(89 days)
The MIS Z-Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): · spondy lolisthesis (grades 3 and 4) at L5-S1 - · trauma (i.e., fracture or dislocation) - · spinal stenosis - · curvatures (i.e.,scoliosis, kyphosis, and/or lordosis) - · tumor - · pseudoarthrosis - · failed previous fusion.
The MIS Z - Pedicle Screw System consists of a variety of Pedicle screws and rods in different sizes. The devices are intended to provide immobilization of the spinal segments for posterior, noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g. osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye. Z-Pedicle Screws: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 55 mm Diameter: 5, 6, 7, 8 mm Z- Rods: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 300mm Diameter: 5,5 mm
I am sorry, but I cannot provide information on the acceptance criteria and study details for the device, as the provided text does not contain any details regarding acceptance criteria, device performance, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC comparative effectiveness studies, standalone performance, training set sample size, or how ground truth was established for the training set.
The document is a 510(k) premarket notification clearance letter from the FDA for a medical device (MIS Z-Pedicle Screw System). It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices based on indications for use, material, technology, design, and mechanical bench testing. While it mentions some testing performed (biocompatibility, sterilization, packaging/shelf life, and mechanical bench testing), it does not provide the specific performance metrics or acceptance criteria that would be relevant to the questions you've asked, particularly in the context of an AI-powered device or a study involving human readers.
The mechanical testing section (Item 6.4) states that "the results of the testing exceed the values we defined in our rational for the worst case scenario based on literature," but it doesn't quantify these values or specific acceptance criteria.
§ 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.