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When used as a pedicle screw fixation system in skeletally mature patients, the DYNESYS Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the DYNESYS Spinal System is indicated for use in patients:

• Who are receiving fusions with autogenous graft only; a)
• b) Who are having the device fixed or attached to the lumbar or sacral spine; and
• c) Who are having the device removed after the development of a solid fusion mass.

The DYNESYS® Spinal System consists of four pedicle screws, two cords and two spacers in a symmetric, bilateral arrangement. The pedicle screws are placed lateral to the facet joints with two screws in the cephalad position and two screws in the caudad position. The superior-inferior distance between the pedicle screws is maintained with the spacers. The cord passes through the eye of the pedicle screw heads and through the centers of the spacers.

This document is a 510(k) Pre-Market Notification for the DYNESYS® Spinal System. It is an application for regulatory clearance, claiming substantial equivalence to a predicate device, rather than a clinical study report describing acceptance criteria and device performance. Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify quantitative acceptance criteria or report performance metrics from a study designed to meet such criteria. It states that "Establishment of equivalence is based on similarities of intended use, design, and performance characteristics" to the predicate device.

2. Sample size used for the test set and the data provenance:
Not applicable. This document does not describe a clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This document does not describe a clinical study with a ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This document does not describe a clinical study with 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 document is for a medical device (spinal system), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This document is for a medical device (spinal system), not for an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. This document does not discuss a clinical study with ground truth. The basis for clearance is substantial equivalence to a predicate device.

8. The sample size for the training set:
Not applicable. This document describes a medical device, not a machine learning model that would have a training set.

9. How the ground truth for the training set was established:
Not applicable. This document describes a medical device, not a machine learning model.

Additional relevant information from the document:

• Device Name: DYNESYS® Spinal System
• Intended Use: "When used as a pedicle screw fixation system in skeletally mature patients, the DYNESYS Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis)."
• Predicate Device: Silhouette™ Spinal Fixation System (K980288)
• FDA Limitation: The FDA added a limitation to the labeling: "The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established." This indicates that while the device was found substantially equivalent for specified uses, potential broader uses were explicitly excluded without further proof.

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