(29 days)
It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial pedicle screws and offset connectors are limited to the thoracic spine (T1-T3) in treating thoracic conditions only. These screws and offset connectors are not intended to be placed in the cervical spine. The components in the SOLANAS Posterior stabilization system can be linked to the components in the Zodiac Polyaxial spinal fixation system offered by Alphatec Spine using the axial rod connectors, parallel rod connectors or transitional rods
- Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- Spondylolisthesis
- Spinal stenosis
- Fracture/Dislocation
- Atlanto/Axial fracture with instability
- Revision of previous cervical spine surgery
- Tumors
The Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graff healing and/or fusion mass development. Device implants include a range of sizes of bone screws, hooks, rods and bridge assemblies to provide the versatility required for the specific conditions listed in the indications. The implants are manufactured from surgical grade titanium alloy (Ti-6AI-4V, ASTM F 136) with an electrolytic conversion coating. All hook components are intended for fixation/attachment to the cervical spine only (CI-C7). It is intended that the implants be removed after successful fusion.
The Solanas Posterior Stabilization System is a rod system designed to improve the stability of the cervical, cervico-thoracic and upper thoracic spine from C1-T3. This titanium alloy (Ti6Al-4V ELI, ASTM F136) system is simple in design and in its application of posterior rod fixation. It contains integrated functioning screws, rods, hooks, and connectors. The laminar hooks are an integral part of this system providing stabilization to the cervical (C1-C7) portion of the spine. These hooks attach to the lamina via the blade portion of the hook on one end and to a rod via a set screw and collar connection on the other end.
The provided text is related to a 510(k) premarket notification for a medical device called the "Solanas Posterior Stabilization System." This document is a regulatory filing for a spinal implant system and does not describe a study involving device performance metrics, human readers, or AI.
Therefore, I cannot extract information related to:
- A table of acceptance criteria and reported device performance (in terms of clinical or algorithmic metrics)
- Sample sizes for test sets or data provenance in the context of device performance
- Number and qualifications of experts for ground truth
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance studies
- Type of ground truth used (expert consensus, pathology, outcomes data)
- Sample size for the training set
- How ground truth for the training set was established
However, I can provide information about the non-clinical testing performed to establish substantial equivalence for this spinal implant system.
Based on the provided text, here is the relevant information:
Acceptance Criteria and Study for the Solanas Posterior Stabilization System (Mechanical Testing)
The Solanas Posterior Stabilization System is a spinal implant. The "acceptance criteria" and "study" mentioned in the document refer to mechanical testing performed to demonstrate that the modified device (with larger hook blades of 7mm and 8mm) is substantially equivalent to a previously cleared predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Static anterior/posterior mechanical property measurements as outlined in ASTM F1798 | "produced acceptable results" |
| Performance per recognized consensus standards and guidance document: "Guidance for Industry and FDA Staff: Spinal System 510(k)s (2004)" | "demonstrates that the Solanas Posterior Stabilization System is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not specify the exact number of units or subassemblies tested. It refers to "a subassembly" and "the subject and predicate devices."
- Data provenance: Not applicable in the context of mechanical testing of physical devices. The testing was performed by Alphatec Spine, Inc.
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. This was mechanical testing of a medical device, not a study involving ground truth established by medical experts. The "ground truth" here is the adherence to mechanical testing standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This refers to consensus among human readers, which is not relevant for mechanical testing.
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 a 510(k) for a physical spinal implant, not an AI or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is for a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this mechanical test, the "ground truth" or reference standard would be the established mechanical testing standards and parameters defined in ASTM F1798 and FDA guidance documents. The performance of the modified device was compared against these standards and the predicate device's performance.
8. The sample size for the training set:
- Not applicable. This refers to mechanical testing, not a dataset used for training an algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document describes a regulatory submission for a physical medical device. The "study" mentioned is a mechanical performance comparison to demonstrate substantial equivalence, rather than a clinical trial or an AI/imaging device performance study with expert-adjudicated ground truth.
§ 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.