(83 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® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) 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.
The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery.
The Navigated Probe is intended to be used during pedicle and disc preparation during spinal fusion procedures.
Navigated 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.
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 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.
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 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 CD HORIZON® Spinal System offers cannulated, multi-axial bone screws that have an opened head (MAS) or closed head (CMAS). The subject screws offer additional angulation for anatomies or trajectories that require a sharper angle than what is typically used when placing a rod into the screw head. The subject MAS and CMAS are provided both sterile and non-sterile.
The subject Medtronic Navigated Reusable probe is specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The subject probe is used to prepare for placement of the subject bone screws into the bone.
The subject Medtronic Reusable drivers, torque multiplier adapter, and taps are spine preparation instruments made of high grade stainless steel. The subject drivers, torque multiplier adapter, and taps are compatible with Medtronic's IPC® POWEREASE® System may be connected to the IPC® POWEREASE® handpiece. The subject drivers, and taps can be used manually using existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece.
The subject Medtronic Navigated Reusable drivers and taps are spine preparation instruments made of high grade stainless steel. These instruments were specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The subject drivers and taps are also compatible with Medtronic's IPC® POWEREASE™ System when connected to the POWEREASE™ handpiece or may be used manually with existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece or the NavLock™ tracker.
The document provided is a 510(k) premarket notification from the FDA for several Medtronic spinal system components and instruments. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and study results for a new AI/Software as a Medical Device (SaMD).
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/SaMD is not present in this document.
This document pertains to traditional medical devices (spinal implants and surgical instruments), and the evaluation methods described are typical for such devices, involving biocompatibility and mechanical testing against recognized standards (e.g., ASTM F1717, ASTM F1798).
Here's the information that can be extracted, albeit not in the context of AI/SaMD:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | The subject devices for biocompatibility are made from widely used medical-grade materials (Cobalt-Chromium-Molybdenum alloys, Titanium-6 Aluminum-4 Vanadium ELI Alloy, Unalloyed Titanium, Stainless Steel, Radel, Silicone, PEEK). For permanent implants (bone screws), they are classified as "Implant Devices - Tissue/bone - C Permanent (>30 days)." For instruments with limited body contact (up to 24 hours), they are classified accordingly. |
| Mechanical Testing (Bone Screws): | The subject devices met the pre-determined acceptance criteria for all tests, indicating substantial equivalence to predicate Medtronic bone screws. |
| Specific Mechanical Tests: | Static Compression |
| Static Torsion | |
| Construct Compression Fatigue | |
| Axial Grip | |
| Axial Torsion | |
| Flexion Extension Static | |
| Flexion Extension Fatigue | |
| Design Validation (Instruments): | Performed and demonstrated that the subject instruments performed as intended. |
Missing Information (as it relates to AI/SaMD):
- Specific numerical values or thresholds for the acceptance criteria for mechanical testing are not detailed (e.g., "Pass" is stated, but the exact pass/fail criteria and specific measured values are not provided).
- The document does not describe the types of studies typically conducted for AI/SaMD (e.g., diagnostic accuracy studies).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not present as the studies described are in vitro mechanical and biocompatibility tests of physical devices, not data-driven performance evaluations of an algorithm. There is no "test set" in the context of data for an AI/SaMD.
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 present. Ground truth in the context of AI/SaMD refers to expert-validated labels or outcomes. For traditional medical devices and the tests described, ground truth is established by objective measurements against engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not present. Adjudication is relevant for resolving discrepancies in expert labeling of data, which is not applicable to the types of tests described in this document.
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 present. MRMC studies are specific to evaluating diagnostic devices, particularly those involving human readers and AI assistance. This document describes physical spinal system components and instruments.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not present. There is no standalone algorithm being evaluated in this submission.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the biocompatibility evaluation, the "ground truth" is defined by established international standards (ISO-10993) and the known safe history of the materials used in medical implants.
- For mechanical testing, the "ground truth" is established by adherence to recognized ASTM standards (e.g., ASTM F1717, ASTM F1798) and pre-determined engineering acceptance criteria.
8. The sample size for the training set
- This information is not present. There is no "training set" as this is not an AI/SaMD submission.
9. How the ground truth for the training set was established
- This information is not present. As there is no training set for an AI/SaMD, this question is not applicable.
§ 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.