HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A by HOWMEDICA, INC.

The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Mesh Ingrowth Shells with Peri-Apatite™ Coating are intended to be used in the primary ingromented reconstruction of the proximal femur and acetabulum, respectively.

Device Description

The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum. These devices are identical to the previously cleared Asymmetric Stem, Vitalock® Cluster Shell, Vitalock® Spiked Shell and Mesh Shells, except for the presence of a thin layer of hydroxyapatite coating applied to the porous coated surface.

AI/ML Overview

This 510(k) summary (K982248) is for a medical device regulatory submission, not a study evaluating device performance against acceptance criteria. Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, and performance metrics cannot be directly extracted from this document, as it is not a clinical study report.

The document discusses the regulatory clearance of a hip prosthesis with a coating, asserting substantial equivalence to previously cleared devices. Substantial equivalence is the primary "acceptance criteria" for 510(k) submissions, meaning the new device is as safe and effective as a legally marketed predicate device.

Here's an attempt to answer what can be gleaned from the provided text, and where the information is explicitly not present:

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

Acceptance Criteria	Reported Device Performance
Intended Use Equivalence: Same as predicate devices for primary uncemented reconstruction of the proximal femur and acetabulum.	The devices are "identical to the previously cleared Asymmetric Stem, Vitalock® Cluster Shell, Vitalock® Spiked Shell and Mesh Shells, except for the presence of a thin layer of hydroxyapatite coating applied to the porous coated surface." The Peri-Apatite™ coating is "the same coating previously characterized and cleared in 510(k) K971206."
Materials Equivalence: Same as predicate devices.	Stated as equivalent.
Design Equivalence: Same as predicate devices.	Stated as equivalent.
Relative Indications and Contraindications Equivalence: Same as predicate devices.	Stated as equivalent.
Safety and Effectiveness Equivalence: To be as safe and effective as the predicate devices.	The FDA determined the devices are "substantially equivalent" for the stated indications, indicating they meet this criterion. However, the FDA explicitly restricts claims for "enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation," and states that "The data presented support equivalence with no additional claims over a conventional porous coated hip prosthesis (i.e., biological fixation only)."

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

Not applicable / Not provided. This document is a regulatory submission based on substantial equivalence, not a clinical study report requiring a test set of patient data. The "data presented" mentioned by the FDA likely refers to engineering testing, material characterization, and comparisons to predicate devices, rather than a clinical outcomes study with a test set of patient cases.

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 / Not provided. Ground truth establishment by clinical experts for a test set is not part of this 510(k) substantial equivalence submission.

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

Not applicable / Not provided. Adjudication methods are relevant for clinical studies, which is not what this document describes.

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 / Not provided. This device is a hip implant, not an AI diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant to this submission.

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

Not applicable / Not provided. This is not an AI algorithm.

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

Not applicable in the context of a "test set" for performance evaluation. The "ground truth" for this 510(k) submission is the regulatory acceptance of the predicate devices as safe and effective. The new device is compared against the predicate's known characteristics and regulatory status. Material characterization and engineering testing would have their own "ground truths" (e.g., measured material properties against specifications).

8. The sample size for the training set

Not applicable / Not provided. This is not a machine learning model.

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

Not applicable / Not provided. This is not a machine learning model.

Summary

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AUG 3 1 1998

K98 2248

510(k) Summa

Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, Proprietary Name: and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite™ Coating

Porous Coated Hip Prosthesis and Acetabular Shell with Common Name: Precipitated Calcium Phosphate Coating

21 CFR 888.3358 Classification Name and Reference: Hip Joint Metal/Polymer/Metal semi-constrained Porous coated uncemented prosthesis.

Proposed Regulatory Class: Class II

Device Product Code: LPH/MEH

Frank Maas For information contact: Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 6-26-98

The Peri-Apatite™ coating is the same coating previously characterized and cleared in 510(k) K971206.

The substantial equivalence of these devices is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Meridian® ST Stem and Vitalock® Solid Back Shell with Peri-Apatite™ Coating (K971206), Asymmetric Stem (K955871), Vitalock® Cluster Shell (K933102), Vitalock® Spiked Shell (K953664), and Mesh Ingrowth Shells (K973163).

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three wavy lines representing the three branches of government.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 1998

Mr. Frank Maas Manager, Regulatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

K982248 Re : Howmedica® Asymmetric Stem, Vitalock® Cluster and Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite™ Coating Requlatory Class: II Product Codes: MEH and LPH Dated: June 26, 1998 Received: June 26, 1998

Dear Mr. Maas:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:

You may not label or in any way promote these devices for "enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional porous coated hip prosthesis (i.e., biological fixation only).

Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

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.

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Page 2 - Mr. Frank Maas

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning this your device in the Federal Reqister. Please note: 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 Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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Page 3 - Mr. Frank Maas

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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Indications for Use

K982248 510(k) Number (if known):

Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, Device Name: and Acetabular Shells with Mesh Ingrowth Surface with Peri-Apatite ™ Coating

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

12 Prescription Use (Per 21 CFR 801.108)

$\frac{k}{q}$ OR

Over-The-Counter Use No

(Optional Format 1-2-96)

(Division) Sign-Off)
Division of General Restorative Devices,
510(k) Number K982248

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.