(67 days)
The RABEATM Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. This device is intended to be implanted in pairs.
The supplemental internal fixation systems that may be used with the RABEATM Spinal Implant are the same as those used with the Curved PEEK Tetris™ Spinal Implant and include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
The RABEATM Spinal implant is a rectangular frame. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies.
The frame is forged from PEEK (PEEK-OPTIMATM LT1), which is radiolucent, and incorporates small Titanium alloy (TiAl6V4) marker pins so the device can be located within the body. The marker pins meet ASTM F-136 and ISO 5832/3.
The RABEATM Spinal Implant is available in a variety of sizes ranging from 5mm to 30mm. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition. The RABEATM is implanted in pairs.
This document is a 510(k) summary for the RABEA™ Spinal Implant. It outlines the device description, intended use, and a comparison to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found in an AI/ML device submission. Instead, it demonstrates substantial equivalence to a previously cleared device.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. This document describes a traditional medical device (spinal implant) seeking 510(k) clearance based on substantial equivalence to a predicate device. It does not present acceptance criteria or reported performance data in the context of an AI/ML device study. Performance is implicitly tied to demonstrating the same materials, design, indications for use, and operating principles as a cleared predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This document is not a study report for an AI/ML device. It's a 510(k) summary for a physical implant.
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):
- Not Applicable. Ground truth creation in the context of expert review for AI/ML models is not relevant to this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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:
- Not Applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this device's clearance would be its physical and mechanical properties, material biocompatibility, and functional equivalence to the predicate, as tested through engineering methods, not clinical data and expert consensus in the way an AI/ML device would be.
8. The sample size for the training set:
- Not Applicable.
9. How the ground truth for the training set was established:
- Not Applicable.
Summary of what can be gathered from the provided text:
- Device Name: RABEA™ Spinal Implant
- Submitter: SIGNUS Medizintechnik GMBH
- Predicate Device: Curved PEEK Tetris™ (cleared under K041888 on 8/10/04)
- Device Description: A rectangular frame made from PEEK (PEEK-OPTIMATM LT1) with spikes for anchorage and small Titanium alloy (TiAl6V4) marker pins. Available in sizes from 5mm to 30mm and intended to be implanted in pairs.
- Intended Use: To replace a vertebral body resected or excised due to tumor or trauma/fracture in the thoracolumbar spine (T1 to L5). Intended for use with supplemental internal fixation, similar to the predicate device's compatible systems (e.g., DePuy AcroMed titanium plate or rod systems like Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
- Substantial Equivalence Claims (Statements of Technological Comparison):
- Same indication for use
- Same operating principle
- Same basic design
- Same materials
- Implanted using the same surgical techniques and equipment
Conclusion:
The provided 510(k) summary is for a physical spinal implant and relies on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than presenting a study with acceptance criteria and performance metrics for an AI/ML algorithm.
§ 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.