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The PASS 2 Spinal System includes a pedicle system intended to provide immobilization and stabilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

When used as a pedicle screw system, the PASS 2 Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS 2 components consist of pedicle screws, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

This 510(k) premarket notification for the PASS 2 Spinal System is for a Class II medical device, specifically a posterior pedicle screw system and sacral plate. The submission describes modifications and an extension of the product range. The "acceptance criteria" here refers to the performance standards the device must meet to be considered substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This is a submission for a spinal implant system (hardware), not a diagnostic or AI-driven device that would involve a "test set" of patient data in the typical sense. The testing is mechanical engineering testing of the components. Therefore, the concept of sample size for a test set of data and its provenance is not applicable here. The "sample" would refer to the physical components tested for mechanical strength. The document does not specify the number of components tested.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable. The "ground truth" for a mechanical device is established by standardized material and mechanical testing procedures, not by human expert assessment of clinical data.

4. Adjudication Method for the Test Set

This is not applicable as the testing is mechanical and follows defined ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This is not applicable. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) with and without AI assistance. This submission concerns mechanical performance of a surgical implant.

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

This is not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this device is based on mechanical testing standards, specifically ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ASTM F1798 (Standard Guide for Evaluating the Static and Fatigue Performance of Posterior Spinal Systems). The "ground truth" is that the device components perform within acceptable mechanical limits defined by these standards.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical mechanical implant, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

This is not applicable. The ground truth for mechanical testing is established by the specified ASTM standards and laboratory protocols, not by a "training set."

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