(83 days)
The M.U.S.T. Mini posterior cervical screws system is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The M.U.S.T. Mini posterior cervical screws system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the M.U.S.T. Mini posterior cervical screws system may be connected to the M.U.S.T. system rods with the M.U.S.T. Mini rod connectors. Transition rods with differing diameters may also be used to connect the M.U.S.T. Mini posterior cervical screws system to the M.U.S.T. system. Refer to the M.U.S.T. system package insert for a list of the M.U.S.T. indications of use.
The M.U.S.T. MINI Posterior Cervical Screws System is a multi-component system constructed from titanium and CoCrMo materials, consisting of rods that are longitudinally interconnected and anchored to adjacent vertebrae using screws. Stability enhancement is possible by means of interconnection mechanisms and transverse connectors used as cross connectors.
The M.U.S.T. MINI Posterior Cervical Screws System is intended to stabilize and fuse the spine in degenerative disc disease, spinal fusion, cervical fractures, and in surgically repaired spinal pseudo-arthrosis. In addition, the M.U.S.T. MINI Posterior Cervical Screws System is used in deformity correction e.g. scoliosis to correct and stabilize the spine.
The M.U.S.T. MINI Posterior Cervical Screws System consists of polyaxial screws (full and partially threaded), cannulated polyaxial screws (full and partially threaded), hooks, cross connectors, connectors and rods (straight and transition) are manufactured of Titanium-6Aluminum-4Vanadium Extra Low Interstitial (Ti-6Al-4V ELI). The M.U.S.T. MINI Posterior Cervical Screws System rods (straight and transition) are manufactured of Cobalt-Chromium-Molybdenum Alloy.
The provided text describes the submission for a medical device called the "M.U.S.T. MINI Posterior Cervical Screws System" to the FDA for 510(k) clearance. This type of submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving efficacy through clinical studies for new uses.
Therefore, the document does not contain information about:
- Acceptance criteria for an AI/algorithm-based device and reported device performance. The device is a physical surgical implant, not an AI or algorithm.
- Sample size used for a test set or data provenance for an AI/algorithm.
- Number of experts or their qualifications for establishing ground truth for an AI/algorithm test set.
- Adjudication method for an AI/algorithm test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data) for an AI/algorithm.
- Sample size for a training set (AI/algorithm).
- How ground truth for a training set was established (AI/algorithm).
The document primarily focuses on demonstrating substantial equivalence of a physical medical device (spinal screws system) through:
- Comparison of Technological Characteristics: Detailed tables comparing the subject device's materials, dimensions (screw diameter, length, rod diameter, length), device usage, biocompatibility, and sterilization status to several predicate devices (e.g., Synthes Synapse Systems, Synthes Cervifix/Axon Systems, Medtronic Vertex Reconstruction System).
- Performance Data (Non-Clinical Studies): The document lists various mechanical tests conducted to support substantial equivalence. These tests include:
- Static and dynamic compression (Per ASTM F1717-15)
- Static and dynamic torsion (Per ASTM F1717-15)
- Static axial and torsional grip (Per ASTM F1798-13)
- A-P screw pull out (Per ASTM F1798-13)
- Flexion-extension (Per ASTM F1798-13)
- Torque to failure
- Cadaver Testing (listed but no details provided)
- Design Comparisons
- Pyrogenicity (Bacterial Endotoxin Test and Pyrogen Test per European Pharmacopoeia and USP)
- Acceptance Criteria for the Mechanical Tests: The text states that "acceptance criteria that were based on standards and FDA guidance document 'FDA Guidance for Industry and FDA Staff, Spinal System 510(k)s'". However, the specific quantitative acceptance criteria values (e.g., minimum load to failure, maximum displacement) and the exact reported performance results of the subject device against these criteria are not explicitly provided in the excerpt. The document states that these tests "support a substantial equivalence determination," implying the device met these criteria.
In summary, the provided document is a 510(k) summary for a physical medical device and does not contain the information requested regarding acceptance criteria and studies for an AI/algorithm-based device.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.