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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
Who are having the device removed after the development of a solid fusion mass. d)

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 orioin 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 lateral offset addition will function as an offset rod connector. There are clinical applications in which a surgeon will need to have the inter-operative ability to attach rods in an offset manner when building a construct.

The input provided describes a medical device, the Blackstone™ Spinal Fixation System - Lateral Offset, which is a modification to an existing system. The document is a 510(k) summary for premarket notification to the FDA.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document discusses:

• Device Description: The components and materials of the Blackstone™ Spinal Fixation System, specifically the lateral offset addition.
• Intended Use / Indications for Use: The clinical applications and patient populations for which the device is intended.
• Substantial Equivalence: The basis for claiming substantial equivalence to other legally marketed devices (Synthes, Interpore Cross, and Surgical Dynamics).
• FDA Communication: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Key elements missing from the provided text that would be necessary to answer the prompt are:

• Acceptance Criteria: Specific performance metrics (e.g., strength, durability, fatigue life, accuracy) with defined thresholds that the device must meet.
• Study Design and Results: Any testing (e.g., mechanical testing, clinical trials, bench testing) performed to evaluate the device's performance against defined criteria.
• Test Set Details: Sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods for any test data.
• Comparative Effectiveness Study: Information on MRMC studies or standalone algorithm performance.
• Training Set Details: Sample size and ground truth establishment for any training data.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, or details about a study proving the device meets acceptance criteria based solely on the provided text. The document is a regulatory submission for substantial equivalence, which primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through comparison of design, materials, and intended use, rather than detailed performance study results against specific criteria in the way a clinical trial or algorithm validation study would present them.

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