(117 days)
The Spine 360 Talon Spinal System is 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 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 (pseudoarthrosis).
The Talon Spinal Fixation System was cleared for use via K071824, and is comprised of polyaxial screws, locking plugs, spinal rods and rod to rod connectors. The Talon System can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Spine 360 proposes to add new smaller diameter (4.5mm) screws in various lengths, cannulated screws in various diameters and lengths, pedicle screw spacers as well as the minimally invasive surgical technique for use with the Spine 360 Talon Spinal System. The new components are based upon the same fundamental scientific technology and do not alter the indications for use as compared to the existing system.
This excerpt focuses on the Spine 360 Talon Spinal System, a medical device, and the documentation provided does not include the detailed information about acceptance criteria and a study design that you are requesting for a typical AI/software-as-a-medical-device (SaMD) submission.
The provided document is a 510(k) Summary for a Premarket Notification (K102995) for a Spinal Fixation System. This is a physical medical device (implants for spinal fusion) and the regulatory submission heavily relies on non-clinical (mechanical) testing and demonstration of substantial equivalence to predicate devices, rather than clinical performance studies with acceptance criteria based on human or AI-assisted performance metrics.
Therefore, I cannot directly extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: The acceptance criteria for this device are related to mechanical properties (e.g., strength, stiffness, fatigue) and functional equivalence to predicate devices, not diagnostic performance metrics like sensitivity, specificity, or AUC.
- Sample size used for the test set and the data provenance: Not applicable in the context of this device's testing. Mechanical tests involve test specimens, not patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for mechanical testing would be direct measurements from the tests themselves.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is not a diagnostic device involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant.
- The type of ground truth used: For this device, the "ground truth" for non-clinical testing refers to the physical properties measured during mechanical tests against established ASTM standards and against predicate device performance.
- The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
What is present in the document is:
1. Acceptance Criteria (implied through non-clinical test summary and substantial equivalence justification):
The acceptance criteria for this type of device are primarily based on:
- Meeting or exceeding the performance standards of recognized ASTM standards (e.g., ASTM F1717-09 for Static Compression Bending, Dynamic Compression Bending).
- Demonstrating equivalence or better performance (in terms of compression bending performance, stiffness, and dynamic compression bending fatigue strength) compared to the predicate devices.
- Providing stability greater than tolerated thresholds in range of motion and stiffness limits of the human lumbar spine, and adequately stabilizing a fusion site.
2. Reported Device Performance (Summary):
The document states:
- "The Spine 360 Spinal Fixation System proposed additional 4.5 screws, cannulated screws and spacers demonstrated equivalence or better in compression bending performance and stiffness to the predicate device listed."
- "The dynamic compression bending fatigue strength for the Spine 360 Spinal Fixation System had already demonstrated a greater endurance strength than predicates referenced."
- "The Spine 360 Spinal Fixation System including the smaller 4.5 screws, cannulated screws and spacers will provide stability greater than the tolerated thresholds in range of motion and stiffness limits of the human lumbar spine and will adequately stabilize a fusion site."
In summary, the provided document describes a medical device undergoing a 510(k) clearance process based on substantial equivalence and mechanical testing, not a software or AI device requiring the type of clinical validation study details you've requested.
§ 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.