(102 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, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
The Life Spine Anterior Lumbar Fixation System (Presidio) consists of a variety of plates and screws. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.
The provided text describes the 510(k) summary for the "Life Spine Anterior Lumbar Fixation System (Presidio™)". It details the device, its intended use, and claims substantial equivalence to predicate devices based on performance data. However, the document does not present acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be described for a medical device's performance validation using a test set of data with ground truth, especially for AI/ML devices.
Instead, the performance data section states: "Biomechanical testing in accordance with appropriate ASTM standards was conducted to demonstrate substantial equivalence to the predicate devices." This implies that the 'acceptance criteria' are related to meeting or demonstrating equivalence in biomechanical properties to already cleared devices, rather than a specific numerical target for a diagnostic or predictive performance metric.
Therefore, many of the requested items (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth) are not applicable or not provided in the context of this 510(k) submission, which focuses on demonstrating substantial equivalence through biomechanical testing for a spinal fixation system, not an AI/ML diagnostic or prognostic device.
Here's an attempt to structure the answer based on the available information and highlighting what is not provided:
Acceptance Criteria and Device Performance for Life Spine Anterior Lumbar Fixation System (Presidio™)
The provided document describes a spinal fixation system, not an AI/ML device, and thus the performance evaluation focuses on biomechanical equivalence rather than diagnostic or predictive accuracy against a test set with ground truth.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from 'Substantial Equivalence') | Reported Device Performance |
|---|---|---|
| Biomechanical Performance | Demonstrate substantial equivalence to predicate devices via in vitro biomechanical testing in accordance with appropriate ASTM standards. | "Biomechanical testing in accordance with appropriate ASTM standards was conducted to demonstrate substantial equivalence to the predicate devices." |
| Indications for Use | Equivalence in intended use compared to predicate devices. | "The Life Spine Anterior Lumbar Fixation System (Presidio) was shown to be substantially equivalent to previously cleared devices in indications for use..." |
| Design, Function, Materials | Equivalence in design, function, and materials used compared to predicate devices. | "...design, function, and materials used." |
Note: The document does not specify quantitative thresholds or specific biomechanical test results (e.g., stiffness, fatigue life, pull-out strength in N or cycles) that would constitute 'acceptance criteria'. The acceptance is based on demonstrating "substantial equivalence" to predicate devices through these tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable in the context of an AI/ML device. For biomechanical testing, the sample size (number of constructs tested) is not specified.
- Data Provenance: Not applicable for a typical AI/ML data provenance. The "data" refers to results from in vitro biomechanical tests, not patient data from a specific country or retrospective/prospective studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. Ground truth as understood in AI/ML validation (e.g., expert consensus on image findings, pathology reports) is not relevant for the biomechanical testing of this physical medical device. The "truth" in this context is established by the validated biomechanical testing methods and comparison to predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for reconciling differences in expert annotations or diagnoses, which is not relevant for biomechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. It is not applicable to the biomechanical testing of a spinal implant.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- No. This relates to AI/ML algorithm performance. The device is a physical spinal fixation system, not a software algorithm.
7. Type of Ground Truth Used
- Not applicable in the AI/ML sense. The "ground truth" for the biomechanical testing would be the measured physical properties (e.g., range of motion, load-to-failure) of the tested constructs, assessed against established ASTM standards and data from predicate devices. It is not expert consensus, pathology, or outcomes data in the clinical diagnostic sense.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/ML device. Biomechanical testing involves evaluating a sample of manufactured devices.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.