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The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/Ilium) and non-pedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The M.U.S.T. Pedicle Screw System devices are fixation devices intended for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Pedicle Screw System includes cannulated or non-cannulated poly-axial pedicle screws (K12115, K132878), cannulated or noncannulated mono-axial pedicle screws (K132878), set screws (K121115), straight and pre-bent rods (K121115), and cross connectors (K132878).

The new lateral connectors can be used when a certain off-set screw has to be implanted with the rod. The lateral connectors offer the same interface to the monoaxial screw (K132878). The lateral connectors are offered in three sizes (20, 40 and 60 mm sizes) to accept a 5.5mm rod and manufactured of Ti-6Al-4V ELI (ISO 5832-3, ASTM F136).

The new anodized rods and anodized enhanced rods act as a connector between the different screws to create a stable construct. The screws are used in combination with 5.5mm titanium allov rods. This allows the surqeon to choose the construct stiffness based on the indication by maintaining the screw sizes. They are offered as a 5.5mm diameter in various lengths (100, 200, 300 and 480 mm sizes) and manufactured of Ti-6AI-4V ELI (ISO 5832-3, ASTM F136).

The new rod-to-rod connectors can be used to connect two rods to increase the construct stability. The cross connectors have a medial/lateral length adjustable element in order to address different distances. Rod distances from 35mm to 98 mm can be addressed with the different connector sizes. The rod to rod connectors are manufactured of Ti-6AI-4V ELI (ISO 5832-3. ASTM F136) and the set-screws are made of Co-Cr-Mo (ISO 5832-12, ASTM F1537).

This FDA 510(k) premarket notification describes the M.U.S.T. Pedicle Screw System and its substantial equivalence to predicate devices. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication method, MRMC studies, standalone performance), or training set information.

Instead, this document focuses on:

• Indications for Use: The system is intended for posterior non-cervical pedicle fixation and non-pedicle/anterolateral fixation for conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients.
• Device Description: It includes cannulated/non-cannulated poly-axial and mono-axial pedicle screws, set screws, straight and pre-bent rods, cross connectors, new lateral connectors, new anodized rods, and new rod-to-rod connectors.
• Comparison to Predicate Devices: The document asserts that the indications for use, design features, and materials of the subject devices are substantially equivalent to those of the predicate devices (M.U.S.T. Pedicle Screw System K121115, K141988, K141044, K132878; Expendium Spine System K041119; Synergy D2 Spinal Implants K984578; MOSS Miami Spinal System K983583). Detailed tables compare materials, sterilization, device usage, sizes, rod compatibility, and shelf life.
• Performance Testing: It states that a risk analysis was conducted, and design verification was performed with written protocols and pre-defined acceptance criteria based on standards, FDA guidance, and comparison to predicate devices. Mechanical tests mentioned are:
  • Static Compression Bending Strength ASTM F1717
  • Static Torsion Strength ASTM F1717
  • Dynamic Compression Bending Strength ASTM F1717
  • Static Transverse Moment ASTM F1798
  • Four-Point Dynamic Bending Strength ASTM F2193

Since the provided document is a 510(k) summary for a medical device and not a study report for an AI/CAD system, it does not include the detailed performance study information requested about acceptance criteria, test set, ground truth, etc., typically associated with such systems. The document confirms that specific mechanical tests were performed to support substantial equivalence, but it does not provide the quantitative acceptance criteria or the specific numerical results of these tests, nor does it refer to studies involving human readers or AI.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the manner you requested for AI/CAD systems.

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