(189 days)
When intended for pedicle screw fixation, implants are 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). Levels of pedicle screw attachment for these indications range from T1 to the sacrum.
When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative disc disease (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, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.
As a pedicle screw system, the BacFix® Spinal Fixation System is also intended for patients having Grade 3 or Grade 4 spondylolisthesis at L5-S1, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established. Levels of pedicle screw fixation for these indications range from L3 to the sacrum.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are: Idiopathic scoliosis. Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. Spinal fractures (acute reduction or late deformity). Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Neoplastic disease. Spondylolisthesis. Spinal Stenosis. Failed previous fusion.
The cable-screws, cables and spinous process grommets are indicated for: Defect of pars lateralis. Spondylolisthesis. Cables and spinous processes grommets may be used for interspinous wiring if additional stability is needed.
The purpose of this abbreviated 510(k) Notification is to add Staple, Nut and Washer components to the BacFix Spinal Fixation System and also to expand the existing indications to include anterolateral spinal fixation. The Spinal Concepts, Inc. BacFix® Ti Spinal Fixation System Staple, Nut and Washer are titanium alloy devices (Ti-6Al-4V, per ASTM F136), which are non-sterile single use components. These devices function as a means of stabilizing the bone screw and to reduce negative effects of screw to bone purchase. These components are particularly desirable in an anterior spinal construct because load can be spread over a greater surface area.
This 510(k) summary describes a modification to an existing device, the BacFix® Ti Spinal Fixation System. It focuses on adding new components (Staple, Nut, and Washer) and expanding indications for use, particularly for anterolateral spinal fixation. As such, the study described is primarily a mechanical test rather than a clinical study involving human outcomes.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Test Data: Performance in accordance with FDA recognized standard ASTM F1717-96, to verify that the added components met established design requirements and performance standards. | Mechanical Test Data: "Mechanical testing data was collected in accordance with FDA recognized standard ASTM F1717-96, to verify that the added components met established design requirements and performance standards." (The document implies successful completion, as the K030087 notification was cleared.) |
Explanation: The document explicitly states the acceptance criterion for the new components (Staple, Nut, Washer) is to meet the requirements and performance standards outlined in ASTM F1717-96. The device's performance is reported as having successfully undergone this testing, implying compliance. Specific numerical results are not provided in this summary but would have been part of the full 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the mechanical tests. Mechanical testing typically involves a set number of specimens (e.g., 5-10 per test condition) to establish statistically significant results for material properties and device performance.
- Data Provenance: The data is from mechanical testing, which is performed in a lab setting, not from human subjects. Therefore, provenance details like "country of origin of the data" or "retrospective/prospective" are not applicable in the clinical sense. It's an engineering test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This study is a mechanical test of a physical device, not a diagnostic or prognostic medical device that requires expert interpretation of data (e.g., images, physiological signals) to establish ground truth. The "ground truth" for mechanical testing is defined by the objective physical properties and performance limits set by the ASTM standard.
4. Adjudication Method for the Test Set
- Not applicable. See explanation for #3. Adjudication methods are relevant for clinical studies where expert consensus is needed to resolve discrepancies in interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- No. This is a mechanical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related effect sizes are not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This is a mechanical device, not an algorithm. Standalone performance refers to the performance of an AI algorithm independent of human interaction.
7. The Type of Ground Truth Used
- Mechanical Performance Standards: The ground truth for this study is defined by the established design requirements and performance standards outlined in the FDA recognized standard ASTM F1717-96. This standard dictates the test methods and acceptance criteria for spinal implant constructs.
- For example, ASTM F1717-96 specifies tests for static and dynamic compression bending, torsion, and axial pull-out, with specified load levels and cycles. The "ground truth" is whether the device can withstand these tests without failure and remain within acceptable deformation limits.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" for mechanical testing of this nature. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See explanation for #8.
§ 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.