(50 days)
The Reliance Spinal Screw System is a pedicle screw system intended to provide immobilization 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: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reliance Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used posteriorly, the Reliance Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for: spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The Reliance Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
When used in a percutaneous, posterior approach with MIS instrumentation, the Reliance Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.
The Posterior Reliance Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated polyaxial screws, cannulated reduction screws, hooks, reduction hooks, set screws and transverse connectors.
The Anterior Reliance Spinal Screw System consists of spinal rods, monoaxial screws, staples, and set screws. The Anterior Reliance staples and screws are intended to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section)
The Reliance Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.
The subject Reliance Spinal Screw offers two new fenestrated screw systems (single and circumferential) for use with saline or radiopaque dye only, a percutaneous screw system, and two barend rod systems. These additions will be available in similar sizes, material and configurations as the currently approved Reliance Spinal Screws.
This document is a 510(k) Premarket Notification from the FDA regarding the Reliance Spinal Screw System. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study to prove acceptance criteria for a new device's performance. Therefore, the requested information, which pertains to studies demonstrating a device's performance against defined acceptance criteria (common for AI/ML or diagnostic devices), is largely not applicable in this context.
However, I can extract the relevant information regarding acceptance criteria in the form of substantial equivalence and the type of data presented to support that equivalence.
Here's an analysis based on the provided text:
Device: Reliance Spinal Screw System
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for a spinal screw system, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices in terms of design, materials, intended use, and mechanical performance. There isn't a performance table in the typical sense of a diagnostic or an AI/ML device (e.g., sensitivity, specificity).
| Acceptance Criteria (for Substantial Equivalence to Predicate Devices) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Intended Use: Match predicate devices. | The Indications for Use are consistent with the predicate devices. |
| Levels of Attachment: Match predicate devices. | The device is intended for fixation at the thoracic, lumbar, and sacral spine, consistent with predicate devices. |
| Design/Configuration: Similar components (rods, screws, hooks, etc.). | The subject device introduces new fenestrated screw systems (single and circumferential), a percutaneous screw system, and two barend rod systems. These are presented as additions/modifications to the existing Reliance Spinal Screw System (K162066) and are considered similar in configuration. |
| Material: Identical or recognized biocompatible and mechanically sound materials. | Components are available in titanium alloy (ASTM F-136) and stainless steel (ASTM F-138). Cobalt-Chrome rods (ASTM F-75 and ASTM F-1537) are also available. These materials are consistent with those found in predicate devices. |
| Size Range: Comparable to predicate devices. | The additions are available in "similar sizes" to the currently approved Reliance Spinal Screws. |
| Strength/Mechanical Performance: Meet recognized standards, or demonstrate no new worst-case scenario. | Non-Clinical Testing (Static Compressive, Static Torsion, Dynamic Compressive) was performed in accordance with ASTM F1717 on the predicate Reliance Spinal Screw System. The current submission argues that the changes and additions "do not represent a new worst case; therefore, no new mechanical performance testing is warranted." |
| Sterilization & Biocompatibility: Consistent with predicate devices. | The subject device is stated to be "substantially equivalent to the predicate devices in terms of sterilization and biocompatibility." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. There is no "test set" in the context of clinical performance evaluation for this type of device in this document. The mechanical testing was done on the predicate device, and the current device is deemed to not require new testing due to no new worst-case scenario.
- Data Provenance: Not applicable for a typical clinical test set. The data cited are from non-clinical mechanical testing standards (ASTM F1717) applied to the predicate device. The information is retrospective in the sense that it relies on prior testing of the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" established by experts in the context of a clinical test set from this document. The assessment is based on engineering principles, materials science, and regulatory comparison.
4. Adjudication method for the test set:
- Not applicable. No clinical test set requiring adjudication 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 is not a diagnostic device or 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 algorithm or AI device.
7. The type of ground truth used:
- The "ground truth" in this context is implicitly the historical safety and effectiveness of the identified predicate devices as demonstrated by their prior FDA clearance and adherence to recognized mechanical testing standards (ASTM F1717). This is a regulatory "ground truth" for substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is described.
In summary: This 510(k) submission for the Reliance Spinal Screw System demonstrates substantial equivalence to predicate devices primarily through non-clinical assessment of design, materials, and existing mechanical testing data from the predicate device, rather than presenting a performance study against specific acceptance criteria for a new clinical performance claim.
§ 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.