(81 days)
The SCI BacFix® Ti Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws, transverse connectors, cable-screws, cables and spinous process grommets which are indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1).
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 or 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these indications range to T1 to the sacrum.
As a pedicle screw system, the BacFix® Spinal Fixation System is also intended for patients having Grade 3 or Grade 4 spondylolisthesis at LS-S1, when utilizing autologous bone graft, when affixed to the posterior when deling and intended to be removed after solid fusion is established. Levels of pedicle screw fixation for this indication are 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 Bach IT Spinal Fixation System is intended to or also with ASTM F136. The BacFix Spinal System is manufactured from thamall andy, which vehip.comectors and other ancillary components. The FTRaton System moudes secews, 1003, noored for market under K973687, and supplemented through II (calif Bach IX 11 Spillar Fixation System was cleared ink transverse connector), K003351 (addition of additional JTUK Submissions: Troughts (addition of end-to-end and side-by-side connectors).
The provided document describes the BacFix Spinal Fixation System and its substantial equivalence to a predicate device, the Isola Spinal System, rather than presenting a study to prove acceptance criteria for a novel device through clinical trials or performance metrics against specific targets. This 510(k) submission relies on nonclinical (biomechanical) testing to demonstrate equivalence.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of traditional acceptance criteria with quantitative performance metrics, this submission uses the concept of "substantial equivalence" to a predicate device. The primary "acceptance criterion" is that the BacFix system's biomechanical properties fall within the established range of the predicate device.
| Acceptance Criterion (via Substantial Equivalence to Isola Spinal System) | Reported Device Performance (BacFix Spinal Fixation System) |
|---|---|
| Indications for Use: Same as predicate device (Isola Spinal System). | Same as predicate, encompassing temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1), pedicle screw fixation for various conditions (T1 to sacrum), Grade 3 or 4 spondylolisthesis at L5-S1, and non-pedicle posterior screw fixation for non-cervical spine. Special indications for cable-screws, cables, and spinous process grommets. |
| Materials: Biocompatible, similar to predicate. | Titanium 6Al-4V. Predicate uses Stainless steel or titanium. (Deemed equivalent, as both are biocompatible and commonly used in spinal implants). |
| Components: Similar screws, rods, hooks, transverse connectors. | Screws, rods, hooks, transverse connectors. Predicate has "Same." |
| Product Labeling: Includes all necessary warnings. | Instructions for use and box labeling including all the necessary warning statements. Predicate has "Same." |
| Packaging/Sterilization: Non-sterile, single use only. | Non-sterile, single use only. Predicate has "Same." |
| Biomechanical Test Results: Stiffness range, per ASTM 1717-96, must be within the range of the Isola Spinal System. | Stiffness range, per ASTM 1717-96, within the range of the Isola Spinal System. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of number of devices or constructs. The document mentions "Mechanical testing was conducted on the stiffest and most flexible data collected for BacFix data." This implies a limited set of configurations or specimens were tested to represent the range of the device. The data provenance is not specified, but it would have been generated in a controlled laboratory setting (nonclinical).
- Data Provenance: Nonclinical, laboratory-generated biomechanical test data designed to conform to ASTM F1717-96 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a nonclinical bench test, not a study involving expert assessment of medical images or patient outcomes. The "ground truth" here is the physical performance of the device under mechanical load, measured against established engineering standards (ASTM F1717-96) and compared to a predicate device's known performance.
4. Adjudication Method for the Test Set
Not applicable. This is a nonclinical bench test. No adjudication by human observers 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 a 510(k) submission for a spinal fixation system, not an AI/imaging device. No MRMC study was performed or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a mechanical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is the biomechanical performance data (stiffness range) of the BacFix system as measured according to ASTM F1717-96, and then compared to the known biomechanical performance data of the Isola Spinal System, also measured against the same standard. Essentially, direct physical measurement against a standardized test method.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device that does not use a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device submission.
§ 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.