(170 days)
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC® POWEREASE™ System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.
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The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
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MEDTRONIC REUSABLE INSTRUMENTS COMPATIBLE WITH THE IPC® POWEREASE® System
The Medtronic Reusable drivers and taps that are compatible with Medtronic's IPC® POWEREASE® System are spine preparation instruments, which are manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The subject taps and drivers may be connected to the POWEREASE® Driver or used manually if desired. These instruments are also compatible with various Medtronic spinal implant systems.
This document is a 510(k) Pre-market Notification for the Medtronic Sofamor Danek CD HORIZON® Spinal System and the IPC® POWEREASE® System. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/algorithm-driven device.
Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable or not provided in this type of regulatory submission.
The document primarily addresses the safety and effectiveness of the device by comparing its technological characteristics and intended uses to previously cleared devices.
Here's an attempt to answer the questions based on the provided text, indicating when information is not applicable or not found.
1. A table of acceptance criteria and the reported device performance
This document does not present a table of specific acceptance criteria (e.g., performance metrics like sensitivity, specificity, accuracy) or quantitative device performance metrics in the context of an algorithm's classification or prediction capabilities. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of indications for use, technological characteristics, and material safety.
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 submission does not describe a clinical study with a test set of patient data to evaluate algorithmic performance. The "performance data" mentioned refers to material biocompatibility and mechanical testing (not detailed in this summary).
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. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is described.
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/algorithm device that supports human readers; it is a spinal surgical system (implants and instruments).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for an algorithmic performance evaluation is described. The "performance data" refers to biocompatibility testing, where the "ground truth" would be established by standard analytical and biological testing methods for materials.
8. The sample size for the training set
Not applicable. This document is not about an AI/algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary of Relevant Information from the Document:
While the direct questions about "acceptance criteria" for an algorithm's performance are not applicable, the document does contain information about how the substantial equivalence of the device was demonstrated, which is the regulatory "acceptance criterion" for a 510(k) submission.
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Device Description:
- CD HORIZON® Spinal System: Consists of various shapes and sizes of rods, hooks, screws, CROSSLINK® plates, staples, and connecting components, which can be rigidly locked into various configurations.
- MEDTRONIC REUSABLE INSTRUMENTS COMPATIBLE WITH THE IPC® POWEREASE® System: Spine preparation instruments (drivers and taps) manufactured from materials commonly used in orthopedic procedures. These can be connected to the POWEREASE® Driver or used manually.
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Predicate Devices (used for comparison to establish substantial equivalence):
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Comparison of Technological Characteristics:
- The subject Medtronic CD HORIZON® Reusable drivers and taps, compatible with the IPC® POWEREASE® System, have the same fundamental technology and stainless steel materials as the predicate devices.
- Materials: Medical grade stainless steel (ASTM A564, ASTM F899, ASTM A693, Custom 465, Custom 455, 17-4 Stainless Steel).
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Performance Data (Type of data provided, not quantitative results):
- Biocompatibility: The instruments are classified as external communicating devices with limited body contact (up to 24 hours), according to FDA's Draft Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing. (No specific test results are provided in this summary, but the materials meet standards).
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Conclusion: Based on risk analysis and supporting documentation, the subject CD HORIZON® Spinal System is substantially equivalent to the listed predicates.
In essence, this document demonstrates that the new device is as safe and effective as previously cleared devices by showing similar design, materials, and intended use, rather than demonstrating improved or specific quantitative performance against defined clinical acceptance criteria through a study with a test set of data.
§ 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.