(252 days)
The Eminent Spine Black Diamond Rattlesnake Lumbar Plating System is indicated for use via a lateral / anterolateral surgical approach above the great vessels in the treatment of the thoracolumbar spine (T1-L5). The Eminent Spine Red Diamond Rattlesnake Lumbar Plating System is indicated for use via an anterior surgical approach below the bifurcation of the great vessels in the treatment of the lumbosacral (L1-S1) spine. The Diamond Rattlesnake System is intended to provide temporary stabilization as an adjunct to fusion using a lateral approach in skeletally mature patients for the treatment of the following acute and chronic instabilities and deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudarthrosis, spondylolysis, spondylolisthesis, deformity (scoliosis, kyphosis, and or lordosis), spinal stenosis, fracture (including dislocation and subluxation), tumor, or failed previous spine surgery.
The Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System consists of a variety of plates and screws. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. The plates are manufactured in a variety of configurations with lengths of 21 to 33mm in a single level plate and 64 to 76mm in a two level plate. Additionally, the non-locking screws are provided in diameters of 5.5mm with lengths of 25 - 50mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient. The Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.
The document describes a 510(k) submission for the Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System. This is a spinal intervertebral body fixation orthosis, a medical device used for temporary stabilization as an adjunct to fusion in the lumbar and thoracolumbar spine.
It's important to understand that a 510(k) submission is for demonstrating substantial equivalence to a predicate device, not for proving novel clinical claims or efficacy through extensive clinical studies in the same way a PMA (Pre-Market Approval) process would. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance testing designed to show the new device performs at least as well as the predicate device(s) in specific mechanical properties.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Reference to Predicate) | Reported Device Performance (Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System) |
|---|---|
| Meet or exceed performance of predicate devices in: | Meets or exceeds the performance of the predicate device(s) |
| Static axial compression (per ASTM F1717) | Results show satisfactory performance |
| Dynamic axial compression (per ASTM F1717) | Results show satisfactory performance |
| Static torsion (per ASTM F 1717) | Results show satisfactory performance |
Note: The document explicitly states "The results of these studies show that the subject Eminent Spine Black / Red Diamond Rattlesnake Lumbar Plating System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent." The specific numerical acceptance criteria (e.g., minimum load, cycles to failure) are not detailed in this summary, but are implied to be derived from the predicate device performance and the ASTM F1717 standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. For non-clinical (mechanical) testing of medical devices like this, sample sizes are typically determined by statistical validation requirements for the specific test (e.g., 5-10 samples per test condition to achieve statistical significance). The document only mentions "Nonclinical testing was performed..."
- Data Provenance: Not specified. This is non-clinical lab testing, not human data. The testing would have been conducted in a laboratory setting, likely in the US (where Eminent Spine, LLC and Secure BioMed Evaluations are located).
- Retrospective or Prospective: Not applicable as this is non-clinical mechanical testing, not a clinical study involving human subjects or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable in this context. "Ground truth" and "experts" as described (e.g., radiologists) are relevant for clinical studies, particularly those involving image interpretation or clinical diagnosis. For a spinal implant's mechanical testing, the "ground truth" is established by adherence to recognized engineering standards (like ASTM F1717) and the physical measurements obtained during the tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable for non-clinical mechanical testing. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretations or clinical outcomes.
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
- This question is not applicable. This describes a spinal implant, not an AI software or imaging system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This device is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on established engineering principles and standards for mechanical testing (ASTM F1717). The performance of the device is compared against the known or expected performance of legally marketed predicate devices under these standardized test conditions.
8. The sample size for the training set
- This question is not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. Training sets are typically used for machine learning or AI models.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as point 8.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.