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The FIXXSURE™ Anterior Lumbar Plate and Screw System is indicated for use via the anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc conformed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.

The FIXXSURE™ Anterior Lumbar Plate and Screw System's implants are a lumbar Plate System intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). The FIXXSURE™ Anterior Lumbar Plate and Screw System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of the screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.

The provided text describes the regulatory clearance of a medical device, the FIXXSURE™ Anterior Lumbar Plate and Screw System, by the FDA. It details the device's indications for use, its classification, and asserts its substantial equivalence to a predicate device.

However, the text does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the context of device performance metrics often associated with AI/ML systems or diagnostic accuracy studies.

Instead, the document details bench testing for mechanical properties to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of what can and cannot be answered from the provided text according to your request:

Information Present:

• Acceptance Criteria and Reported Device Performance (Table): The document does not provide a table with specific quantitative acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, nor does it report such metrics for the FIXXSURE™ system. Instead, it states that the device "met all pre-defined acceptance criteria" based on non-clinical testing and that "Bench testing to evaluate the mechanical properties of the FIXXSURE™ Anterior Lumbar Plate and Screw System showed similar or higher mechanical value than the predicate marketed devices."
• Type of Ground Truth Used: For the mechanical bench testing mentioned, the "ground truth" would be the engineering specifications and performance characteristics defined by the ASTM F1717-18 standard and comparisons to the predicate device's known mechanical values. This is not directly comparable to "expert consensus, pathology, or outcomes data" typically used in AI/ML or diagnostic studies.

Information NOT Present:
The following items are not available in the provided text, as the document focuses on regulatory clearance for a traditional medical implant based on mechanical performance, not an AI/ML-driven diagnostic or treatment selection device:

• Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method (e.g., 2+1, 3+1, none) for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The sample size for the training set
• How the ground truth for the training set was established

Summary of Device Performance Study (based on available text):

Study Type: Non-clinical bench testing for mechanical properties.
Purpose: To demonstrate substantial equivalence to a legally marketed predicate device (AccelFix Lumbar Plate System, K192481).
Standards Applied: ASTM F 1717-18 (Static Compression Bending Test, Static Tension Bending Test, Static Torsional Test, Dynamic Compression Bending Test).

Acceptance Criteria and Reported Performance (Based on interpretation of the text):

• Mechanical values comparable to or better than the predicate device (AccelFix Lumbar Plate System).
• Not represent a "new worst case" compared to the predicate/reference device. | - Met all pre-defined acceptance criteria.
• Showed similar or higher mechanical value than the predicate marketed devices in static compression, static tensile, static torsion, and dynamic compression testing. |
  | Material Composition | - Made from Ti-6Al-4V ELI titanium alloy (ASTM F136). | - Manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136), same material as predicate devices. |
  | Design and Function | - Design features (e.g., spikes for stability, curvature for anatomic fit) consistent with intended function. | - Substantially equivalent to predicate systems in terms of design, materials, indications for use, and sizing. |

Note: The text explicitly states "The FIXXSURE™ Anterior Lumbar Plate and Screw System met all pre-defined acceptance criteria..." and "Bench testing to evaluate the mechanical properties of the FIXXSURE™ Anterior Lumbar Plate and Screw System showed similar or higher mechanical value than the predicate marketed devices." These statements are the closest the document comes to reporting device performance against acceptance criteria. The specific numerical values or ranges for these mechanical properties are not disclosed in this document.

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