(110 days)
The FloSpine Canaveral Pedicle System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used for posterior non-cervical pediction in pediatric patients, the Canaveral Pedicle Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Canaveral Pedicle Screw System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to the posterior approach.
The Canaveral Pedicle Screw System is indicated to provide the surgeon with a minimally invasive approach for posterior spine surgery.
The FloSpine Canaveral Pedicle Screw System comprises non-sterile, single use, titanium alloy components for creating a posterior spinal implant construct. The system attaches to the spine through a component system comprising of pedicle screw assemblies for open and minimally invasive procedures, rods, hooks and set screws. The system is designed to stabilize the spine during the fusion process. The screws are available as monoaxial, uniplanar and polyaxial screws in both cannulated and non-cannulated forms. The rods are available as straight and precurved rods and are available in 2 diameters and multiple lengths. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136. Some rods are made from cobalt chrome which complies with ASTM F1537.
The provided text is a 510(k) Summary for the Canaveral Pedicle Screw System. It outlines the device description, indications for use, and a comparison to predicate devices, along with performance standards for pre-clinical testing.
However, the document does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or details about training sets. The primary focus of this document is to establish substantial equivalence to predicate devices for regulatory clearance based on materials, function, sizes, and mechanical test results, as per ASTM F1717-10.
Therefore,Based on the provided document, the following is what can be extracted:
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Table of acceptance criteria and the reported device performance:
The document refers to mechanical testing as per ASTM F1717-10, but does not provide specific acceptance criteria values or the device's reported performance against those criteria in a table format. It states that the device is substantially equivalent to predicate devices based on "mechanical test results." -
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available in the provided text. The document refers to "pre-clinical testing" for mechanical performance but does not specify sample sizes or data provenance. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable and not available. The document describes mechanical performance testing, not a study involving human assessment of images or clinical outcomes that would require expert-established ground truth. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not available. As above, the testing described is mechanical, not involving human adjudication. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not available. The device is a "Pedicle Screw Spinal System," a physical implant, not an AI-powered diagnostic or assistive tool for human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not available, as the device is a physical implant, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the mechanical testing would be defined by the specified parameters and methodologies of the ASTM F1717-10 standard itself. It's about engineering specifications and material properties, not clinical ground truth. -
The sample size for the training set:
This information is not applicable and not available. The document describes a physical medical device, not an AI or machine learning model that would require a training set. -
How the ground truth for the training set was established:
This information is not applicable and not available, for the same reason as point 8.
§ 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.