FOUNDATION POROUS COATED HEMISPHERICAL SHELL by ENCORE ORTHOPEDICS, INC.

The Foundation® Porous Coated Hemispherical Acetabular Cup is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis of femoral neck fracture, and revision arthroplasty where bone loss is minimal. This system includes a metal-backed shell and modular polyethylene liner and is to be used press-fit. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Device Description

The Foundation® Porous Coated Hemispherical Acetabular Cup is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surfaces are coated with commercially pure titanium beads (ASTM F67) for the purpose of providing a porous surface for enhanced press-fit fixation.

The hemispherical shells are available with and without screw holes. It is hemispherical in shape and is available in sizes 44mm - 70mm.

AI/ML Overview

This is a 510(k) summary for a medical device (hip implant), not an AI/ML predictive device. Therefore, much of the requested information regarding AI/ML study design and performance metrics is not applicable.

Here's an interpretation of the provided text in the context of device approval, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was tested)	Reported Device Performance (Result)
Attachment strength of liners to shell	All results are sufficient for in-vivo loading.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document states "Testing on this device included attachment strength of liners to shell," but does not give the number of samples tested.
Data Provenance: Not specified, but implied to be laboratory testing conducted by Encore Orthopedics®, Inc. (the manufacturer). This is a physical device test, not data from patients or a specific country.
Retrospective/Prospective: Not applicable, as this refers to a physical device test.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for the "attachment strength of liners to shell" would be based on engineering specifications and physical testing methods, not expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. This refers to the process of resolving disagreements among experts during ground truth establishment, which isn't relevant for a physical engineering test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

Engineering Specifications/Physical Measurement Standards: For the "attachment strength of liners to shell," the ground truth would be based on predefined engineering requirements for material strength and adhesion, measured through physical testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a training set. If 'training set' were broadly interpreted as design iterations or preliminary tests, the size is not specified.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of AI/ML. For a physical device, development uses engineering principles and material science.

Summary of the Device Approval in the Provided Text:

The provided documents are a 510(k) premarket notification for a medical device (Foundation® Porous Coated Hemispherical Acetabular Cup), which is a hip implant. The approval process for such devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy or AI/ML performance studies.

The "Test Results" section indicates that "Testing on this device included attachment strength of liners to shell. All results are sufficient for in-vivo loading." This statement represents the critical acceptance criterion and the device's performance in meeting it. The FDA's letter states that they have reviewed the 510(k) notification and determined the device is "substantially equivalent" to predicate devices for its stated indications for use. This means the device's design, materials, and (limited) performance data presented were deemed comparable to devices already on the market.

Summary

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Summary of Safety and Effectiveness

K974093

Encore Orthopedics®, Inc. 9800 Metric Blvd. Austin, TX 7875 512-832-9500

Trade Name: Foundation® Porous Coated Hemispherical Acetabular Cup

Common Name: Metal backed acetabular component

Classification Name: Hip joint metal/polymer semi-constrained uncemented prosthesis per 21 CFR 888.3358

Description: The Foundation® Porous Coated Hemispherical Acetabular Cup is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surfaces are coated with commercially pure titanium beads (ASTM F67) for the purpose of providing a porous surface for enhanced press-fit fixation.

The hemispherical shells are available with and without screw holes. It is hemispherical in shape and is available in sizes 44mm - 70mm.

Intended Use: The Foundation® Porous Coated Hemispherical Acetabular Cup is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, theumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. The intended use is press-fit.

Comparable Features to Predicate Device(s): The spherical shape, titanium substrate, and the indexability of liners in shell and bone screw holes are features that are comparable to other devices in commercial distribution. The outside surface of the shell is porous coated to provide a porous surface for enhanced fixation.

Test Results: Testing on this device included attachment strength of liners to shell. All results are sufficient for in-vivo loading.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 1998

Ms. Debbie De Los Santos ·Requlatory Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard 78758 Austin, Texas

K974093, K974095, and K973119 Re : Trade Name: Foundation® Porous Coated Spiked Acetabular Cup Foundation® Porous Coated Hemispherical Acetabular Cup Foundation® Porous Coated Flared Rim Acetabular Cup Regulatory Class: II Product Code: LPH Dated: October 28 and November 19, 1997 October 30 and November 21, 1997 Received:
Dear Ms. De Los Santos:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ substantially-equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Debbie De Los Santos

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your circing privalence of your device to a legally Finding or subbeancear oquresults in a classification for your marketed produces mits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosures

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510(k) Number (if known):	K974043
Device Name:	FOUNDATION POROUS COATEDHEMISPHERICAL ACETABULAR CUP
Indications For Use:

Foundation® Porous Coated Hemispherical Acetabular Cup Indications For Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K977093

Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.