(120 days)
The Gallery™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Gallery™ Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
The Gallery™ Laminoplasty Fixation System consists of implantable plates and screws that will act as a buttress to maintain decompression after a laminoplasty procedure.
The provided document describes the "Gallery™ Laminoplasty Fixation System," a medical device intended for spinal fixation. It outlines the device's indications for use and a summary of mechanical testing conducted to establish substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test/Standard) | Reported Device Performance |
|---|---|
| Four-point bend test (ASTM F382-99) | Met all mechanical test requirements based on worst-case construct testing and engineering rationale. |
| Axial pullout test (ASTM F543-07) | Met all mechanical test requirements based on worst-case construct testing and engineering rationale. |
| Cantilever bend test | Met all mechanical test requirements based on worst-case construct testing and engineering rationale. |
| Dimensional Analysis | Detailed analysis comparing nominal dimensions to predicates, indicating similarity. |
| Substantial Equivalence | Determined to be substantially equivalent to predicate devices (Synthes ARCH Fixation System (K032534) and Blackstone Laminoplasty Fixation System (K043338)) in intended use, indications, technological characteristics, and principles of operation. No new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in the context of a clinical study or AI model evaluation. The "performance data" refers to mechanical testing of the device itself.
- Sample Size: Not explicitly stated as a number of devices or iterations, but implied to be sufficient for mechanical testing according to the listed ASTM standards and worst-case construct testing.
- Data Provenance: The data is from mechanical testing performed on the device itself (Gallery™ Laminoplasty Fixation System) rather than human or animal subjects. No country of origin is mentioned for the data, as it is laboratory-based mechanical testing. The testing is assumed to be prospective to the submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
N/A. This information is not relevant as the study described is mechanical testing of a medical device, not a human reader or AI study where ground truth would be established by experts.
4. Adjudication Method for the Test Set:
N/A. This is not applicable to the mechanical testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No MRMC comparative effectiveness study was mentioned. The document describes mechanical testing of a spinal fixation system, not an AI or human-reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No standalone algorithm performance study was mentioned. The device is a physical implantable system, not a software algorithm.
7. The Type of Ground Truth Used:
The "ground truth" here refers to the established standards and specifications for material properties and mechanical performance of spinal fixation devices. These are implicitly defined by the ASTM standards (ASTM F382-99, ASTM F543-07) and engineering rationale for worst-case construct testing.
8. The Sample Size for the Training Set:
N/A. This device is a physical medical implant, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
N/A. This question is not applicable to the device described.
§ 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.