(67 days)
The CD HORIZON® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The CD HORIZON® Growth Rod Conversion Set may be used with any cleared traditional CD HORIZON® Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK Rods. SPIRE™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.
The CD HORIZON® Growth Rod Conversion Set consists of a variety of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct which can be surgically lengthened on a periodic basis as the patient grows. The CD HORIZON® Growth Rod Conversion Set components are manufactured from stainless steel and titanium alloy and are designed to interact with rod-based pedicle screw/hook constructs in which the rods range in diameter from 3.5mm to 5.5mm. The CD HORIZON® Growth Rod Conversion Set is specifically to be used with any traditional CD HORIZON® Spinal System (3.5mm to 5.5mm) fusion construct cleared for pediatric usage. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK Rods, SPIRE® Spinous Process Plates and/or Shape Memory Alloy (SMA) Staples. The CD HORIZON® Growth Rod Conversion Set is limited to a posterior approach.
This document is a 510(k) Premarket Notification from the FDA regarding the "CD HORIZON® Growth Rod Conversion Set." It primarily addresses the substantial equivalence of the device to a predicate device, rather than providing a detailed study proving performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not available in the provided text.
However, I can extract the following information based on the document's content:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on specific performance metrics or acceptance criteria for the new device as would be found in a clinical trial report.
Instead, the document states:
- Technological Characteristics: "The subject CD HORIZON® Growth Rod Conversion Set Spinal System has the same fundamental scientific technology as the predicate Harrington Spinal Rod System for the treatment of spinal deformities in a nonfusion manner. Additionally, the subject CD HORIZON® Growth Rod Conversion Set connectors are substantially equivalent to similar connectors previously cleared in the CD HORIZON® Spinal System (K121764, SE 08/21/12)."
- Conclusion: "The design features, materials used, manufacturing and sterilization methods are equivalent to the pre-amendment Harrington Spinal Rod System device used to treat early onset deformities including early-onset scoliosis in a non-fusion manner and to previously cleared connectors which are contained within the CD HORIZON® Spinal System (K121764)."
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 provided. The document mentions "non-clinical testing" and "comparisons were made to Harrington Rod System," but does not specify sample sizes, data provenance, or study design (retrospective/prospective) related to a test set for performance evaluation.
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 provided. The document does not describe the establishment of ground truth by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. There is no mention of a test set or associated 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 is not applicable to this device. The device is a "Growth Rod Conversion Set" for spinal surgery, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. The device is a surgical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. The document focuses on performance testing to support fusion applications and comparisons to a predicate device, rather than establishing a ground truth for a diagnostic or predictive algorithm.
8. The sample size for the training set
This information is not provided. Given that this is a surgical implant device undergoing 510(k) clearance by demonstrating substantial equivalence, there would typically not be a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons mentioned in point 8.
§ 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.