· 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

Device Description

The MasterLoc™ Stem: Lateralized Plus implants are a line extension to Medacta's MasterLoc Stem product line (cleared under K151531 and K160289). The MasterLoc "" Stem: Lateralized Plus implants offer an additional caput-collum-diaphyseal (CCD) angle of 122° and neck offsets for various patient anatomies. The MasterLoc™ Stem: Lateralized Plus implants include cementless, flat, dual tapered design stems intended for total hip arthroplasty in primary or revision surgery.

The MasterLoc™ Stem: Lateralized Plus implants are made with a titanium alloy substrate (Ti6Al7Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery -Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy. The surface treatment consists of Ti coating with a thickness of 700 um in the proximal 2/3 of the shaft to improve proximal fixation. The distal portion of the stems are uncoated with a satin finish obtained from glass bead blasting.

The MasterLoc " Stem: Lateralized Plus implants are available in sizes 4 to 12, with a range of stem lengths from 126.5 mm to 147.5 mm. The stems have a Eurocone (12/14 taper with an angle of 5° 42' 30'') and the necks are polished.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "MasterLoc™ Stem: Lateralized Plus," which is a hip prosthesis. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the same way a new drug or novel medical device might.

Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy for an AI/ML device is not directly applicable to this submission. This 510(k) is for a prosthetic implant, and its "acceptance criteria" are related to mechanical performance and biocompatibility to demonstrate it functions similarly to existing, cleared devices.

However, I can extract the information that is relevant to testing and performance data for this device, which serves a similar purpose of demonstrating safety and performance.

Here's a breakdown of the available information based on your requested categories, tailored to what's present in this 510(k) document:

Acceptance Criteria and Device Performance (Adapted for a Prosthetic Device):

This submission doesn't define "acceptance criteria" in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) or a specific "reported device performance" in that sense. Instead, the acceptance criteria are inherent in the standards to which the device was tested, and the "reported device performance" is the successful completion of these tests.

Acceptance Criteria Category (Implied by Standards)	Reported Device Performance (Implied by Submission)
Fatigue Resistance (Stem)	Device successfully passed fatigue testing per ISO 7206-4.
Fatigue Resistance (Head/Neck)	Device successfully passed fatigue testing per ISO 7206-6.
Range of Motion (ROM)	Device successfully passed range of motion testing per EN ISO 21535.
Pyrogenicity (Endotoxin Levels)	Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter <85>). Pyrogen test conducted according to USP chapter <151>. (Implied successful, as no adverse findings reported preventing clearance).
Material Composition	Titanium alloy substrate (Ti6Al7Nb) according to ISO 5832-11.
Surface Treatment	Ti coating with a thickness of 700 um in the proximal 2/3 of the shaft. Distal portion uncoated with satin finish (glass bead blasting).

1. A table of acceptance criteria and the reported device performance:
As detailed above. The "acceptance criteria" are the successful completion of tests adhering to the specified ISO and EN standards. The "reported device performance" is that these tests were conducted and the device met the requirements of these standards, allowing for a substantial equivalence determination.

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

Sample Size for Test Set: Not explicitly stated as a "test set" in the context of data for an algorithm. For mechanical testing, the sample size refers to the number of physical devices tested. This information is not provided in the document (number of stems tested for fatigue, ROM, pyrogenicity).
Data Provenance: The tests conducted are non-clinical (mechanical and pyrogenicity) and were performed to international standards (ISO, EN, European Pharmacopoeia, USP). The location of these tests is not specified, but the submitter (Medacta International SA) is based in Switzerland. These are prospective tests performed on new devices manufactured for this submission, not retrospective data.

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. This is not a study requiring expert readers or ground truth establishment in the diagnostic sense. The "ground truth" for mechanical properties is determined by physical measurements against established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no human interpretation or adjudication method described for the mechanical and pyrogenicity tests.

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 a diagnostic device or an AI/ML algorithm. No human reader studies were conducted as part of this submission.
The document explicitly states under "Clinical Studies": "no clinical studies were conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on well-established engineering and material science standards (ISO, EN) and pharmacopoeia standards (USP, European Pharmacopoeia) for mechanical properties, material composition, and biocompatibility (pyrogenicity). These standards define acceptable limits and testing methodologies.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device that uses 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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December 7, 2017

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medacta International SA % Elizabeth Rose Manager, Regulatory Affairs Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504

Re: K173267

Trade/Device Name: MasterLoc™ Stem: Lateralized Plus 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, KWY, LPH, LZY Dated: October 10, 2017 Received: October 11, 2017

Dear Ms. Rose:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known)

K173267

Device Name MasterLoc™ Stem: Lateralized Plus

Indications for Use (Describe)

The hip prosthesis MasterLoc™ is designed for cementless use in total or partial hip arthroplasty 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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3.0 510(k) Summary

I. Submitter

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: Stefano Baj, Regulatory Affairs Manager, Medacta International SA Consultant: Elizabeth Rose, Regulatory Affairs Manager, Medical Devices, Mapi USA, Inc. Date Prepared: October 10, 2017 Revised: November 29, 2017

II. Device

Device Proprietary Name:	MasterLoc™ Stem: Lateralized Plus
Common or Usual Name:	Total Hip Prosthesis
Classification Name:	Hip joint metal/polymer semi-constrained cemented or
	nonporous uncemented prosthesis
FDA Product Code:	LZO, MEH, KWY, LPH, LZY
Regulation Number:	21 CFR 888.3353, 21 CFR 888.3390, 21 CFR 888.3358, 21
	CFR 888.3360
Device Classification	2

III. Predicate Device

Substantial equivalence is claimed to the following devices: Primary Predicate:

MasterLoc™ Stem, K151531, Medacta International SA .
MasterLoc™ Stem, K160289, Medacta International SA ●

Additional Predicates:

Anthology Hip Stem, K052792, Smith & Nephew, Inc. ●

Device Description IV.

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patient anatomies. The MasterLoc™ Stem: Lateralized Plus implants include cementless, flat, dual tapered design stems intended for total hip arthroplasty in primary or revision surgery.

V. Indications for Use

The hip prosthesis MasterLoc™ is designed for cementless use in total or partial hip arthroplasty 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.

VI. Comparison of Technological Characteristics

The MasterLoc™ Stem: Lateralized Plus and the predicate devices share the following characteristics:

. sizes:
lengths;
taper;
substrate material;
coating;
device usage;
sterility;
shelf life; and
packaging.

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The MasterLoc" Stem: Lateralized Plus implants are technologically different from the predicate devices as follows:

CCD angle, and
neck offset.

VII. Performance Data

Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed in support of a substantial equivalence determination:

Non-Clinical Studies

Performance Tests
- range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants o Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants:
- fatigue testing: ISO 7206-4 Third Edition 2010-06-15 Implants for Surgery o Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components [Including AMENDMENT 1 (2016)]; and
- fatigue testing: ISO 7206-6 Second Edition 2013-11-15 Implants for Surgery o Partial and Total Hip Joint Prostheses - Part 6: Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components.
Pyrogenicity
- O the Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>) and the pyrogen test according to USP chapter <151> for pyrogenicity determination; and
- the subject devices are not labeled as non-pyrogenic or pyrogen free. o

Clinical Studies

no clinical studies were conducted.

VIII. Conclusion

Based on the above information, the MasterLoc ""Stem: Lateralized Plus can be considered substantially equivalent to the identified predicate devices.

Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The MasterLoc "Stem: Lateralized Plus implants are as safe and effective as the predicate devices, Medacta's MasterLoc " Stem (K151531 and K160289) and Smith & Nephew's Anthology Hip Stem (K052792).

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.