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The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scolosis. Additionally, the system is intended to treat pediatic patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, connectors, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ISO 5832-3 ASTM F136 and cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, connectors, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend the PASS LP Spinal System, with the addition of new components:

• -'Top loading, cannulated pedicle screws'
• -'Top loading, non-cannulated pedicle screws'
• -'Top loading, cannulated iliac screws'
• -'Top loading, non-cannulated iliac screws'
• 'Closed, cannulated iliac screws' -
• 'Closed, non-cannulated iliac screws' -

The provided document is a 510(k) premarket notification for a medical device called the "PASS LP Spinal System". It describes the device, its intended use, comparison to predicate devices, and performance data. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

The performance data section (page 7) lists:

• Biocompatibility Testing: Conducted according to FDA blue book Memorandum #G95-1 and ISO 10993-1. Specific tests included Cytotoxicity, Sensitization, Irritation, Systemic toxicity, and Pyrogen Testing.
• Mechanical Testing: Performed on additional components (static bending, static torsion, dynamic compression bending according to ASTM F1717). The document states these tests indicate "the products are as mechanically sound as other devices commercially available."
• No Finite Element Analysis were performed.
• No Clinical Study was performed.
• No Animal Study was performed.

This information relates to the physical and biological properties of the spinal implant system, not the performance of an AI or algorithm. Therefore, I cannot provide the requested details regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, or adjudication methods, as these are not present in the provided text.

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