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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

• M.U.S.T. S2AI: Design validated for new features. |
  | Mechanical Performance (Worst-Case Determination - ASTM F1798-21) | - M.U.S.T. Link cross connector for Ø5.5 and Ø6 rods: Worst-case determined and tested. (Implicitly, the performance met the specified standard for interconnections, supporting substantial equivalence).
• Interconnection mechanism: Worst-case determined and tested. (Implicitly, performance met standard). |
  | Mechanical Performance (Static and Dynamic Compression Bending - ASTM F1717-21) | - Pedicle screw constructs: Tested for static and dynamic compression bending. (Implicitly, the performance met the specified standard for pedicle screw internal spinal fixation systems, supporting substantial equivalence). |
  | Mechanical Performance (Static Torsion - ASTM F1717-21) | - Pedicle screw constructs: Tested for static torsion. (Implicitly, the performance met the specified standard, supporting substantial equivalence). |
  | Mechanical Performance (Tulip Opening) | - Forces causing tulip opening during final tightening: Evaluated. (Implicitly, demonstrated that the forces are within acceptable limits for safe use). |
  | Biocompatibility | - Assessment conducted: (Implicitly, the device components are biocompatible according to established standards, including the M.U.S.T. SI Screw coating validation for S2AI screws). |
  | Pyrogenicity (Bacterial Endotoxin Test - EP §2.6.14 / USP ) | - Tests conducted: Bacterial endotoxin test (LAL test) performed. (Implicitly, results demonstrated acceptable endotoxin levels). |
  | Pyrogenicity (Pyrogen Test - USP ) | - Tests conducted: Pyrogen test performed for pyrogenicity determination. (Implicitly, results demonstrated acceptable pyrogen levels).
  (Note: The devices are not labeled as non-pyrogenic or pyrogen-free.) |
  | Shelf-Life | - Evaluation conducted: (Implicitly, the device's shelf-life was determined and validated to ensure product stability and performance over time.) |

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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The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/lium) and nonpedicle 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. Extension - Straight Connectors and Additional Screws are intended to be used as part of the M.U.S.T. Pedicle Screws System (K121118, K132878, K141988, K153664) for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Pedicle Screws System includes: cannulated or non-cannulated poly-axial pedicle screws (K121115and K132878), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K121115), straight and pre-bent rods (K121115), cross connectors (K132878), enhanced screws and rods designed for percutaneous surgery (K141988), and cannulated or non-cannulated reduction screws (K153664). The M.U.S.T. Additional Pedicle Screws (standard and enhanced pedicle) are made of Ti6Al4V ELI (ISO 5832-3, ASTM F136-13) and CoCrMo (ISO 5832-12, ASTM F1537-11), while the M.U.S.T. Additional Reduction Screws are made of Ti6A14V ELI (ISO 5832-3, ASTM F136-13). The screw shaft is color anodized to simplify the identification of the screw diameter. The pedicle screw has a dual lead thread to simplify the screw insertion and reduce the number of turns. The threads are designed with a cylindrical diameter. The M.U.S.T. Straight Connectors and Additional Screws introduces the following additional components: Pedicle screw, Enhanced Solid Pedicle screw, Enhanced Cannulated Pedicle screw, Reduction Pedicle screw, Reduction Cannulated Pedicle screw, Straight Cross Connector.

The provided document is a 510(k) Premarket Notification for the M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws. It focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and performance testing.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

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

The document doesn't explicitly list specific numerical acceptance criteria. Instead, it states that the acceptance criteria were "pre-defined" and "based on the standards, FDA guidance, and comparison to the predicate device system." The reported device performance is a general statement that the device "met all acceptance criteria" and "is substantially equivalent to 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)

• Sample Size: The document repeatedly mentions "the worst-case device" for each of the mechanical tests (Dynamic Compression Bending, Static Compression Bending, Static Torsion). This implies a very small sample size, potentially a single representative device or a small set of devices configured to represent the most challenging conditions. The exact number is not explicitly stated.
• Data Provenance: The study is a laboratory-based mechanical testing study, not a clinical study involving human or animal data. Therefore, concepts like country of origin, retrospective, or prospective do not apply in the typical sense. It is an engineering verification study.

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 section is not applicable to this type of device and study. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717-12) and the inherent physical properties and design specifications of the device, rather than expert judgment or clinical outcomes.

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

This section is not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert interpretations of data (e.g., imaging, clinical assessments). For mechanical testing, the "adjudication" is inherent in the adherence to established test standards and the objective measurement of physical properties.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This type of study evaluates the performance of AI-assisted diagnostic or classification systems in a clinical context, often involving human readers interpreting medical images. The M.U.S.T. Pedicle Screw System Extension is a physical orthopedic implant, not an AI diagnostic tool.

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

A standalone performance evaluation (in the context of AI algorithms) is not applicable to this device. This device is a physical implant and does not involve any AI algorithms.

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

The "ground truth" for the performance data in this document is based on engineering standards and specifications. Specifically, the mechanical tests were performed according to ASTM F1717-12 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The acceptance criteria were based on these standards, FDA guidance, and comparison to the predicate device's established performance.

8. The sample size for the training set

This question is not applicable as there is no "training set" in the context of a physical device mechanical performance study. Training sets are relevant for machine learning algorithms.

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

This question is not applicable for the same reason as point 8.

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