(81 days)
The Kestrel™ Buttress Plate System is indicated for use to stabilize the allograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, or anterolateral spinal systems made of compatible materials. This device is not intended for load bearing applications.
The Innovasis Kestrel™ Buttress Plate System is a temporary implant used to prevent allograft or autograft extrusion or IBFD expulsion. The Kestrel Buttress Plate System consists of plates and bone screws. The Kestrel System is also intended to provide stabilization and augment development of a solid spinal fusion. The Kestrel Buttress Plate System fixates to the anterior portion of the lumbar vertebral body. The construct may be employed alone or with other anterior, or anterolateral spinal systems made of compatible materials.
The provided text describes a medical device, the Kestrel™ Buttress Plate System, and its clearance process with the FDA. However, it does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria for software or AI-driven devices.
The document is a 510(k) premarket notification for a Class II medical device, which is a spinal intervertebral body fixation orthosis. This type of device is a physical implant made of materials like Titanium, and its performance is evaluated through non-clinical performance testing, primarily mechanical tests.
Therefore, the following information cannot be extracted from the provided text:
- Table of acceptance criteria and reported device performance: This document does not detail specific acceptance criteria or performance metrics related to software or AI. It mentions "Performance Data: (Non-clinical)—Performance testing includes static and dynamic cantilever bend, torque to failure and axial pullout." but does not provide the criteria or results.
- Sample size for the test set and data provenance: Not applicable, as this is for mechanical testing, not a dataset for software.
- Number of experts used to establish ground truth and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only without human-in-the-loop performance): Not applicable.
- Type of ground truth used: For physical devices, ground truth is typically engineering specifications and physical measurements, not expert consensus or pathology on a dataset.
- Sample size for the training set: Not applicable, as there is no mention of an algorithm or AI model being trained.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document pertains to the regulatory clearance of a physical medical implant (Kestrel™ Buttress Plate System) through substantial equivalence to a predicate device, based on mechanical performance testing, not a software or AI-driven medical device requiring the type of data requested in the prompt.
§ 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.