(67 days)
In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth 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, as part of a growing rod construct.
CREO® Stabilization System: In-Line Connector Growing Rods consist of rod-to-rod connectors which can be surgically lengthened on a periodic basis as the patient grows. These connectors may be used as part of a growing rod construct consisting of rods, screws, hooks, offset connectors, and cross-connectors, and are limited to a posterior approach. When used as part of a growing rod system, In-Line Connector Growing Rods are intended for use only with CREO® Stabilization System fusion constructs cleared for pediatric use. In-Line Connector Growing Rods are manufactured from titanium alloy.
REVERE® Stabilization System: In-Line Connector Growing Rods consist of rod-to-rod connectors which can be surgically lengthened on a periodic basis as the patient grows. These connectors may be used as part of a growing rod construct consisting of rods, screws, hooks, offset connectors, and cross-connectors, and are limited to a posterior approach. When used as part of a growing rod system, In-Line Connector Growing Rods are intended for use only with REVERE® Stabilization System fusion constructs cleared for pediatric use. In-Line Connector Growing Rods are manufactured from titanium alloy.
The provided documents are a 510(k) summary and FDA clearance letters for the CREO® Stabilization System and REVERE® Stabilization System. These documents pertain to medical devices, specifically stabilization systems for spinal deformities, not AI/ML-driven diagnostic or prognostic tools. Therefore, much of the requested information about acceptance criteria, study design for AI performance, expert adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable to this submission.
The FDA clearance is based on the substantial equivalence of the devices to legally marketed predicate devices, not on a study proving the device meets specific acceptance criteria in the context of AI/ML performance metrics (like sensitivity, specificity, AUC).
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for medical devices (spinal stabilization systems) and not an AI/ML diagnostic tool, traditional performance metrics like sensitivity, specificity, or AUC with predefined acceptance criteria are not provided. The "performance" is demonstrated by showing that the technological characteristics and intended use are substantially equivalent to existing, legally marketed predicate devices.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Primary Basis for Clearance: Substantial Equivalence to Predicate Devices | The subject CREO® and REVERE® implants have the same intended use, similar indications for use, similar technological characteristics and design, same materials, and the same principles of operation as predicate CD HORIZON Growth Rods (K133904, K150200) and K2M Growing Spine System (K161028), as well as previously cleared versions of CREO® and REVERE® Stabilization Systems. |
| Safety Profile | Based on clinical literature review, the safety profile of the subject devices is equivalent to that of the predicate devices. Risks associated with growing rod use were identified and mitigated through design and surgical technique. |
| Technological Characteristics (as compared to predicates) | Identical technological characteristics, including design, intended use, material composition, function, and range of sizes. |
| Mechanical Testing, Sterilization, Biocompatibility, Endotoxin Testing (not performed for this specific submission but implied by prior clearances) | "No mechanical testing, sterilization, biocompatibility, or endotoxin testing was completed for this submission as these devices are previously cleared." This implies that the components used have already met these criteria in prior submissions for the devices themselves or their constituent parts, and the current submission is for additional indications for existing components (in-line connectors) within the systems. |
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. This submission is for substantial equivalence of a physical medical device. It does not involve a "test set" in the context of evaluating an AI/ML algorithm's performance on a dataset. The "data" provenance mentioned is a "clinical literature review."
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. There was no "ground truth" to establish for a test set in the context of AI/ML performance. The review of clinical literature would have been performed by the manufacturer's regulatory and clinical affairs team to support their claims of safety and equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no "test set" requiring adjudication for AI/ML performance.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of AI/ML. The "ground truth" for this medical device submission is the established safety and effectiveness of the predicate devices and the scientific and engineering principles demonstrating the equivalence of the new device. The submission mentions a "clinical literature review" which would draw from published studies, which in turn might report on pathology, outcomes data, or expert clinical observations for the predicate and similar devices.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set for which a ground truth needs to be established.
§ 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.