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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.

Ask a specific question about this device

The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/ilum) and 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 purpose of this submission is to add the M.U.S.T. MC Cross Connectors to the M.U.S.T. Pedicle Screw System (K132878, K171170, K121115, K153664, K141988) for the stabilization and fusion of the non-cervical spine. The M.U.S.T. Pedicle System includes a wide range of implants: Rods, Polyaxial and Mono-axial Pedicle Screws, Hooks, Connectors of various design and size, that are used in combination to compose a spinal construct.

The provided text describes a 510(k) premarket notification for the M.U.S.T. Pedicle Screw System, which is a medical device for spinal fixation. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing novel clinical studies to prove performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert validation, ground truth, MRMC studies, standalone performance, training set) typically associated with a de novo or PMA submission for a new device's efficacy and safety is not applicable to this 510(k) summary.

Here's how the provided information aligns with the request, highlighting what is and isn't available from this document:

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

• Not Applicable in this Context. For a 510(k), the "acceptance criteria" for the device's performance are primarily established by the performance of the predicate devices. The study performed is to demonstrate that the new device (M.U.S.T. MC Cross Connectors) performs equivalently to the predicate devices and meets relevant industry standards rather than achieving specific performance metrics against a disease outcome.

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

• Not Applicable for clinical data.
• Mechanical Testing:
  • Sample Size: The document states that "worst-case implants" were tested, but it does not specify the exact number of samples used for each test (Static compression/bending, Dynamic compression bending).
  • Data Provenance: The provenance of the data is from internal testing conducted by Medacta International SA. The country of origin for the testing facility is not explicitly stated, but Medacta International SA is based in Switzerland. The studies are prospective in the sense of being planned tests on newly manufactured components.

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)

• Not Applicable. This is a mechanical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth establishment. The "ground truth" for mechanical testing is derived from engineering principles and validated test standards.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert review of images or clinical outcomes. For mechanical performance testing, the results are typically quantitative and objective, based on physical measurements and material 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

• Not Applicable. An MRMC study is relevant for diagnostic devices, particularly those involving image interpretation by human readers, often comparing human performance with and without AI assistance. This device is a surgical implant, not a diagnostic tool, and involves no human "readers" in the context of interpretation.

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

• Not Applicable. This question is also relevant for AI/software as a medical device (SaMD). The M.U.S.T. Pedicle Screw System is a physical implant, not an algorithm.

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

• Mechanical Testing Standards. For the non-clinical performance tests, the "ground truth" is implied by the adherence to and successful completion of established industry standards for spinal implant testing, specifically ASTM F1717 (Static compression/bending and Dynamic compression bending) and European Pharmacopoeia §2.6.14 / USP chapter and for pyrogenicity. The acceptance criteria are embedded within these standards.

8. The sample size for the training set

• Not Applicable. The concept of a "training set" doesn't apply to the mechanical testing of a physical medical device like this, which doesn't involve machine learning algorithms.

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

• Not Applicable. As there is no training set for an algorithm, this question is not relevant.

Summary of Relevant Information from the Document for a 510(k):

The document explicitly states:

• "No clinical studies were conducted." This reinforces that the focus is on non-clinical, mechanical performance and comparison to predicate devices.
• Performance Tests: The device underwent "Non-Clinical Studies" including:
  • Static compression / bending per ASTM F1717
  • Dynamic compression bending per ASTM F1717
  • Cadaver studies (though no specifics are given beyond "Cadaver studies O")
  • Pyrogenicity testing (Bacterial Endotoxin Test per European Pharmacopoeia §2.6.14/USP chapter and pyrogen test per USP chapter ).
• Acceptance Criteria for Non-Clinical Tests: "Testing was conducted according to written protocols with acceptance criteria that were based on standards." The implicit acceptance criteria are that the device meets or exceeds the performance of legally marketed predicate devices, as defined by the standards (e.g., ASTM F1717) and the specific testing protocols.

In essence, for a 510(k) for a physical implant, the "study that proves the device meets the acceptance criteria" is primarily the non-clinical performance testing demonstrating that the device is substantially equivalent to existing, legally marketed predicate devices, by meeting relevant recognized standards. This is a comparison of technological characteristics and performance, not a clinical efficacy study with human subjects.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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, 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 (K12115, K132878, K141988) 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 (K121115, 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. pedicle screw system also includes the enhanced screws and rods designed for percutaneous surgery (K141988).

This Special 510(k) introduces a new design of the pedicle screw head (Tulip). The new design features two additional tabs in order to perform the rod reduction with the setscrew. The tulip has also changed materials from to CoCrMo to Ti6Al4V ELI.

The size range of the modified Pedicle Screws introduced with this 510(k) is the same as the predicate devices.

The M.U.S.T. Extension consists of the following components, which are all provided in both sterile and unsterile packaging:

Solid Poly-Axial Pedicle Screws: Diameter 4.5, 5, 6, 7mm, Length 20-90mm, Material Ti6Al4V ELI (ISO 5832-3 ASTM F 136)
Cannulated Poly-Axial Pedicle Screws: Diameter 5, 6, 7mm, Length 25-90mm, Material Ti6Al4V ELI (ISO 5832-3 ASTM F 136)

Here's an analysis of the provided FDA 510(k) summary for the M.U.S.T. Pedicle Screw System, focusing on the acceptance criteria and study information:

It's important to note that this document is a 510(k) Summary, which is a concise overview of the information submitted for regulatory clearance. It often highlights the conclusion of testing rather than providing exhaustive detail about the study methodology. Therefore, some specific details you requested may not be explicitly stated.

Acceptance Criteria and Reported Device Performance

The document describes the performance testing in a general way, comparing it to predicate devices rather than providing specific numerical acceptance criteria and results for independent performance.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not explicitly stated. For mechanical tests like those performed (ASTM F 1717), the "sample size" refers to the number of devices tested. This information is typically detailed in the full test report, not the 510(k) summary.
• Data Provenance: The device is manufactured by Medacta International, based in Switzerland. The testing was conducted as part of the submission to the FDA in the USA. The data itself is likely laboratory test data, not patient data, given the nature of the device and tests. Therefore, it would be considered prospective experimental data.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Not Applicable. This device is a mechanical implant (pedicle screw system), not an AI/imaging diagnostic device. Ground truth, in the context of diagnostic performance, is not relevant for this type of submission. The "ground truth" for a mechanical device is its physical properties and mechanical performance under specified loads, measured against established engineering standards (like ASTM F 1717).

4. Adjudication Method (Test Set):

• Not Applicable. See point 3. Adjudication methods are relevant for subjective assessments of diagnostic performance, not for objective mechanical testing.

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

• No. This is not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant or applicable.

6. Standalone (Algorithm Only) Performance Study:

• Not Applicable. There is no algorithm or software component described that would have a "standalone" performance. The device is a physical pedicle screw system.

7. Type of Ground Truth Used:

• For mechanical devices subject to ASTM standards, the "ground truth" is defined by the standardized test procedures and measurement techniques to determine parameters like static and dynamic strength and torsion. The device's performance is measured against the specifications and requirements set forth by these engineering standards. In this case, ASTM F 1717.

8. Sample Size for Training Set:

• Not Applicable. There is no "training set" for a mechanical device like this. Training sets are relevant for machine learning algorithms.

9. How Ground Truth for Training Set Was Established:

• Not Applicable. See point 8.

Summary of the Study (as described in the 510(k) summary):

The study was a series of mechanical performance tests conducted to evaluate the M.U.S.T. Pedicle Screw System, specifically focusing on a new design of the pedicle screw head (Tulip) and a change in material.

• Purpose: To demonstrate that the modified device is substantially equivalent to previously cleared predicate devices in terms of mechanical performance and safety.
• Methods:
  • A risk analysis was performed to identify new risks associated with the design change.
  • Design verification tests were conducted according to written protocols and pre-defined acceptance criteria.
  • The protocols and criteria were based on standards (specifically ASTM F 1717), FDA guidance, and comparison to predicate devices.
  • The mechanical tests performed were:
    • Static compression/bending strength (ASTM F 1717)
    • Dynamic compression/bending strength (ASTM F 1717)
    • Static torsion strength (ASTM F 1717)
• Conclusion: Based on these tests, the M.U.S.T. Extension (the modified components) was considered substantially equivalent to its predicate devices in behavior and performance.

This type of submission relies on engineering standards and direct comparison to a predicate device's established performance to demonstrate safety and effectiveness for substantial equivalence. It does not involve patient data, clinical trials, or expert diagnostic assessments as would be the case for AI/imaging devices.

Ask a specific question about this device

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 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 (K121115, K132878), cannulated or non cannulated mono-axial pedicle screws (K132878), set screws (K121115), straight and pre-bent rods (K121115), and cross connectors (K132878).

The M.U.S.T. Extension introduces a new design of the pedicle screws and rods, featuring additional mechanical interfaces for dedicated instruments designed for percutaneous surgery. On the pedicle screw head (Tulip), there are four additional small grooves on the upper rim to enhance the attachment to the Percutaneous Tower. Additionally, the tip of the screw is more tapered to enhance the insertion into the bone, in case the bone tap is not used (cannulated screws only). The Rods are provided with a hexagonal interface on one extremity and a bulleted nose on the opposite, to allow insertion by means of a dedicated handle through the tissue. The Rods have new intermediate lengths and the bent rods have an increased curvature.

The provided document is a 510(k) premarket notification for a medical device called the "M.U.S.T. Pedicle Screw System." This type of document is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through a clinical study with acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, the requested information for acceptance criteria and a study proving the device meets these criteria in the context of an AI medical device is not directly applicable here. This document describes a traditional spinal implant, and the performance testing is focused on mechanical characteristics rather than algorithmic performance.

However, I can extract the information relevant to how the device's "performance" (mechanical integrity and equivalence) was assessed based on the provided text:

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

The document states that "design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system." It also mentions that "The M.U.S.T. Extension was compared to the worst case predicate device and it was determined that the M.U.S.T. Extension is not worst case." This implies that the acceptance criteria for each test were met if the M.U.S.T. Extension performed at least as well as or better than the worst-case predicate.

However, the specific quantitative acceptance criteria or the reported device performance values are not explicitly listed in the provided text. The document refers to the following tests (from ASTM F 1717) without providing the actual results:

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

• Sample Size: The document does not specify the sample size for the mechanical performance testing. This information would typically be detailed in the test protocols themselves, which are not included in this summary.
• Data Provenance: The testing was "conducted to written protocols," implying laboratory-based mechanical testing. The origin of the components would be Medacta International SA (Switzerland) and Medacta USA. The nature of the testing (mechanical stress, fatigue, etc.) suggests it's a prospective lab study rather than human clinical data.

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

This question is not applicable to this type of device. There is no concept of "ground truth" established by experts in the context of mechanical performance testing of a pedicle screw system. The evaluation is based on objective measurements against engineering standards.

4. Adjudication method for the test set:

Not applicable. There's no "adjudication" required for mechanical testing results; they are empirical measurements.

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:

Not applicable. This is a spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was performed or is relevant.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used:

For mechanical testing, the "ground truth" is typically defined by engineering standards (e.g., ASTM F 1717) and the measured physical properties of the materials and devices.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that would have a "training set."

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

Not applicable.

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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. pedicle screw system is intended to be used for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. pedicle screw system is characterized by different sizes of screws and rods. The screws are fixed in the pedicle and the vertebrae. The rods act as a connector between the different screws to create a stable construct. The M.U.S.T. pedicle screw implants can be applied with the common surgical technique for posterior instrumentation. The M.U.S.T. pedicle screw implants are made of Titanium alloy (Ti6Al4V ELI - ISO 5832-3, ASTM F136) and CoCrMo (ISO 5832-12, ASTM F 1537). The M.U.S.T. pedicle screw implants consist of either cannulated or non cannulated poly-axial pedicle screws. The screws are offered with a diameter between 4.5 and 7mm and a length between 20 and 90mm. 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 pedicle screw is connected by 5.5mm Titanium alloy (Ti6Al4V ELI - ISO 5832-3, ASTM F136) or CoCrMo (ISO 5832-12, ASTM F 1537) rods to create a stable construct. The rods are offered straight and pre bent. The pre bent rods have a curvature of 200mm. The construct is secured using a set screw made of CoCrMo (ISO 5832-12, ASTM F 1537). The pedicle screws, set screws and rods are available both in sterile and unsterile packaging.

The Medacta M.U.S.T. pedicle screw system's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the "sample size" in terms of number of screws or rods tested for the M.U.S.T. pedicle screw system. It states that "mechanical testing of the M.U.S.T. pedicle screw system included static and dynamic compression bending and static torsion according to ASTM F1717." ASTM F1717 is a standard for spinal implant testing that typically specifies the number of samples required for each test. However, the exact number used in this specific submission is not detailed.

The data provenance is from mechanical testing in a laboratory setting, not from clinical human or animal data. Therefore, there is no country of origin or retrospective/prospective designation in the human data sense.

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

Not applicable. The ground truth for this device is based on engineering standards and mechanical testing results, not expert medical consensus or clinical outcomes. The "ground truth" is defined by the performance benchmarks established by the ASTM F1717 standard and the performance of legally marketed predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as the "test set" involves objective mechanical measurements against a standard, not subjective interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, and its primary evaluation for substantial equivalence is based on biomechanical performance against established standards and predicate devices, not on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a conceptual sense, the performance testing described is "standalone" as it focuses solely on the mechanical properties of the device itself (algorithm only, if one considers the device's design and material properties as its "algorithm") without human intervention during the actual tests of the device's mechanical strength and durability.

7. The Type of Ground Truth Used

The ground truth used is based on mechanical performance standards (ASTM F1717) and the demonstrated performance of legally marketed predicate devices. The M.U.S.T. pedicle screw system was deemed "substantially equivalent" to these predicates in terms of mechanical performance.

8. The Sample Size for the Training Set

Not applicable. This report describes the evaluation of a physical medical device (pedicle screw system) through mechanical testing, not a machine learning algorithm that requires a "training set" of data.

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

Not applicable, as there is no "training set" in the context of this device's evaluation.

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