(128 days)
The Radius™ Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the Radius™ Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative disc disease (DDD) (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, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion. The Radius™ Spinal System can also be linked to the Xia® Titanium Spinal System via the Ø5.5 mm to Ø6.0 mm Radius™ rod-to-rod connector
This 510(k) is intended to introduce an extension to the existing Radius™ Spinal System. The proposed line extension includes additional staples, and connectors.
This document describes a Special 510(k) Premarket Notification for a line extension to the Radius™ Spinal System, not a software device or an AI model. Therefore, the typical acceptance criteria and study designs associated with AI/ML-driven medical devices (like those related to performance metrics, expert reviews, ground truth, and training/test sets) are not applicable here.
The provided text pertains to a Class III and Class II spinal fixation system, which is a physical implant. The "study" mentioned refers to engineering analysis and testing to demonstrate compliance with FDA guidance for spinal systems, focusing on material, design, and indications for use.
Here's an breakdown of the relevant information provided, structured to show why the requested AI/ML specific details cannot be fulfilled:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Type | Acceptance Criteria Standard | Reported Device Performance | Comments (Why AI/ML criteria are not applicable) |
|---|---|---|---|
| Substantial Equivalence (Core for this submission) | Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004, regarding material, design, and indications for use as compared to predicate devices. | "Documentation is provided which demonstrates the new components of the Stryker Spine Radius™ Spinal System to be substantially equivalent to the predicate devices in terms of material, design, and indications for use." | This is about physical device attributes and intended use, not AI-driven performance metrics like sensitivity, specificity, AUC, etc. |
| Mechanical/Physical Testing | Not explicitly detailed in the summary, but implied by "Engineering analysis and testing." This would typically involve fatigue testing, static testing, torsional rigidity, etc., as per relevant ASTM or ISO standards for spinal implants. | "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spine Radius™ Spinal System, including the subject components." | Specific performance values (e.g., N.m for torsion, cycles for fatigue) are not included in this summary. These are physical characteristics, not AI performance metrics. |
| Material Compatibility | Biocompatibility standards (e.g., ISO 10993). | Not explicitly stated, but implied by "material" aspect of substantial equivalence. The device is a "Spinal Fixation Appliance" likely made of metals (e.g., Titanium as per the linked Xia® Titanium Spinal System). | This pertains to the materials used in the physical device, not an AI model. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This is a physical device, and testing involves physical specimens and engineering analyses, not a "test set" of data in the AI/ML sense.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. "Ground truth" in this context refers to established engineering principles, regulatory standards, and comparison to legally marketed predicate devices, not expert consensus on medical images or patient data.
- Qualifications of Experts: The experts involved would be engineers, materials scientists, and regulatory affairs professionals specializing in medical device design and spinal implants.
4. Adjudication Method
- Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in human annotations or diagnostic interpretations for AI model training or evaluation. For a physical device, compliance is assessed against predefined engineering specifications and regulatory guidance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. This type of study is specifically designed to assess the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. It is not relevant for a physical spinal implant.
- Effect Size of AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. There is no algorithm or software being evaluated for standalone performance.
7. The Type of Ground Truth Used
- Type of Ground Truth: For this type of device, the "ground truth" for demonstrating substantial equivalence is:
- Regulatory Standards: Compliance with FDA's Guidance for Spinal System 510(k)'s (May 3, 2004).
- Engineering Principles: Adherence to established mechanical, material, and design specifications.
- Predicate Device Characteristics: Direct comparison of the new components to the material, design, and indications for use of the predicate devices (Stryker Spine Radius™ Spinal System, Stryker Spine Xia® Spinal System, Medtronic Sofamor Danek CD Horizon® Legacy™ System).
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is a physical device, not an AI model requiring a training data set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable.
In summary: The provided document describes a regulatory submission for a physical medical device (a line extension to a spinal fixation system). The "acceptance criteria" and "study" refer to engineering analyses and testing to ensure the new components are substantially equivalent to existing predicate devices and comply with FDA regulations for spinal implants. The concepts of AI/ML performance, ground truth, and data sets (training/test) are not relevant to this submission.
§ 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.