(53 days)
The SpineWorks™ FixxSure® X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:
- i) Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra;
- ii) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
- iii) Fracture;
- Dislocation; iv)
- Scoliosis: v)
- vi) Kyphosis;
- vii) Spinal tumor; and
- viii) Previous failed fusion (pseudarthrosis).
The SpineWorks™ FixxSure® X-Link can also be used with the Talon® Pedicle Screw System.*
The SpineWorks FixxSure X-Link is a transverse stabilizing device utilized to increase the strength of a pedicle screw instrumentation construct in posterior spinal fusion. The FixxSure implant comes in multiple lengths and has the capability of being manipulated into various planes of anqulation. The FixxSure implant has a proprietary dual locking mechanism allowing maximum cross-Link/rod connection while maintaining ease of insertion/use.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria & Test | Reported Device Performance |
|---|---|
| Mechanical Testing | |
| Dynamic compression bending | Both constructs successfully completed 5,000,000 cycles. |
| (ASTM F1717-14) | |
| Applied load: 175N (7.0Nm) | |
| Frequency: 5Hz | |
| Test duration: 5,000,000 cycles |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Two Excella II pedicle screw constructs with the FixxSure X-Link were tested.
- Data Provenance: The document does not specify the country of origin for the data. The testing was non-clinical, implying it was conducted as part of the device development and validation by Innovasis, Inc. or a contracted testing facility. It is retrospective in the context of the 510(k) submission, meaning the tests were completed before the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the "test set" in this context refers to physical device constructs undergoing mechanical testing, not a dataset requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" in this context refers to physical device constructs undergoing mechanical testing, not a dataset requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not applicable. The document describes a mechanical performance (non-clinical) study, not a clinical effectiveness study involving human readers or AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. The device, FixxSure® X-Link, is a physical medical implant, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective mechanical performance metrics as defined by the ASTM F1717-14 standard. The standard itself provides the criteria for evaluating the device's ability to withstand dynamic compression bending without failure for a specified number of cycles.
8. The Sample Size for the Training Set
This information is not applicable. As a physical implant, there is no "training set" in the context of machine learning or algorithm development. The device's design is based on engineering principles and previous successful designs (predicates).
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above. The device's design and manufacturing rely on validated engineering specifications and quality control, not on a "ground truth" derived from a training dataset.
§ 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.