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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: spondylolistis 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 allov (Ti-6Al-4V ELI) that conforms to ISO 5832-3 ASTM F136 and cobaltchromium 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, 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 Pedicle hooks'
• -'Top loading Transverse Process hooks'

The provided text describes a 510(k) premarket notification for the "PASS LP Spinal System," a medical device. This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with defined acceptance criteria in the manner one might expect for a novel AI/software device.

Therefore, the input document does not contain the requested information regarding acceptance criteria and a study proving a device meets those criteria for software or AI performance.

The document is about a spinal implant system and discusses:

• Its intended use.
• Comparison of its technological characteristics (design, materials) to predicate devices.
• Biocompatibility testing (which followed standards like ISO 10993) and mechanical testing (using Finite Element Analysis based on ASTM F1798 standards to compare with predicate devices).
• Explicitly states "No clinical studies were performed" and "No animal studies were performed."

Given the nature of the document, the following points based on your request cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of medical device submission where "performance" is primarily structural integrity and biocompatibility, demonstrated through testing against relevant standards rather than a clinical performance metric.
2. Sample size used for the test set and the data provenance: Not applicable. The "tests" here are biomechanical and biocompatibility tests, not a clinical test set for AI/software performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. No ground truth in the context of data labeling is mentioned.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Explicitly stated "No clinical studies were performed."
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: This device is a physical implant, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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