(77 days)
The Blackstone Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.
The Blackstone Laminoplasty Fixation System is a device comprised of non-sterile, single use, titanium and titanium allov components. The specially shaped plates, made of commercially pure (CP) titanium, are designed to fit the anatomy of the dorsally elevated lamina. The plates have screw holes on both ends, which allow for attachment to the vertebral body, and a screw hole in the center for attachment to the allograft.
The screws, made of titanium alloy (6AL-4V ELI, per ASTM F-136), are available in variety of lengths and diameters in order to meet individual anatomical requirements.
The provided document is a 510(k) Pre-Market Notification for the Blackstone™ Laminoplasty Fixation System. It establishes substantial equivalence to a predicate device, the Synthes Arch™ Fixation System (K032534), rather than presenting a study demonstrating that the device meets specific acceptance criteria through a clinical or performance study of the device itself.
Therefore, most of the requested information regarding acceptance criteria, performance data, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies cannot be extracted from this document as it serves a different purpose in the regulatory pathway.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting specific performance acceptance criteria for the Blackstone Laminoplasty Fixation System itself, nor results from a study showing it meets such criteria. Regulatory submissions for devices relying on substantial equivalence typically reference the predicate device's performance or established standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. No test set or associated sample size is described for the Blackstone Laminoplasty Fixation System.
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)
- Cannot be extracted. No ground truth establishment related to a test set for this device is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. No test set or adjudication method 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
- Cannot be extracted. This is a medical device for spinal fixation, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be extracted. This is a medical device for spinal fixation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be extracted. No ground truth data for a specific study of this device is presented.
8. The sample size for the training set
- Cannot be extracted. No training set is described.
9. How the ground truth for the training set was established
- Cannot be extracted. No training set or ground truth establishment for it is described.
Summary of Relevant Information from the Document:
While the document doesn't fit the requested structure directly (as it's a 510(k) for substantial equivalence), here's what it does provide:
- Device Name: Blackstone™ Laminoplasty Fixation System
- Intended Use/Indications for Use: For use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty to hold or buttress an allograft, preventing its expulsion or spinal cord impingement.
- Device Description: Non-sterile, single-use components made of titanium and titanium alloy. Comprises specially shaped plates (CP titanium) with screw holes (for attachment to vertebral body and allograft) and screws (titanium alloy, 6AL-4V ELI) in various lengths/diameters.
- Predicate Device: Synthes Arch™ Fixation System (K032534). The Blackstone system is considered substantially equivalent to this predicate. This substantial equivalence is the "proof" for regulatory clearance, relying on the predicate device's established safety and effectiveness.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.