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The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) 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 is intended to be used as part of the M.U.S.T. pedicle screw system (K121115, K132878) 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 non cannulated mono-axial pedicle screws (K132878), set screws (K121115), straight and pre-bent rods (K12115), and cross connectors (K132878). The M.U.S.T. Extension consists of the following components, which are all provided in both sterile and unsterile packaging: Wide blade hook, Pedicle hook, Pedicle hook screw, Angled hook, Offset hook, Narrow blade hook.

The provided text describes the M.U.S.T. Extension device as an adjunct to the M.U.S.T. Pedicle Screw System. The document is an FDA 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "design verification was conducted to written protocols with pre-defined acceptance criteria." However, it does not explicitly list these acceptance criteria or present the detailed results of the device's performance against them in a table format. Instead, it relies on geometrical comparisons and the assumption that the new components are not "worst case" compared to predicate devices for which testing was previously done.

2. Sample Size for Test Set and Data Provenance:

The document does not describe a separate "test set" in the context of an AI/algorithm. The focus is on physical device testing. The "geometrical comparisons" mentioned do not involve a sample size of patient data or data provenance. The assessment is based on the design of the device components.

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

Not applicable. This document pertains to a medical device's physical and mechanical properties, not an AI algorithm requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

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

No MRMC study was done, as this document is for a physical medical device (pedicle screw system components), not an AI-assisted diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

No standalone algorithm study was done or is applicable to this device submission.

7. Type of Ground Truth Used:

The "ground truth" in this context refers to established engineering and biomechanical principles and standards used for evaluating the performance of implantable devices. The document implies compliance with these standards based on the geometric similarity to predicate devices. There is no biological or clinical "ground truth" derived from patient data described.

8. Sample Size for the Training Set:

Not applicable. There is no AI algorithm being trained or evaluated in this submission.

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

Not applicable for the reasons stated above.

Summary of Device Acceptance and Study Information from the Text:

The document asserts that the M.U.S.T. Extension is substantially equivalent to its predicate devices based on:

• Indications for Use: They are the same as the predicate devices.
• Design Features: The M.U.S.T. Extension components (hooks, screws) have similar design features to existing components in the M.U.S.T. system (K121115, K132878) and other predicate devices.
• Materials: All components are made from Ti6Al4V ELI (ISO 5832-3/ASTM F 136), which is a commonly accepted material for such implants and is consistent with predicate devices.
• Performance Testing (Reaffirmation based on geometric comparison):
  • A risk analysis was conducted to identify new risks.
  • Design verification was performed with predefined acceptance criteria based on standards, FDA guidance, and comparison to predicate devices.
  • Geometrical comparisons were performed for the implant/rod/set screw interface (hooks) and implant/bone interface (hooks).
  • It was determined that "There were not any additional tests performed on the hooks as the interface to the rod, the tulip and thread geometry, the set screw and the final tightening torque are exactly the same as for the M.U.S.T. monoaxial screws (K132878)."
  • Conclusion: "Therefore, the biomechanical implant performance regarding yield strength, fatigue strength and construct stiffness can be considered at least equal to the predicate devices."

The study described is not a clinical trial or an AI algorithm validation. It is a design verification and substantial equivalence demonstration based on engineering principles, material science, and comparison to previously cleared predicate devices, arguing that the new components perform at least as well as the already tested existing components. The acceptance criteria and "proving" of the device are implied through conformity with established standards for similar devices and the principle of substantial equivalence rather than explicit, novel performance benchmarks.

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The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) 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 consists of the following implants that are to be used as part of the M.U.S.T. pedicle screw system (K121115):

• New sizes (diameter and length) of the solid polyaxial pedicle screws that were cleared under K121115
• Solid and cannulated monoaxial pedicle screws
• Cross connectors
  The M.U.S.T. Extension is intended to be used as part of the M.U.S.T. pedicle screw system for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Extension includes different sizes of screws and cross connectors. The screws are fixed in the pedicle and the vertebrae. The straight and pre-bent rods (K121115) act as a connector between the different screws to create a stable construct. The cross connectors act as a stabilizing construct between the rods on each side of the vertebrae. The cross connectors have an adjustable medial/lateral length in order to address various distances between the rods depending on the patient's anatomy. Rod distances from 35mm to 98 mm can be addressed with the various connector sizes. The connector offers an angular adjustable central joint in order to align the connection to the rod. The anqular adjustable feature as well as the size range of the connectors is within the range of the predicate devices. The M.U.S.T. Extension can be applied with the common surgical technique for posterior instrumentation.
  The M.U.S.T. Extension cross connectors are made of Titanium alloy (Ti6AI4V ELI -ISO 5832-3, ASTM F136) and come in 4 sizes: 35-42, 40-50, 48-66, and 64-98. The M.U.S.T. Extension pedicle screws are made of either Titanium alloy (Ti6Al4V ELI - ISO 5832-3, ASTM F136) or a combination of Titanium alloy (Ti6AI4V ELI - ISO 5832-3, ASTM F136) and CoCrMo (ISO 5832-12, ASTM F 1537). The M.U.S.T. Extension solid polyaxial pedicle screws have diameters of 8, 9, and 10mm and lengths between 20 and 100mm in 5mm increments. The M.U.S.T. Extension solid monoaxial pedicle screws have diameters between 4.5 and 7mm and lengths between 25 and 65mm in 5mm increments in addition to screws with a diameter of 8mm with lengths between 25 and 90mm. The M.U.S.T. Extension cannulated monoaxial pedicle screws have diameters between 5 and 7mm and lengths between 40 and 60mm in 5mm increments. 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 construct is secured using a set screw made of CoCrMo (ISO 5832-12, ASTM F 1537). The pedicle screws are available both in sterile and unsterile packaging while the cross connectors are available in sterile packaging.

The provided text describes a medical device, the M.U.S.T. Extension, and its substantial equivalence to predicate devices, rather than a study proving performance against acceptance criteria for an AI/ML powered device. The document is a 510(k) summary for a spinal pedicle screw system extension.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set size, and how training ground truth was established) are not applicable to this submission.

However, I can extract the acceptance criteria and a description of the testing performed for this mechanical device.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Description:

The study performed was a design verification study to evaluate the M.U.S.T. Extension's mechanical properties.

• Objective: To demonstrate that the M.U.S.T. Extension is substantially equivalent to its predicate devices in terms of mechanical performance.
• Methodology:
  • A risk analysis was conducted to identify any new risks associated with the changes in the M.U.S.T. Extension.
  • Design verification tests were conducted according to written protocols with predefined acceptance criteria.
  • These protocols and acceptance criteria were based on established standards (specifically ASTM F 1717), FDA guidance, and comparison to existing predicate devices.
  • Testing was performed on the "worst case component size and option/design based on engineering analysis."
  • The M.U.S.T. Extension's performance was compared to the "worst case of the predicate devices."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a number of devices. "Worst case component size and option/design" was tested.
• Data Provenance: Not applicable in the context of clinical data. This is mechanical testing data for new device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for mechanical testing is based on engineered specifications and established standards, not expert consensus on clinical data.

4. Adjudication method for the test set:

• Not applicable. Mechanical testing results are objectively measured against predefined thresholds.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No, this was not a MRMC comparative effectiveness study. It was mechanical testing of a medical device's components.

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

• Not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used:

• For mechanical properties, the "ground truth" or reference was based on established industry standards (ASTM F 1717) and the performance of currently marketed, legally predicate devices. The acceptance criteria were derived from these standards and predicate device performance.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device.

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