(283 days)
The Black Widow Anterior Buttress Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing applications.
The Black Widow Anterior Buttress Plate is designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Specific system features include: Plate uniquely shaped to conform to anterior spine anatomy. Two peas which engage the vertebral body and prevent rotation. An extremely low profile plate with a full radius around the perimeter and a screw that sits flush with the anterior surface of the staple. A self-tapping screw in multiple lengths. The devices are manufactured from Ti6Al4V per ASTM F136. The plates are designed to be used in spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.
The provided text describes a medical device submission (K081770 for the Black Widow Anterior Buttress Plate System) to the FDA. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria, expert adjudication, or AI performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and AI performance is not applicable to this document because it describes a mechanical device that underwent mechanical testing for substantial equivalence, not a machine learning or AI-driven diagnostic device.
Here's why the specific questions cannot be answered from the provided text:
- Acceptance Criteria & Reported Performance: The document states that "Mechanical test results, conducted in accordance with ASTM F1717, demonstrate that the Black Widow Anterior Buttress Plate System is substantially equivalent to the predicate device." It does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or exact device performance values from these mechanical tests. It only states the conclusion of substantial equivalence.
- Sample Size (Test Set) & Data Provenance: This pertains to clinical or imaging data. As this is a mechanical device, no such "test set" of clinical data was used for evaluation in this submission.
- Number of Experts, Qualifications & Adjudication Method: These are relevant for studies involving human interpretation or clinical outcomes. They are not applicable to the mechanical testing performed for this device.
- MRMC Comparative Effectiveness Study: This is specific to AI or diagnostic imaging studies comparing human reader performance with and without AI. Not applicable here.
- Standalone Performance (Algorithm Only): This refers to AI algorithm performance without human intervention. Not applicable as no AI is involved.
- Type of Ground Truth: Ground truth (e.g., pathology, expert consensus) is established for clinical conditions or diagnostic accuracy. For a mechanical device, the "ground truth" would be engineering specifications and physical properties, which are evaluated through mechanical tests (like ASTM F1717).
- Sample Size (Training Set): This refers to data used to train AI models. Not applicable as no AI is involved.
- How Ground Truth for Training Set was Established: Again, not applicable as no AI training occurred.
In summary, the provided document from a 510(k) premarket notification for a spinal implant describes mechanical testing for substantial equivalence, not an evaluation of an AI or diagnostic device that would involve the specific criteria outlined in your request.
§ 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.