Search Results

As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System Rod/Plate System and Techtonix™ System are indicated for:

• Long and short curve scoliosis
• Vertebral fracture or dislocation
• Spondylolisthesis
• Degenerative disc disease (defined as back pain of discogneic origin with degeneration of the disc confirmed by history and radiographic studies)
• Previously failed fusion
• Spinal tumor

Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics® Spinal System Rod/Plate System and Techtonix™ System are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
• In addition, the Osteonics® Spinal System Rod/Plate System and Techtonix™ System are indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

This submission is intended to expand the Osteonics® Spinal System Rod/Plate System product line by adding the Techtonix™ System, a low profile posterior plate system. Similar to its predicate device, the Techtonix™ System is comprised of anatomical shaped plates and bone screws available in a variety of lengths, and blockers (which tighten the bone screws to the plates). The components of the subject device are fabricated from Titanium alloy as described in ASTM F-136 and ISO 5832-3. The Techtonix™ System will be provided non-sterile.

This document is a 510(k) premarket notification for a line extension to an existing spinal system. It does not describe any acceptance criteria or studies related to computational device performance, algorithm evaluation, or AI assistance.

The document is for a physical medical device (spinal fixation system components) and primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Description of Device Modification: Adding low-profile posterior plate systems (Techtonix™ System) to the existing Osteonics® Spinal System Rod/Plate System.
• Materials: Both the predicate and subject devices are fabricated from Titanium alloy (ASTM F-136 and ISO 5832-3).
• Intended Use/Indications: The uses are expanded to explicitly include the Techtonix™ System, maintaining similar indications for non-pedicle and pedicle screw applications.
• Technological Comparison: Stating that components share intended use and basic design concepts, and that "Mechanical testing demonstrated comparable mechanical properties to the predicate devices."

Therefore, based on the provided text, I cannot answer most of your questions as they pertain to the evaluation of a computational device or AI system, which is not the subject of this 510(k) submission.

Here's what I can extract regarding the physical device's evaluation, though it doesn't align with the AI/computational evaluation framework:

1. Table of Acceptance Criteria and Reported Device Performance: Not provided in the document in the context of performance metrics that would be applicable to an AI or computational device. The document generally states "Mechanical testing demonstrated comparable mechanical properties to the predicate devices," implying that the acceptance criterion was likely that the new components perform at least as well as the predicate device in relevant mechanical tests. Specific numerical acceptance criteria or performance values are not disclosed.

2. Sample Size Used for the Test Set and Data Provenance: Not applicable. This refers to mechanical testing of physical implants, not data analysis.

3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. Ground truth in this context would likely be engineering specifications and results from mechanical testing, not expert consensus on medical images or patient data.

4. Adjudication Method: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable.

6. Standalone Performance: Not applicable as it's a physical device. Its "performance" is measured through mechanical testing, not an algorithm's output.

7. Type of Ground Truth Used: For the mechanical testing, the "ground truth" would be established engineering standards, material properties, and comparison to the predicate device's established performance under those tests.

8. Sample Size for the Training Set: Not applicable (no training set for a physical device).

9. How the Ground Truth for the Training Set was Established: Not applicable.

Ask a specific question about this device