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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 subject M.U.S.T. Pedicle Screw System - Extension is a Medacta M.U.S.T. Pedicle Screws System line extension aiming to include the following new implants:

• M.U.S.T. Uniplanar screws (solid and cannulated);
• M.U.S.T. Uniplanar reduction screws (solid and cannulated);
• M.U.S.T. polvaxial pedicle screws (solid and cannulated);
• M.U.S.T. polyaxial reduction pedicle screws (solid and cannulated);
• M.U.S.T. S2AI polyaxial cannulated screws (with or without HA plasma spray coating, fully and partially threaded);
• M.U.S.T. S2AI polyaxial reduction cannulated screws (with or without HA plasma spray coating, fully and partially threaded);
• M.U.S.T. rod straight, transition and pre-contoured (double curvature, J-rod and Z-rod) of different lengths and Ø5.5 or Ø6.0 mm diameters made of Ti6A14V or CoCrMo alloys;
• M.U.S.T. Link cross connectors for Ø5.5 or Ø6.0 mm rods.
  The M.U.S.T. Pedicle Screw System - Extension implants are provided individually packed, sterile and single-use.

This is a 510(k) premarket notification for a medical device (M.U.S.T. Pedicle Screw System - Extension) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving clinical efficacy or diagnostic accuracy with extensive studies. Therefore, the information provided does not contain the typical details you would find for an AI/software as a medical device (SaMD) study that includes acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader studies.

The provided document describes an extension to an existing pedicle screw system, which primarily involves new implant designs and sizes. The performance data section focuses on non-clinical studies related to mechanical testing and biocompatibility, as is typical for implantable orthopedic devices.

Below is an analysis based on the information available, noting where specific details (like those related to AI/software performance) are not applicable or not provided in this type of submission.

Acceptance Criteria and Study for M.U.S.T. Pedicle Screw System - Extension

Given that this is a 510(k) for an extension to an orthopedic implant system and not an AI/SaMD, the "acceptance criteria" and "device performance" are primarily related to mechanical integrity and biological safety, rather than diagnostic performance metrics. The "study" refers to the non-clinical tests performed to demonstrate these aspects.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the context of this 510(k) submission. The "test set" for this type of device refers to manufactured devices or components subjected to standardized mechanical and biological tests. There are no "patients" or "data provenance" in the sense of clinical study data for these non-clinical tests. The tests are typically performed on a statistically relevant number of samples of the device components/constructs to demonstrate compliance with standards. The specific sample sizes for each mechanical and biological test are not detailed in this summary but would be specified in the full test reports.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. "Ground truth" established by experts is relevant for diagnostic devices or AI/SaMD where clinical judgment is the benchmark. For a pedicle screw system, compliance with engineering standards (e.g., ASTM) and biocompatibility requirements are the "ground truth" for non-clinical testing. This involves engineering and scientific experts familiar with these standards, but not clinical "radiologists" establishing diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies, especially for evaluating subjective diagnoses. Mechanical and biological test results are typically objective measurements against predefined thresholds, not requiring expert adjudication in this manner.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is specific to diagnostic imaging devices or AI/SaMD that assist human readers. It is not relevant for an orthopedic implant like a pedicle screw system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a physical implant, not a software algorithm.

7. Type of Ground Truth Used

For this device, the "ground truth" for demonstrating substantial equivalence and safety/effectiveness relies on:

• Engineering Standards: Compliance with established ASTM (American Society for Testing and Materials) standards for spinal implants (e.g., ASTM F1798-21, ASTM F1717-21) for mechanical performance.
• Biological Standards: Compliance with relevant standards for biocompatibility (ISO 10993 series) and pyrogenicity (European Pharmacopoeia, USP).
• Predicate Device Performance: The primary ground truth is the demonstration that the new components perform equivalently to or better than previously cleared predicate devices, meeting established safety and performance benchmarks.

8. Sample Size for the Training Set

Not applicable. There is no software algorithm or AI model being "trained" for this physical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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