(20 days)
The M.U.S.T. Mini posterior cervical screw system is intended to provide immobilization of spinal segments as an adjunct to fusion, in skeletally mature patient, for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fraumatic dislocations; instability or deformity; failed previous (e.g., pseudarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radior 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 screw 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 screw 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 screw 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.
When used with the Occipital Plate the M.U.S.T Mini posterior cervical screw system is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic junction (occiput - 73) in treatment of the instabilities mentioned above, including occipitocervical dislocation.
The M.U.S.T. MINI poly-axial screws and lateral connectors are a line extension to the previously cleared Medacta M.U.S.T. MINI Posterior Cervical Screws System (K171369).
The poly-axial screws included in the line-extension are equivalent to the ones legally marketed, with the exception of individual length. For the Ø4.5mm poly screws, the length is extended from "26 to 50mm" to "14 to 50mm" (adding the 14 to 24 mm sizes).
The range of Ø4mm and Ø4.5mm partial thread screws design is extended from "26 to 42mm" to "26 to 50mm" (adding the 44 to 50mm sizes) with 2 mm of increments. For the Ø3.5mm partial thread screws, the lengths of 26 to 40mm are added, 2 mm increments.
The range of full thread screw design Ø4.5mm is extended from 26-50mm to 14-50mm with 2 mm increments.
All the poly-axial screws features are the same: intended use, diameters, pitch, threading pitch, length increment, range of motion, driving interface, material, surface finishing, manufacturing process, washing, packaging and final storing condition.
The lateral connectors introduced as line-extension are equivalent to the ones legally marketed, with the exception of the length: same intended use, diameter of the shaft, fixing interfaces, material, surface finishing, machining, washing, packaging and final storing condition.
The Lateral connector included in this line extension are aimed the product range from 10-15mm to 10-30mm, in steps of 5mm.
The M.U.S.T. MINI poly-axial screws and lateral connectors are manufactured from Ti-6Al-4V ELI (ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4vanadium alloy + ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)), the same material of the previous cleared M.U.S.T. MINI M.U.S.T. MINI Posterior Cervical Screws System (K171369).
I am sorry, but the provided text is a 510(k) premarket notification for a medical device (M.U.S.T. MINI Posterior Cervical Screws System). This document is focused on demonstrating substantial equivalence to predicate devices and discusses the device's mechanical properties, indications for use, and a comparison of technological characteristics.
It does not contain information about an AI/ML-based device, nor does it discuss acceptance criteria, device performance, ground truth establishment, or clinical study designs relevant to AI/ML product validation (e.g., MRMC studies, standalone performance).
Therefore, I cannot extract the information required to answer your request about acceptance criteria and the study that proves the device meets them in the context of an AI/ML product.
§ 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.