(124 days)
The NeuroVention LamiFix Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The NeuroVention LamiFix Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
The NeuroVention LamiFix Laminoplasty Plating System is comprised of various sized, pre-bent miniplates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at the center and both ends of the plate to allow for attachment to the bone. The center hole in the plate is used for attachment to bone allograft spacers that are provided in a variety of sizes. The screws intended for use with the mini-plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.
This submission describes a medical device, the NeuroVention LamiFix Laminoplasty Plating System, which is a spinal implant. The "study" mentioned here refers to the mechanical performance testing conducted to ensure the device's structural integrity and equivalence to predicate devices, not a clinical study involving human or animal subjects in the way an AI/software device would typically be evaluated for diagnostic accuracy.
Here's the breakdown of the information requested, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Performance Standard) | Device Performance |
|---|---|
| Static Axial Compression Bending | Tested per modified ASTM F1717-11 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." The text implies the device met the requirements necessary to demonstrate substantial equivalence to predicate devices, though specific pass/fail thresholds are not explicitly stated. |
| Static Torsion | Tested per modified ASTM F1717-11 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." The text implies the device met the requirements necessary to demonstrate substantial equivalence. |
| Dynamic Axial Bending Compression | Tested per modified ASTM F1717-11 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." The text implies the device met the requirements necessary to demonstrate substantial equivalence. |
Explanation: The acceptance criteria are implicitly defined by the modified ASTM F1717-11 standard and the need to demonstrate substantial equivalence to the predicate device (Synthes Arch™ Fixation System (AFS)). The reported performance is that the device was tested according to these standards, and the conclusion drawn is that its overall technology characteristics and mechanical performance data lead to the conclusion of substantial equivalence. Specific numerical results or direct comparisons to predicate device data are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. For mechanical testing of medical devices, samples typically refer to the number of physical device units tested. The ASTM standard would specify minimum test sample sizes.
- Data Provenance: The device itself was tested, not patient data. The testing was performed in accordance with modified ASTM F1717-11, which is an industry standard for spinal implant constructs. Since it's mechanical testing, there's no concept of country of origin for "data" or retrospective/prospective. The testing was laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is mechanical testing of a physical device, not an assessment requiring expert interpretation of clinical data. The "ground truth" is established by the physical properties and performance of the material and device under stress, measured using calibrated equipment.
4. Adjudication method for the test set:
- Not applicable. As this is mechanical testing, there is no human adjudication of "ground truth" as there would be for, say, image interpretation. Testing results are quantitative measurements against predefined specifications.
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 physical medical device (spinal implant), not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Quantitative Mechanical Properties: The "ground truth" for this type of device is its ability to withstand specified mechanical forces (axial compression bending, torsion, dynamic axial bending compression) as defined by a recognized standard (modified ASTM F1717-11). The measurements obtained from the physical tests represent the objective performance of the device.
8. The sample size for the training set:
- Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for a mechanical device.
§ 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.