(54 days)
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
| Acceptance Criteria Category | Reported Device Performance (Summary from Non-Clinical Studies) |
|---|---|
| Design Validation | - M.U.S.T. Uniplanar & Polyaxial Screws, Rods, and Cross Connectors: Design validated to ensure compatibility with existing and new implants and instruments. |
- 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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.