(71 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone™ Ascent POCT 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) atlanto/axial fracture with instability
f) occipitocervical dislocation
g) revision of previous cervical spine surgery
h) tumors
The occipital bone screws are limited to occipital fixation only.
The hooks placement is indicated from C1-T3.
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™ POCT System allows for wire/cable attachment to the posterior cervical spine.
The Blackstone™ Ascent POCT 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 system's design is intended promote immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine. The Blackstone™ Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, multi-axial screws, plates, bone screws, and Songer Cables. The hooks are designed to be compatible with and work in conjunction with the components in the current Blackstone Ascent POCT System.
This 510(k) premarket notification (K033980) does not describe a study involving acceptance criteria or device performance. Instead, it is a Premarket Notification for a System Modification for the Blackstone™ Ascent Posterior Occipital-Cervical-Thoracic System Hooks.
The basis for this submission is Substantial Equivalence to a previously cleared device (Blackstone™ Ascent POCT System, K030197), not a new study demonstrating performance against specific acceptance criteria.
Therefore, most of your requested information (1-9) cannot be provided from the given document, as it pertains to a performance study which was explicitly not conducted or presented in this 510(k).
Here's what can be inferred or stated based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. No performance study was conducted or reported in this 510(k). The device is cleared based on demonstrating substantial equivalence to a predicate device.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or data provenance is mentioned as part of a performance study.
- 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 test set or ground truth establishment is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 surgical implant system, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a surgical implant system, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. No training set is relevant for this type of submission.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of the document's approach:
The manufacturer, Blackstone Medical, Inc., is seeking clearance for new "Hooks" components as a modification to their existing Blackstone™ Ascent POCT System (K030197). Their basis for substantial equivalence hinges on the new hooks being compatible with and working in conjunction with the components of the already cleared system. The FDA's letter confirms that they have reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, meaning it allows the device to proceed to market without requiring new clinical performance studies because it is sufficiently similar to an already approved device.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.