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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), spondy lolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudoarthrosis, 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 fusion to treat adolescent idiopathic scoliosis. 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 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, clamps, 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 or cobaltchromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

The purpose of this submission is to add components to the PASS LP implant range to treat Pars interarticularis fracture.

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 hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. These components can be rigidly locked into a variety of configurations.

The provided text describes the 510(k) premarket notification for the PASS LP Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for a new device's performance characteristics. Therefore, many of the requested categories related to clinical studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted directly from this type of regulatory submission.

However, I can extract information regarding the performance data provided to support the substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table for device performance in the way one might expect for a new diagnostic or AI intervention. Instead, it relies on demonstrating substantial equivalence to existing predicate devices through mechanical testing. The implicit acceptance criterion is that the new components perform comparably to the predicates in standard mechanical tests.

2. Sample size used for the test set and the data provenance

The document mentions "Dynamic Compression Bending Tests, following the ASTM F1717 'Standard Test Methods for Spinal Implants Constructs in a Vertebrectomy Model' were carried out."

• Sample Size: The specific number of devices tested in the Dynamic Compression Bending Tests (n for each test group) is not provided in this document.
• Data Provenance: The tests were "carried out" as part of the submission process, implying these were prospective bench tests conducted specifically for this regulatory submission. The country of origin for the data is implicitly France, where Medicrea® International S.A. is based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The "ground truth" for the mechanical performance of a spinal implant is determined by established engineering standards (ASTM F1717) and the physical properties observed in the bench tests, not by expert consensus in a clinical setting.

4. Adjudication method for the test set

This section is not applicable. Mechanical tests against a standard do not typically involve human adjudication in the same way clinical or image-based studies do. The results are quantitative measurements against predetermined pass/fail criteria (often, remaining within a certain deviation of predicate performance).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. This document concerns a spinal implant system, not a diagnostic device or AI system that assists human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable. This document concerns a spinal implant system, not an AI algorithm.

7. The type of ground truth used

The ground truth used for evaluating the device's performance was:

• Mechanical performance metrics as defined by the ASTM F1717 standard for "Spinal Implants Constructs in a Vertebrectomy Model." This involves quantitative measurements of force, displacement, and cycles to failure under defined loading conditions.
• Performance of legally marketed predicate devices (CD Horizon Spinal System - K140449, and PASS LP Spinal System - K123138) against the same standard, effectively setting the "ground truth" for acceptable performance.

8. The sample size for the training set

This section is not applicable. This document concerns a spinal implant system, not a device that utilizes a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This section is not applicable. There is no "training set" in the context of this device and evaluation.

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