(50 days)
The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
The Presidio Anterior Lumbar Fixation System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. 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 options including lengths of 32mm-53mm lengths and curvature of R 50mm, 100mm, and 250mm. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and lengths of 18mm-40mm. The lock plate is manufactured in one size to fit with all plate lengths. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
The Presidio Anterior Lumbar Fixation System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.
This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the typical sense of AI/Software as a Medical Device (SaMD).
Therefore, many of the requested elements for describing a study proving acceptance criteria will not be directly applicable or present in this type of submission. This document describes a spinal fixation system, which is a physical implant, not a software device.
Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For physical medical devices like the "Life Spine Anterior Lumbar Plate System (Presidio)", acceptance criteria are typically met by demonstrating performance through standardized biomechanical testing, rather than a clinical study with accuracy metrics. The "performance data" section states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static compression per ASTM F1717 | Data presented to demonstrate substantial equivalency to predicate device. |
| Static torsion per ASTM F1717 | Data presented to demonstrate substantial equivalency to predicate device. |
| Dynamic compression per ASTM F1717 | Data presented to demonstrate substantial equivalency to predicate device. |
| Screw push-out testing per ASTM F1717 | Data presented to demonstrate substantial equivalency to predicate device. |
| Material Composition | Titanium alloy 6AL-4V-ELI per ASTM F-136, same as predicate. |
| Design, Indications for Use, Sizing | Deemed substantially equivalent to predicate device. |
Explanation:
The document does not provide specific numerical acceptance thresholds or detailed performance results (e.g., maximum load, stiffness values). Instead, it states that "Performance Data: Static compression, static torsion, dynamic compression and screw push out testing per ASTM F1717 was presented to demonstrate the substantial equivalency of the Life Spine Anterior Lumbar Fixation System (Presidio)." This indicates that the device's performance in these tests was considered comparable enough to the predicate device to justify its substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of a human or image data test set. This submission refers to biomechanical testing of physical components. The "sample size" would refer to the number of devices or components tested in the lab for static/dynamic loading and screw pull-out. This specific number is not provided in the summary, but such tests typically involve multiple samples to establish statistical significance.
- Data Provenance: Not applicable in the context of typical AI/SaMD data provenance (country of origin, retrospective/prospective). The "data" here refers to biomechanical test results generated in a laboratory setting, likely in the US where the company is 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 a physical device, and "ground truth" established by experts in the sense of AI/SaMD (e.g., image annotation) is not relevant. The "ground truth" for this device's performance is established by standardized material and biomechanical testing protocols (ASTM F1717) and engineering principles. The FDA reviewers (e.g., Division of Orthopedic Devices) are experts in evaluating such submissions.
4. Adjudication method
- Not Applicable. Pertains to expert consensus for ground truth/labels, which isn't relevant here.
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 implant, not an AI software/diagnostic device. MRMC studies are used for evaluating diagnostic performance, typically for imaging devices or AI algorithms assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used
- For biomechanical performance: The "ground truth" would be the results of the standardized biomechanical tests (ASTM F1717) against pre-defined engineering and safety specifications, and comparison to the predicate device's known performance.
- For material composition: ASTM F-136 standard for titanium alloy 6AL-4V-ELI.
8. The sample size for the training set
- Not Applicable. This concept is for AI/machine learning models. For a physical device, there isn't a "training set" in this sense. The design and manufacturing processes are refined through engineering development and testing.
9. How the ground truth for the training set was established
- Not Applicable.
In summary:
This 510(k) submission for the Life Spine Anterior Lumbar Plate System (Presidio) demonstrates substantial equivalence to predicate devices through biomechanical testing per ASTM F1717 standards (static compression, static torsion, dynamic compression, screw push-out) and confirmation of material composition (ASTM F-136). The acceptance criteria are implicitly met by demonstrating performance comparable to the predicate device, as required for 510(k) clearance. Many of the requested details are specific to AI/SaMD or clinical studies, which are not applicable to this type of physical device submission.
§ 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.