(35 days)
The Spinal Concepts, Inc. BacFix™ ti Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws and transverse connectors which are indicated to provide temporary stability of the thoracic, thoracolumbar or lumbar spine (T1-SI).
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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these indications range from T1 to the sacrum.
In addition, when intended for pedicle screw fixation, implants are intended for treatment of severe spondylolisihesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of solid fusion. The levels of screw fixation for these indications range from L3 to the sacrum.
When intended for non-pedicle, posterior screw fixation of the noncervical spine, the indications are:
- Idiopathic scoliosis.
- Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spacticity.
- 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 Spinal Concepts, Inc. BacFix™ ti Spinal Fixation System consists of a combination of titanium components which include rods, hooks, locking wedges, screws and transverse connectors which are indicated to provide temporary stability of the thoracic, thoracolumbar or lumbar spine (TI-S1). The BacFix™ Spinal Fixation System consists of longitudinal members (spinal rods), in diameters of 5.5 and 6.0mm, in two hardnesses, and a variety of lengths; spinal anchor components, hooks and screws (mono-axial and multi-axial) of various diameters (5.0, 6.0, 7.0 and 8.0mm) and lengths; locking connectors (threaded wedge and nut or non-threaded wedge and locking clip) sized to fit the spinal rods; and a transverse connector assembly (link), also in various lengths. Hooks and screws may be placed at any position along the spinal rods. Wedges are used to connect the spinal rods to screws (hooks and links). These components are preassembled outside the wound, eliminating the need to pre-plan the position of each eyebolt on the spinal rod. A spinal rod is positioned within the open face of the wedge. Fixation of the construct is accomplished using an instrument that applies a three point shear clamp. Addition of the hex nut (when using threaded wedge) and optional use of the locking clip (when using the non-threaded wedge) complete the implant. Anchor components may be added to (or removed from) the construct at any time during the procedure.
The provided document describes the BacFix™ ti Spinal Fixation System (K983260). This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials. Therefore, the questions related to AI/algorithm performance, ground truth, expert adjudication, training/test sets, and human reader improvement are not applicable to this type of document.
The document focuses on demonstrating substantial equivalence through:
- Material, design, and function comparison to predicate devices.
- Mechanical testing to show the device can withstand clinical loading and maintain mechanical integrity.
Here's a breakdown of the relevant information provided:
1. Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for a 510(k) submission are that the new device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. This is demonstrated through comparison of materials, design, function, and performance data where relevant.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material Equivalence: Materials used for the implant. | BacFix™ ti System: |
- Ti-6Al-4V ELI (ASTM F-136)
- Ti-6AL-7Nb (ASTM F-1295)
- Unalloyed titanium (ASTM F-67)
Predicate BacFix™ System:
- 316L Stainless Steel
- 22-13-5 Stainless Steel
Synthes Universal Spinal System (Predicate):
- Ti-6AL-7NB
- CP (chemically Pure) titanium |
| Design Equivalence: Components and overall structure. | BacFix™ ti System: Rods, hooks, locking wedges, screws, transverse connectors. Bilateral, dual spinal rods connected with transverse rod linkages. Rods attached to thoracic/lumbar spine with hooks, and sacral spine with screws.
Reported Performance: "Substantially equivalent in material, design, and function to the existing BacFix™ Spinal Fixation System and the Synthes Universal Spinal System." |
| Function Equivalence: Purpose and mechanism of action. | BacFix™ ti System: Provides temporary stability of the thoracic, thoracolumbar or lumbar spine (T1-S1) as an adjunct to fusion for various instabilities/deformities (e.g., spondylolisthesis, fracture, scoliosis, kyphosis, spinal tumor, failed fusion). Also for severe spondylolisthesis (grades 3&4) and non-pedicle posterior screw fixation for various conditions.
Reported Performance: "Substantially equivalent in material, design, and function to the existing BacFix™ Spinal Fixation System and the Synthes Universal Spinal System." |
| Mechanical Performance: Ability to withstand loads. | Static and Fatigue Testing Results: "demonstrated the BacFix™ ti to be substantially equivalent to the BacFix™ and the Synthes Universal Spine System and able to withstand clinical loading and maintain mechanical integrity." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The "test set" in this context refers to the samples of the device and predicate devices used for mechanical testing. The specific number of devices tested is not provided in this summary.
- Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer or a contracted lab. The document does not indicate country of origin for mechanical testing data. The study is a pre-market submission, not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study involving expert assessment of data to establish ground truth (e.g., image interpretation). The "truth" here is established by engineering and mechanical testing standards.
4. Adjudication method for the test set
- Not applicable. No expert adjudication process is described 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 spinal fixation system, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a spinal fixation system, not an AI diagnostic device.
7. The type of ground truth used
- Ground Truth: For the mechanical testing, the "ground truth" or reference performance is established by the performance of the legally marketed predicate devices (BacFix™ Spinal Fixation System and Synthes Universal Spinal System) and published data, adhering to accepted engineering and biomechanical standards for spinal implants. This is based on objective physical measurements rather than expert consensus on medical images or pathology.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
§ 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.