ÆQUOS- Knee- Endoprosthesis is intended to provide mobility and reduce pain by replacing the damaged knee joint articulation. Candidates for total knee joint includes patients with a severely painful and/or severly disabled joint resulting from different syndromes.

The indications are:

. Damaged and seriously damaged and painful knee joints with relevant malfunction, instability or subluxation of the joint
Therapy resistant bow contracture of more than 20° or non compensable . malposition of the anatomical axis from approximatly 15-20°
Double sided joint anchylosis or anchylosis of the opposite hip joint ●
All conservative therapies were unsuccessful or joint conserving operations . provide no success or have already failed
Failure after implantation of monocondylar implants .
Stiffening of the joint is contraindicated .

Device Description

The ÆQUOS knee endoprosthesis consists of:

Femoral components in anatomic and asymmetrical design a) manufactured from cast CoCr alloy (ASTM F75). Femoral components are intended for cemented use only.
b) Tibial baseplate in anatomic design manufactured from cast CoCr alloy (ASTM F75). The tibial baseplate is a non-porous, stemmed configuration and intended for cemented use only.
c) Tibial inserts in anatomic and asymmetrical design manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE)
d) Tibial spacers

AI/ML Overview

The provided document, K033260, is a 510(k) summary for the ÆQUOS Knee Endoprosthesis, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Crucially, a 510(k) summary for a knee endoprosthesis does not typically include clinical studies or data on device performance against specific acceptance criteria in the way that an AI/ML medical device submission would. The basis of a 510(k) for this type of device relies on material composition, design, and intended use comparison to predicate devices, along with adherence to recognized performance standards (e.g., ASTM, ISO) for physical and mechanical properties.

Therefore, I cannot extract the information required for the prompt as it pertains to a device cleared through substantial equivalence based on physical and material characteristics, rather than a performance-based clinical study typical of AI/ML devices.

Specifically:

A table of acceptance criteria and the reported device performance: Not present in this type of submission. Performance is implied by meeting material and design specifications and substantial equivalence to established predicate devices. There are no "reported device performance" metrics like sensitivity, specificity, or accuracy for a knee implant in this context.
Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" of clinical cases or data in the context of an AI/ML device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not a diagnostic device.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What is present and relevant to the closest interpretation of "acceptance criteria" for this type of device are:

Performance Standards: The document states, "Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001." These standards define the "acceptance criteria" for the physical and mechanical properties of the implant materials and manufacturing processes.
Material Composition: ÆQUOS Knee Endoprosthesis components are manufactured of Cobalt Chromium Alloy (ASTM F75) and Ultra-High Molecular Weight PolyEthylene (ISO 5834-2). Adherence to these material standards is an "acceptance criterion."
Sterilization Validation: Sterilization is validated according to ISO 11137 to achieve a Sterility Assurance Level (SAL) of 10⁻⁶, which is an "acceptance criterion" for sterility.
Substantial Equivalence: The primary "study" or justification for a 510(k) is demonstrating substantial equivalence to legally marketed predicate devices (Anatomic Total Knee (K000978), Columbus (CR) Total Knee System (K023788), Nexgen Complete Knee Solution Trabecular Metal (K024161), Maxim Accel Knee System (K023546)). The "study" in this case is a comparison of technological characteristics, noting "Æquos is substantially equivalent to the predicate devices with respect to physical/technical and material characteristics."

To reiterate, the provided document does not contain the information requested in the prompt because it pertains to a different category of medical device submission.

Summary

{0}------------------------------------------------

K033260

Image /page/0/Picture/1 description: The image is a blank white canvas with a few small, indistinct markings in the lower right corner. These markings appear to be composed of short, dark lines or dots, but their exact nature is unclear due to their small size and low resolution. The rest of the image is uniformly white, lacking any other discernible features or patterns.

000 Implantate /

*MEBIC

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitters Name:	aap Implantate AG
	Lorenzweg 5
	12099 Berlin
DEC - 7 2004	Germany
	Phone: +49 30 750 19 0
	Fax: +49 30 750 19 111
Contact Name:	Marc Seegers, Director Quality Managementemail: m.seegers@aap.de
Name of Device:	ÆQUOS Knee Endoprosthesis cemented
Classification Name:	Knee joint patellofemorotibialpolymer/metal/polymersemi-constrained cemented prosthesis
Common/Usual Name:	Knee-Endoprosthesis
Proprietary Name:	ÆQUOS-Knee- Endoprosthesis
Device Class:	Class II
Product Code:	87 J WH
Classification:	CFR Chapter I, Title 21 § 888.3560 Knee jointpatellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Review Panel:	Orthopaedics

Performance Standards:

Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001.

Material Composition:

ÆQUOS- Knee- Endoprosthesis components are manufactured of Cobalt Chromium Alloy (ASTM F75) and Ultra-High Molecular Weight PolyEthylene (ISO 5834-2)

Intended Use:

The indications are:

. Damaged and seriously damaged and painful knee joints with relevant malfunction, instability or subluxation of the joint
Therapy resistant bow contracture of more than 20° or non compensable . malposition of the anatomical axis from approximatly 15-20°
Double sided joint anchylosis or anchylosis of the opposite hip joint ●

{1}------------------------------------------------

All conservative therapies were unsuccessful or joint conserving operations . provide no success or have already failed
CalB
Failure after implantation of monocondylar implants .
K 033266
Stiffening of the joint is contraindicated .
The contra-indications are:
Badly condition of the patient .
. Badly condition of the skin
Untreated malfunction of the metabolism .
Joint destruction caused by haemophilia, tabes or after infections .
Instability of the joint ligaments .

The ÆQUOS knee endoprosthesis is only for use with bone cement

Device Description:

The ÆQUOS knee endoprosthesis consists of:

Femoral components in anatomic and asymmetrical design a) manufactured from cast CoCr alloy (ASTM F75). Femoral components are intended for cemented use only.
b) Tibial baseplate in anatomic design manufactured from cast CoCr alloy (ASTM F75). The tibial baseplate is a non-porous, stemmed configuration and intended for cemented use only.
c) Tibial inserts in anatomic and asymmetrical design manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE)
d) Tibial spacers

Predicate Devices for Substantial Equivalence:

ÆQUOS is similar in size, material and intended use to the

Anatomic Total Knee (K000978) of Biomet, Inc. .
Columbus (CR) Total Knee System (K023788) of Aesculap, Inc. .
Nexgen Complete Knee Solution Trabecular Metal (K024161) of Implex . Corp.
Maxim Accel Knee System (K023546) of Biomet, Inc. .

Comparision of Technological Characteristics: Æquos is substantially equivalent to the predicate devices with respect to physical/technical and material characteristics.

Page 2 of 3

oop Implanta

MEBIC

{2}------------------------------------------------

<033260

Image /page/2/Picture/1 description: The image shows a handwritten symbol or character. It appears to be a combination of curved and straight lines, possibly part of a larger script or notation. The symbol is drawn with thick strokes, giving it a bold and distinct appearance against the white background.

app Implantate /

Sterilisation Information:

The ÆQUOS Knee- Endoprosthesis are distributed in sterile condition.

The instruments and implants provided in non-sterile condition must be decontaminated, cleaned and sterilised prior to each surgery. All packaging materials must be removed.

Recommendations for sterilisation are contained in the package insert.

Note: These devices are sterilised by end users utilizing the approved/outlined quidelines found in the AAMI Guideline "Good Hospital Practice: Steam Sterilisation and Sterility Assurance" and in ANSI/AAMI/ISO 11737 guidelines to achieve the acceptable Sterility Assurance Level (SAL).

Devices which are available in sterile condition are sterilised with gamma radiation sterilisation. A radiation dose of at least 2.5 Mrad is utilized. The sterility assurance level (SAL) is 10°. The validation has been carried out according to the standard ISO 11137.

Image /page/2/Picture/13 description: The image contains the acronym "MEBIC" in bold, sans-serif font. The letters are closely spaced and appear to be in all caps. The acronym is the main focus of the image and is centered.

Image /page/2/Picture/10 description: The image shows two words, "comphar" and "geo", stacked vertically. The word "comphar" is at the top, with a small circle above it. The word "geo" is at the bottom, with a partial circle around it. The font of the two words is different, with "comphar" being a lighter font and "geo" being a bold font.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 7 2004

Mr. Marc Seegers Director Quality Management aap Implantate AG Lorenzweg 5 12099 Berlin Germany

Re: K033260 Trade/Device Name: ÆQUOS Knee Endoprosthesis Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: November 26, 2004 Received: November 29, 2004

Dear Mr. Seegers:

We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve a nowe 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 for use batter in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner or provise they to they accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 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); 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.

{4}------------------------------------------------

Page 2 - Mr. Marc Seegers

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter notification. The FDA finding of substantial equivalence of your device to a legally premailed 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 11 you a 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

MEB

Cori] pi

Indications for Use Statement

Page 1 of 1

510(k) Number (if known): 长033260

Device Name: ÆQUOS Knee Endoprosthesis

Indications for Use:

Damaged and seriously damaged and painful knee joints with relevant malfunction, . instability or subluxation of the joint
Therapy resistant bow contracture of more than 20° or non compensable malposition . of the anatomical axis from approximatly 15-20°
Double sided joint anchylosis or anchylosis of the opposite hip joint .
All conservative therapies were unsuccessful or joint conserving operations provide no . success or have already failed
Failure after implantation of monocondylar implants .
Stiffening of the joint is contraindicated .

Prescription Use v (Per 21 CFR 801.109) OR

Over-The-Counter Use

R. Mark A. Milkersen

Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K033260

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.