(58 days)
The Blackstone™ Fusion Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spondylolisthesis;
c) Fracture;
d) Spinal stenosis:
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
f) Tumor:
g) Pseudoarthrosis;
h) Revision of previous surgery
The Blackstone Fusion Cervical Plating System is a titanium alloy, multiple component system comprised of a variety of non-sterile, single-use components that allow the surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.
This excerpt is not focused on the acceptance criteria or a study proving device performance as typically understood for AI/ML or diagnostic devices. Instead, it's a 510(k) premarket notification for a traditional medical device: the Blackstone™ Fusion Anterior Cervical Plating System.
The document primarily establishes substantial equivalence to previously cleared predicate devices, which is the regulatory pathway for this type of device. Therefore, the questions related to AI/ML device performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable in this context.
Here's how to address the provided information based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be found for a diagnostic or AI device. For this type of device (a spinal plating system), the "criteria" for market clearance are primarily established through demonstrating substantial equivalence to pre-existing, legally marketed devices.
The "reported device performance" is not quantified in the way an AI/ML device's performance would be. Instead, it relies on the established safety and effectiveness of the predicate devices.
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 is a traditional mechanical implant, not an AI/ML or diagnostic device that requires a test set of data for performance evaluation in the described manner.
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. There is no "ground truth" establishment in this context as there is no diagnostic output or classification being generated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication 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 applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's clearance is its physical and material properties, design, and intended use being substantially equivalent to legally marketed predicate devices, which have already demonstrated safety and effectiveness through their own regulatory pathways (e.g., clinical experience, previous testing, etc.).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.