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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. Combined Set Screws are intended to be used as part of the M.U.S.T. Pedicle Screw System (cleared under K12115, K132878, K141044, K141988, K153664, K162061, and K171170) 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 and K132878), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K12115), straight and pre-bent rods (K121115 and K162061), cross connectors (K132878), hooks (K141044), enhanced screws and rods designed for percutaneous surgery (K141988 and K162061), cannulated or non-cannulated reduction screws (K153664), connectors (K162061 and K171170), and standard, enhanced, and reduction pedicle screws (K171170). The M.U.S.T. Combined Set Screws are manufactured from CoCrMo alloy (ISO 5832-12 and ASTM F1537-11) and are provided sterile and non-sterile screw is packaged individually as well as in packages of 2, 4, 6, and 8 screws. The non-sterile screw is packaged individually.

The provided text describes a 510(k) premarket notification for a medical device, the M.U.S.T. Combined Set Screws. It focuses on demonstrating substantial equivalence to a predicate device, not on validating an AI algorithm. Therefore, many of the requested items related to AI device performance, such as human reader improvement with AI, ground truth establishment for training and test sets, and multi-reader multi-case studies, are not applicable or cannot be extracted from this document.

However, I can extract information regarding the device's acceptance criteria, the study conducted, and other relevant details provided in the submission for the M.U.S.T. Combined Set Screws.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, it refers to performance studies conducted in accordance with specific ASTM standards. The acceptance criteria are implicitly that the device performs equivalently to the predicate device and meets the requirements of these standards. The reported device performance is that it met these standards and thus is "as safe and effective as the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of an AI algorithm, nor does it provide details on sample sizes for the mechanical and pyrogenicity tests beyond indicating that the tests were performed. The "data provenance" information (country of origin, retrospective/prospective) is not applicable to the device testing described. The materials for the device itself are CoCrMo. The manufacturing company, Medacta International SA, is located in Switzerland.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a physical medical implant (surgical screws), not an AI diagnostic or prognostic tool requiring expert-established ground truth from images or clinical data. The "ground truth" for this device would be its physical and mechanical properties, assessed through standardized laboratory tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable, as there is no "test set" in the context of expert review for an AI algorithm. The device's performance was evaluated through laboratory testing against established engineering and material standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The M.U.S.T. Combined Set Screws are a physical orthopedic implant, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The "device" in question is a physical hardware component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is based on established engineering standards and material properties, specifically through performance testing in accordance with:

• ASTM F1717-15 (for dynamic compression bending of spinal implant constructs)
• ASTM F1798-13 (for static and fatigue properties of interconnection mechanisms)
• Sawbones Testing (a simulated biomechanical environment)
• LAL Endotoxin Test (for pyrogenicity/safety of materials)

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI algorithm.

9. How the ground truth for the training set was established

This information is not applicable. There is no "training set."

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