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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 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 and caps for sacral plates, when used for posterior non-cervical pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scollosis. Additionally, the system is intended to treat pediatric 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 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, 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-6Al-4V ELI) that conforms to ASTM F136 and ISO 5832-3.

A subset of PASS LP 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 to the PASS LP range, with the addition of those new components:

• TULIP GENESIS Non-cannulated Pedicle Screws
• TULIP GENESIS Non-cannulated Iliac Screws
• TULIP GENESIS Cannulated Pedicle Screws
• TULIP GENESIS Cannulated Iliac Screws
• TULIP GENESIS Breakable Setscrew

This document is a 510(k) Pre-Market Notification from the FDA for the PASS LP Spinal System. It is an approval letter and a summary of the device and its intended use, not a study evaluating its performance against acceptance criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information as the document does not contain details about:

1. Acceptance criteria and reported device performance related to an AI/ML model. This document is for a medical implant (spinal fixation system), not a software device that relies on performance metrics like accuracy, sensitivity, or specificity.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Stand-alone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
8. Sample size for a training set.
9. How ground truth for the training set was established.

The "Performance Data" section (g) only mentions mechanical testing according to ASTM F1717-18 for static compression bending, static torsion, and dynamic compression bending tests, concluding that the products are "as mechanically sound as other devices commercially available." This refers to the physical properties of the spinal implants, not the performance of an AI or Machine Learning algorithm.

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