(169 days)
The BLACKSTONE MEDICAL, INC. Anterior Cervical Plate System is to be used for anterior screw fixation of the cervical spine (C2-C7). The indications are as follows:
Indications:
Degenerative Disc Disease (ddd)* *Back pain of discogenic origin with degeneration of the disc as confirmed by history and radiographic studies. Spondylolisthesis Fracture Spinal Stenosis Deformities (i.e., scoliosis, kyphosis, lordosis) Tumor Pseudoarthrosis Revision of previous failed fusion surgery
The principal components of the Blackstone Medical Inc. Anterior Cervical Plate System are plates, screws, and locking plate made from titanium 6Al-4V Eli alloy, as per ASTM F-136. The instrument set includes
6 Degree/15 Degree Plate Holder and Guide 6 Degree/0 Degree Plate Holder and Guide Freehand Guide Drill with Adjustable Stop Bone Tap with Adjustable Stop Bone Screw Driver Lock Plate Screw Driver Plate Bender Tack and Tack Holder
After determining the appropriate plate length, the plate is positioned on the anterior surface of the cervical spine. The cannula is seated into the plate at the correct cranial /caudal and convergent angle. Once the drill bit has been placed in the cannula and drilled, the tap is inserted into the cannula, the vertebral bodies are tapped and the screws are inserted. The screws are then tightened to ensure that they are seated below the surface of the plate. The cannula is removed. The lock plate is positioned over the bone screws and secured with lock plate screw driver.
This document is a 510(k) summary for the Blackstone Medical Inc. Anterior Cervical Plate System. It describes a medical device, and 510(k) summaries do not typically include detailed information about "acceptance criteria" and "studies proving device meets acceptance criteria" in the way that an AI/software as a medical device (SaMD) submission would.
In the context of this 510(k) submission, "acceptance criteria" and "studies" are generally understood as demonstrating Substantial Equivalence to a predicate device, rather than proving performance against specific quantitative metrics for an AI algorithm. The "study" mentioned is a comparative Finite Element Analysis (FEA).
Here's an attempt to answer your questions based on the provided text, while acknowledging that the requested information format (especially for AI/SaMD) might not perfectly align with a traditional hardware device 510(k):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Blackstone Plate vs. Synthes Plate via FEA) |
|---|---|
| Similar mechanical properties (stiffness) | 288% stiffer than the Synthes Plate |
| Similar mechanical properties (stress) | Maximum stress was 41% less than the Synthes Plate |
| Similar indications for use | Indications are similar to predicate devices (CODMAN, SYNTHES, SOFAMOR DANEK ORION) |
| Similar materials (e.g., Titanium 6Al-4V Eli alloy) | Manufactured from titanium 6Al-4V Eli alloy |
| Safe and effective for intended use | Deemed "Substantially Equivalent" by FDA, implying safety and effectiveness |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial or algorithm test set. The comparison was a Finite Element Analysis (FEA), which is a computational simulation. There isn't a "sample size" of physical specimens or patient data described for this comparison.
- Data Provenance: Not applicable. FEA is a simulation method.
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)
- The concept of "experts establishing ground truth" for a test set is not directly applicable here. The "ground truth" for the mechanical comparison was established by the FEA model and its parameters. The report does not specify the number or qualifications of engineers who conducted or verified the FEA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical studies or expert review processes, which are not described for this FEA.
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 a hardware device focused on spinal fusion, not an AI/SaMD designed for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device. The FEA is a standalone computational analysis, but it doesn't fit the "algorithm only" context of AI/SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the mechanical comparison was derived from Finite Element Analysis (FEA) models and the underlying material properties and geometric specifications of the Blackstone and Synthes plates. It's a computational "truth" based on engineering principles and assumptions.
8. The sample size for the training set
- Not applicable. There is no concept of a "training set" for this type of device submission. FEA models are built based on design specifications and material science, not "trained" on data samples.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the "study" demonstrating performance (as per the provided text):
The "study" cited is a Finite Element Analysis (FEA) which compared the Blackstone Cervical Plate to a Synthes Performance Cervical Plate.
- Methodology: FEA was used to determine the difference in stiffness and stress between the two plates.
- Findings:
- The Blackstone Plate was reported to be 288% stiffer than the Synthes Plate.
- The maximum stress associated with the Blackstone Plate was 41% less than the Synthes Plate.
This FEA was used to support the claim of Substantial Equivalence by demonstrating comparable or superior mechanical performance to a legally marketed predicate device (Synthes Performance Cervical Plate). The FDA's 510(k) clearance (K974885) indicates that this evidence, along with other comparisons (materials, indications for use), was sufficient to establish substantial equivalence.
§ 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.