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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone™ Posterior Cervical System is indicated for:
a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
b) spondylolisthesis
c) spinal stenosis
d) fracture/dislocation
e) atlantoaxial fracture with instability
f) occipito-cervical dislocation
g) revision of previous cervical spine surgery
h) tumors

The occipital bone screws are limited to occipital fixation only.

The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Blackstone™ Posterior Cervical System allows for wire/cable attachment to the posterior cervical spine.

The Blackstone™ Posterior Cervical System is a titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The Blackstone™ Posterior Cervical System consists of an assortment of rods, set-screws, cross connectors, multi-axial screws, plates, bone screws and Songer Cables.

This document is a 510(k) Premarket Notification for the Blackstone™ Posterior Cervical System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a diagnostic or AI-driven aid.

Therefore, many of the requested categories (e.g., acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

The primary "study" presented here is a comparison to a predicate device to establish substantial equivalence.

Here's a breakdown of the information that is available or can be inferred, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. This submission is for a medical device (spinal implant) and relies on substantial equivalence to a predicate device, not on a clinical "test set" of patients or data in the context of a diagnostic or AI study. The "test" is a comparison of design, materials, and intended use against an already cleared device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. No "ground truth" establishment by external experts for a test set is described in this type of submission for a spinal implant. The FDA itself (specifically, the Division of General, Restorative and Neurological Devices) reviews the submission and determines substantial equivalence based on the provided documentation, which details the device's characteristics and comparison to the predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No adjudication method for a test set is described. The determination of substantial equivalence is made by the FDA reviewer(s) based on the submitted materials.

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 mechanical device (spinal implant), not a diagnostic tool or AI-assisted system. MRMC studies are irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not Applicable. For this type of submission, the "ground truth" for demonstrating safety and effectiveness is largely established by the predicate device's prior FDA clearance and its demonstrated history of safe and effective use. The new device then needs to demonstrate that it is sufficiently similar in design, materials, intended use, and performance characteristics to the predicate.

8. The sample size for the training set:

• Not Applicable. This is a mechanical device, not an AI or diagnostic system that requires a "training set."

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

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