(130 days)
The SP-Fix® Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The SP-Fix® spinous process fixation plate is intended for use with bone graft material and is not intended for stand-alone use.
The SP-Fix® Spinous Process Fixation Plate System consists of plates, rods, and barrels that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. SP-Fix® implants are composed of titanium allov (per ASTM F136) and PEEK radiolucent polymer (per ASTM F2026).
Here's an analysis of the provided 510(k) summary for the Globus Medical Inc. SP-Fix® Spinous Process Fixation Plate, specifically addressing the requested information about acceptance criteria and the supporting study:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report or a comprehensive technical specification. Therefore, much of the requested information (like specific acceptance criteria values, detailed study designs, and ground truth establishment for AI systems) is not present in this type of document, as it's not typically required for a 510(k) for this type of device (a spinal fixation plate). This submission relies on engineering rationale and mechanical testing, not a clinical effectiveness study with human readers or AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Criterion: Substantial equivalence in technological characteristics (design, dimensions, intended use, materials, performance characteristics) compared to predicate devices. | Performance: Mechanical testing (static plate dissociation) was conducted, and an engineering rationale was provided. The results demonstrated substantial equivalence. Additional SP-Fix® implants perform "as well as or better than the predicate device." |
| Criterion: Ability to provide supplemental stabilization of spinal segments to support fusion. | Performance: Indicated for use in achieving supplemental fusion for specified conditions (degenerative disc disease, spondylolisthesis, trauma, tumor). The mechanical testing and engineering rationale support this function in comparison to the predicate device. |
| Criterion: Mechanical strength sufficient for the intended use and to be "as well as or better than the predicate device." | Performance: Static plate dissociation testing was performed. The exact values or specific acceptance thresholds are not provided in this summary, but the conclusion is that the new implants perform "as well as or better than the predicate device." |
Explanation: The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented (mechanical testing) supports this determination by showing that the new device's mechanical properties are comparable or superior to the predicate. Specific quantifiable thresholds for "static plate dissociation" are not typically disclosed in a public 510(k) summary, as they are part of the detailed testing protocol submitted to the FDA.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a spinal implant. The "test set" here refers to the samples used in mechanical testing, not a clinical dataset for an AI or human reader study. The number of physical units tested for "static plate dissociation" is not specified in this summary.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not applicable. The data is from laboratory mechanical testing, not human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission is for a medical device (spinal fixation plate) and relies on mechanical testing and engineering rationale, not expert clinical review (e.g., radiologist consensus) to establish ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This relates to clinical studies with human observers or AI outputs, which is not the basis of this 510(k) submission.
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. An MRMC study was not done. This device is a physical implant, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Testing Measurements: The "ground truth" for this device's performance is established through physical measurements and destructive testing in a laboratory setting (e.g., force required for static plate dissociation). This is compared against the known performance characteristics of the predicate device.
8. The Sample Size for the Training Set
- Not applicable. This refers to machine learning algorithms. The device does not involve a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. The device does not involve a "training set" or AI.
§ 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.