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The BASG, Inc., SOLAS AnatomixTM, Spinal System is a modular pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the SOLAS Anatomix™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

The SOLAS Anatomix™ is intended for anterior/anterolateral and posterior, non-cervical and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as hen' pain of discogenic origin with degeneration of the disc confirmed by history and padiographic studies), spondylolisthesis, trauma (i.e., fracture and/or dislocation) spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion.

The SOLAS Anatomix Spinal System is a new modular spinal fixation system which can be used for anterior, antereolateral, posterior applications. This system includes screws, housing assemblies, rods, connectors and a cross-link mechanism in conjunction with specialized instruments which facilitate application. All implant components are fabricated from Titanium allov that conforms to ASTM F 136.

The document describes the SOLAS Anatomix™ Spinal System, a modular spinal fixation system. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) device.

Instead, the document is a 510(k) summary for a medical device (spinal system) that outlines:

• Device Description: The components and materials of the SOLAS Anatomix™ Spinal System.
• Intended Use: The clinical conditions for which the device is indicated, such as severe spondylolisthesis and various spinal instabilities or deformities.
• Technological Characteristics - Comparison to Predicates: The statement that the device is substantially equivalent to legally marketed predicate devices in terms of materials, design, indications for use, and operational principles.
• Performance Data - Comparison to Predicates: It states that mechanical testing results (following ASTM F1717-04) demonstrated equivalence to predicate devices and are detailed in the body of the application. A "Table 5.1 on next page summarizes the required testing and comparisons" is mentioned, but this table is not provided in the input text.
• 510(k) Clearance Letter: A letter from the FDA confirming the substantial equivalence determination.

Therefore, I cannot provide the requested information for an AI/ML device as the provided input is for a traditional spinal implant system. The performance data mentioned (mechanical testing via ASTM F1717-04) pertains to the physical and mechanical properties of the implant, not to the performance of an AI/ML algorithm in terms of diagnostic accuracy or other AI/ML specific metrics.

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