(77 days)
The Life Spine ALIF Buttress Plate System in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
The Life Spine ALIF Buttress Plate System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy Ti-6A1-4V-ELI per ASTM F-136.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the ALIF Buttress Plate System components with components from any other system or manufacturer. The ALIF Buttress Plate System components should never be reused under any circumstances.
This is a 510(k) premarket notification for a medical device (Life Spine ALIF Buttress Plate System), not a study demonstrating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not present in this document.
The document states that the device is "substantially equivalent" to predicate devices based on design, materials, indications for use, and sizing. Substantial equivalence is the basis for 510(k) clearance, meaning no new clinical studies are typically required to demonstrate safety and effectiveness if the device is similar enough to an already cleared device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. This document does not present specific acceptance criteria or performance data from a study. It asserts substantial equivalence based on comparisons to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No clinical or performance test sets are described in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided. No 'ground truth' establishment using experts for a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This device is a spinal implant, not an AI-assisted diagnostic tool. An MRMC study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. There is no discussion of ground truth as no clinical or performance study data is presented.
8. The sample size for the training set:
- Cannot be provided. There is no mention of a training set as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established:
- Cannot be provided. No training set and therefore no ground truth for a training set is discussed.
Information that can be extracted relevant to the submission:
- Device Name: Life Spine ALIF Buttress Plate System
- Indications for Use: The Life Spine ALIF Buttress Plate System in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load-bearing applications.
- Regulatory Class: Class II
- Product Code: KWQ
- Material: Titanium alloy (Ti-6Al-4V ELI) per ASTM F-136.
- Basis for Clearance: Substantial Equivalence to predicate devices (Vail Buttress Plate System K180755, RCS Anterior Buttress Plate System K092659, Life Spine Sentry Lateral Plate System K180166) in terms of design, materials, indications for use, and sizing.
§ 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.