(83 days)
The Synthes Anterior Tension Band System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated 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 Synthes Anterior Tension Band System consists of a range of plate sizes and 5.5 mm cancellous screws with a locking head. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar / lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are manufactured from Titanium alloy.
This document is a 510(k) premarket notification for a medical device called the "Synthes Anterior Tension Band (ATB) System." It is a regulatory submission for a spinal implant, not an AI/ML medical device. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, training/test sets, and MRMC studies are not applicable to this document.
The document focuses on demonstrating substantial equivalence to a legally marketed predicate device, which is the standard for 510(k) submissions for traditional medical devices. The "acceptance criteria" here refers to the FDA's decision criteria for substantial equivalence based on the device's design, materials, indications for use, and performance within the context of established orthopedic standards, rather than AI performance metrics.
Here's an analysis based on the provided document, acknowledging the non-AI nature:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance (Implied by FDA Clearance) |
|---|---|
| Material Composition: Use of biocompatible and mechanically sound materials. | "All components are manufactured from Titanium alloy." (Titanium alloy is a commonly accepted material for orthopedic implants.) |
| Indications for Use: Alignment with existing predicate devices for spinal fixation. | Indicated for "lumbar and lumbosacral (L1-S1) spine instability" due to various conditions (fracture, tumor, DDD, etc.). This matches the established uses of similar spinal fixation systems. |
| Surgical Approach: Compatibility with established surgical techniques. | Indicated for "lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels." This covers standard approaches for lumbar/lumbosacral fixation. |
| Mechanical Performance/Stability: Demonstrated ability to provide stabilization to permit spinal fusion. | The device "provide(s) stabilization to permit the biological process of spinal fusion to occur." (While specific mechanical test data isn't in this summary, it would have been part of the full 510(k) submission, likely showing equivalent mechanical properties to the predicate). |
| Substantial Equivalence: Demonstrated similarity in principle of operation, indications, and technological characteristics to a legally marketed predicate device. | FDA determined the device is "substantially equivalent... to legally marketed predicate devices." This is the ultimate "acceptance" for a 510(k). |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a 510(k) submission for a physical medical device (spinal implant), not an AI/ML device. There is no "test set" in the context of an algorithm's performance evaluation. The substantial equivalence determination is based on a comparison to predicate devices, material properties, and manufacturing controls, typically supported by bench testing and sometimes cadaveric studies, not clinical data in the same way an AI model would be tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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. See point 2. This device is not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See point 2. This is a physical implant, not an algorithm.
7. The type of ground truth used
- Not Applicable. For a physical implant, the "truth" is established through engineering principles, material science, biomechanical testing, and clinical experience with comparable predicate devices. The ground truth for this type of device relates to its safety and effectiveness for its intended use, typically demonstrated through non-clinical performance data and comparison to predicates.
8. The sample size for the training set
- Not Applicable. See point 2.
9. How the ground truth for the training set was established
- Not Applicable. See point 2.
In summary, the provided document details a regulatory submission for a traditional medical device (a spinal implant) and its clearance by the FDA based on substantial equivalence. It does not provide information relevant to the testing and validation of an Artificial Intelligence or Machine Learning (AI/ML) medical device.
§ 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.