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The Advantage Lumbar System - ALIF, PLIF, TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Advantage Lumbar – ALIF, PLIF, TLIF's implants are interbody fusion devices intended for use as an aid in spinal fixation. These hollow, rectangular implants are offered in a variety of widths, lengths, heights, and lordotic angles designed to adapt to a variety of patient anatomies. They have serrations on the superior and inferior surfaces designed for fixation, ergonomically shaped anterior edges, and flat posterior edges. Radiopaque markers have been embedded within the implants, which are designed to allow for visualization in radiographic images.

The provided document is a 510(k) summary for the Intelivation LLC's Advantage Lumbar System, which is an intervertebral body fusion device. The document explicitly states that no performance testing was required for this device.

The rationale provided is that the "subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring names of systems that have already been cleared under K121567 and K131981."

Therefore, based on the provided text, it is not possible to describe acceptance criteria or a study that proves the device meets the acceptance criteria, as no such study was conducted or deemed necessary by the FDA for this particular 510(k) clearance due to the device's substantial equivalence to already cleared predicates.

All sections of your request related to acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be answered as the submission states no testing was required for this particular device.

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The Golden Isles Pedicle Screw System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine as follows:

The Golden Isles System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoathrosis; and failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Golden Isles Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (1.5-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (d) who are having the device removed after the development of a solid fusion mass.

The Golden Isles Pedicle Screw System is a spinal fixation system consisting of a variety of components including pedicle screws, modular head bodies, and various types and sizes of rods. The components are designed to be rigidly locked into a variety of configurations with each construct being appropriate for the individual patient. The Golden Isles Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V) or cobalt chrome alloy (Co-28Cr-6Mo).

The provided text describes a 510(k) premarket notification for the "Golden Isles Pedicle Screw System". However, it explicitly states that no performance data or studies were required or conducted because the device is "identical to the predicate device" (Preference Elite Pedicle Screw System, K162160).

Therefore, the requested details about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study cannot be extracted from this document, as such a study was not performed for the Golden Isles Pedicle Screw System.

Here's what can be stated based on the provided text:

The Golden Isles Pedicle Screw System did not undergo a specific study to demonstrate its performance against acceptance criteria. The FDA cleared its marketability based on its substantial equivalence to a legally marketed predicate device (K162160), asserting that the subject and predicate devices are identical.

Therefore, the following information, relating to a performance study, is not applicable or not provided in this document:

1. Table of Acceptance Criteria and Reported Device Performance: Not applicable, as no performance testing was required or conducted for this specific device due to its identical nature to the predicate.

2. Sample Size Used for the Test Set and Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications: Not applicable.

4. Adjudication Method for the Test Set: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was conducted.

6. Standalone Performance Study (algorithm only without human-in-the-loop performance): Not applicable.

7. Type of Ground Truth Used: Not applicable.

8. Sample Size for the Training Set: Not applicable.

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

Explanation from the document:
The document explicitly states:

• "The subject and predicate devices are identical and therefore, no performance testing is required: This submission is only transferring the name of a system that has already been cleared under K162160. No testing is required."
• "The Golden Isles Pedicle Screw System and the primary predicate, Preference Elite Pedicle Screw System have the same intended use and identical indications, technological characteristics and principles of operation. There are no technological differences between the Golden Isles Pedicle Screw System and its predicate. Hence the Golden Isles Pedicle Screw System is substantially equivalent to the primary predicate."

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