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 AMIStem and Quadra - Line Extension is comprised of the following femoral stems:

Quadra H STD #00 Short neck
Quadra S STD #00 Short neck
AMIStem H STD Stem #00
AMIStem H LAT Stem #0
AMIStem H Collared STD and LAT, multiple sizes

The subject devices have the same material as the predicate devices (titanium alloy, according to ISO 5832-11, 1994, Implants for surgery - Metallic materials - part 11: Wrought titanium 6-aluminum 7-niobium alloy).

The AMIStem H and Quadra H have the same coating as the predicate devices: Hydroxyapatite coating, material according to ASTM F1185.

The Quadra H STD #00 Short neck, Quadra S STD #00 Short neck, AMIStem H STD Stem #00, and AMIStem H LAT Stem #0 are a smaller size than the predicate devices and are intended for patients with a smaller bone structure.

The AMIStem H Collared differs from the AMIStem H (KQ93944) only for the presence of the collar. The collar of the stem is designed to achieve contact only with the medial femoral cortex and to provide a path for direct axial stress transfer from the prosthesis to the proximal femur avoiding the over-insertion of the stem in case of subsidence.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the AMIStem and Quadra - Line Extension, which are femoral stems for hip prostheses. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness through extensive clinical trials with acceptance criteria for a new device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for training/test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance does not apply directly to this 510(k) summary.

However, I can extract the information that is relevant to the substantial equivalence determination.

Here's a breakdown based on the provided text:

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

The concept of "acceptance criteria" for a new, novel device is not explicitly stated as this is a line extension demonstrating substantial equivalence to predicate devices. The primary "acceptance criterion" in this context is demonstrating that the new devices perform the same as the predicate devices and do not raise new safety or effectiveness concerns.

Feature/Test	Acceptance Criteria (Implied for Substantial Equivalence via Predicate)	Reported Device Performance
Material Composition	Same as predicate devices (titanium alloy, ISO 5832-11)	Subject devices have the same material as predicate devices.
Coating	Same as predicate devices (Hydroxyapatite, ASTM F1185)	AMIStem H and Quadra H have the same coating as predicate devices.
Mechanical Performance (Fatigue/Strength)	Meet standards for hip prostheses (ISO 7206-4 and ISO 7206-6) and perform comparably to predicate devices.	Tested in accordance with ISO 7206-4 and ISO 7206-6. Did not raise any new issues of safety and effectiveness, indicating comparable performance.
Intended Use	Same as predicate devices.	Same intended use as predicate devices.
Basic Design Principles	Similar to predicate devices, with smaller sizes or addition of a collar for specific benefits.	Quadra H STD #00 Short neck, Quadra S STD #00 Short neck, AMIStem H STD Stem #00, and AMIStem H LAT Stem #0 are smaller versions. AMIStem H Collared differs by the presence of a collar for axial stress transfer. These differences are deemed not to alter fundamental safety or effectiveness significantly from the predicates.

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

Sample Size for Test Set: Not applicable. This submission relies on performance testing against established standards and comparison to predicate devices, not on a clinical "test set" of patient data for algorithm evaluation.
Data Provenance: Not applicable. The focus is on mechanical testing and material compatibility, not clinical data provenance in the typical sense of a diagnostic or AI device.

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 a study requiring expert ground truth for a diagnostic outcome. The "ground truth" for the device's acceptable performance is defined by adherence to international standards (ISO, ASTM) and comparison to legally marketed predicate devices.

4. Adjudication method for the test set

Not applicable. This is not a study involving human adjudication of results.

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 passive implant; it does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a mechanical implant; it does not involve algorithms or AI.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence is based on:

Engineering Standards: Compliance with international standards such as ISO 7206-4, ISO 7206-6 (for mechanical performance), and ISO 5832-11, ASTM F1185 (for materials).
Predicate Device Performance: The established safety and effectiveness track record of the legally marketed predicate devices. The subject devices are shown to perform similarly and use the same materials and coating as these predicates.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device.

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

Not applicable. This is not an AI/algorithm-based device.

Summary

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JUN - 8 2012

Image /page/0/Picture/2 description: The image shows the word "Medacta" in a simple, sans-serif font. The first letter, "M", is stylized with two triangles pointing upwards, creating a unique visual element. A horizontal line runs beneath the entire word, adding a subtle emphasis to the logo. The overall design is clean and modern, suggesting a professional and reliable brand.

International

510(k) Summary

Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Mr. Adam Gross Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com

Date Prepared: 03/30/2012

DEVICE INFORMATION

Trade/Proprietary Name: AMIStem and Quadra - Line Extension Common Name: Femoral Stem Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

21 CFR 888.3353 Class II Device Product Codes: LZO, MEH

Predicate Devices: K072857 - Medacta Total Hip Prosthesis System-Quadra S, CoCr Ball Heads, Medacta International K082792 - Quadra H; Quadra R, Medacta International K093944 - AMIStem H; Quadra S-H (SN), Medacta International

AMIStem and Quadra - Line Extension 510(k)

Section 5 - Page 2 of 4

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Product Description

The AMIStem and Quadra - Line Extension is comprised of the following femoral stems:

Quadra H STD #00 Short neck ●
Quadra S STD #00 Short neck .
AMIStem H STD Stem #00 ●
AMIStem H LAT Stem #0
AMIStem H Collared STD and LAT, multiple sizes

The AMIStem H and Quadra H have the same coating as the predicate devices: Hydroxyapatite coating, material according to ASTM F1185.

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.

Section 5 - Page 3 of 4

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Comparison to Predicate Devices

The intended use, materials, and performance characteristics for all of the femoral stems that are the subject of this submission are the same as the correspondent femoral stems already registered in the predicate devices.

Performance Testing

The AMIStem and Quadra - Line Extension was tested in accordance with ISO 7206-4 and ISO 7206-6. The subject devices did not raise any new issues of safety and effectiveness and are substantially equivalent to the predicate devices.

Conclusion:

Based on the above information, the AMIStem and Quadra - Line Extension can be considered as substantially equivalent to its predicate devices.

AMIStem and Quadra - Line Extension 510(k)

Section 5 - Page 4 of 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol consists of three curved shapes resembling a person embracing or supporting another, representing the department's mission of providing essential services and protecting the health of all Americans.

Public Health Service

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

Medacta International % Medacta USA Mr. Adam Gross Director of Regulatory and Quality 4725 Calle Quetzal, Unit B Camarillo, CA 93012

Re: K121011

Trade/Device Name: AMIStem and Quadra - Line Extension 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, MEH Dated: May 8, 2012 Received: May 9, 2012

Dear Mr. Gross:

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

JUN - 8 2012

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Page 2 - Mr. Adam Gross

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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,

Erin D. Keith

+s Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: AMIStem and Quadra - Line Extension

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 × (21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Devi e Evaluation (ODE)

Asnt

ﺘﺮ

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIZIOII 510(k) Number .

AMIStem and Quadra - Line Extension 510(k) March 30, 2012

Section 4 - Page 2 of 2

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.