(89 days)
The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF system is to be used with the anterior lateral plate that is included in the system, and may also be used with the Sintea Biotech PLS Spinal System. Additionally, the use of bone grafting material with the DSC/ALF System is optional.
The Sintea Biotech DSC/ALF system is a dorsolumbar somatic vertebral body replacement device with its own supplemental fixation. The DSC/ALF Spinal System provides two basic components: A VBR (DSC) and an anterior lateral fixation plate (ALF). The DSC has a hollow internal module that can slide in relation to an external tightening module, which enables the former to be locked in the most suitable position by means of two screws for each individual case. A safety screw is also provided. Both modules can be completed with extremity covers that optimise the contact with the vertebral bodies between which the device is inserted, thus ensuring better primary stability. The ALF is composed of two plates that connect to the anterior side of a vertebra by two screws. The two plates are connected by a rod that ranges from 32mm to 92mm in length. All components of the DSC/ALF Spinal System are made of medical grade titanium alloy (Ti-6Al-4V) as described by ASTM Standard F136.
The provided 510(k) summary for the DSC/ALF Spinal System describes a medical device, not an AI/ML powered device. Therefore, the requested information pertaining to acceptance criteria and performance studies in the context of AI/ML, such as sample sizes for test/training sets, expert consensus for ground truth, adjudication methods, or MRMC studies, is not applicable to this document.
The performance data included in the summary is related to mechanical testing of the device to demonstrate substantial equivalence to a predicate device, as per FDA guidance for spinal systems.
Here's an overview of the "performance data" as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Not explicitly stated in the provided text. The document refers to "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s', May 2004." This guidance would outline specific mechanical performance tests (e.g., compression, torsion, fatigue) and their associated acceptance criteria for spinal implants. | The document states "is presented in the body of the 510(k)." This implies the device met the required mechanical performance standards, as it received a substantial equivalence determination. Specific numerical performance values are not provided in this summary. |
| Material Equivalence | Material used is medical grade titanium alloy (Ti-6Al-4V) as described by ASTM Standard F136 and is the same as the predicate device. | The DSC/ALF Spinal System is made of medical grade titanium alloy (Ti-6Al-4V) as described by ASTM Standard F136, and the material used is the same as the predicate device (VBR™ (K003155) Made by Ulrich GmbH & Co). |
| Functional Design | Substantially equivalent to predicate device. | The DSC/ALF Spinal System is substantially equivalent to the VBR™ (K003155) Made by Ulrich GmbH & Co, with respect to functional design. |
| Indications for Use | Substantially equivalent to predicate device. | The DSC/ALF Spinal System is substantially equivalent to the VBR™ (K003155), with respect to indications for use. |
| Principles of Operation | Substantially equivalent to predicate device. | The DSC/ALF Spinal System is substantially equivalent to the VBR™ (K003155), with respect to principles of operation. |
2. Sample size used for the test set and the data provenance: Not applicable (not an AI/ML study). Mechanical testing would involve a certain number of device samples, but this is not detailed for the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML study).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (not an AI/ML study).
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 (this is a physical medical device, not an AI-powered diagnostic/interpretive tool).
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): For mechanical testing, the "ground truth" or reference standard would be the established engineering specifications and performance requirements outlined in the referenced FDA guidance and ASTM standards for spinal implants.
8. The sample size for the training set: Not applicable (not an AI/ML study).
9. How the ground truth for the training set was established: Not applicable (not an AI/ML study).
§ 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.