The HA Taperloc® Porous Femoral Stem & HA Taperloc® Porous Lateralized Femoral Stem are indicated for use for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed.

Device Description

The HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems are the same as the predicate Taperloc® Femoral Stem (K921301), except for the additions of Hydroxyapatite Coating and additional sized femoral stems.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems).

This document explicitly states there was NO clinical testing performed to establish substantial equivalence for this device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable or cannot be extracted from this document, as a clinical study was not conducted.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as this was a 510(k) submission primarily relying on substantial equivalence to a predicate device, not performance against predefined clinical criteria.
Reported Device Performance: No clinical performance data is reported as no clinical testing was performed. The non-clinical testing focused on mechanical properties and deemed the device substantially equivalent to the predicate.

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

Not Applicable: No clinical test set was used because no clinical testing was performed.
Non-Clinical Testing: "Mechanical Testing with an Engineering Justification" was performed, but specific sample sizes for these tests are not provided in this summary.

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

Not Applicable: No clinical test set and thus no ground truth established by experts for a clinical comparison. Mechanical testing would have involved engineers and a review by the FDA.

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

Not Applicable: No clinical test set.

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 prosthetic hip joint stem, not an AI-assisted diagnostic or imaging device. There was no MRMC study conducted, and no AI component is described.

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

Not Applicable: This device is a prosthetic hip joint stem, not an algorithm.

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

Not Applicable: For the purposes of demonstrating substantial equivalence for this medical device, the "ground truth" was established through comparison of materials, design, sizing, and indications to a legally marketed predicate device (Taperloc® Femoral Stem K921301), and mechanical testing to ensure no new risks. No clinical ground truth (like pathology or outcomes data) was used in a clinical study.

8. The sample size for the training set:

Not Applicable: No clinical study involving a training set was performed for this 510(k) submission.

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

Not Applicable: No clinical study involving a training set was performed.

Summary of the basis for substantial equivalence for this device:

The "HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems" achieved substantial equivalence based on:

Device Description: Being "the same as the predicate Taperloc® Femoral Stem (K921301), except for the additions of Hydroxyapatite Coating and additional sized femoral stems."
Indications for Use: Being the same as the predicate device.
Summary of Technologies: Materials, design, sizing, and indications are "similar or identical to the predicate devices."
Non-Clinical Testing: "Mechanical Testing with an Engineering Justification determined that the HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems' components presented no new risks and were, therefore, substantially equivalent to the predicate device."
Lack of Clinical Testing: Explicitly stated, "No clinical testing was provided as a basis for substantial equivalence."

Summary

{0}------------------------------------------------

K020963

APR 1 6 2002

Image /page/0/Picture/2 description: The image shows the logo for BIOMET CORPORATE HEADQUARTERS. The word BIOMET is in a stylized font with thick, black lines. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, sans-serif font.

SUMMARY OF SAFETY AND EFFECTIVENESS

Biomet Orthopedics, Inc. Applicant or Sponsor: 56 East Bell Drive Warsaw, IN 46581-0587

Contact Person: Dalene T. Binkley Telephone: (219) 267-6639

Proprietary Name: HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems

Common Name: Prosthetic Hip Joint - Hydroxyapatite (HA) Coated Porous Femoral Stem

Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, nonporous, calcium-phosphate

Device Classification: Class II

Legally Marketed Device to which Substantially Equivalence is Claimed: Taperloc® Femoral Stem (K921301)

Device Description: The HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems are the same as the predicate Taperloc® Femoral Stem (K921301), except for the additions of Hydroxyapatite Coating and additional sized femoral stems.

Indications for Use: The indications for the HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems are for ) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed.

Summary of Technologies: The HA Taperloc® Porous Femoral Stems & HA Taperioc® Porous Lateralized Femoral Stems' components-the materials, design, sizing, and indications are similar or identical to the predicate devices.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

대

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

ORFICE 219.267.6639

FAX 219.267.8137

E-MAIL biomet@biomet.com

0000

{1}------------------------------------------------

Non-Clinical Testing: Mechanical Testing with an Engineering Justification determined that the HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems' components presented no new risks and were, therefore, substantially equivalent to the predicate device.

Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.

000000000

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2002

Ms. Dalene Binkley Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K020963

Trade Name: HA Taperloc® Porous Femoral Stem & HA Taperloc® Porous Lateralized Femoral Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MEH Dated: March 22, 2002 Received: March 25, 2002

Dear Ms. Binkley:

We have reviewed your Section 510(k) premarket 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, 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{3}------------------------------------------------

Page 2 - Ms. Dalene Binkley

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark A. Millhussen

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

Enclosure

{4}------------------------------------------------

510 (k) NUMBER (IF KNOWN): _ k 02096 3

DEVICE NAME: HA Taperloc® Porous Femoral Stem & HA Taperloc® Porous Lateralized Femoral Stem

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Mark N Millham

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number _

0000

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.