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Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic 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 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.
When used with MDM® Liners
Treatment of nonumion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liner
The Trident® Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident® II Acetabular Shells are indicated for cementless use only.

Device Description

The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and dome hole plugs are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident® Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments. The purpose of this Special 510(k) is to add an additional dome hole plug option for use with the Trident® II Acetabular System.

AI/ML Overview

This document is a 510(k) summary for the Stryker Orthopaedics Trident® II Acetabular System. It primarily focuses on demonstrating substantial equivalence to a predicate device for the addition of an acetabular dome hole plug option.

Based on the provided text, the device is a medical implant, not an AI/ML powered device, and therefore the request to describe acceptance criteria and associated studies for an AI/ML device is not applicable.

Here's the breakdown of why the requested information cannot be provided from this document:

No AI/ML Component: The device described, the Trident® II Acetabular System, is a hip joint prosthesis. The document discusses its components (shells, screws, liners, dome hole plugs), intended use, indications for use, and a comparison to predicate devices, all of which are characteristic of traditional medical devices. There is no mention of artificial intelligence, machine learning, software algorithms for image analysis, or any computational diagnostic or prognostic functionality.
Focus on Substantial Equivalence for a Physical Component: The primary purpose of this 510(k) filing is to add an "additional dome hole plug option." The entire "Non-Clinical Testing" section explicitly states "No new non-clinical testing was performed." Instead, it references analyses for "equivalence in dimensions and MR evaluation" and prior bacterial endotoxin testing. This is typical for a minor modification to an already cleared physical device, not for a new AI/ML product.

Therefore, the following information points from your request are not present because they relate to the evaluation of an AI-powered medical device:

A table of acceptance criteria and the reported device performance: Not applicable.
Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
Stand-alone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In conclusion, this document describes a physical medical device (hip implant components) and its regulatory clearance process, which does not involve the type of AI/ML performance evaluation criteria and studies you are inquiring about.

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K Number

K063616

Device Name

TRIDENT II ACETABULAR SYSTEM

Manufacturer

HOWMEDICA OSTEONICS CORP

Date Cleared

2006-12-20

(15 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® II X3® Polyethylene bearing inserts, which are also the subject of this submission. If additional fixation is desired, the dome screw holes, if present, have . been designed to accept Howmedica Osteonics 6.5mm or 5.5mm bone screws.

The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation with the mating Trident® II X36 Polyethylene Inserts.

Indications for Use:

· 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 inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Device Description

This Special 510(k) submission is intended to add the Trident® II Acetabular System. This system is a minor modification to the locking mechanism of the predicate Trident Acetabular System.

AI/ML Overview

Here's an analysis of the provided text regarding the Trident® II Acetabular System, focusing on the acceptance criteria and the study proving it:

Acceptance Criteria and Device Performance for Trident® II Acetabular System

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Properties	Comparable mechanical properties to predicate device	Mechanical testing demonstrated comparable mechanical properties to the predicate components.
Material	Same as predicate device	Shares the same materials as the currently available acetabular components of the Trident® Acetabular System.
Design Concept	Basic design concepts same as predicate device	Shares the same basic design concepts as that of the currently available acetabular components of the Trident® Acetabular System.
Intended Use	Same as predicate device	Shares the same intended use as that of the currently available acetabular components of the Trident® Acetabular System.
Substantial Equivalence	Demonstrates substantial equivalence to predicate device based on mechanical properties and design.	Mechanical testing demonstrated comparable mechanical properties to the predicate components and substantial equivalence to these devices.

2. Sample Size and Data Provenance:

The document does not provide details on specific sample sizes for the mechanical testing. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, the study involved mechanical testing of the device, implying laboratory-based data rather than patient data.

3. Number of Experts and Qualifications for Ground Truth:

The document does not mention the use of experts to establish ground truth. The evaluation of the device was based on mechanical testing and comparison to a predicate device, not on expert interpretations of clinical data or images.

4. Adjudication Method:

Adjudication methods (e.g., 2+1, 3+1, none) are relevant for studies involving human interpretation or clinical outcomes. This submission focuses on engineering analysis and comparison to a predicate device, so an adjudication method is not applicable and not mentioned.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for evaluating the impact of a device (often AI-assisted) on human reader performance, which doesn't apply to a mechanical implant like an acetabular system.

6. Standalone (Algorithm Only) Performance:

No standalone (algorithm only) performance study was done. This refers to the performance of an AI algorithm without human intervention, which is not relevant to a mechanical hip implant.

7. Type of Ground Truth Used:

The ground truth for this device's acceptance was:

Mechanical Test Results: The measured mechanical properties of the Trident® II Acetabular System itself.
Predicate Device Specifications/Performance: The established mechanical properties, materials, and design concepts of the legally marketed predicate Trident Acetabular System.

Essentially, the device's performance was compared directly to engineering standards and a pre-existing, approved device.

8. Sample Size for the Training Set:

There is no mention of a "training set" because this is a medical device, not an AI or machine learning model. The evaluation is based on mechanical testing and comparison.

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

As there is no training set mentioned or relevant for this type of device submission, this question is not applicable.

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