(85 days)
The F1 MPS Modular Pedicle Screw System (F1 MPS) is intended for posterior, non-cervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment; Severe spondy|olisthesis (grades 3 and 4) of the L5-S1 vertebra; Fracture; Dislocation; Spinal stenosis; Scoliosis or kyphotic deformities; Spinal Tumor; Schuermann's disease; Failed previous fusion.
The F1 MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.
The F1 MPS is also intended to stabilize the posterior non-cervical fixation indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft.
The F1 MPS system is modular system composed of cannulated and non-cannulated pedicle screws of various lengths and diameters which are designed to accept a 5.5mm rod in various lengths. The components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient.
This submission addresses the line extension of CONNECT-L Transverse Connector and JOUST minimally invasive rods to the F1 MPS Modular Pedicle Screw System (K142531), and make FDA aware of minor changes to F1 MPS for manufacturability.
The CONNECT-L Transverse Connector comes in fixed and variable sizes. The JOUST™ minimally invasive rods are used in a minimally invasive approach. The JOUST™ minimally invasive manual surgical instruments aid in percutaneous approach. Additional 5.5mm rods are added to this system to allow for ease of entry.
The F1 MPS system is provided non-sterile. The system is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 and/or cobalt-chromium-molybdenum per ASTM F1537.
The provided document is a 510(k) summary for the DeGen Medical F1 MPS Modular Pedicle Screw System. It describes a medical device, specifically a spinal implant, and its mechanical testing to demonstrate substantial equivalence to predicate devices. It does not contain information about an AI/ML powered medical device, nor does it present clinical study data with acceptance criteria for such a device.
Therefore, I cannot fulfill your request to describe acceptance criteria and associated study details for an AI/ML powered medical device based on this document. The document focuses on hardware (pedicle screw system), not software or AI performance.
§ 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.