Search Results

The NUBIC™ 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 LS) and is intended for use with supplemental internal fixation.

The NUBIC™ may be implanted singularly or in pairs.

The supplemental internal fixation systems that may be used with the NUBIC™ Spinal Implant include, but are not limited to, SIGNUS CONKLUSION System, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).

Not Found

The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document is a 510(k) premarket notification letter from the FDA to Signus Medical, LLC. for the NUBIC™ Spinal Implant. It states that the device is substantially equivalent to a predicate device based on similarities in functional design, indication for use, principles of operation, materials, and performance characteristics.

The letter explicitly mentions:

• Device Name: NUBIC™ Spinal Implant
• Regulation Number: 21 CFR 888.3060 (Spinal intervertebral body fixation orthosis)
• Regulatory Class: II
• Product Code: MQP
• Indications for Use: To replace a vertebral body resected or excised due to tumor or trauma/fracture in the thoracolumbar spine (T1-L5), used with supplemental internal fixation.
• Predicate Device: RABEA™ cleared under K043316.
• Basis for Substantial Equivalence: Similarities in functional design, indication for use, principles of operation, materials, and performance characteristics. It also states the NUBIC™ is "Implanted using the same surgical techniques and equipment; Used in conjunction with the same types of supplemental internal fixation systems; The same manufacturing environment; The same sterilization process; and The same packaging configurations."

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study details.
6. Standalone (algorithm only) performance study details.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device