(124 days)
TranS1® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2-LEVEL System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectorny, or for assistance in the performance of L4-S1 interbody fusion.
The AxiaLIF® 2-LEVEL System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2-LEVEL System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.
The Trans1® AxiaLIF® II System is made of medical grade titanium alloy conforming to such standards as ASTM F-136.
The provided text is a 510(k) Premarket Notification summary for a medical device called the "TranS1® AxiaLIF® II System." It primarily focuses on demonstrating substantial equivalence to a predicate device and specifying the indications for use.
Crucially, this document does NOT describe specific acceptance criteria and a study demonstrating the device meets those criteria, as typically found in clinical trials or performance studies that assess a device's accuracy or efficacy.
Instead, the submission is focused on regulatory clearance by demonstrating substantial equivalence to an already legally marketed device (TranS1® AxiaLIF® System). This means the FDA found the new device to be as safe and effective as the predicate device, based on shared technological characteristics and indications for use.
Therefore, many of the requested details such as sample sizes for test and training sets, expert qualifications, ground truth establishment, or specific performance metrics (like accuracy, sensitivity, specificity for diagnostic devices, or specific outcome measures for therapeutic devices) are not present in this type of regulatory submission. This document is a summary of the 510(k) application, not a detailed study report.
Here's an attempt to answer the questions based only on the provided text, while acknowledging its limitations:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or reported device performance in the context of a study demonstrating numerical compliance to those criteria. The primary "acceptance criterion" for this 510(k) submission was to demonstrate substantial equivalence to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable / Not provided. This document does not describe a test set or data from a study designed to evaluate performance metrics. The submission focuses on substantial equivalence based on technological characteristics and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable / Not provided. The concept of "ground truth" for a test set, as it relates to accuracy or performance assessment, is not detailed in this regulatory summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided. Adjudication methods are relevant for studies that require expert review of cases to establish ground truth, which is not the type of study described 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. The TranS1® AxiaLIF® II System is an anterior spinal fixation system, not a diagnostic device involving human readers or AI assistance. Therefore, an MRMC comparative effectiveness study is not relevant to this device's regulatory submission as described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As a spinal fixation system, this device is a surgical implant and does not involve an "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable / Not provided. This document does not detail a study that uses a "ground truth" for evaluating device performance as would be relevant for diagnostic or AI-driven systems. For a surgical implant, "ground truth" might refer to clinical outcomes, but no such study is presented here.
8. The sample size for the training set
Not applicable / Not provided. This document does not describe a training set, as it is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable / Not provided. This question is irrelevant for the type of device and regulatory submission described in the provided text.
Summary of what IS stated in the document regarding "acceptance" for regulatory purposes:
- Substantial Equivalence: The primary "acceptance criterion" for the 510(k) process is demonstrating substantial equivalence to a legally marketed predicate device.
- Predicate Device: The TranS1® AxiaLIF® II System was deemed substantially equivalent to the TranS1® AxiaLIF® System.
- Regulatory Action: The FDA issued a letter allowing the device to be marketed, signifying that it met the requirements for substantial equivalence.
The provided text is a regulatory filing summary, not a scientific study report describing performance against acceptance criteria.
§ 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.