Search Results

The Posterior Lumber System Multi-Axial Screw DESCO is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion.

The Posterior Lumbar System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylothesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to Sacrum) with removal of the implants after the attainment of a solid fusion.

As a special 510(k) submission, the predicate device to which we are claiming equivalence is our own product, Sintea Biotech's Posterior Lumbar System (K020085). This 510(k) submission represents a modification to the predicate, in which the locking cap threads are modified and additional size diameter screws are added to the already cleared Posterior Lumbar System.

This document is a 510(k) premarket notification for a medical device called the "Posterior Lumbar System Multi-Axial Screws - DESCO" by Sintea Biotech, Inc. It's a review by the FDA determining substantial equivalence to predicate devices, rather than a study proving acceptance criteria for a new AI/software device.

Therefore, the provided document does not contain any of the requested information regarding acceptance criteria or a study proving a device meets acceptance criteria for an AI/software product. The document pertains to a traditional medical device (pedicle screws) and its regulatory clearance process, where "substantial equivalence" is the key determination, not performance against specific acceptance criteria in the context of an AI study.

Specifically, there is no information on:

1. A table of acceptance criteria and reported device performance for an AI/software.
2. Sample sizes or data provenance for a test set.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
5. Standalone algorithm performance.
6. Type of ground truth used (e.g., pathology, outcomes data) in the context of an AI study.
7. Sample size for a training set.
8. How ground truth for a training set was established.

The document primarily focuses on the device's indications for use and its substantial equivalence to previously cleared devices (K020085 and K043355), with a modification to locking cap threads and the addition of new screw sizes. The "Performance Data" section explicitly states to "Please see 510(k) submission for the Sintea Biotech's Multi-Axial Screws System, K043355," indicating that any relevant performance testing would be documented in that predicate device's submission, and would likely involve mechanical or biocompatibility testing for a physical implant, not software performance.

Ask a specific question about this device