Search Results

The Multi-Axis Cross-Connectors are intended to be used with the other components of the Opus "Spinal System.

Indications For Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Opus™ Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Opus" Spinal System is indicated for pedicle screw fixation in skeletally mature . patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions using autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

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). The plates for the Opus™ Spinal System range from 41-75 mm in length. Longer plates will be added to the Opus" Spinal System in order to cover the maximum of surgical configurations. The three additional subject plates will range in length from 90 -120 mm.

The provided text describes a 510(k) submission for a modification to the Opus™ Spinal System, specifically adding longer plates. The submission focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. There is no information in the provided text about a study involving human readers, AI, or ground truth derived from expert consensus, pathology, or outcomes data, as the device is a spinal fixation system, not a diagnostic or AI-driven tool.

Therefore, many of the requested categories are not applicable to this type of device and study.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the sample size (number of test specimens) used for the fatigue testing. The data provenance is implied to be from internal testing by Howmedica Osteonics Corp, located in Allendale, NJ, USA. The testing is for a device modification, implying a prospective evaluation of newly manufactured components.

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

Not applicable. The ground truth for mechanical performance is established through standardized engineering tests, not expert human interpretation.

4. Adjudication method for the test set

Not applicable. Mechanical testing does not involve adjudication.

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 is a medical device (spinal implant), not a diagnostic imaging or AI-assisted system. No human reader or AI interaction is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used

The ground truth for this device is based on mechanical testing standards and direct physical measurement of properties like fatigue resistance, ensuring the modified device maintains structural integrity and performance equivalent to the predicate device.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model, so there is no "training set."

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

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

Ask a specific question about this device