Search Results

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The PILOT® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.

When used as a posterior spine thoracic/lumbar system, the PILOT® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis). (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

When implanted in the thoracic, lumbar, and/or sacral spine, the PILOT® Spinal System provides additional support during spinal fusion. The PILOT® Spinal System consists of screws and rods in a variety of shapes and sizes. The PILOT® Spinal System is manufactured from medical grade titanium alloy and will be sold non-sterile.

This document (K080502) is a 510(k) summary for the PILOT® Spinal System by Life Spine. It indicates that the device was found substantially equivalent to previously cleared devices.

Based on the provided text, there is no acceptance criteria or study information related to device performance, AI/algorithm efficacy, sample sizes, ground truth establishment, or expert adjudication.

The document primarily focuses on:

• Device Description: The PILOT® Spinal System consists of screws and rods made of medical grade titanium alloy for posterior pedicle screw fixation.
• Intended Use: Provides additional support during spinal fusion in the thoracic, lumbar, and/or sacral spine for skeletally mature patients to stabilize and immobilize spinal segments. Indications include degenerative disc disease, trauma, curvatures, spinal tumor, failed previous fusion, pseudarthrosis, spinal stenosis, and spondylolisthesis.
• Substantial Equivalence: The device was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used. This is a common regulatory pathway for medical devices where extensive clinical outcome studies (as would be required for novel AI devices) are often not necessary if equivalence to a predicate device can be demonstrated.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because it is not present in the given text. This type of 510(k) submission generally relies on demonstrating equivalence to an existing device rather than presenting novel performance study data against specific quantitative acceptance criteria.

Ask a specific question about this device