(85 days)
The new CD HORIZON® ECLIPSE™ components are intended for the following indications:
When used as an anterolateral thoracic/lumbar 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.
The CD HORIZON® system is also 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.
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.
Certain implant components from other 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; DYNA-LOK® bolts; and 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.
The purpose of this 510(k) submission is to add CD HORIZON® ECLIPSE™ (4.5mm rods and associated bone screws to the system.
This document is a 510(k) Pre-market Notification for the CD HORIZON® Spinal System. It seeks to add CD HORIZON® ECLIPSE™ (4.5mm rods and associated bone screws) to the existing system. The core of this document is demonstrating substantial equivalence to a predicate device, which in this case, is the CD HORIZON® Spinal System itself.
Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as it would apply to a machine learning or diagnostic device with performance metrics (sensitivity, specificity, etc.) is not directly applicable here. This document is about regulatory clearance for a medical implant, not a diagnostic algorithm.
Let's break down why and how to interpret the provided information in the context of your request:
Key Takeaway: This is a 510(k) submission for a physical medical implant, not a software/AI device. The "acceptance criteria" here is primarily demonstrating "substantial equivalence" to a legally marketed predicate device, rather than meeting specific performance thresholds like accuracy or recall.
Here's how to address your specific points based on the provided text, recognizing the different nature of this medical device submission:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a spinal implant system seeking substantial equivalence to itself, the "acceptance criteria" are not performance metrics in the way you might expect for a diagnostic device. Instead, the acceptance criterion is demonstrating that the new components (CD HORIZON® ECLIPSE™ rods and screws) are substantially equivalent in intended use, fundamental scientific technology, and safety/effectiveness considerations to the existing, legally marketed CD HORIZON® Spinal System.
| Acceptance Criterion (for 510(k)) | Reported Device "Performance" (Conclusion) |
|---|---|
| Substantial Equivalence to Predicate Device (CD HORIZON® Spinal System) | "Documentation was provided which demonstrated the CD HORIZON Spinal System to be substantially equivalent to itself." "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical study with a "test set" in the context of evaluating an AI or diagnostic device's performance. The "documentation" supporting substantial equivalence typically includes:
- Design specifications and materials: Showing the new components are similar in design and material to the predicate.
- Mechanical testing: Bench testing (e.g., fatigue, static strength) to demonstrate that the new components meet established standards or are comparable to the predicate.
- Biocompatibility testing: To ensure the materials are safe for implantation.
The text does not specify the details of any mechanical or biocompatibility testing, including sample sizes or data provenance. The focus of this summary is the regulatory conclusion.
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 is not applicable. "Ground truth" in this context would likely refer to engineering specifications and performance standards for an implant, not an expert panel's interpretation of medical data. The FDA's review process itself involves internal experts (e.g., engineers, medical officers) evaluating the submission, but they are not establishing "ground truth" for a test set in the way a radiologist panel would for an imaging AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above.
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 is not applicable. An MRMC study is designed for evaluating diagnostic performance, typically with AI assistance for human readers. This submission is for a physical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. There is no algorithm being evaluated in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a medical implant like the CD HORIZON® Spinal System, "ground truth" in terms of its safety and effectiveness is established through:
- Engineering principles and biomechanical testing standards: Demonstrating that the device can withstand the forces it will experience in the body.
- Material science: Confirming biocompatibility and durability of materials.
- Clinical experience (of the predicate): The existing CD HORIZON® Spinal System has a track record of safe and effective use, which the new components are leveraging through substantial equivalence.
The document doesn't detail these underlying "truths" but relies on the FDA considering them established for the predicate device.
8. The sample size for the training set
This is not applicable. There is no AI model or "training set" in this context.
9. How the ground truth for the training set was established
This 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.