Search Results

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

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.

Ask a specific question about this device