(28 days)
The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
d) Who are having the device removed after the development of a solid fusion mass.
The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
b) Fracture;
c) Dislocation;
d) Scoliosis;
e) Kyphosis:
f) Spinal tumor; and
g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
b) spondylolistheses;
c) spinal stenosis;
d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
e) tumor;
f) pseudoarthrosis;
g) previous failed fusion; and
h) trauma (i.e., fracture or dislocation).
The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
b) spondylolistheses;
c) spinal stenosis;
d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
e) tumor;
f) pseudoarthrosis;
g) previous failed fusion; and
h) trauma (i.e., fracture or dislocation)
The Blackstone Spinal Fixation System (SFS) is comprised of titanium allov (Ti-6AL-4V ELI per ASTM F136) devices in a variety of non-sterile, single-use components. This system allows a surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws and hooks to the non-cervical spine.
The SFS Parallel Rod Connectors will function as rod connectors. They are fabricated of titanium alloy (Ti-6AL-4V) and are provided in both top-loading and front-loading configurations. Both configurations allow for rod components to be connected side-to-side, rather than end-to-end, as with the currently marketed Blackstone SFS Axial Domino (Connector) (K030241 SE 2-21-03).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Blackstone SFS Parallel Rod Connectors:
It's important to note that the provided text is a 510(k) summary for a medical device (spinal fixation system component), not a research paper detailing a study on an AI/ML device. Therefore, the questions about AI/ML specific aspects (like multi-reader multi-case studies, standalone algorithm performance, or ground truth for training) are not directly applicable to this document. This document describes the regulatory submission for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical equivalence to predicate devices (Blackstone™ Spinal Fixation System (K994217) and Blackstone™ SFS Axial Domino (K030241)) | Mechanical testing was conducted to demonstrate substantial equivalence to the predicate devices. (Specific performance metrics like strength, fatigue resistance, etc., are not detailed in this summary but would have been part of the full submission). |
| Compatibility with existing Blackstone SFS components | System is comprised of titanium alloy components. SFS Parallel Rod Connectors will function as rod connectors allowing connection side-to-side. (Implied compatibility through material and function description within the existing system). |
| Meeting intended use and indications for use | The device (as part of the Blackstone Spinal Fixation System) is aligned with the stated indications for non-cervical spinal use, including pedicle screw fixation and non-pedicle screw fixation for various conditions. |
Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the (implied) acceptance criteria is a mechanical testing study.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated in this 510(k) summary. For mechanical testing of medical devices, sample sizes are typically determined by relevant ISO standards (e.g., ISO 12189 for pedicle screw spinal systems, ISO 1584 for spinal implants) and statistical considerations to provide adequate confidence in the results. This information would be in the full engineering report, not the summary.
- Data Provenance: The studies are likely prospective mechanical tests performed in a laboratory setting, not on human or animal data. The country of origin for the data would typically be the location of the testing facility, which is not specified but would generally be linked to the manufacturer (Blackstone Medical, Inc., USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:
This question is not applicable to this type of device and study. "Ground truth" in the context of mechanical testing refers to the objective physical properties and performance characteristics of the materials and device components. Test protocols and acceptance criteria are established by engineers and regulatory experts based on national and international standards, not by clinical "experts" establishing ground truth in the diagnostic sense.
4. Adjudication Method for the Test Set:
This question is not applicable. Adjudication methods are typically for clinical studies involving human interpretation or assessment. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure) that do not require adjudication in the way clinical interpretations do. The results are compared directly against pre-defined acceptance criteria based on engineering principles and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. This is a physical medical device, not an AI/ML diagnostic tool. Such studies are typically for evaluating the impact of AI algorithms on human reader performance in interpreting medical images.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device, in the context of its performance validation, is established through:
- Engineering specifications and material properties: The physical and chemical characteristics of titanium alloy (Ti-6AL-4V ELI per ASTM F136).
- Established mechanical testing standards: Compliance with relevant ASTM (American Society for Testing and Materials) or ISO (International Organization for Standardization) standards for spinal implants, which dictate how tests are performed and what constitutes acceptable performance (e.g., fatigue life, static strength).
- Performance of predicate devices: The "known" performance of legally marketed equivalent devices (K994217, K030241) serves as a benchmark for equivalence.
8. The Sample Size for the Training Set:
This question is not applicable. There is no "training set" in the context of a physical medical device's mechanical testing to demonstrate substantial equivalence.
9. How the Ground Truth for the Training Set was Established:
This question is 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.