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

Device Description

The BiPolar cup is a sub-component of an endoprosthetic replacement for the human hip where it assumes the function of the natural femoral head and is combined with a prosthesis head and a hip stem. It consists of a highly polished CoCr shell and a polyethylene insert. In vivo, the shell articulates directly with the well-preserved acetabulum while the insert articulates with a modular head component of a femoral hip. The head is held in place by a retaining ring that is pre-assembled into the insert of the cup. The BiPolar components are available in a variety of sizes to allow the surgeon to rebuild the natural anatomy of the hip joint as accurately as possible while implanting the hemi-arthroplasty.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Aesculap BiPolar Acetabular Cup, which is a medical device. This type of notification focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through clinical studies. Therefore, the information requested in your prompt (e.g., acceptance criteria, detailed study design, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not typically found in a 510(k) summary for a device like this.

510(k) submissions for orthopedic implants often rely on bench testing (biomechanical, material characterization) and comparison to predicate devices, rather than extensive human clinical trials to establish safety and effectiveness.

Here's a breakdown of what can be extracted from the document, and why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biomechanical Stability (implied from predicate equivalence and testing description)	"Biomechanical testing was performed to evaluate the effects of destructive forces on the ball/cup assembly for both head diameters at the extreme size ranges."
Material Composition (CoCr shell, UHMWPE insert)	"highly polished Cobalt Chrome alloy (CoCrMo) shell and a polyethylene (UHMWPE) insert."
Locking Mechanism (Polyethylene ring)	"uses a polyethylene ring" (same as Plus device)
Self-centering	"self-centering as well."
Size Range (22mm or 28mm heads; 39mm to 60mm outer diameters)	"offered to fit either 22 mm or 28 mm heads and are available in a range of outer diameters from 39mm to 60 mm."
Substantial Equivalence to Predicate Devices	"Aesculap®, Inc. believes that the BiPolar Acetabular Cup is substantially equivalent to the following legally marketed predicate devices: Biomet Ringloc Bi-Polar Acetabular Component (K051569); Plus Orthopedics Bipolar Prosthesis CoCrMo (K982447); Aesculap Excia Total Hip System (K042344); Aesculap BiContact Hip Stem and Femoral Head (K040191)."

Study that Proves the Device Meets the Acceptance Criteria:

The document mentions "Biomechanical testing was performed to evaluate the effects of destructive forces on the ball/cup assembly for both head diameters at the extreme size ranges." The primary "proof" for regulatory clearance is the demonstration of substantial equivalence to existing, legally marketed predicate devices through comparison of technological characteristics and performance data (which includes the described biomechanical testing).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The biomechanical testing likely used a sample of physical devices for mechanical evaluation, not a human "test set" in the clinical trial sense.
Data Provenance: Not specified, but given it's biomechanical testing, it would have been conducted in a laboratory setting, likely at the manufacturer's facility or a contract lab. It is not clinical data (retrospective or prospective).

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

This information is not applicable to this type of submission. There was no "ground truth" derived from expert consensus on imaging or clinical outcomes for a "test set" as would be seen in, for example, an AI/radiology study. The "ground truth" for biomechanical testing is typically defined by engineering standards and measurement accuracy.

4. Adjudication method for the test set

Not applicable. There was no human interpretation or adjudication required for this type of biomechanical 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

No. This is not an AI/imaging device. MRMC studies are not relevant here.

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

For the biomechanical testing: The "ground truth" would be established by engineering specifications and validated testing methodologies to measure and quantify "destructive forces" and the integrity of the "ball/cup assembly."

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

Not applicable. See point 8.

Summary

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K060707

510(k) Premarket Notification

BiPolar Acetabular Cup

Page 1 of 2

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

Aesculap BiPolar Acetabular Cup 15 March 2006

Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034

ESTABLISHMENT REG. #: 2916714

CONTACT: Matthew M. Hull 610-984-9072 (phone) 610-791-6882 (fax)
Aesculap BiPolar Acetabular Cup TRADE NAME:
COMMON NAME: BiPolar Acetabular Cup
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented CLASSIFICATION NAME: or Uncemented

888.3390 REGULATION NUMBER:

KWY PRODUCT CODE:

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the BiPolar Acetabular Cup is substantially equivalent to the following legally marketed predicate devices:

Biomet Ringloc Bi-Polar Acetabular Component (K051569)

Plus Orthopedics Bipolar Prosthesis CoCrMo (K982447)

Aesculap Excia Total Hip System (K042344)

Aesculap BiContact Hip Stem and Femoral Head (K040191)

DEVICE DESCRIPTION

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Page 2 of 2

INDICATIONS FOR USE

The Aesculap BiPolar Cup is for uncemented use in conjunction with a standard cemented or uncemented femoral replacement implant for the following:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis
Rheumatoid arthritis 2)
Correction of functional deformity 3)
Treatment of non-union, femoral neck fracture and trochanteric fractures of the 4) proximal femur with head involvement, unmanageable using other techniques

TECHNOLIGICAL CHARACTERISTICS(compared to predicate(s))

This is exactly the same Bipolar cup that was cleared for Plus Orthopedics in 510(k) # K982447 as thev are both made by the subcontractor Ortek A.G. in Switzerland. This BiPolar Cup is marketed by Aesculap for use with the femoral components of their previously cleared Excia and BiContact Hip Systems. Just like the Plus and Biomet devices this new Aescular Acetabular Cup will be made with a highly polished Cobalt Chrome alloy (CoCrMo) shell and a polyethylene (UHMWPE) insert. All three devices use a locking ring mechanism, the Aesculap device is the same as the Plus device using a polyethylene ring while the Biomet device uses a metal ring. Both the Aesculap and Plus Bipolar Cups are self-centering as well. The devices are offered to fit either 22 mm or 28 mm heads and are available in a range of outer diameters from 39mm to 60 mm. The Biomet predicate O.D. ranqe is from 41 mm to 70 mm.

PERFORMANCE DATA

Biomechanical testing was performed to evaluate the effects of destructive forces on the ball/ cup assembly for both head diameters at the extreme size ranges.

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C. PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT [As required by 21 CFR 807.87(k)]

I certify that, in my capacity as Regulatory Affairs Manager for Aesculap® Inc., I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

Matt Hindsill

Matthew M. Hull, RAC Regulatory Affairs Manager

3/15/06
Date

Date

Premarket Notification 510(k) Number

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Image /page/3/Picture/0 description: The image shows a black and white circular logo. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. Encircling the bird is text, which appears to be part of the logo's official name or designation. The text is arranged along the circumference of the circle, creating a border around the central image.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

y 3 1 2006

Aesculap®,Inc. c/o Mr. Matthew M. Hull 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K060707/S1

Trade/Device Name: Aesculap BiPolar Acetabular Cup Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY Dated: May 11, 2006 Received: May 12, 2006

Dear Mr. Hull:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 statutis 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

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Page 2 - Mr. Hull

CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Halent Semer

Mark N. Melkerson, M.S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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BiPolar Acetabular Cup

ન્મ

A. INDICATIONS FOR USE STATEMENT

510(k) Number: 40160707

Device Name: Aesculap BiPolar Cup

Indications for Use;

The Aesculap BiPolar Cup is for uncemented use in conjunction with a standard cemented or uncemented femoral replacement implant for the following:

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

and/or Over-the-Counter Use _ Prescription 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)

Oharbare Driehnd for mMM
(Division Sign-Off)

Division of General, Restorative. and Neurological Devices

510(k) Number K060702

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.