(90 days)
The Endoskeleton TA VBR is for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Endoskeleton TA VBR is intended for use with supplemental internal spinal fixation systems. The Endoskeleton TA VBR may be used with bone graft material or bone graft substitute.
The Endoskeleton TA VBR is a titanium implant that is oval in shape. The implant is available in a range of sizes in 0-7º lordotic angles, higher in the anterior than the posterior, to restore spinal lordosis. The center of the implant is hollow and can be filled with bone graft material. The device is available in a range of sizes to accommodate the individual patient's anatomic space. The surface of the implant is roughened to improve stability and resistance to expulsion. A set of customized instruments will be provided for use with the Endoskeleton TA VBR to facilitate its implantation.
The provided text is a 510(k) summary for a medical device (Endoskeleton TA Vertebral Body Replacement). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics, or a study proving that the device meets specific performance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided document.
The document focuses on demonstrating substantial equivalence to predicate devices based on:
- Identical intended use.
- Very similar indications for use and technological features.
- Substantially similar implantation procedure.
- A statement that "Any minor differences between the Endoskeleton TA VBR and the predicates do not raise any new types of safety or effectiveness issues, and performance data in the submission demonstrate that these differences do not adversely impact its safety or effectiveness." However, the actual performance data or the criteria against which it was measured are not detailed in this summary.
In the context of the provided text, the "study that proves the device meets the acceptance criteria" is essentially the submission demonstrating substantial equivalence to already cleared devices, rather than a specific performance study with defined acceptance criteria and reported outcomes in the way you've outlined for a typical AI/diagnostic device.
To directly answer your request based only on the provided text, I must state that the information requested is not available.
§ 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.