Intended Use: The Osteonics® Secur-Fit™-HA PSL® ABC Shell is intended for cementless fixation within the prepared acetabulum. Osteonics® ABC Cementable Polyethylene Insert is intended for cemented assembly to the metal shell. The Osteonics® Modular Acetabular Cup is compatible with any appropriately selected Osteonics hip stem/femoral head combination. In addition, the Osteonics® ABC Cementable Polyethylene Insert - because its assembly method is independent of the inner geometry of the mating shell - is compatible with any commercially available Osteonics metal acetabular shell component.

Indications: 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.

Device Description

The Osteonics® Modular Acetabular Cup components are single-use devices. Each Osteonics® Modular Acetabular Cup consists of two pieces: an Osteonics® Secur-Fit™-HA PSL® ABC Shell, and a mating Osteonics® ABC Cementable Polyethylene Insert.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for a medical device (Osteonics® Modular Acetabular Cup), which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present in the provided document.

Here's a breakdown of the available information and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Push-out Strength: Not explicitly stated in terms of a numerical range or minimum value. The text only states that the performance is "comparable" to predicate devices.

Reported Device Performance:

Performance Metric	Reported Performance
Push-out Strength	"comparable in terms of push-out strength to predicate shell/insert assembly methods and mechanisms."

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

Sample Size for Test Set: Not specified. The document mentions "laboratory testing" but does not provide details on the number of samples tested.
Data Provenance: The testing was "Laboratory testing" undertaken to characterize the push-out strength. No information on country of origin or whether it was retrospective/prospective (which is not applicable for this type of lab testing).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This section describes a lab test for mechanical strength, not a study requiring expert interpretation or ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. This refers to a review process for clinical data, which is not relevant to a mechanical lab test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not done. The document describes a mechanical test of device components, not a clinical effectiveness study involving human readers or AI.

6. Standalone (Algorithm Only) Performance Study

No. This is not relevant. The device is a physical medical implant, not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable. The "ground truth" for a mechanical test like push-out strength is the physical measurement itself, as determined by laboratory instruments and protocols. It's not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. Sample Size for the Training Set

Not applicable. This refers to machine learning. The device is a physical implant, and no machine learning model was developed or trained.

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

Not applicable. (See point 8).

Summary

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K963959

510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Modular Acetabular Cup (HA-Coated Version)

Submission Information

DEC 1 9 1996

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

Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Contact Person:

Terry Sheridan Regulatory Affairs Specialist

October 1, 1996

Date of Summary Preparation:

Device Identification

Proprietary Name:

Common Name:

Classification Name and Reference:

•

Osteonics® Modular Acetabular Cup

Artificial Acetabular Component

Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained, Cemented or Non-porous Uncemented Prosthesis 21 CFR §888.3353

Predicate Device Identification

The Osteonics® Modular Acetabular Cup components are substantially equivalent to the following compeitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:

Osteonics® Secur-Fit™-HA PSL® Shells: Osteonics Corporation. ●
. Osteonics® Restoration GAP Acetabular Cups: Osteonics Corporation.
Osteonics® Omnifit® Cup Inserts: Osteonics Corporation. .

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Device Description

Intended Use:

The Osteonics® Secur-Fit™-HA PSL® ABC Shell is intended for cementless fixation within the prepared acetabulum. Osteonics® ABC Cementable Polyethylene Insert is intended for cemented assembly to the metal shell. The Osteonics® Modular Acetabular Cup is compatible with any appropriately selected Osteonics hip stem/femoral head combination. In addition, the Osteonics® ABC Cementable Polyethylene Insert - because its assembly method is independent of the inner geometry of the mating shell - is compatible with any commercially available Osteonics metal acetabular shell component.

Indications:

The indications for the use of the Osteonics® Modular Cup, 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.

Statement of Technological Comparison:

The substantial equivalence of the Osteonics® Modular Cup components to the predicate devices identified above - in terms of materials, intended uses, and design features - is based on the following.

Materials:

Osteonics® Secur-Fit™ HA PSL® ABC Shells

The Osteonics® Secur-Fit™-HA PSL® ABC Shells, like the predicate Osteonics® Secur-Fit™-HA PSL® Shells, are manufactured from CP Titanium, and feature an outer coating of arc-deposited CP Titanium and a plasma-sprayed coating of hydroxylapatite.

Osteonics® Cementable Polyethylene Inserts

The mating Osteonics® Cementable Polyethylene Inserts, like the predicate Osteonics® Omnifit® Cup Inserts (Series II) are manufactured from UHMWPE.

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Intended Use:

Osteonics® Secur-Fit ™-HA PSL® ABC Shells

The subject Osteonics® Secur-Fit™-HA PSL® ABC Shells and the predicate Osteonics® Secur-Fit™-HA PSL® ABC Shells share the same indications for use, and both shells are intended for cementless fixation within the prepared acetabulum.

Osteonics® Cementable Polyethylene Inserts

The Osteonics® ABC Cementable Polyethylene Inserts and the predicate Osteonics® Omnifit® Cup Inserts share the same indications for use. The Osteonics® ABC Cementable Polyethylene Inserts are intended for cemented assembly to their mating shells. This assembly method is predicated by the commercially available Osteonics® Omnifit® Cup Inserts (Series II), which have been determined substantially equivalent for cemented assembly to the commercially available Osteonics® Restoration GAP Acetabular Shells.

Design:

Osteonics® Secur-Fit™-HA PSL® ABC Shells

The subject Osteonics® Secur-Fit™-HA PSL® ABC Shell differs most notable from the commercially available Osteonics® Secur-Fit™-HA PSL® Shell with regard to its interior geometry. The subject device has a tapered interior geometry, and is intended to receive a cementable polyethylene insert.

Both the subject Osteonics® Secur-Fit™-HA PSL® ABC Shells and the predicate Osteonics® Secur-Fit™ HA PSL® Shells are manufactured from the same materials, feature the same basic shape, and feature the same Osteonics' AD-HA coating.

Osteonics® ABC Cementable Polyethylene Inserts

The Osteonics® ABC Cementable Polyethylene Inserts have several features which make them relatively more amenable to the cemented assembly method than their predicate inserts. These features include:

. Machined-in grooves: These grooves allow interdigitation with the bone cement.
. Roughened outer/back surface: The back/outer surface of the insert has been roughened to provide a stronger insert/cement interface than would be characteristic of a smoother polyethylene surface.

Neither the machined in grooves, nor the roughened finish of the outer surface raise any new questions with regard to safety or effectiveness; both of these features are routinely employed in commercially available, one-piece, all-polyethylene acetabular cup designs.

Both the subject Osteonics® ABC Cementable Polyethylene Inserts and the predicate Osteonics® Omnifit® Cup Inserts (Series II) maintain a bearing area polyethylene thickness which is >6mm. Both the subject and the predicate inserts come in a wide range of inner diameter and outer

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diameter sizes. Both the subject and the predicate inserts come in versions with a 0°, 10°, or 20° hooded face.

Performance Data:

Laboratory testing was undertaken to characterize the push-out strength of the Osteonics® Cementable Polyethylene Inserts when assembled to their mating acetabular shells. The test results demonstrate that the shell/insert assembly method for the Osteonics® Modular Acetabular Cup components is comparable in terms of push-out strength to predicate shell/insert assembly methods and mechanisms.

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.