EXETER CERAMIC FEMORAL HEADS by HOWMEDICA OSTEONICS CORP.

The Exeter Ceramic Femoral Heads are intended to be used with modular femoral components in primary and secondary cementless total hip replacement procedures. These devices are intended to articulate with a polyethylene cup or a metal backed polyethylene cup component to reconstruct painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, subcapital fracture, or a revision of a failed femoral prosthesis. The Exeter Ceramic Femoral Heads are intended to be used with the femoral components of the previously released Exeter hip stems - and Exeter II Total Hip System (K891454).

Device Description

This device is a modular femoral head component which is affixed to a femoral stem component and articulates with a polyethylene acetabular cup or a metal backed polyethylene acetabular cup to reconstruct painful and/or severely disabled hip joints resulting from osteoarthritis, theumatoid arthritis, post-traumatic arthritis, avascular necrosis, subcapital fracture or a revision of a failed femoral prosthesis. The Exeter Ceramic Femoral Heads described in this submission are a modification of a previously cleared Zirconia head (K972381) and Orthinox® head (K891454). The modification is a slight change in the taper angle of the device.

AI/ML Overview

Here's an analysis of the provided text regarding the Exeter Ceramic Femoral Heads, structured to address your specific questions about acceptance criteria and the supporting study:

The provided 510(k) summary for the Exeter Ceramic Femoral Heads does not describe a study involving human subjects or AI. Instead, it focuses on the mechanical performance and substantial equivalence to previously cleared devices. Therefore, many of your questions related to clinical studies, human readers, ground truth, and training sets will not be directly applicable to this specific submission.

Here's the information extracted and interpreted based on the document:

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

Acceptance Criteria	Reported Device Performance
Ultimate compression strength: ≥ 46 kN (as specified in FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems)	All heads tested for ultimate compression strength exceeded loads greater than 46 kN.

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

Sample Size: Not explicitly stated as a number (e.g., "N=X heads"). The document says "All heads tested for ultimate compression strength," implying that all units intended for testing met the criteria, but the exact count of heads tested is not provided.
Data Provenance: Not applicable in the context of human data. This was a laboratory mechanical test.

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 this context refers to the specified mechanical performance requirement (46 kN), which is based on an FDA guidance document, not expert consensus on human data.

4. Adjudication method for the test set

Not applicable. The "test set" here refers to the ceramic femoral heads subjected to mechanical testing. The assessment was against a single, objective numerical standard (46 kN), not a subjective assessment requiring adjudication.

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 document describes a medical device (femoral head for hip replacement), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance are not relevant.

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

No. This is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's acceptance was the regulatory standard for ultimate compression strength for ceramic ball hip systems, specifically: "46 kN as specified in the FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems."

8. The sample size for the training set

Not applicable. There is no AI model or "training set" involved in the development of this mechanical device.

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

Not applicable. See point 8.

Summary of the K993889 Submission Focus:

The K993889 submission is a 510(k) premarket notification for a Class II medical device. Its primary purpose is to demonstrate substantial equivalence to existing, legally marketed predicate devices. This demonstration heavily relies on:

Equivalence in intended use, materials, design, operational principles, and relative indications and contraindications.
Performance data from mechanical testing to ensure the device meets established safety and performance standards for its type (in this case, ultimate compression strength).

The specific modification described is a "slight change in the taper angle." The mechanical testing (ultimate compression strength) confirms that this modification, and the device as a whole, maintains the required structural integrity as per FDA guidance.

Summary

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K993889

FEB 1 1 2000

510(k) Summary

Device: Exeter Ceramic Femoral Heads

The substantial equivalence is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to devices currently in commercial distribution including: V40™ Zirconia Femoral Heads (K972361) and Exeter II Total Hip System (K891454).

All of the named devices are intended to be used as the modular femoral head component of a total hip replacement. The basic design of these devices is generally the same, with varying diameters and lengths of internal tapers to accommodate individual patient needs. The material used in the manufacture of these femoral heads is also the same as the V40™ Zirconia Femoral Heads.

Assembly of all the named femoral head components to an appropriate femoral stem component requires similar instrumentation and preparation. All of the named Exeter Ceramic Femoral Heads are intended to articulate with the femoral components of the previously released Exeter Orthinox® (Rex 734 stainless steel) hip sterns with a 5° 43' taper. Relative indications and contraindications for all of the zirconia heads named are the same.

Testing of the Exeter Ceramic Femoral Heads included ultimate compression strength testing. All heads tested for ultimate compression strength exceeded loads greater than 46 kN as specified in the FDA Guidance Document for the Proparation of Premarket Notifications for Ceramic Ball Hip Systems.

For information contact:

Nancy J. Rieder Rutherford Regulatory Affairs Howmedica Osteonics Corp. 359 Veterans Boulevard Rutherford, NJ 07070 Phone: Fax: (201) 507-6870 E-mail: NRieder@HowOst.com

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Public Health Service

FEB 1 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth A. Staub Vice President Quality Assurance, Regulatory Affairs and Clinical Research Howmedica Osteonics Corporation 359 Veterans Boulevard Rutherford, New Jersey 07070

Re: K993889 Trade Name: Exeter Ceramic Femoral Heads Regulatory Class: II Product Code: LZO Dated: November 11, 1999 Received: November 16, 1999

Dear Ms. Staub:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 Regulations, Title 21, Parts 800 to 895. A 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 (OS) 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.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Elizabeth A. Staub

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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting 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

Page 1 of 1

510(k) Number (if known): K993889

Device Name: Exeter Ceramic Femoral Heads

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)	X
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Over-The-Counter Use(Optional Format 1-2-96)
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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K993889

Regulation Number and Section

N/A