(58 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 (DDD - 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, 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 titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.
With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted.
When used for posterior non-cervical pedicle screw fixation in pediatric patients. CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel 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 diagnosed pediatric patients --------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 and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
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: DDD, spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, 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 Vertex™ indications.
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC™ Powerease™ System. Do not implant the instruments.
The IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC™ Powerease™ System is indicated for drilling, tapping and driving screws 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. Do not implant instruments.
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.
A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5 to 6.35mm), hooks, screws, CrosslinkTM plates and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. Screws used in pediatric cases are only cleared for use via a posterior approach. Components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium alloy, and medical grade cobalt-chromiummolybdenum alloy.
Certain implant components from other Medtronic spinal systems can be used with the CD Horizon™ Spinal System in non- pediatric cases. These components include TSRH™ rods, hooks, screws, plates, Crosslink™ plates, connectors, staples and washers, GDLH™ rods, hooks, connectors and Crosslink™ bar and connectors; Liberty™ rods and screws; Dynalok™ Plus and Dynalok Classic™ bolts along with rod/bolt connectors; and Medtronic multi-axial rods and screws. Note: certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so the correct components are used in the spinal construct.
CD Horizon™ hooks are intended for posterior use only. CD Horizon™ staples and CD Horizon™ Eclipse™ rods and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD Horizon™ 4.5mm rods and associated components may be used posteriorly.
CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, medical grade cobalt-chromiummolybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
Never use stainless steel and titanium implant components in the same construct.
Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. The CD Horizon™ Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTì). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.
PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column.
To achieve best results, do not use CD Horizon™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD Horizon™ System components should ever be reused under any circumstances.
Medtronic Navigated Reusable Instruments are spine preparation instruments made of high grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field.
Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. These instruments are also compatible with Medtronic's IPC™ Powerease™ System when connected to the Powerease™ Driver.
The Medtronic Reusable Instruments compatible with Medtronic's IPC™ Powerease™ System are spine preparation instruments, manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. Instruments may be connected to the Powerease™ Driver or used manually. These instruments are also compatible with various Medtronic spinal implant systems.
This looks like a 510(k) submission summary for a spinal system, not a device that uses AI/ML for diagnostic or prognostic purposes, which is typically where the detailed acceptance criteria and study design information you're asking for would be found.
The document describes a mechanical spinal system and its instruments, focusing on substantial equivalence to predicate devices based on design, intended use, indications for use, and mechanical testing. It does not contain information about AI-driven performance, ground truth establishment, expert adjudication, or human-in-the-loop studies.
Therefore, I cannot provide the information requested in your bullet points because the provided text does not contain it. The acceptance criteria mentioned refer to mechanical performance tests for the spinal implants and instruments, not diagnostic performance of an AI algorithm.
Specifically:
- 1. A table of acceptance criteria and the reported device performance: The document states that "For subject devices that are tested have met the predetermined acceptance criteria for all tests." The tests are identified as ASTM F1798 (Axial Grip, Axial Torsion, Flexion Extension Static, Flexion Extension Fatigue) and ASTM F1717 (Static Compression, Static Torsion, Compression Fatigue). However, the specific quantitative acceptance criteria (e.g., maximum deflection, fatigue cycles survived) and the exact reported performance values are not detailed in this summary.
- 2. Sample sized used for the test set and the data provenance: Not applicable in the context of mechanical testing of physical implants. The "test set" here refers to the physical devices undergoing mechanical stress tests.
- 3. Number of experts used to establish the ground truth...: Not applicable. Ground truth for an AI device is clinical truth, not mechanical test results.
- 4. Adjudication method...: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable for mechanical spinal implants. The "ground truth" for these tests would be the physical properties and structural integrity of the materials and design under specified loads.
- 8. The sample size for the training set: Not applicable (no AI/ML training is described).
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this document pertains to a traditional medical device (spinal hardware) and confirms its substantial equivalence through mechanical testing, not through clinical performance evaluation of an AI/ML algorithm.
§ 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.