The indications for the use of the Osteonics® GAP-II Restoration Acetabular Shells, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:

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.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Class III cavitary and segmental defects.

Device Description

The Osteonics® GAP-II and GAP-IIS Restoration Acetabular Shells are single use components which are intended for placement within the acetabulum, and which are intended to provide an articulating surface for corresponding Osteonics' femoral head/stem components. The two iliac plates on the GAP-IIS shell are shorter than those of the GAP-II shell. Each Osteonics® GAP-II or GAP-IIS Restoration Acetabular Cup is assembled from two separate components: an Osteonics® GAP-II or GAP-IIS Restoration Acetabular Shell and a predicate Osteonics® Omnifit® Cup Insert, ABC Cementable Polyethylene Insert, Osteonics® Concentric Polyethylene Acetabular Cup, or Osteonics® Flanged Polyethylene Acetabular Cup. The polyethylene cups and inserts are intended to be affixed to the shell via polymethylmethacrylate (PMMA) bone cement.

The Osteonics® GAP-II and GAP-IIS Restoration Acetabular Shells are manufactured from ASTM F-67 Commercially Pure Titanium (CP Ti). The shells are available in a range of outer diameter shell sizes. The Osteonics® GAP-II and GAP-IIS Restoration Acetabular Shells feature a basic spherical geometry. 18 to 26 acetabular dome screw holes (depending on the size of the shell), two superior plates, a 20° superior/posterior hood, an inferiorly located acetabular notch hook, a satin-finished interior surface, and a grit-blasted exterior surface.

Bone screws placed through the dome and/or lip of the acetabular shell are used to secure the Osteonics® GAP-II or GAP-IIS Restoration Acetabular Shell within the prepared acetabulum. The shells are designed to allow some of the bone cement (used to fix the polyethylene liner to the shell) to be extruded through any unoccupied acetabular dome screw holes. In additional acetabular dome screws, and in order to further enhance the potential for initial and long term stable shell fixation despite large bony defects, the Osteonics® GAP-IIS Restoration Acetabular Shells employ an inferior hook, superior plates, and a superior posterior hood. The inferior hook is crimped around the acetabular notch. The shell hood covers the superior rim of the acetabular cavity, and the superior plates and can be secured to the acetabulum and/or ilium with Osteonics® 6.5mm Restoration GAP Plate Screws.

AI/ML Overview

This document, a 510(k) Premarket Notification, describes the Osteonics® GAP-II Restoration Acetabular Shells. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific acceptance criteria based on novel performance metrics.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission. The assessment here is primarily based on comparing features and intended use to an already cleared device and mechanical testing to ensure foundational safety and performance.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device:
- Substrate Material	Manufactured from ASTM F-67 Commercially Pure Titanium (CP Ti). Substantially equivalent to legally marketed plated shell in predicate Osteonics® Restoration Acetabular Cup Series.
- Indications for Use	Substantially equivalent to legally marketed plated shell in predicate Osteonics® Restoration Acetabular Cup Series. Explicitly listed indications include painful disabling joint disease (degenerative, rheumatoid, post-traumatic arthritis, avascular necrosis), revision of unsuccessful procedures, clinical management problems, poor or inadequate bone stock, and Class III cavitary or segmental defects.
- Availability of Screw Holes for Acetabular Screw Fixation	Substantially equivalent to legally marketed plated shell in predicate Osteonics® Restoration Acetabular Cup Series. Features 18 to 26 acetabular dome screw holes.
- Basic Cup Geometry	Spherical. Substantially equivalent to predicate Osteonics® Restoration Acetabular Cup Series.
- Inferior Hook and Superior Plates (for GAP-IIS)	Substantially equivalent in terms of design and function to similar characteristics on the iliac plated cup version in the Osteonics® Restoration Acetabular Cup Series.
- Insert Assembly Method	Inserts (predicate Osteonics® Omnifit® Cup Inserts, Concentric Polyethylene Acetabular Cup, or Flanged Polyethylene Acetabular Cup) are assembled to the shells using bone cement. This assembly method is predicated by the Osteonics® Restoration Acetabular Cups.
Mechanical Performance:
- Fatigue Strength	Mechanical testing performed to demonstrate substantial equivalence to predicate acetabular shell designs.
- Shell/Insert Assembly Method	Mechanical testing performed to demonstrate substantial equivalence to predicate acetabular shell designs.

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

Not applicable for clinical performance study. The submission focuses on substantial equivalence through material properties, design comparison, and mechanical bench testing. There is no mention of a "test set" in the context of clinical data or patient outcomes. The "test set" would be the specific devices or components subjected to the mechanical tests. The document doesn't specify the sample size for these mechanical tests, nor the country of origin or whether the data was retrospective or prospective.

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

Not applicable. No ground truth established by experts in the context of clinical performance is mentioned or required for this type of submission focused on substantial equivalence.

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

Not applicable. No adjudication method for a test set is mentioned.

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 hip implant component, 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 hip implant component, not an algorithm.

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

For the mechanical testing, the "ground truth" would be the established engineering standards and performance of the predicate device. The document states "Mechanical testing has been performed to demonstrate the substantial equivalence of this Osteonics acetabular shell design to predicate acetabular shell designs in terms of its fatigue strength and shell/insert assembly method." This implies that the performance of the predicate device and relevant mechanical standards served as the benchmark.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of AI or machine learning for this device.

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

Not applicable. There is no "training set" for this device.

Summary

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APR 2 9 1998

K980774

510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® GAP-II Restoration Acetabular Shells

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

Contact Person:

Date of Summary Preparation:

Device Identification

Proprietary Name:

Common Name:

Classification Name and Reference:

Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Kate Sutton Regulatory Affairs Specialist

February 26, 1998

Osteonics® GAP-II Restoration Acetabular Shells

Acetabular Shell

Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained. Cemented or Non-Porous Uncemented Prosthesis 21 CFR 8888.3353 3

Predicate Device Identification

The Osteonics® GAP-II Restoration Acetabular Shells employ features which are substantially equivalent to features of the following Osteonics predicate device, which has been cleared for marketing via the 510(k) process:

. Osteonics® Restoration Acetabular Cup Series

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Device Description

Intended Use:

The Osteonics® GAP-IIS Restoration Acetabular Shells are total hip replacement components are intended to resurface the acetabulum, and are intended to be used in conjunction with commercially available Osteonics femoral stems and compatible Osteonics modular femoral bearing heads. The Osteonics® GAP-II and GAP-IIS Restoration Acetabular Shells are single-use devices. The metal shells are intended for screw fixation within the prepared acetabulum, while the polyethylene inserts are intended for cemented fixation within the metal shells. The Osteonics® GAP-II and GAP-IIS Restoration Acetabular Shells have been specifically designed to address cases involving major bony defects of the acetabulum which may require extensive reconstruction and bone grafting. The indications for the Osteonics® GAP-IIS Restoration Acetabular Shells include the following:

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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.
Bone stock which is of poor quality or which is inadequate for other reconstructive techniques ● as indicated by deficiencies of the acetabulum.
Class III cavitary or segmental defects. .

Performance Data:

Mechanical testing has been performed to demonstrate the substantial equivalence of this Osteonics acetabular shell design to predicate acetabular shell designs in terms of its fatigue strength and shell/insert assembly method.

Statement of Technological Comparison:

The features of the Osteonics® GAP-II or GAP-IIS Restoration Acetabular Shell, either alone or in combination, are substantially equivalent to corresponding features of Osteonics predicate device as follows.

The Osteonics® GAP-II and GAP-IIS Restoration Acetabular Shells are substantially equivalent, in terms of substrate material, indications for use, and availability of screw holes for the employment of acetabular screw fixation, to the legally marketed plated shell in the predicate Osteonics® Restoration Acetabular Cup Series.

The cup geometry of the Osteonics® GAP-II and GAP-IIS Restoration Acetabular Shells is spherical, and as such, is substantially equivalent in terms of its basic geometry to the predicate Osteonics® Restoration Acetabular Cup Series.

The inferior hook and superior plates of the Osteonics® GAP-IIS Restoration Acetabular Shells are substantially equivalent in terms of design and function to similar characteristics featured on the iliac plated cup version in the Osteonics® Restoration Acetabular Cup Series.

The inserts used with the Osteonics® GAP-II or GAP-IIS Restoration Acetabular Shells are the predicate Osteonics® Omnifit® Cup Inserts, Osteonics® Concentric Polyethylene Acetabular Cup, or Osteonics® Flanged Polyethylene Acetabular Cup. These inserts are assembled to the Osteonics® GAP-II or GAP-IIS Restoration Acetabular Cup Shells through the use of bone cement. This assembly method is predicated by the Osteonics® Restoration Acetabular Cups.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1998

Ms. Elizabeth A. Staub Director, Quality Assurance and Regulatory Affairs Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re : K980774 Trade Name: GAP-II Restoration Acetabular Shells Regulatory Class: LZO and JDI Product Code: II February 26, 1998 Dated: March 2, 1998 Received:

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 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 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. Elizabeth A. Staub

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.

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.

Cella 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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510(k) Number (if known): K980774

Device Name: Osteonics® GAP-II Restoration Acetabular Shells

Indications For Use:

The indications for the use of the Osteonics® GAP-II Restoration Acetabular Shells, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:

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. ------------
. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Class III cavitary and segmental defects. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Divisor Sign-Off) Division is General Restorative 510(k) Number Prescription Use y la OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional 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.