Search Results

The SYMPHONY OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g. pseudarthrosis);
• · Tumors involving the cervical/thoracic spine;
• · Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
• · Degenerative disease of the facets with instability.

The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.

The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.

The SYMPHONY OCT System may be connected to the EXPEDIUM Spine System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.

The SYMPHONY OCT System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as offset rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors (e.g., cross connectors) to link the longitudinal components for additional stability.

The provided text is a 510(k) summary for the SYMPHONY™ OCT System, which is a posterior spinal fixation system. It does not describe a study that uses AI or machine learning, nor does it discuss acceptance criteria in the context of diagnostic accuracy or performance metrics commonly associated with AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on the substantial equivalence of the device to existing predicate devices based on its intended use, technological characteristics, materials, and non-clinical performance data (mechanical testing and MR compatibility).

Therefore, I cannot provide the requested information about acceptance criteria and study details related to an AI/ML device's performance because this document does not pertain to such a device. The "performance data" section refers to mechanical testing for spinal implants and MR compatibility, not to the diagnostic or analytical performance of an AI/ML algorithm.

Here's why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: The document discusses non-clinical mechanical testing (Static Torsion, Static Compression, Dynamic Compression) and MR compatibility. It states these tests were conducted "in alignment with the following standards" and that "Results demonstrated compatibility conditions." However, it does not provide specific numerical acceptance criteria (e.g., minimum torque resistance, maximum displacement force) or the specific numerical results obtained for the SYMPHONY™ OCT System components against these criteria.

2. Sample size used for the test set and the data provenance: This refers to data for an AI/ML algorithm. The document describes mechanical and MR compatibility testing of physical components, not a test set of medical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is relevant for AI/ML diagnostic or analytical studies. The document describes engineering tests, not expert-adjudicated ground truth for medical images or other data.

4. Adjudication method: Not applicable to the reported mechanical and MR compatibility testing.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating observer performance with and without AI assistance, which is not relevant to a spinal implant system.

6. Standalone performance study: Not applicable. The document describes the mechanical and MR properties of the device itself, not the performance of an algorithm.

7. Type of ground truth used: Not applicable. Ground truth typically refers to confirmed diagnoses or outcomes in clinical studies, not the results of engineering tests.

8. Sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

To summarize, the provided text describes a medical device clearance for a spinal fixation system, not an artificial intelligence medical device. Therefore, the specific questions regarding acceptance criteria and study design for AI/ML performance cannot be answered from this document.

Ask a specific question about this device