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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 is comprised of titanium alloy (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 domino addition will function as a rod connector. There are clinical applications in which a surgeon will need to have the inter-operative ability to attach rods when extending a construct.

The provided text is a 510(k) summary for the Blackstone™ Spinal Fixation System, specifically the "domino" addition. It describes the device, its intended use, and states the basis for substantial equivalence. Crucially, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

Instead, it asserts substantial equivalence to a predicate device (Danek device) that has already been cleared by the FDA. This means the device is considered safe and effective because it is sufficiently similar to a device already on the market, rather than through independent performance testing against specific acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on equivalence, not performance against pre-defined metrics.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method 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 device is a spinal fixation system, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described in the context of performance testing.
8. The sample size for the training set: No training set is described.
9. How the ground truth for the training set was established: No training set ground truth is described.

Summary of available information related to equivalence:

• Basis of Substantial Equivalence: The Blackstone™ Domino is considered substantially equivalent to the Danek device, which has been cleared by the FDA for certain anterior and pedicle fixation use indications.
• Device Description: The Blackstone™ Spinal Fixation System is comprised of titanium alloy (6AL-4V ELI, per ASTM F136) devices in a variety of non-sterile, single-use components intended to build a spinal implant construct. The "domino" addition functions as a rod connector for extending a construct.
• Intended Use/Indications for Use: The document details various indications for the Blackstone Spinal Fixation System, including:
  • Pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint, adjunct to fusion with autogenous bone graft, fixed to L3 and below, and removed after solid fusion.
  • Pedicle screw system for skeletally mature patients providing immobilization and stabilization as an adjunct to fusion for instabilities/deformities of the thoracic, lumbar, and sacral spine (e.g., degenerative spondylolistheses with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion).
  • Anterolateral non-pedicle screw fixation for non-cervical spine (e.g., degenerative disc disease, spondylolistheses, spinal stenosis, spinal deformities, tumor, pseudoarthrosis, previous failed fusion, trauma).
  • Posterior non-pedicle screw fixation system for non-cervical spine (same indications as anterolateral non-pedicle screw fixation).

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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 (1.3 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 4.5mm, 5.5mm, and 7.5mm Multi-Axial Screws are titanium alloy (6AL-4V ELI, per ASTM F136) devices, which are non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the noncervical spine.

The Blackstone Spinal Fixation System consists of an assortment of screws and rods which have received 510(k) clearance (#K994217, and #K020674).

This is a 510(k) premarket notification for a medical device (spinal fixation system), not an AI/ML device. Therefore, the concepts of acceptance criteria, study data, ground truth, expert adjudication, and training/test sets as they relate to AI/ML performance metrics are not applicable to this document.

The document describes the device, its intended use, and claims substantial equivalence to previously cleared devices based on its design and indications for use. The FDA's review confirms this substantial equivalence.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Ask a specific question about this device