page 13 of 75

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.