(20 days)
The GATEWAY™ Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) 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), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.
The GATEWAY™ Thoracolumbar Plate System consists of plates of various lengths to be used with polyaxial or monoaxial REVERE™ screws and variable or fixed bone screws. Polyaxial or monoaxial REVERE™ screws attach to the rod portion of the plate and variable or fixed bone screws are inserted through the plate, for fixation of GATEWAY plates to the vertebral bodies of the thoracolumbar spine (T1-L5). REVERE™ locking caps are used to connect polyaxial or monoaxial screws to the rod portion of the plate. Optional staples may be used for additional fixation of polyaxial or monoaxial screws to vertebral bodies. Implants are composed of titanium alloy, as specified in ASTM F136. F1295.
This 510(k) summary for the GATEWAY™ Thoracolumbar Plate System describes a medical device, not an AI or software device. Therefore, many of the requested categories for AI/software performance evaluation are not applicable.
Here's an analysis based on the provided text, focusing on what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s", May 3, 2004 | "Mechanical testing... is presented." (The specific results meeting the criteria are not detailed in this summary but are stated to have been presented.) |
| Substantial equivalence to predicate devices (Globus REVERE™ Stabilization System K061202 and DePuy Profile Anterior Thoracolumbar Plate K973060) in technical characteristics, performance, and intended use. | The FDA reviewed the 510(k) and "determined the device is substantially equivalent... to legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a hardware device. Performance is evaluated through mechanical testing, not a clinical test set with patient data.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert clinician consensus.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a hardware device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a hardware device.
7. The Type of Ground Truth Used
For mechanical testing, the "ground truth" would be the engineering specifications and performance standards outlined in ASTM F136 and F1295, as well as the FDA's "Guidance for Spinal Systems 510(k)s."
8. The Sample Size for the Training Set
Not applicable. This is a hardware device. Design and manufacturing involve engineering principles and testing, not a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. Testing and design are based on established engineering principles and FDA guidance, not a machine learning training set with "ground truth" established by experts.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria is primarily mechanical testing. The 510(k) summary explicitly states: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s', May 3, 2004 is presented."
The ultimate "proof" of meeting acceptance criteria for substantial equivalence also comes from the FDA's review and determination. The FDA's letter (K062407) states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This determination is based on the data provided, including the mechanical testing results, and comparison to the predicate devices.
The acceptance criteria are met when the mechanical test results demonstrate performance comparable to the predicate devices and in compliance with relevant FDA guidance, and when the FDA officially agrees that the device is substantially equivalent based on its technical characteristics, performance, and intended use.
§ 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.