(203 days)
The Blackstone Medical Inc. "Classic" Anterior Cervical Plate is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: a) degenerative disc disease (ddd)* * 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); tumor; f) g) pseudoarthrosis; h) revision of previous surgery
The Blackstone™ "Classic" Anterior Cervical Plate 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 document describes the Blackstone™ "Classic" Anterior Cervical Plate, a medical device for spinal fixation. It's a 510(k) premarket notification, which means the manufacturer is asserting substantial equivalence to previously cleared devices rather than providing a study demonstrating the device meets specific acceptance criteria through novel performance data.
Therefore, the requested information elements related to performance studies, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable or cannot be extracted from this document directly. This type of submission relies on bench testing and comparison to predicate devices to demonstrate safety and effectiveness.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated in terms of performance metrics. | Not Applicable (N/A). The submission asserts substantial equivalence based on design, materials, and intended use to predicate devices already cleared by the FDA. Performance is implicitly accepted if it matches the predicate. |
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 document does not describe a clinical performance study with a test set of patient data, but rather a submission for substantial equivalence based on design and comparison to predicate devices. The "tests" would be bench testing.
- Data Provenance: Not applicable.
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. Ground truth establishment for a patient-based test set is not described as this is not a study requiring such data.
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 device is a physical implant, not an AI diagnostic tool, and therefore an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth in the context of clinical performance data is discussed. The "ground truth" for this submission is that predicate devices are considered safe and effective, and this device is substantially equivalent.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth establishment for it.
Summary of the "Study" (Basis for Substantial Equivalence):
The "study" or basis for clearance is a substantial equivalence comparison to two predicate devices:
- Blackstone™ III° Anterior Cervical Plating System (K012184)
- Blackstone™ Anterior Cervical Plate System (K974885)
The document states: "The Blackstone™ "Classic" Anterior Cervical Plate System by its very nature is substantially equivalent to the Blackstone™ III° Anterior Cervical Plating System (K012184) and the Blackstone™ Anterior Cervical Plate System (K974885). The FDA has cleared this device, for anterior fixation to the cervical spine from C2 to C7."
This means the manufacturer demonstrated that the new device has the same intended use, similar technological characteristics (e.g., titanium alloy, screws, plates), and is as safe and effective as the previously cleared predicate devices. The "performance" is inferred to be adequate because it is substantially equivalent to devices already on the market and considered safe and effective by the FDA.
§ 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.