(80 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, 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 and/or allograft. 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.
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.
- 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. The subject devices include:
• Bone screws
• Rods
• Set Screws
• Extender
• Extender Cap
• Accessories, case, caddies trays, and lids which may be used to transport and sterilize the subject implants and instruments.
The subject CD HORIZON® Spinal System device will be available in similar sizes as the predicate systems.
- MEDTRONIC NAVIGATED REUSABLE INSTRUMENTS For use with StealthStation® and IPC® POWEREASE™ Systems
Medtronic Navigated Reusable Screwdriver is a spine preparation instrument made of high grade stainless steel. This instrument was 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 Screwdriver is compatible with various Medtronic spinal implant systems. This screwdriver is also compatible with Medtronic's IPC® POWEREASET™ System when connected to the POWEREASET™ Driver.
This document refers to the FDA 510(k) premarket notification for the CD HORIZON® Spinal System and Medtronic Navigated Reusable Instruments.
It's important to understand that this is a 510(k) Summary, which establishes substantial equivalence to predicate devices, rather than proving novel safety and efficacy through clinical trials with specific acceptance criteria in the way a PMA (Premarket Approval) submission would. As such, the information you're looking for regarding specific acceptance criteria, study details, human reader performance, and ground truth establishment in the context of an "AI device" is not directly applicable to this type of submission for these specific medical devices.
The "device" in this context refers to spinal implants (rods, screws, etc.) and navigated surgical instruments, not an AI or algorithm-driven diagnostic or therapeutic device. The "studies" are primarily mechanical testing and biocompatibility evaluations to ensure material safety and functional equivalence to already approved devices.
Therefore, many of your requested points, particularly those related to AI algorithm performance, ground truth, expert consensus, and MRMC studies, will not be found in this document.
Here's an attempt to answer your questions based on the provided text, with clarifications where the information is not present or not relevant to this type of device submission:
1. A table of acceptance criteria and the reported device performance
For the CD HORIZON® Spinal System (implants), the acceptance criteria are generally related to the design and material characteristics being equivalent to legally marketed predicate devices, and demonstrating mechanical integrity and biocompatibility.
For the Medtronic Navigated Reusable Instruments, the acceptance criteria relate to the instruments having the same fundamental technology and material as predicate devices, and being suitable for their intended use with the StealthStation® System and IPC® POWEREASE™ System.
| Acceptance Criteria (Implied from the 510(k) Summary) | Reported Device Performance/Evidence from Submission |
|---|---|
| For CD HORIZON® Spinal System: | |
| Material Biocompatibility (as per ISO-10993) | • Bone screws, rods, set screws: Made of identical materials (Cobalt-28-Chromium-6-Molybdenum, Unalloyed Titanium, Titanium-6 Aluminum-4 Vanadium ELI) as predicate devices, conforming to relevant ASTM standards (F1537, F67, F136). Classified as permanent, >30 day body contact. |
| • Extender, Extender Cap, Screwdriver: Made of same medical grade stainless steel as predicate devices, conforming to ASTM standards (F899, A564, A693, A276). Classified as limited, up to 24 hours body contact. | |
| • Cases/trays: Non-patient contacting, no biocompatibility testing required. | |
| • Materials (Cobalt Chrome, Titanium, Stainless Steel) have a long history of safe use, so specific testing not required for these. | |
| Mechanical Equivalence to Predicate Devices | • Subject devices evaluated for substantial equivalence to predicate devices (K142847, K091974, K113529, K132639, K102555, K141605). |
| • Determined that subject devices do not represent a new worst case. | |
| • Engineering rationales used to demonstrate substantial equivalence. | |
| For Medtronic Navigated Reusable Instruments: | |
| Fundamental Technology & Material Equivalence | • Same fundamental technology and stainless steel material as predicate devices (K140454). |
| Compatibility with StealthStation® and IPC® POWEREASE™ Systems | • Specifically designed for use with StealthStation® System. |
| • Compatible with IPC® POWEREASE™ System. | |
| Intended Function for Locating Anatomical Structures | • Intended to assist surgeons in precisely locating anatomical structures during spinal surgery. |
| • Tracks instruments using Medtronic single-use sterile spheres and StealthStation® Image Guidance System. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable in the context of this 510(k) summary. The submission relies on mechanical testing, material specifications, and comparisons to legally marketed predicate devices, not on a human clinical "test set" with patient data.
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)
This information is not applicable. There was no "test set" requiring expert ground truth in the way an AI diagnostic algorithm would. The determination of "substantial equivalence" is made by the FDA based on the provided engineering, material, and performance data, and comparison to predicate devices, not by clinical experts establishing a ground truth for a dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Since there was no clinical "test set" requiring ground truth establishment, there was no adjudication method.
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
This information is not applicable. The devices (implants and navigated instruments) are not AI-driven diagnostic or interpretative tools. No MRMC comparative effectiveness study was performed or is relevant for this type of device submission. The instruments are tools to assist the surgeon in placement, but their effectiveness is not measured by "human reader improvement with AI."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. These devices are not standalone algorithms. The navigated instruments are tools used by a human surgeon, relying on image guidance systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The "ground truth" for this submission revolves around:
- Material specifications: Conformance to ASTM standards for metals.
- Mechanical performance: Engineering rationales and testing to ensure the devices perform equivalently to predicates in terms of strength, fatigue, etc. (Though specific test results are not detailed in this summary, they would be part of the full submission).
- Biocompatibility: Conformance to ISO-10993 standards and historical safe use of materials.
8. The sample size for the training set
This information is not applicable. These are not AI/machine learning devices, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. As these are not AI/machine learning devices, there is no "training set" or associated ground truth.
§ 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.