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The following are specific indications for the Osteonics® Spinal System:

As a non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• Long and short curve scoliosis .
• . Vertebral fracture or dislocation
• . Spondylolisthesis
• . Degenerative disc disease (defined as back pain of discogenic 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 is 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 (pseudarthrosis).
• In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-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.

The Osteonics® Spinal System is comprised of single use, non-sterile devices manufactured from ASTM F-136-96 Titanium alloy (Ti6A1-4V ELI). The Osteonics® Spinal System Sacral Offset Connector Assembly may be used in any application where supplemental sacral screw placement is desired by the surgeon. This assembly allows a sacral connector with supplemental sacral screw to the joined to the spinal rod in the sacral offset blocker secures the sacral screw to the connector assembly. The Clamping Screw is used with the Sacral Offset Connector to provide a stable lock on the longitudinal spinal rod.

This document describes a 510(k) premarket notification for a medical device, specifically the Osteonics® Spinal System - Sacral Offset Connector Assembly. The submission focuses on demonstrating substantial equivalence to predicate devices through material, design, and intended use comparison.

However, the provided text does not contain information about acceptance criteria for device performance or a study proving that the device meets such criteria.

The document primarily covers:

• Submission Information: Sponsor, contact, date, device identification (proprietary name, common name, classification name).
• Predicate Device Identification: Listing similar commercially available spinal systems.
• Device Description: Materials, intended use (sacral screw placement, connecting to spinal rod, clamping screw for stable lock).
• Intended Use/Indications For Use: Detailed list of spinal conditions for which the system is indicated, both as a non-pedicle screw system and as a pedicle screw fixation system.
• Statement of Technological Comparison: Asserts substantial equivalence based on materials, intended uses, and basic design concepts, and mentions that "Fatigue and static testing demonstrates the mechanical and endurance properties of these components."

Missing Information:

The document explicitly states that "Fatigue and static testing demonstrates the mechanical and endurance properties of these components" under the "Statement of Technological Comparison." This indicates that some form of testing was performed. However, the details required to directly answer your request are not present in the provided text.

Specifically, the following information is not provided:

1. A table of acceptance criteria and the reported device performance: While testing is mentioned, no specific criteria (e.g., maximum load, cycles to failure) or numerical results are given.
2. Sample size used for the test set and the data provenance: No information on the number of devices tested or if the data was retrospective/prospective, or country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is a mechanical device, so expert review of "ground truth" in clinical image interpretation or diagnosis would not be applicable in this context.
4. Adjudication method for the test set: Not applicable for mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a mechanical spinal fixation device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a mechanical device.
7. The type of ground truth used: For mechanical testing, the "ground truth" would be the measured physical properties or failure points under specified conditions, defined by engineering standards. The document only states "Fatigue and static testing," but no specific standards or detailed methodology.
8. The sample size for the training set: Not applicable, as this is a mechanical device, not an AI alogorithm that uses training data.
9. How the ground truth for the training set was established: Not applicable.

To answer your request thoroughly, additional documentation regarding the specific fatigue and static testing performed on the Osteonics® Spinal System Sacral Offset Connector Assembly would be required. This would typically be found in engineering reports or test summaries that are part of the full 510(k) submission, but are not included in this excerpt.

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