(87 days)
Blackstone™ III° 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) pseudarthrosis;
h) revision of previous surgery
The Cover Plate addition for the Blackstone™ III° Anterior Cervical Plating System is a titanium alloy (6AL-4V ELI, per ASTM F136) device which is a non-sterile, single use component. When used with the Blackstone™ III° Anterior Cervical Plating System a surgeon can build an anterior cervical implant construct. The system's design is intended to stabilize the cervical spinal operative site during the fusion process of a bone graft in the disc space.
This document is a 510(k) premarket notification for a medical device: the Blackstone™ III Anterior Cervical Plating System Cover Plate (System Addition). It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.
Here's an analysis of the provided text in relation to the requested information about acceptance criteria and a study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, there are no specific acceptance criteria or detailed device performance metrics reported for this particular submission. The document focuses on establishing substantial equivalence to predicate devices rather than presenting the results of a performance study with pre-defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
No test set, sample size, or data provenance (country of origin, retrospective/prospective) is mentioned in this 510(k) submission. This is a premarket notification for an addition to an existing system, and the primary argument for clearance is substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth establishment related to a test set is discussed.
4. Adjudication Method for the Test Set:
Not applicable. No test set or adjudication method is discussed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. This device is a physical implant, not an AI-driven diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a physical medical implant, not an algorithm or AI system.
7. Type of Ground Truth Used:
Not applicable. There is no mention of a ground truth in the context of device performance, as the submission focuses on substantial equivalence.
8. Sample Size for the Training Set:
Not applicable. As this is not an AI/algorithm-based device, there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
Summary of Findings Regarding Device Acceptance and Study:
The provided 510(k) submission for the Blackstone™ III Anterior Cervical Plating System Cover Plate (System Addition) does not contain information regarding acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI or diagnostic device.
Instead, the submission relies entirely on the concept of substantial equivalence to predicate devices that have already been cleared by the FDA. The argument for substantial equivalence is based on:
- Identical Indications for Use: The new Cover Plate, when used with the existing system, has the same intended use and indications (anterior fixation to the cervical spine from C2 to C7 for various conditions) as the predicate devices.
- Similar Technology/Materials: The Cover Plate is made of titanium alloy (6AL-4V ELI, per ASTM F136), which is standard for such implants.
- Existing Regulatory Clearance: The predicate devices (Blackstone™ III Anterior Cervical Plating System (K012184) and Blackstone™ Anterior Cervical Plate System (K974885)) were previously cleared by the FDA for the same indications.
The FDA's response letter confirms the finding of "substantial equivalence," allowing the device to be marketed. This regulatory pathway does not typically require new clinical or performance studies with specific acceptance criteria if equivalence to a legally marketed predicate can be adequately demonstrated. Therefore, the "study" proving the device's compliance is, in this context, the demonstration of substantial equivalence to existing, cleared devices.
§ 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.