(249 days)
The Triple-Fix Spinal System is a pedicle screw system 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: degenerative spondylolithesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudoarthrosis).
The posterior Triple-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The posterior Triple-Fix System, when not used with pedicle screws is indicated for hook, wire, and /or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.
The Advanced Spine Technology Triple-Fix Spinal System is a system that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, plates, and accessory connection components.
The provided document does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria in the way typical for AI/ML device submissions (e.g., performance metrics against a defined standard). This 510(k) pertains to a spinal fixation system, which is a physical medical device, not an AI/ML algorithm.
Therefore, many of the requested categories are not applicable to traditional hardware device submissions like this one. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a clinical or algorithmic study.
Here's an analysis based on the information provided and a recognition of the device type:
Device Type: Spinal Fixation System (physical hardware)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from Substantial Equivalence and Testing) | Reported Device Performance (from submission) |
|---|---|
| Substantial Equivalence to Predicate Devices: |
- Product Components
- Indications for Use
- Materials
- Product Labeling
- Packaging/Sterilization | The Triple-Fix Spinal System is substantially equivalent to the Isola Spinal System and the Mirage Spinal System.
- Product Components: Screws, Connectors, Plates, Rods, and offset Connectors (similar to predicates).
- Indications for Use: Identical to predicates.
- Materials: Stainless Steel or Titanium (similar to predicates).
- Product Labeling: Instructions for use and box labeling including all necessary warning statements (similar to predicates).
- Packaging/Sterilization: Non-sterile, single use only (similar to predicates). |
| Mechanical Performance: - Meeting relevant ASTM standards for spinal implant systems (e.g., ASTM F1717) | Testing was completed as per ASTM F1717 in order to demonstrate equivalence. The results of testing are included in appendix 1 of the submission. (Specific results are not detailed in the provided text, but the statement indicates the testing was done and met the requirements to demonstrate equivalence). |
| Biocompatibility: (Implied for implantable devices) | Manufactured from titanium which complies with ASTM F136 (a standard for wrought titanium-6aluminum-4vanadium alloy for surgical implant applications). This compliance suggests biocompatibility. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of an AI/ML test set. For mechanical testing (like ASTM F1717), a certain number of device samples would be tested, but the specific number is not provided in this summary.
- Data Provenance: Not applicable in the AI/ML sense. Mechanical testing data would be generated in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical implant, not an AI/ML diagnostic or prognostic tool requiring expert consensus for ground truth.
4. Adjudication method for the test set
- Not applicable.
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 a physical device.
7. The type of ground truth used
- Not applicable in the AI/ML context. For a physical device, the "ground truth" for demonstrating safety and effectiveness relies on:
- Validated engineering principles and materials standards: Such as compliance with ASTM F136 for materials and ASTM F1717 for mechanical testing.
- Demonstration of substantial equivalence to legally marketed predicate devices: Which have established safety and effectiveness.
8. The sample size for the training set
- Not applicable. There is no AI/ML training set for this device.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML training set for this device.
Summary of Device Acceptance Philosophy (for this type of device):
The acceptance of the Triple-Fix Spinal Fixation System is based primarily on demonstrating substantial equivalence to existing legally marketed predicate devices (Isola Spinal System, Mirage Spinal System). This involves showing similar:
- Design and components
- Intended use and indications
- Materials of construction
- Labeling
- Packaging and sterilization
Crucially, the submission also references mechanical testing (ASTM F1717) to scientifically demonstrate that the device performs equivalently to or better than the predicate devices in terms of its structural integrity and functional requirements in a simulated environment. The "acceptance criteria" here are that the device meets the performance characteristics of its predicates and relevant engineering standards, thereby ensuring comparable safety and effectiveness.
§ 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.