The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint.

The devices are intended for:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral ephiphysis
Patients suffering from disability due to previous fusion .
Patients with acute femoral neck fractures ♥

Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for cementless applications.

Device Description

Aesculap Plasmafit Pro Acetabular Cup System and Vitelene Insert is a modular hip prostheses system intended to be used in conjunction with a prosthetic femoral head and hip stem in total hip arthroplasty.

Aesculap Plasmafit Pro consists of a cementless titanium acetabular cup, a highly crosslinked (B-75 kGv) ultra-high molecular weight polyethylene (UHMW-PE) vitamin E insert, 40mm Biolox® delta, 40mm ISODUR® heads and optional titanium screws.

The hemispherical titanium cup with a slightly flattened dome is coated with a titanium plasma spray on the outer surface which aims to provide a high level of primary stability with its rough finish. Plasmafit Pro cups are available in three (3) similar designs only varying in the number of holes (0, 3, 5/7) around the apex. The number of holes are adapted for optional anchoring 6.5mm diameter titanium alloy screws that may be used to ensure primary stability. Plasmafit Pro anchoring screws are an option available separately in sizes 16mm to 68mm lengths.

Vitelene is designed with a taper-fit to the interior surface of Plasmfit Pro cups. The vitamin E insert has been shown to be more resistant to oxidation than conventional UHMWPE. Characterization of the oxidation indices of aged (ASTM F2003) and un-aged Vitelene measured according to ISO 5834-4 did not decrease . Further, Vitelene remains resistant to oxidation after 5 million cycles of wear as demonstrated in testing performed in accordance to ISO 14242.

Plasmafit Pro cups are available in sizes ranging from 40mm - 70mm.

Plasmafit Pro Acetabular Cup System and Vitelene insert may be used with Aesculap Biolox® delta and ISODUR® (CoCrMo) 40mm ball heads along with the following cleared compatible components: Aesculap Hip Implant Systems Excia, Metha, Prevision, and Unisyn and cleared Aesculap femoral heads: Biolox® Option, Biolox® Forte, Biolox® Delta, and CoCrMo to offer several interoperative implant options taking into consideration different patient bone conditions.

AI/ML Overview

The provided text is related to a 510(k) Premarket Notification for a medical device (Plasmafit Pro Acetabular Cup and Vitelene Insert), not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity) is not applicable here.

Instead, this document describes the device's characteristics, its intended use, and argues for its substantial equivalence to previously cleared predicate devices based on non-clinical performance data.

Here's an analysis based on the provided text, reinterpreting "acceptance criteria" as the basis for substantial equivalence:

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

The document does not present a formal table of quantitative acceptance criteria as would be seen for AI/ML performance. Instead, the "acceptance criteria" for this traditional medical device submission revolve around demonstrating substantial equivalence to existing predicate devices.

Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance (Summary from text)
Indications for Use (IFU)	The Plasmafit Pro Acetabular Cup System and Vitelene Insert have IFUs that are comparable to those of the predicate devices. They are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint for conditions like severe hip pain (rheumatoid arthritis, osteoarthritis, etc.), hip dysplasia, previous fusion, and acute femoral neck fractures. Intended for cementless applications.
Design	The device is a modular hip prosthesis system consisting of a cementless titanium acetabular cup (with plasma spray coating for primary stability), a highly crosslinked UHMWPE vitamin E insert, and compatible femoral heads (Biolox® delta, ISODUR®). Cup designs vary slightly in the number of holes (0, 3, 5/7). The overall design is presented as substantially equivalent to predicates.
Material Composition	Consists of titanium for the cup, highly crosslinked UHMWPE with vitamin E for the insert, and CoCrMo or ceramic for the femoral heads. These materials are consistent with commonly used materials in predicate devices.
Function	The device functions as a component in total hip arthroplasty, replacing the hip joint. The Vitelene insert enhances oxidation resistance. The device's primary stability and mechanical properties are designed to be functionally equivalent.
Range of Sizes	Plasmafit Pro cups are available in sizes 40mm - 70mm, and anchoring screws from 16mm to 68mm. These ranges are within those typically found in predicate devices.
Non-clinical Performance Testing	Testing was performed "where applicable per FDA Guidance documents" to demonstrate substantial equivalence to predicate devices. Specifically mentioned:
	- Characterization of oxidation indices of aged (ASTM F2003) and un-aged Vitelene (ISO 5834-4) showed no decrease, indicating resistance to oxidation.
	- Vitelene remained resistant to oxidation after 5 million cycles of wear (ISO 14242).
	- Adherence to FDA Guidance documents for "Testing of Metallic Plasma Sprayed Coating on Orthopedic Implant," "Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement," and "Testing Non-Articulation, 'Mechanically Locked,' Modular Implant Components."
Safety and Effectiveness	The conclusion of the submission, and FDA's determination, is that the device is "substantially equivalent" to predicate devices, implying that it is as safe and effective as legally marketed devices. The non-clinical testing supports this.

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

This information is not provided in the document. The "tests" performed are non-clinical (mechanical, material characterization) on the device components, not diagnostic tests on patient data. Therefore, concepts like "test set," "data provenance," "country of origin," "retrospective/prospective," and "sample size for test set" in the context of an AI/ML device do not apply. The tests mentioned (e.g., ASTM F2003, ISO 5834-4, ISO 14242) are standardized laboratory tests for device materials and wear.

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

Not applicable. This is not an AI/ML device, and there is no "ground truth" derived from expert review of patient data. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and standards against which the device performance is measured (e.g., the specified oxidation resistance limits in ISO 5834-4).

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

Not applicable, as there is no "test set" in the diagnostic sense, nor human expert adjudication. The "adjudication" for non-clinical tests typically involves adherence to standardized testing protocols and interpretation of results by qualified engineers/scientists.

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 not an AI/ML device, so no MRMC study, human readers, or AI assistance is involved.

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

Not applicable. This is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For non-clinical performance, the "ground truth" is defined by established engineering and materials science standards and specifications (e.g., ISO and ASTM standards for material properties, wear, and oxidation resistance).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set. The device itself is manufactured to specifications derived from design and engineering principles.

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

Not applicable, for the same reasons as above.

Summary

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510(k) Premarket Notification

Plasmafit Pro Acetabular Cup and Vitelene Insert

K122783

Page 1 of 3

510(k) SUMMARY (as required by 21 CFR 807.92)

Plasmafit Pro Acetabular Cup System and Vitelene Insert

October 30, 2013

COMPANY:

Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034

Establishment Registration Number: 3005673311

OCT 3 0 2013

CONTACT:

Julie Tom Wing 610-984-9147 (phone) 610-791-6882 (fax) julie.tomwing@aesculap.com

TRADE NAME:

Plasmafit Pro Acetabular Cup System and Vitelene Insert

COMMON NAME:

Acetabular Cup and Insert

CLASSIFICATION NAME(s):

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis;

Hip joint metal/polymer semi-constrained cemented prosthesis;

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis;

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

REGULATION NUMBER: 888.3358; 888.3350; 888.3360; 888.3353

CLASSIFICATION
PRODUCT CODE(S):	OQG

SUBSEQUENT
PRODUCT CODE(S):	LPH; JDI; OQH; LWJ; LZO; OQI

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K122783

Page 2 of 3

DEVICE DESCRIPTION

Plasmafit Pro cups are available in sizes ranging from 40mm - 70mm.

PURPOSE FOR PREMARKET NOTIFICATION

The purpose for this submission is to gain marketing clearance for Aesculap Implant Systems Plasmafit Pro Acetabular Cup. Vitelene insert, optional titanium screws and 40mm Biolox® and 40mm ISODUR® femoral heads.

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Plasmafit Pro Acotabular Cup and Vitelene Insert

K122783

Page 3 of 3

INDICATIONS FOR USE

The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint.

The devices are intended for:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis. . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral . ephiphysis
. Patients suffering from disability due to previous fusion
Patients with acute femoral neck fractures .

Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for cementless applications.

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, LLC believes that the Plasmafit Pro Acetabular Cup System and Vitelene insert is substantially equivalent to:

. Excia Total Hip System (Aesculap - K042344)
Excia Total Hip System (Aesculap K061699) .
EXp Acetabular Shell Insert (StelKast, Inc. K094035) .
Mectacer 40mm Biolox Delta Heads (K11215) .
Mpact 40mm Ball Heads (K103721) t

TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s)}

Aesculap Implant Systems Plasmafit Pro Acetabular Cup and Vitelene Insert is an acetabular cup system that is substantially equivalent to the predicate devices previously cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to predicate devices through comparison of indications for use, design, material composition, function and range of sizes.

PERFORMANCE DATA

As recommended by the FDA Guidance for Industry and FDA Staff - Non-clinical testing was performed to demonstrate that Plasmafit Pro Acetabular Cup and Vitelene Insert System is substantially equivalent to other predicate devices. In addition, testing was performed where applicable per FDA Guidance documents:

"Testing of Metallic Plasma Spraved Coating on Orthopedic Implant to Support . Reconsideration of Postmarket Surveillance";
"Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone . Cement"
"Testing Non-Articulation, "Mechanically Locked," Modular Implant Components ●

Testing demonstrated that the Plasmafit Pro Acetabular Cup System and Vitelene Insert is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the logo is a stylized image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 30, 2013

Aesculap Implant Systems, Incorporated Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K122783

Trade/Device Name: Plasmafit Pro Acetabular Cup System and Vitelene Insert Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: OQG, LPH, JDI, OQH, LWJ, LZO, OQI Date: October 24, 2013 Receiver: October 28, 2013

Dear Ms. Julie Tom Wing:

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

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Page 2 - Ms. Julie Tom Wing

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/ResourcesforYou/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin Keith

for

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

Enclosure

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A. INDICATIONS FOR USE STATEMENT

K122783 510(k) Number:

Device Name: Plasmafit Pro Acetabular Cup System and Vitelene Insert

Indications for Use:

The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint.

The devices are intended for:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral ephiphysis
Patients suffering from disability due to previous fusion .
Patients with acute femoral neck fractures ♥

Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for cementless applications.

Prescription Use X and/or Over-the-Counter Use (per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.