Intended Use: The Osteonics® Modular Acetabular Cup components are single-use devices. The polyethylene insert is intended for cemented assembly to the metal shell. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. 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, theumatoid 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® PSL® MicroStructured® ABC Shell, and a mating Osteonics® ABC Cementable Polyethylene Insert. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. The polyethylene insert is intended for cemented assembly to the metal shell.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Premarket Notification Summary from 1996 for a medical device (Osteonics® Modular Acetabular Cup). This type of document is a regulatory submission for demonstrating substantial equivalence to a predicate device. It is not a clinical study report or a publication detailing a rigorous scientific investigation with statistical endpoints as would be expected for modern AI/ML device submissions. Therefore, many of the requested categories (especially those related to AI/ML device performance, ground truth, expert opinions, and multi-reader studies) are not applicable to this historical device submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Push-out Strength (of shell/insert assembly)	"comparable in terms of push-out strength to predicate shell/insert assembly methods and mechanisms"
Bearing Area Polyethylene Thickness	">6mm" (for both subject and predicate inserts)
Material Composition (for Shells)	ASTM F-67 Commercially Pure Titanium with F-67 CP Titanium beads (matched predicate)
Material Composition (for Inserts)	UHMWPE (matched predicate)
Intended Use	Matched predicate devices
Indications for Use	Matched predicate devices
Basic Shape/Coating (for Shells)	Same basic shape and Osteonics® MicroStructured® coating (matched predicate)
Design Features (Grooves/Roughened Surface on Inserts)	Routinely employed in commercially available products; no new safety/effectiveness questions raised.
Range of Sizes (Inner/Outer Diameter)	"wide range" (matched predicate)
Hooded Face Options (0°, 10°, 20°)	Matched predicate

Study Details Based on Provided Text

Given the nature of the document (a 510(k) summary), it primarily focuses on demonstrating substantial equivalence rather than presenting detailed clinical trial results or standalone algorithm performance.

Sample Size(s) Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "Laboratory testing" and "test results" for push-out strength, but does not provide the number of samples tested.
- Data Provenance: The "Laboratory testing" was conducted to characterize the device. This implies internal company testing rather than external or patient data. No country of origin is specified, but it's an Osteonics Corporation submission (USA). It is a prospective test of the device components.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This device is a mechanical implant; "ground truth" in the context of expert medical opinion for diagnostic or AI performance is not relevant here. The ground truth for mechanical properties (like push-out strength) would be derived directly from physical measurements and engineering standards.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1) are used for resolving disagreements among human reviewers (e.g., radiologists) when establishing ground truth for diagnostic studies. This is a mechanical device performance evaluation.
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 document predates widespread AI/ML in medical devices and focuses on an orthopedic implant. No MRMC studies or AI assistance were involved.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is a physical orthopedic implant, not a software algorithm.
The Type of Ground Truth Used:
- Engineering Measurements/Physical Testing: For the push-out strength, the "ground truth" is the measured force required to cause failure, compared against predetermined engineering specifications or predicate device performance. For material composition and dimensions, the ground truth is established through material testing and dimensional measurements against design specifications.
Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of this mechanical device submission. The device design and materials are based on established engineering principles and prior predicate devices.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, this question is not relevant.

Summary

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Osteonics® Modular Acetabular Cup (MicroStructured® Version)

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

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® Modular Acetabular Cup

Artificial Acetabular Component

Hip Joint Metal/Polymer/Metal Semi-Constrained, Porous Coated, Uncemented Prosthesis 21 CFR §888.3358

Predicate Device Identification

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

Osteonics® Omnifit® PSL® MicroStructured® Shells: Osteonics Corporation. .
Osteonics® Restoration GAP Acetabular Cups: Osteonics Corporation. .
Osteonics® Omnifit® Cup Inserts: Osteonics Corporation. .

K963946

510(k) Summary

VAL.2@ub

JAN 27 1997

Osteonics Corporation

Allendale, NJ 07401-1677

Regulatory Affairs Specialist

59 Route 17

Terry Sheridan

October 1, 1996

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Device Description

Intended Use:

The Osteonics® Modular Acetabular Cup components are single-use devices. The polyethylene insert is intended for cemented assembly to the metal shell. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. 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 Acetabular 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, theumatoid 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 Acetabular Cup System components to the predicate devices identified above - in terms of materials, intended uses, and design features - is based on the following.

Materials:

Osteonics® PSL® MicroStructured® ABC Shells

The Osteonics® PSL® MicroStructured® ABC Shells, like the predicate Osteonics® Omnifit® PSL® MicroStructured® Shells are manufactured from ASTM F-67 Commercially Pure Titanium, and feature a beaded, porous coating of ASTM F-67 CP Titanium beads.

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Osteonics® ABC Cementable Polyethylene Inserts

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

Intended Use:

Osteonics® PSL® MicroStructured® ABC Shells

The subject Osteonics® PSL® MicroStructured® ABC Shells and the predicate Osteonics® Omnifit® PSL® MicroStructured® Shells share the same indications for use, and both shells are intended for cemented or cementless fixation within the prepared acetabulum.

Osteonics® ABC Cementable Polyethylene Inserts

The subject 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® PSL® MicroStructured® ABC Shells

The subject Osteonics® PSL® MicroStructured® ABC Shells differ most notably from the commercially available Osteonics® Omnifit® PSL® MicroStructured® Shells with regard to their interior geometries. The subject device has a tapered interior geometry, and is intended to receive a cementable polyethylene insert.

Both the subject Osteonics® PSL® MicroStructured® ABC Shells and the predicate Osteonics® Omnifit® PSL® MicroStructured® Acetabular Shells are manufactured from the same materials, feature the same basic shape, and feature the same Osteonics® MicroStructured® 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.

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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 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® ABC 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

§ 888.3358 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.