(139 days)
The Coral ™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The purpose of this submission is for additional sizes and designs of polyaxial screws for the Coral ™ Spinal System. The Coral ™ Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies. The Coral ™ Spinal System implant components are fabricated from medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136.
This is a 510(k) premarket notification for a medical device, specifically the Coral™ Spinal System. It is an application for additional sizes and designs of polyaxial screws, indicating it's an update to an existing device (K041592). The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a novel study proving specific acceptance criteria for a new AI/software device.
Therefore, most of the requested information cannot be extracted from this document because it describes a hardware spinal implant system, not an AI/software device. The document centers on demonstrating that the new components are substantially equivalent to previously cleared devices based on materials, intended use, and mechanical testing, not on clinical performance metrics with an AI component.
Here's what can be gathered, with answers to points that are applicable:
1. A table of acceptance criteria and the reported device performance
- Not applicable for an AI/software device as this is a hardware spinal implant.
- The core of the "acceptance criteria" for this submission is demonstrating substantial equivalence to predicate devices. This is achieved by showing similarities in:
- Indications for use
- Operating principle
- Materials
- Surgical techniques and equipment type
- Manufacturing environment
- Sterilization process
- Packaging configurations
- Mechanical testing (mentioned generically as a reason for substantial equivalence, but no specific criteria or results are provided in this summary).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes a physical medical device (spinal implant). The "test set" for this type of device typically refers to a set of mechanical tests performed in a lab, not a clinical dataset in the context of AI/software. There is no usage of terms like "test set," "data provenance," or "country of origin of data" in this context.
3. 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)
- Not applicable. See point 2. Ground truth establishment with experts is not relevant for this type of hardware device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 2.
5. 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
- Not applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable directly in the AI/software sense. For a physical device, "ground truth" might refer to established engineering standards or biomechanical principles used to design and test the device. The document mentions "mechanical testing" generally, which would be compared against such standards, but no specific ground truth type is detailed.
8. The sample size for the training set
- Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/software device.
Summary of Device Performance (from the perspective of a hardware device):
The document states that the additional components for the Coral™ Spinal System are substantially equivalent to the predicate device (K041592). This claim is supported by:
- Mechanical Testing: Although no specific results or criteria are provided in this summary, the document explicitly mentions "mechanical testing" as evidence for substantial equivalence, alongside the use of "established, known materials." This implies that the new components underwent mechanical tests to demonstrate performance comparable to the predicate device and relevant industry standards.
- Material Composition: The components are fabricated from "medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136 and ISO 5832-3," which indicates adherence to recognized material standards for biocompatibility and strength.
- Design and Function: The components maintain the same indications for use, operating principle, surgical techniques, manufacturing environment, sterilization process, and packaging configurations as the predicate device.
The FDA's decision to clear the device (K070962) with a finding of substantial equivalence indicates that the submitted evidence and performance data (including implied mechanical testing data not detailed in this summary) were deemed sufficient to meet the regulatory requirements for this type of hardware medical device.
§ 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.