The Foundation 8mm Forged Cemented Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended to be used with cement with acetabular components or with unipolar heads.

Device Description

The proximal body of the Foundation™ Non-Porous Stem is trapezoidal in cross-sectional geometry and tapers proximal to distal and lateral to medial. The proximal body has one rib on the anterior and posterior surfaces that run the length of the proximal body. Polymethylmethacrylate "buttons" are placed on the anterior, lateral and medial surfaces of the proximal body to assure that the implant is centered in the metaphseal region of the femur with a 1.5 mm cement mantle. The proximal body of the femoral stem is grit blasted to a surface of 4-6 u. This device is fabricated from forged CoCrMo alloy.

The distal portion of the stem is conical in shape. It necks down at the distal end to receive a flanged PMMA canal centralizer. This centralizer assures that the distal stem is centered in the femoral canal and helps to maintain a even cement mantle around the distal stem. The Foundation 8mm Forged Cemented Stem has a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 135°.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "8mm Forged Cemented Stem." This document describes the device, its intended use, and its basis for substantial equivalence to a predicate device. It also briefly mentions testing results. However, it does not contain a detailed study design or comprehensive acceptance criteria typically found for AI/ML-driven medical devices.

Based on the provided information, I can extract what is available regarding acceptance criteria and supporting evidence. Please note that many of the requested fields (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable because this is a traditional medical device (a hip stem) and not an AI/ML diagnostic or prognostic tool.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Mechanical Performance:
Survive 5 million cycles at 450 lbs.	Device shown to survive this condition. (Implied acceptance based on positive statement.)
Morse Type Taper integrity	Laboratory testing conducted. (Implied acceptable performance, as it led to clearance.)
Biocompatibility/Material:
Fabricated from forged CoCrMo alloy	Device is fabricated from this material. (Compliance with established material standards for orthopedic implants.)
Design Specifications:
Proximal body: trapezoidal, tapers	Device features described as such. (Design adherence.)
Proximal body: one rib anterior/posterior	Device features described as such. (Design adherence.)
PMMA "buttons" for centering	Device includes these buttons. (Design adherence for cement mantle.)
Proximal body: grit blasted (4-6 µ)	Device features described as such. (Design adherence for surface finish.)
Distal portion: conical, centralizer	Device features described as such. (Design adherence for distal centering.)
Calcar collar	Device includes a calcar collar. (Design adherence.)
Morse type taper for modular heads	Device has this taper. (Design adherence for head compatibility.)
Neck/stem angle: 135°	Device has this angle. (Design adherence.)
Intended Use Equivalence:
Indications for use for total/hemi-hip arthroplasty, noninflammatory degenerative joint disease, rheumatoid arthritis, functional deformity correction, revision procedures, and fracture treatment.	The device's stated indications for use match these broad categories and are deemed substantially equivalent to the predicate device.

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 is a mechanical orthopedic implant, not an AI/ML algorithm requiring a dataset of patient images or clinical data. The "test set" in this context refers to mechanical testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or outcomes. For this device, "ground truth" would be the engineering specifications and performance limits for mechanical components, which are typically established through engineering standards and validated through laboratory testing, not expert clinical consensus on a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is not a clinical study involving human readers or expert adjudication of diagnostic findings.

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

No. This is a mechanical implant device, 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 device is a physical hip stem, not an algorithm. Its "standalone" performance refers to its mechanical integrity under specified load conditions, which was tested.

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

For mechanical devices (like this hip stem), the "ground truth" is typically defined by:
- Engineering Specifications and Standards: Material properties (e.g., CoCrMo alloy), geometric dimensions (e.g., 135° neck/stem angle, specific tapers, centralizer designs), surface finishes (e.g., 4-6 µ grit blast).
- Biomechanical Performance Requirements: Ability to withstand specific loading conditions for a defined number of cycles (e.g., 450 lbs for 5M cycles).
- Functional Equivalence: Demonstrated similarity in design principles and intended function to legally marketed predicate devices, implying similar safety and effectiveness.

8. The sample size for the training set

Not Applicable. This is a mechanical orthopedic implant, not an AI/ML algorithm requiring a training dataset.

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

Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for it.

Summary

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6/1/99

510(k) Summary f Safety and Effectiven

(1) Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
(2) Trade or proprietary device name: Common or usual name: Classification name:

Encore Orthopedics, Inc. 9800 Metric Blvd., Austin, TX 78758 (512) 834-6237 Debbie De Los Santos April 7, 1999

8mm Forged Cemented Stem Cemented Hip Stem Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350 and Hip joint Femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR 888.3360

Legally marketed predicate device: 9mm Forged Cemented Stem (K961809) (3)
(4) Subject device description:

(5) Subject device intended use:

(6) Basis for substantial equivalence:

Features comparable to predicate devices include the Foundation® 9mm Forged Cemented Stems approved for commercial distribution in K961809, CoCrMo substrate, distal femoral canal centralizer, proximal cement spacers, calcar collar, proximal ribs on body, roughened proximal body, modular heads and unipolar heads.

(7) Test Results

This stem was analyzed using finite element analysis and is shown to survive 450 pounds for 5M cycles.

Laboratory testing of the Morse type taper was conducted.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus-like symbol with three parallel lines that curve and resemble a stylized human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1999 JUN

Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758

K991227 Re: 8mm Forged Cemented Stem Trade Name: Regulatory Class: II Product Code: JDI Dated: April 7, 1999 Received: April 12, 1999

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 enclosure) 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, Druq, and Cosmetic Act (Act). 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.

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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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 rnscribed in your 510(k) premarket notification. The FDA assoring 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 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,

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

Enclosure

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K991227 510(k) Number (if known): __

Device Name:

Indications For Use:

Foundation® 8mm Cemented Hip Stem Indications For Use

The indications for use of the Foundation 8mm cemented total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OROver-The-Counter Use_ (per 21 CFR 801.109) (Optional Format 1-2-96)_

teolilo

(Division Orvision 5 i Ok) Num

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.