(128 days)
The NuVasive Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Laminoplasty Fixation System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.
The NuVasive Laminoplasty Fixation System consists of different sizes of plates and screws that can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.
The provided text is for a 510(k) Premarket Notification for the NuVasive Laminoplasty Fixation System. It describes a medical device for spinal surgery. The document is a regulatory submission, not a study report detailing acceptance criteria and performance data in the context of an AI-powered device or diagnostic tool.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment is not available in this document because it pertains to the regulatory clearance of a physical medical implant, not a software or AI-driven diagnostic device.
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing or not applicable:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit in text | Not explicit in text |
| Substantial Equivalence to predicate device | Demonstrated substantial equivalence in indications for use, design, material, and function to Synthes's Arch™ System (K032534). |
| Mechanical Testing standards met | Mechanical testing was presented (details not provided). |
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 discusses a physical medical device (implants) and its regulatory clearance, not a data-driven device or diagnostic tool that would typically involve test sets or data provenance in the context of performance evaluation.
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. This information is not relevant to the regulatory submission for this type of medical device. "Ground truth" in the context of data for a device performance study is not established for this product.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This information is not relevant to the regulatory submission for this type of medical device.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating observer performance with diagnostic tools, especially AI, which is not what this document is about. The document explicitly states "Summary of Clinical Tests (Not Applicable)".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The concept of "ground truth" as it applies to performance evaluation of algorithms or diagnostic tests is not relevant to this medical device submission. The substantial equivalence was based on direct comparison to a predicate device and mechanical testing results.
8. The sample size for the training set
- Not Applicable. There is no "training set" for this type of medical device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no corresponding ground truth to establish.
§ 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.