(108 days)
The T2™ SCEPTOR™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 SCEPTOR™ Spinal System consists of a series of end caps and endcleats which must be attached to a PYRAMESH-C® device to form a complete construct. The final construct is to be used with supplemental fixation. Specifically, the T2TM SCEPTOR™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the T2™ SCEPTOR™ device is intended to be used with bone graft.
The Medtronic Sofamor Danek T2™ SCEPTOR™ System is comprised of a set of various angled and non-angled endcleats and end caps which are affixed to the ends of the PYRAMESH-C® implants. These devices serve to grip the inferior and superior end plates, thus allowing for expulsion resistance. The pyramid-shaped openings located along the wall of the PYRAMESH-C® device allows grafting material to be placed inside the hollow core of the device to help achieve a solid fusion. The device is made from commercially pure titanium or titanium alloy conforming to such voluntary standards as ASTM F67 and ASTM F136 or the ISO equivalents 5832-2 and 5832-3, and is available in various sizes to match the patients' anatomical requirements. The T2™ SCEPTOR™ device, used in conjunction with the PYRAMESH-C® device, is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine. These systems include the ZPLATE-II™ Anterior Fixation System, the CD HORIZON® Spinal System, the TSRH® Spinal System, the DYNALOK™ CLASSIC Spinal System, and the Laurain DeWald Anterior Fixation System.
I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets them with the level of detail requested. This document is a 510(k) summary and an FDA clearance letter for the Medtronic Sofamor Danek T2™ SCEPTOR™ Spinal System.
Here's why I cannot fulfill your request completely and what information is (and isn't) present:
What the document does provide:
- Device Name: T2™ SCEPTOR™ Spinal System
- Company: Medtronic Sofamor Danek, Inc.
- Indications for Use: To replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (fracture) in the thoracolumbar spine (T1-L5), in conjunction with a PYRAMESH-C® device and supplemental spinal fixation systems.
- Substantial Equivalence: The document states that the device is substantially equivalent to predicate devices (VERTE-STACK® Spinal System and PYRAMESH-C Spinal System) based on "mechanical test results." However, it does not describe the mechanical tests, the acceptance criteria for those tests, or the specific results in detail.
Limitations based on your request:
- Table of acceptance criteria and reported device performance: This information is not explicitly detailed in the document. While "mechanical test results" are mentioned as part of demonstrating substantial equivalence, the specific criteria (e.g., specific load endurance, fatigue limits, pull-out strength) and the reported performance values are not provided.
- Sample size used for the test set and data provenance: Not mentioned. Mechanical tests typically use specific numbers of samples, but these are not provided.
- Number of experts used to establish ground truth and qualifications: Not applicable. This device clearance relies on mechanical testing for substantial equivalence, not clinical studies with "ground truth" established by human experts in the context of diagnostic or prognostic AI.
- Adjudication method: Not applicable for mechanical testing.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This clearance is for a spinal implant, not a diagnostic or AI-assisted device that would involve human readers interpreting images.
- Standalone (algorithm only) performance: Not applicable. There is no AI algorithm involved in the information provided for this device.
- Type of ground truth used: For mechanical equivalence, the "ground truth" would be the performance of the predicate devices or established engineering standards (e.g., ASTM standards for material properties and mechanical performance). The document mentions conforming to ASTM F67 and ASTM F136 for materials, but not specific test results against predicate devices.
- Sample size for the training set: Not applicable as there is no AI algorithm.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) clearance summary for a spinal implant, which confirms its substantial equivalence based on mechanical tests. It does not contain the detailed study protocols, acceptance criteria, specific test results, or clinical study data that would be relevant to the questions about "device performance" in the context of diagnostic accuracy, AI, or human-in-the-loop improvements.
§ 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.