The Osteonics® HA-AD Coated Devices are single-use, acetabular of femoral hip implant devices intended for cementless applications. The following indications for use are consistent with previous submissions for these acetabular and femoral components intended for cementless application.

Indications for Osteonics® HA-AD Acetabular Components

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous failed femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Indications for Osteonics® HA-AD Femoral Components
For use as a Bipolar Hip Replacement :

Femoral head/neck fractures or non-unions.
Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty.

For use as a Total Hip Replacement:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis. rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Device Description

The devices which are the subject of this 510(k) are commercially-available Osteonics hip acetabular and hip femoral components featuring Osteonics' HA-AD coating.

AI/ML Overview

The provided text describes a 510(k) submission for Osteonics HA-Coated Devices, focusing on claims related to the performance of their HA-AD coating. It is noteworthy that this submission is from 1999, and the type of detailed performance criteria, ground truth establishment, and multi-reader studies applied to modern AI/ML devices were not standard practice for medical device submissions at that time.

Therefore, many of the requested categories for AI/ML device studies will not be present in this document.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the way a modern AI/ML device submission would, with quantifiable thresholds for performance metrics. Instead, it refers to "additional performance claims" demonstrated by referenced literature.

Acceptance Criteria (Implied)	Reported Device Performance
Increase in bone apposition compared to AD coated samples	Performance: HA/AD coating increases bone apposition (Ref. 1). Study: "Cortical Remodeling and Bone Apposition to a Textured Canine Hip Implant with and without Hydroxylapatite." Agins HJ, BauerTW, Kudrna JC, Cannestra V, Ming J. Trans, AAOS, February 1997.
Increase in linear bone contact compared to AD coated samples	Performance: HA/AD coating increases linear bone contact (Ref. 3). Study: "Biomechanical and Histological Analysis of an HA-Coated, Arc Deposited CPTi Canine Hip Prosthesis." Walenciak MT, Zimmerman MC, Harten RD, Ricci JL, Stamer DT. J. Biomed. Mater. Res. 31 (4):465-474, 1996.
Increase in degree of bone penetration into implantable chambers	Performance: HA/AD coating increases the degree of bone penetration into implantable chambers (Ref. 2). Study: "Arc Deposited CP Titanium with and without Hydroxyapatite Coating. Preclinical Evaluation Using the Canine Implantable Chamber Model." Hawkins M, Ricci JL. (Book chapter)
Early evidence of increased bony response	Performance: Increased bony response may be evidenced as early as 6 weeks after implantation. Study: Implied from the referenced animal studies, likely Ref. 1 and 2.

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

Sample Size: Not specified in the provided text for the individual studies. The studies are described as using "animal models" (canine hip implant, canine implantable chamber model, canine hip prosthesis).
Data Provenance: Animal models (canine). All studies appear to be prospective experimental studies. The original location/country of the animal studies is not stated within this 510(k) summary.

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

This information is not provided. Given the nature of these animal studies (histological and biomechanical analyses), the "ground truth" would likely be established by trained researchers and pathologists examining tissue samples and conducting measurements, but explicit details on the number or qualifications of experts are absent.

4. Adjudication Method for the Test Set

This information is not provided.

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 MRMC study was done, as this submission pre-dates the common use of AI in medical devices and the associated study designs.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable, as the device is a physical implant, not an algorithm. Therefore, "standalone" performance testing in the AI/ML sense was not conducted. The "performance data" refers to the biological response to the coating.

7. The Type of Ground Truth Used

The ground truth used was histological analysis (e.g., bone apposition, linear bone contact, bone penetration) and biomechanical analysis performed on animal tissue samples. This is analogous to pathology or biological outcomes data in a clinical context.

8. The Sample Size for the Training Set

No "training set" in the context of AI/ML algorithms is mentioned or relevant here, as this device is a physical implant, not a software algorithm. The studies referenced are experimental studies on the biological performance of the coating.

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

Not applicable, as there is no "training set" for an AI/ML algorithm. The ground truth for the performance studies themselves (as described in point 7) was established through scientific experimental methods, including histological and biomechanical assessments, as detailed in the referenced research papers.

Summary

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HOWMEDICA/OSTEONICS

201 934 4368 P.05/07

JUL 2 3 1999

K980076

510(k) Summary

Osteonics HA-Coated Devices

510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® HA-AD Coated Devices

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677
Contact Person:	Marybeth NaughtonRegulatory Affairs Team Member
Date of Summary Preparation:	July 14, 1999

Device Identification

Proprietary Name:	Osteonics HA-AD Coated Devices
Common Name:	Artificial hip implant components
Classification Name and Reference:	Hip joint metal/ceramic/polymersemi-constrained cemented or non-porous uncemented prosthesis21 CFR §888.3353

Predicate Device Identification

The subject Osteonics HA-AD Coated devices have already been determined substantially equivalent. This 510(k) involves only the addition of specific claims related to the performance of Osteonics' HA-AD coating.

Device Description

The devices which are the subject of this 510(k) are commercially-available Osteonics hip

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Osteonics HA-Coated Devices

510(k) Summary

acetabular and hip femoral components featuring Osteonics' HA-AD coating.

Intended Use

All devices covered by this submission are single-use, acetabular or femoral hip implant devices intended for cementless applications.

Indications for Osteonics® HA-AD Acetabular Components

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous failed femoral head replacement, cup arthroplasty or other . procedure.
Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques ● as indicated by deficiencies of the acetabulum.

Indications for Osteonics® HA-AD Femoral Components

For use as a Bipolar Hip Replacement :

Femoral head/neck fractures or non-unions. .
. Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular . involvement or distortion.
Pathological conditions or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.

For use as a Total Hip Replacement:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Statement of Technological Comparison

Each device which is subject to this 510(k) has already been determined Substantially Equivalent for its labeled indications. This 510(k) involves no change in design, intended use, indications for use, or materials. The sole purpose of this 510(k) is to obtain FDA's permission to discuss specific performance attributes of Osteonics' HA-AD Coating.

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Osteonics HA-Coated Devices

510(k) Summary

Performance Data

Reports of published literature were presented within this 510(k) to demonstrate additional performance claims for Howmedica Osteonics' HA-AD Coatings. The following points relevant to the performance of Osteonics' HA-AD Coating have been demonstrated in the referenced literature reports:

Howmedica Osteonics' HA/AD (Hydroxylapatite/Arc-Deposited) Coating increases bone apposition (Ref. 1), linear bone contact (Ref. 3) and the degree of bone peneration into implantable chambers (Ref. 2) as compared to AD coated samples as demonstrated in the animal models *. The above increased bony response for HA/AD coated implants may be evidenced as early as 6 weeks after implantation.

Animal data may not predict human clinical results because of inter-species differences.

References:

Agins HJ, BauerTW, Kudrna JC, Cannestra V, Ming J. Cortical Remodeling and Bone Apposition t a レ Textured Canine Hip Implant with and without Hydroxylapatite. Trans, AAOS, February 1997.
と Hawkins M, Ricci JL. Arc Deposited CP Titanium with and without Hydroxyapatite Coating. Preclinical Evaluation Using the Canine Implantable Chamber Model. Hydroxylapatite Coated Hip and Knee Arthroplasty ed: JA Epinette and RGT Geesink, Pp 90-95, Expansion Scientifique Francaise, 1995.
► Walenciak MT, Zimmerman MC, Harten RD, Ricci JL, Stamer DT. Biomechanical and Histological Analysis of an HA-Coated, Arc Deposited CPTi Canine Hip Prosthesis. J. Biomed. Mater. Res. 31 (4):465-474, 1996.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a bird or eagle.

Public Health Service

JUL 23 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marybeth Naughton Regulatory Affairs Team Member Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677

Re: K980070

Trade Name: Osteonics HA-Coated Devices Regulatory Class: II Product Code: MEH Dated: July 2, 1999 Received: July 6, 1999

Dear Ms. Naughton:

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 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 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 (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.

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. Marybeth Naughton

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. Furthermore, for questions regarding 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,

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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Page 1 of 2

510(k) Number (if Known): K980070

Device Name: Osteonics® HA-AD Coated Devices

Indications For Use:

Indications for Osteonics® HA-AD Acetabular Components

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, ● rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous failed femoral head replacement, cup arthroplasty or other procedure.
. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Indications for Osteonics® HA-AD Femoral Components

For use as a Bipolar Hip Replacement :

. Femoral head/neck fractures or non-unions.
Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
. Salvage of failed total hip arthroplasty.

For use as a Total Hip Replacement:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis. rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Prescription Use
(Per 21 CFR 801.109)

esults.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pcolle

(Division Sign-Off) Division of General Restorative De K9800 510(k) Number

y /2 OROver-The-Counter Use (per21CFR 801.109(Optional Prescription Use NO Format 1-2-96)

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.