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510(k) Data Aggregation
(28 days)
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:
| Test Type | Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Static compression/bending yield strength | ASTM F 1717 | Performance at least equivalent to worst-case predicate. | Not explicitly reported. |
| Fatigue compression/bending strength | ASTM F 1717 | Performance at least equivalent to worst-case predicate. | Not explicitly reported. |
| Static compression/bending stiffness | ASTM F 1717 | Performance at least equivalent to worst-case predicate. | Not explicitly reported. |
| Static torsion yield strength | ASTM F 1717 | Performance at least equivalent to worst-case predicate. | Not explicitly reported. |
| Static torsion stiffness | ASTM F 1717 | Performance at least equivalent to worst-case predicate. | Not explicitly reported. |
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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(97 days)
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
| Acceptance Criteria (Measured Metric) | Predicate Device Performance (Reference Standard) | M.U.S.T. Pedicle Screw System Performance |
|---|---|---|
| Static Torsion Yield Torque | Met for predicate devices | Substantially equivalent |
| Static Torsion Stiffness | Met for predicate devices | Substantially equivalent |
| Static Axial Compression | Met for predicate devices | Substantially equivalent |
| Dynamic Axial Compression Performance | Met for predicate devices | Substantially equivalent |
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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