Search Results

The Opus™ Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture and dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Opus™ Spinal System is also intended to be used in conjunction with the titanium hooks from the OSS/Diapason Spinal System and the Xia Spinal System. The Opus™ Spinal System is also intended to be used in conjunction with the Multi-Axis Cross Connectors.

The Opus Spinal System is made up of a range of screws, which are compatible with both the rod and plate components of the system. The components of the system are manufactured from ISO 5832/3 Titanium Alloy (Ti-6Al-4V).

Here's an analysis of the acceptance criteria and study information for the Opus™ Spinal System based on the provided document:

This document is a 510(k) summary for an additional indication for the Opus™ Spinal System. It primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not contain information about AI/ML device performance, human reader studies, ground truth establishment, or training data for such applications.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data or image-based diagnostics. The testing involved mechanical performance on device constructs. The sample size for these mechanical tests is not explicitly stated in the provided text. The provenance is the testing facility, not patient data.

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

Not applicable. This device is a spinal fixation system, not a diagnostic AI/ML device. Ground truth, in this context, would relate to mechanical engineering standards and material properties, not expert interpretations of medical images or clinical outcomes in the usual AI/ML sense.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical or image-based studies where expert consensus is needed. This document describes mechanical testing, which relies on engineering standards and measurements, not expert adjudication in the same way.

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 document is for a spinal implant, not an AI-assisted diagnostic tool. No MRMC studies were performed related to AI assistance.

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

Not applicable. This device is a physical spinal implant; there is no algorithm or standalone performance in the context of AI/ML.

7. The Type of Ground Truth Used

The ground truth for this device's performance evaluation is based on mechanical engineering standards and benchmark performance of the predicate device. The goal was to demonstrate "comparable mechanical properties" to the legally marketed predicate device (OSS/Diapason and Xia® Titanium Hooks).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system that utilizes a "training set."

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

Not applicable. There is no training set for this device in the AI/ML context.

Summary of Device and Study Focus:

The Opus™ Spinal System's 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices (OSS/Diapason and Xia® Titanium Hooks) for additional indications. This equivalence is primarily supported by mechanical performance data (static and fatigue tests) showing "comparable mechanical properties" between the Opus™ Spinal System constructs and the predicate device. The document does not describe any clinical trials, human-in-the-loop studies, or AI/ML performance evaluations.

Ask a specific question about this device