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510(k) Data Aggregation
(21 days)
The Blackstone Modular Pedicle Screw System is intended for non-cervical use in the spine.
The Blackstone Modular Pedicle Screw 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 Modular Pedicle Screw 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 neurological impairment;
b) Fracture:
c) Dislocation:
d) Scoliosis;
e) Kyphosis;
f) Spinal tumor;
g) Failed previous fusion (pseudarthrosis).
The Blackstone Modular Pedicle Screw System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (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) Pseudoarthrosis:
f) Tumor:
g) Trauma (i.e., fracture or dislocation);
h) Failed previous fusion.
The Blackstone Modular Pedicle Screw System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (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) Pseudoarthrosis;
f) Tumor:
g) Trauma (i.e., fracture or dislocation);
h) Failed previous fusion.
The Blackstone™ Modular Pedicie Screw System is comprised of non-sterile, single use, titanium alloy components. The Blackstone Modular Pedicle Screws, smgm attaches to the vertebral body by means of screws to the non-cervical spine and a Jown a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space.
This document is a Premarket Notification Special 510(k) for the Blackstone™ Modular Pedicle Screw System. It declares that the device is substantially equivalent to previously cleared devices. Therefore, a study demonstrating the device meets specific acceptance criteria is not included in this type of submission. Instead, the focus is on showing the new device is as safe and effective as existing legally marketed predicate devices.
Here's an breakdown based on the provided text, largely indicating the absence of the requested study elements due to the nature of a 510(k) submission for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
- Not applicable for this 510(k) submission. The document does not present specific quantitative acceptance criteria or reported device performance data in a table format, as it is focused on demonstrating substantial equivalence to predicate devices rather than proving performance against novel criteria through a new clinical study.
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. This 510(k) submission does not reference a specific "test set" or clinical study with a sample size for an effectiveness or performance evaluation for the new device. Substantial equivalence is typically established through comparison of design, materials, indications for use, and performance claims to 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 applicable. No such expert panel or ground truth establishment is described in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as there is no described test set or clinical performance study.
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 document pertains to a spinal implant system (hardware), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As mentioned above, this is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No "ground truth" as typically understood in performance studies for diagnostic devices is needed or presented here. The basis for approval is substantial equivalence to legally marketed devices.
8. The sample size for the training set
- Not applicable. This submission does not describe a "training set" in the context of machine learning or AI, as it's for a physical medical device.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or ground truth establishment is relevant to this type of 510(k) submission.
Summary of the study conducted (implied by 510(k) process):
The "study" in this context is the comparison of the Blackstone™ Modular Pedicle Screw System to legally marketed predicate devices to demonstrate substantial equivalence.
- Basis of Substantial Equivalence: The document explicitly states: "By its very nature, the Blackstone™ Modular Pedicle Screw System is substantially equivalent to the Blackstone™ Spinal Fixation System (K994217), which has been cleared by FDA for use in spinal fusion surgery." This indicates a comparison of design, materials, and intended use to the predicate device.
- Predicate Devices:
The FDA reviewed the submission and agreed that the new device is substantially equivalent to the predicate devices for the stated indications for use, thus allowing it to be marketed. This approval is based on the information provided in the 510(k) filing, which focuses on demonstrating equivalence rather than presenting new clinical performance data from a dedicated study.
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