The Master stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Master Stems are intended for use with Co-Cr-Mo or ceramic femoral heads and cemented cups, or with Co-Cr-Mo or ceramic femoral heads and Delta TT Acetabular System. When used in partial hip arthroplasty, the Master stems are intended for use with Lock Bipolar Heads.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
rheumatoid arthritis;
treatment of femoral head and neck fractures;
revisions in cases of good remaining femoral bone stock.

Device Description

The Master femoral stem is a monolithic, collarless, tapered wedge shaped stem intended for press-fit uncemented partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Limacorporate CoCrMo alloy femoral heads (K112158) or Biolox Delta ceramic femoral heads and with either a Limacorporate Cemented Cups or Limacorporate Delta TT Acetabular System cup. When used in partial hip arthroplasty. the Master" femoral stem is used with a Limacorporate CoCrMo alloy femoral heads coupled with a Lock Bipolar Head (Limacorporate K112158).

The Master® femoral stem is made of Ti6Al4V conforming to ASTM F1472 – ISO 5832-3. The proximal 1/2 of the stem has a plasma sprayed coating of titanium alloy (ASTM F1472 - ISO 5832-3). The stem has a tapered rectangular section and the distal anterior and posterior surfaces have a vertical groove for rotational stability. The stem provides a neck with a 12/14 conical taper to couple to Limacorporate CoCrMo allov or Biolox Delta ceramic femoral heads and the necks are mirror-polished and lowered to reduce accidental abrasion and contact between the stem neck and the acetabular cup. The Masters stem is available 13 sizes in both standard and lateralized versions with different CCD angles.

The Biolox Delta ceramic head is a femoral ceramic head with a female 12/14 taper for coupling to the male 12/14 taper of the femoral stem. The Biolox Delta ceramic heads are available in diameters of 28, 32, and 36 mm in three (3) neck lengths (S, M, L); the 36 mm diameter head is also available with a XL neck length.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the Master® Femoral Stem. It is not a study report that details acceptance criteria and device performance. The information provided is primarily for regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted directly from this document. However, I can still provide the limited information that is present and indicate where the document does not contain the requested details.

Here's an analysis of the provided text in relation to your questions:

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

This document does not specify quantitative acceptance criteria or provide a table of reported device performance values. It focuses on demonstrating substantial equivalence to predicate devices through material and design similarities, and non-clinical testing already performed on those predicate devices.

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

The document explicitly states: "Non-Clinical Testing: ...the tests provided in K140975 and K141327 are therefore applicable...". It does not report new non-clinical test data or sample sizes for a "test set" in the context of a new performance study for the Master® Femoral Stem. The tests referenced are from previous 510(k) clearances (K140975 for the Master Femoral Stems and K141327 for the Minima S Hip Stem and Biolox Delta Heads). No information on data provenance (country of origin, retrospective/prospective) is provided for these referenced tests.

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 as there is no mention of a "test set" or ground truth established by experts in this regulatory submission.

4. Adjudication method for the test set

This information is not applicable as there is no mention of a "test set" or adjudication in this regulatory submission.

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

This is not applicable. The device is a physical orthopedic implant (femoral stem) and not an AI-powered diagnostic or decision support system. Therefore, no MRMC study or AI-related effectiveness analysis would be conducted.

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

This is not applicable. The device is a physical orthopedic implant and does not involve any algorithm or AI components.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This is not applicable. The document refers to non-clinical testing (material properties, design specifications, etc.) rather than a study requiring ground truth established by medical experts or pathology for diagnostic accuracy.

8. The sample size for the training set

This is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no mention of a "training set".

Summary of available information related to performance/testing:

The document primarily relies on the concept of substantial equivalence for regulatory clearance. This means that the device is considered safe and effective because it is very similar to legally marketed predicate devices, and the differences do not raise new questions of safety or effectiveness.

Key points:

Non-Clinical Testing: The submission states that non-clinical testing was deemed sufficient and refers to tests provided in previous 510(k) clearances (K140975 and K141327) for predicate devices. It emphasizes that since the materials, design, femoral head sizes, and acetabular components are the same as described in these predicate clearances, "no new issues of safety and effectiveness are introduced."
Clinical Testing: The document explicitly states: "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence."

Therefore, this document does not present a standalone study with specific acceptance criteria and reported device performance for the Master® Femoral Stem itself. Instead, it leverages the existing regulatory clearances and associated testing of its predicate devices to demonstrate equivalence.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design. The profiles are facing to the right and are stacked on top of each other.

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

January 27, 2015

Limacorporate S.p.A % Dr. Stephen J. Peoples, VMD, MS Principal Consultant Peoples & Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814

Re: K143509

Trade/Device Name: Master56 Femoral Stem 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, JDI, KWY, KWY, KWZ, LPH Dated: January 12, 2015 Received: January 13, 2015

Dear Dr. Peoples:

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 (reporting of medical

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Page 2 - Dr. Stephen J. Peoples, VMD, MS

device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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 Statement

510(k) Number (if known): K143509

Masters Femoral Stem Indications for Use

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
· rheumatoid arthritis;
· treatment of femoral head and neck fractures;
· revisions in cases of good remaining femoral bone stock.

Prescription Use X (Part 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 Device Evaluation (ODE)

Page 1 of 1

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Date: November 20, 2014

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy

U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant Phone: 260-645-0327 FAX: +39 0432945512

Product	CommonName	ProductCode	Regulation and Classification Name
MasterSLfemoral stem	Total orHemiHipProsthesis	LZO	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis per 21 CFR 888.3353
		JDI	Hip joint metal/polymer semi-constrainedcemented prosthesis per 21 CFR 888.3350
		KWY	Hip joint femoral (hemi-hip) metal/polymercemented or uncemented prosthesis per 21CFR 888.3390
		KWZ	Prosthesis, Hip, Constrained, Cemented OrUncemented, Metal/Polymer per 21 CFR888.3310
		LPH	Prosthesis, Hip, Semi-Constrained,Metal/Polymer, Porous Uncemented per 21CFR 888.3358

Description:

The Master femoral stem is a monolithic, collarless, tapered wedge shaped stem intended for press-fit uncemented partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Limacorporate CoCrMo alloy femoral heads (K112158) or Biolox Delta ceramic femoral heads and with either a Limacorporate Cemented Cups or Limacorporate Delta TT Acetabular System cup. When used in partial hip arthroplasty the Master" femoral stem is used with a Limacorporate CoCrMo alloy femoral heads coupled with a Lock Bipolar Head (Limacorporate K112158).

Special 510(k) - Device Modification: MasterSu Femoral Stem November 20, 2014

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have a vertical groove for rotational stability. The stem provides a neck with a 12/14 conical taper to couple to Limacorporate CoCrMo allov or Biolox Delta ceramic femoral heads and the necks are mirror-polished and lowered to reduce accidental abrasion and contact between the stem neck and the acetabular cup. The Masters stem is available 13 sizes in both standard and lateralized versions with different CCD angles.

Intended Use/Indications:

The Master stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Master Stems are intended for use with Co-Cr-Mo or ceramic femoral heads and cemented cups, or with Co-Cr-Mo or ceramic femoral heads and Delta TT Acetabular System. When used in partial hip arthroplasty. the Master stems are intended for use with Lock Bipolar Heads.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia:
rheumatoid arthritis:
· treatment of femoral head and neck fractures;
· revisions in cases of good remaining femoral bone stock.

Predicate Devices:

Master Femoral Stems (Limacorporate, K140975): .
Minima S Hip Stem (Limacorporate, K141327) ●

Comparable Features to Predicate Device(s):

The Master Femoral Stems and the Biolox Delta Heads are identical to the Master Femoral Stems cleared in K140975 and the Biolox Delta Heads cleared in K141327.

Non-Clinical Testing:

The design, material, and sizes of the Biolox Delta Femoral Heads for use with the Master" Femoral Stem are identical to the design, material, and sizes of the Biolox Delta Femoral Heads cleared for use with the Minima S Hip (K141327). The conical taper used to couple to the Biolox Delta Head to the Master Femoral Stem is achieved through the same conical taper used to

Special 510(k) - Device Modification: MasterSu Femoral Stem November 20, 2014

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couple the Bilox Delta ceramic head to the Minima Hip Stem (K141327) and the Master" Femoral Stem (K140975) is manufactured from the same material (Ti6A14V alloy) as the Minima S Hip cleared for use with Biolox Delta ceramic heads (K141327). The Master" Femoral Stem with Biolox Delta ceramic heads is intended to be used with the same acetabular cups as cleared for the Minima S Hip and Biolox Delta ceramic heads (K141327). Since the materials, design, femoral head sizes and acetabular components remain the same as described in K140975 and K141327, no new issues of safety and effectiveness are introduced by adding the Biolox Delta ceramic head for use with the Master Femoral Stem and the tests provided in K140975 and K141327 are therefore applicable to use of the Biolox Delta ceramic head with the MasterSL Femoral Stem.

Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence.

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.