Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
Avascular necrosis of the femoral head
Acute traumatic fracture of the femoral head or neck
Failure of previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

Device Description

The modifications to the original Medacta Total Hip Prosthesis system are a line extension to include the Quadra H and Quadra R femoral stems. The Quadra H femoral stems are the same design femoral stems as the Quadra S femoral stems in the original submission but with the application of a hydroxyapatite coating. The Quadra R femoral stems designs are also based on the Quadra S femoral stems in the original submission for the proximal one third with longer length for revision cases. The Quadra R femoral stems also have the application of a hydroxyapatite (HA) coating.

The Quadra H and Quadra R femoral stems are manufactured from a titanium alloy, according to ISO 5832-11, 1994, Implants for surgery - Metallic materials - part 11: Wrought titanium 6-aluminum 7-niobium alloy, the same as the Quadra S femoral stems in the original submission. They are sandblasted and the neck has a mirror polished finish, the same as the Quadra S. They have a standard 12/14 taper for connection to the ball head. the same as the Quadra S. The Quadra H and Quadra R femoral stems differ from the Quadra S in that they have a hydroxyapatite coating applied to the distal portion of the femoral stems.

The Quadra H femoral stems are available in the same four versions. standard or lateralized stem, both reqular and short neck versions. The sizes, dimensions, and options are identical to the Quadra S femoral stems in the original submission.

The Quadra R femoral stems have same design and dimensions in the proximal one third as the Quadra S or Quadra H lateralized standard neck stems. The distal two thirds dimensions are longer for revision cases.

The Quadra H and Quadra R femoral stems work with the same range of ball heads cleared under the original Medacta Total Prosthesis System, K072857, and subsequent submissions for the MectaCer Ceramic ball heads, K073337. and for additional CoCrMo ball heads sizes, K080885. The Quadra H and Quadra R femoral stems with these ball heads work with the Ortho Development's Triplus® Acetubular cups and liners. They can also be used with Medacta CoCrMo femoral ball heads of sizes 22 and 28 and the Ortho Development's Pivot Bipolar heads. These system compatibilities are the same as the original devices. Quadra S femoral stems.

AI/ML Overview

The provided document is a 510(k) summary for a medical device, the Medacta Total Hip Prosthesis System - Quadra H and Quadra R femoral stems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a formal study with acceptance criteria and performance data in the way one might for a novel diagnostic AI product.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics like sensitivity, specificity, or AUC, as well as details about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, is not applicable to this document's content or the regulatory pathway it describes.

The document states:

"No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act."
"Risk analysis was conducted on the impact of these changes and appropriate design verification and validation was conducted under the company's design controls."
"The results from design controls and the information provided in this submission support the conclusion that the Medacta Total Hip Prosthesis System - Quadra H and Quadra R femoral stems are substantially equivalent to their predicate, Medacta Total Hip Prosthesis System - Quadra S femoral stems with respect to indications for use and technological characteristics."

From this, we can deduce some underlying "acceptance criteria" for a 510(k) submission of this nature, which are primarily related to substantial equivalence and safety/effectiveness through design controls and comparison to a predicate.

Here's how we can frame the response based on the provided text, acknowledging the limitations inherent in a 510(k) summary for a hip prosthesis addition:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on 510(k) pathway)	Reported Device Performance (from document)
Indications for Use: Must be the same or similar to the predicate device, not raising new questions of safety or effectiveness.	"The indications for use for the modified system remain the same as the original 510(k), K072857."Indications listed: Severely painful and/or disabled joint due to arthritis (traumatic, rheumatoid polyarthritis, congenital hip dysplasia), avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failure of previous hip surgery/reconstruction. Intended for cementless use in total or partial hip arthroplasty, and in primary or revision surgery.
Technological Characteristics: Must be substantially equivalent or modifications must not raise new questions of safety or effectiveness.	Quadra H and R femoral stems: - Manufactured from titanium alloy (ISO 5832-11), same as Quadra S. - Sandblasted with mirror polished neck, same as Quadra S. - Standard 12/14 taper, same as Quadra S. - Difference: Hydroxyapatite coating applied to distal portion (Quadra H and R). - Quadra H available in same four versions, sizes, dimensions, and options as Quadra S. - Quadra R has same proximal design/dimensions as Quadra S/H lateralized standard neck stems, but distal two-thirds are longer for revision cases. - Work with same range of ball heads and acetabular cups/liners as Quadra S.
Safety and Effectiveness: Demonstrated through design controls and comparison to the predicate device, showing no new or different questions of safety and effectiveness.	"Risk analysis was conducted on the impact of these changes and appropriate design verification and validation was conducted under the company's design controls." "The results from design controls and the information provided in this submission support the conclusion that the Medacta Total Hip Prosthesis System - Quadra H and Quadra R femoral stems are substantially equivalent to their predicate... with respect to indications for use and technological characteristics."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission for an orthopedic implant extension does not describe a "test set" in the context of typical AI/diagnostic performance studies. The "testing" involves design verification and validation under the company's design controls, not clinical trials with patient-specific data to determine diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. Ground truth establishment with experts for image interpretation or diagnostic accuracy is not relevant to this type of device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication for establishing ground truth is not relevant here.

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 document pertains to a hip prosthesis, not an AI-assisted diagnostic tool.

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 device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, "ground truth" would relate to the functional and biomechanical suitability of the implant materials and design, typically established through:

Engineering analyses (stress, fatigue, wear)
Materials testing (biocompatibility, strength)
Bench testing (mechanical performance)
Pre-clinical testing (animal studies, if required for new designs or materials)
Clinical experience with the predicate device and similar designs.

The document states "Risk analysis was conducted on the impact of these changes and appropriate design verification and validation was conducted under the company's design controls." These "design controls" would encompass the types of activities mentioned above to ensure the device meets its specifications and is safe and effective when compared to the predicate.

8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two black triangles pointing upwards, followed by the word "Medacta" in a sans-serif font. Below the word "Medacta" is the word "International" in a smaller font.

DEC 2 9 2008

Special 510(k) Summary

Manufacturer: MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 FAX (+41) 91 696 60 66

Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@njkconsulting.com
Nov. 26, 2008 Date Prepared:

DEVICE INFORMATION

Trade/Proprietary Name: Medacta Total Hip Prosthesis - Quadra H, Quadra R femoral stems Common/Classification Name: Hip Joint, metal/polymer/metal semiconstrained cemented prosthesis

21 CFR 888.3350 Class II Device Product Code: JDI

Medata Total Hip Prosthesis – Quadra S femoral Predicate Device: stems, K072857, cleared on Feb. 4, 2008

Product Description:

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hydroxyapatite coating. The Quadra R femoral stems designs are also based on the Quadra S femoral stems in the original submission for the proximal one third with longer length for revision cases. The Quadra R femoral stems also have the application of a hydroxyapatite (HA) coating.

Indications for Use:

The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.

Hip replacement is indicated in the following cases:

Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
Avascular necrosis of the femoral head .
Acute traumatic fracture of the femoral head or neck .
Failure of previous hip surgery, joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

Comparison to Predicate Device:

The indications for use for the modified system remain the same as the original 510(k), K072857.

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Quadra R femoral stems with these ball heads work with the Ortho Development's Triplus® Acetubular cups and liners. They can also be used with Medacta CoCrMo femoral ball heads of sizes 22 and 28 and the Ortho Development's Pivot Bipolar heads. These system compatibilities are the same as the original devices. Quadra S femoral stems.

Performance Testing

No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act.

Risk analysis was conducted on the impact of these changes and appropriate design verification and validation was conducted under the company's design controls.

Conclusion:

The results from design controls and the information provided in this submission support the conclusion that the Medacta Total Hip Prosthesis System - Quadra H and Quadra R femoral stems are substantially equivalent to their predicate, Medacta Total Hip Prosthesis System - Quadra S femoral stems with respect to indications for use and technological characteristics.

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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 stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDACTA International, SA % NJK & Associates Inc. Ms. Natalie J. Kennel Consultant 1321 Via Tres Vista San Diego, California 92129

DEC 2 9 2008

Re: K082792

Trade/Device Name: Medacta Total Hip Prosthesis System – Quandra J, Quandra R Regulation Number: 21 CFR 888.3050 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: November 26, 2008 Reccived: December 2, 2008

Dear Ms. Kennel:

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 Fanethinents, or ug 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, lusting of devices, good manufacturing practice, labeling, and prohibitions against misbaanding 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, TDA nov 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 af the Act or any Federal statutes and regulations administered by other Federal agencies. Yourmust 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 electionic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

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Page 2 - Ms. Natalie J. Kennel

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Mulhearn

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

Enclosure

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Indications for Use Statement

K082792(pg1/1)

510(k) Number (if known):

Device Name: Medacta Total Hip Prosthesis System - Quadra H, Quadra R

Indications for Use:

The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.

Hip replacement is indicated in the following cases:

Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
Avascular necrosis of the femoral head .
Acute traumatic fracture of the femoral head or neck
Failure of previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Per

A Restorative. Division of Gara and Neurological Devices

510(k) Number Ko 802792

Page _ of _

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.