(29 days)
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.2mm to 6.5mm, including the PROTEX® CT or PROTEX®, REVERE®, or BEACON® Stabilization Systems, using corresponding connectors.
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System consists of 3.5mm iointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps. t-connectors, lateral connectors, parallel connectors, in-line connectors, rod-to-rod connectors, rod extension clamps and occipital plates. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum alloy (CoCr) (per ASTM F1537). Due to the risk of galvanic corrosion following implantation, titanium alloy or CoCr implants should not be connected to stainless steel implants.
Here's a breakdown of the acceptance criteria and study information for the ELLIPSE® Additional Implants, based on the provided K110963 510(k) Summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance | Comments/Results |
|---|---|---|---|
| Mechanical Performance | Static Compression Bending | Not explicitly stated, but "conducted in accordance with... ASTM F1717 to demonstrate substantial equivalence" implies meeting or exceeding predicate device performance. | Successfully demonstrated substantial equivalence to predicate system(s). |
| Dynamic Compression Bending | Not explicitly stated, but "conducted in accordance with... ASTM F1717 to demonstrate substantial equivalence" implies meeting or exceeding predicate device performance. | Successfully demonstrated substantial equivalence to predicate system(s). | |
| Static Torsion | Not explicitly stated, but "conducted in accordance with... ASTM F1717 to demonstrate substantial equivalence" implies meeting or exceeding predicate device performance. | Successfully demonstrated substantial equivalence to predicate system(s). | |
| Dynamic Torsion | Not explicitly stated, but "conducted in accordance with... ASTM F1717 to demonstrate substantial equivalence" implies meeting or exceeding predicate device performance. | Successfully demonstrated substantial equivalence to predicate system(s). | |
| Material Compatibility | Prevention of galvanic corrosion when dissimilar metals are connected. | "titanium alloy or CoCr implants should not be connected to stainless steel implants" (Labeling instruction to mitigate risk) | Risk managed through labeling. |
| Substantial Equivalence | Demonstrates similar technical characteristics, performance, and intended use as predicate devices. | Stated as the "Basis of Substantial Equivalence" for mechanical testing. | Achieved. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states that mechanical testing was "conducted," but does not provide the number of samples tested for each condition.
- Data Provenance: The study is prospective in nature, as it involved conducting new mechanical tests specifically for this submission. The origin of the data is Globus Medical Inc. (the manufacturer).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F1717) and direct measurement of physical properties, not by expert interpretation in a clinical or diagnostic context.
4. Adjudication Method for the Test Set
This is not applicable to mechanical performance testing. Adjudication methods are typically used in studies involving human interpretation (e.g., image reading) to resolve discrepancies among experts.
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 submission is for additional components and material to an existing spinal system, and the performance data provided is mechanical testing to demonstrate substantial equivalence, not a study evaluating human reader performance or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. This device is a mechanical spinal implant system, not an algorithm or AI device.
7. The Type of Ground Truth Used
- For the mechanical testing, the "ground truth" is defined by engineering standards and specifications (e.g., ASTM F1717) for material properties and structural integrity. The performance results are compared against these standards and the known performance characteristics of the predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This submission involves mechanical testing of physical components, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As established in point 8, there is no training set for this type of device submission.
§ 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.