(14 days)
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 spondylolisthesis 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 fixation, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stenosis;
c) Spondylolisthesis;
d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
e) Pseudarthrosis;
f) Tumor;
g) Trauma (i.e., fracture or dislocation);
h) Previous failed fusion.
The Blackstone™ Spinal Fixation System Spacer (System Modification) is a titanium alloy (6AL-4V ELI, per ASTM F136) device, which is a non-sterile, single use component. This device is an adjunct to the Spinal Fixation System, which allows a surgeon to build a spinal implant construct. The system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The device added to the current Spinal Fixation System is listed below with a brief description.
Spacer:
The Spacer is available in one diameter and two thicknesses. This device may be required in various clinical applications, as determined by a qualified surgeon. The Spacer has a spherical recess feature, which allows the head of a pedicle screw to nest in it for congruent contact between components.
The provided document is a 510(k) summary for a medical device (Blackstone™ Spinal Fixation System Spacer Modification) and does not contain information about the performance or acceptance criteria of a study for this specific device modification. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria, as such a study is not described in this document.
Here's why and what information is available (or explicitly not available) based on your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Available: The document does not describe performance acceptance criteria or a study with reported performance specific to the "Spacer" modification. This 510(k) relies on substantial equivalence to predicate devices, not on new performance data demonstrating the Spacer's efficacy against specific criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: No test set is described because no new performance study for the Spacer modification is presented. The substantial equivalence argument is based on the design, materials, and intended use being similar to already cleared predicate devices.
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 Available: No ground truth establishment is described because no new performance study for the Spacer modification is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available: No test set or 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 Delineated (and likely Not Applicable): This device is a mechanical implant (spinal fixation system component), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Delineated (and Not Applicable): As explained above, this is a mechanical medical device, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available: No ground truth is described.
8. The sample size for the training set
- Not Available: There is no mention of a training set as this is not an AI/ML device requiring such data.
9. How the ground truth for the training set was established
- Not Available: There is no mention of a training set or ground truth establishment.
Summary of the Document's Information:
The document serves as a 510(k) premarket notification for a modification to an existing spinal fixation system. Its primary purpose is to demonstrate substantial equivalence of the new "Spacer" component to legally marketed predicate devices.
- Device: Blackstone™ Spinal Fixation System Spacer (System Modification)
- Device Description: A titanium alloy (6AL-4V ELI) non-sterile, single-use component (Spacer) with a spherical recess feature, available in two thicknesses (3mm and 5mm). It is an adjunct to the existing Spinal Fixation System, designed to stabilize the spinal operative site during bone graft fusion.
- Premarket Pathway: 510(k) – Substantial Equivalence
- Predicate Devices:
- Basis of Substantial Equivalence: The modification (Spacer) is an addition to an existing system, and its materials, design, and intended use are deemed similar enough to the cleared predicate devices such that new clinical performance data is not required to establish safety and effectiveness for a 510(k). The FDA's letter concurs with this finding of substantial equivalence.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.