(82 days)
The CD HORIZON® system is intended for the following indications:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:
When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® ECLIPSE® components are intended for the following indications: When used as an anterolateral thoracic/Jumbar system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
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. When connecting to the VERTEX™ Reconstruction System in the cervical spine, components are intended for the following indications:
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEXTM Reconstruction System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The use of VERTEX™ multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable and the CD HORIZON® Spinal System may be used with the VERTEX™ Reconstruction System.
The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal Svstem implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. 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® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
This document is a 510(k) summary for the CD HORIZON® Spinal System, a medical device. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than presenting a study proving performance against specific acceptance criteria in the manner of a new AI/software device. Therefore, many of the requested elements (like sample size for test/training, number of experts, adjudication, MRMC, standalone performance, specific acceptance criteria with reported device performance) are not applicable or cannot be extracted from this type of regulatory document.
However, I can extract information related to what it is trying to prove and the mechanism used.
Here's a breakdown of what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
- Inapplicable. This document is not a clinical trial report with pre-defined acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and reported performance metrics against those criteria. Instead, it's a regulatory submission demonstrating "substantial equivalence" of a medical device (spinal fixation system) to previously cleared devices. The "acceptance criteria" here are broad regulatory requirements for substantial equivalence, satisfied by comparing indications for use and technological characteristics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided. No test set or patient data is mentioned in this summary. The review is based on comparisons of product descriptions, indications for use, and technological characteristics to predicate devices.
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/Not Provided. The concept of "ground truth" established by experts for a test set doesn't apply to this type of device submission. The "truth" in this context is established by the regulatory body (FDA) based on documentation of substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. No test set or adjudication process 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 document concerns a physical spinal implant system, not an AI or software device that would involve human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. As mentioned, "ground truth" in the context of typical AI/diagnostic device studies isn't relevant here. The "truth" is whether the device is substantially equivalent to a predicate device, which is a regulatory and engineering assessment.
8. The sample size for the training set
- Not Applicable/Not Provided. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. No training set or associated ground truth establishment is mentioned.
What can be extracted from the document regarding "acceptance" and "proof":
This document is a 510(k) Premarket Notification, which seeks to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "acceptance criteria" are the regulatory standards for substantial equivalence, primarily focusing on comparable Indications for Use and technological characteristics.
Device: CD HORIZON® Spinal System - Addition of Screw w/ Dual Rod Channel
Regulatory Approval Mechanism/Study: 510(k) Premarket Notification, demonstrating Substantial Equivalence.
Predicate Device(s): The document states: "Documentation was provided which demonstrated the CD HORIZON® SPINOUS PROCESS Plate to be substantially equivalent to pre-amendment devices, as well as to the previously cleared CD HORIZON® Spinal System." This implies the predicate device is a combination of pre-amendment devices and/or the existing CD HORIZON® Spinal System.
Table: "Acceptance Criteria" (Regulatory Requirements for Substantial Equivalence) and "Reported Device Performance" (Claimed Equivalence)
| Acceptance Criteria (Regulatory Requirement for Substantial Equivalence for 510(k)) | Reported Device Performance (Claimed by Manufacturer and Accepted by FDA) |
|---|---|
| Regulation Number/Classification: Device must align with existing classification regulations. | Regulation Numbers: 21 CFR 888.3070 (Pedicle screw spinal system), 21 CFR 888.3060 (Spinal intervertebral body fixation orthosis), 21 CFR 888.3050 (Spinal interlaminal fixation orthosis). Regulatory Class: II. Product Code: MNI, MNH, KWQ, KWP. |
| Indications for Use: New device's indications must be substantially equivalent to or narrower than the predicate device. | Indications for Use: The document provides a comprehensive list of indications for the CD HORIZON® Spinal System, SEXTANT Instrumentation, CD HORIZON® ECLIPSE®, and connection to VERTEX™ Reconstruction System (see sections V and "Indications for Use" on pages 5-7). These are deemed substantially equivalent to the predicate devices. |
| Technological Characteristics: New device must have technological characteristics (e.g., materials, design, performance) substantially equivalent to the predicate, or any differences must not raise new questions of safety and effectiveness. | Technological Characteristics: The specific addition is a "Screw w/ Dual Rod Channel" to the existing CD HORIZON® Spinal System. The K031833 submission implies that the design and performance of this addition are substantially equivalent to existing components or do not raise new safety/effectiveness concerns. (Specific details of the technical comparison are not in this summary but were part of the full 510(k) submission). |
| Safety and Effectiveness: Demonstrated by substantial equivalence, meaning the device is as safe and effective as a legally marketed device. | FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This is the FDA's acceptance that the device meets the safety and effectiveness bar for substantial equivalence. |
§ 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.