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The PASSmed which includes the subject components, is a pedicle screw 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 the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

As a pedicle screw system PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra 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.

It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The PASSmed Spinal System consists of pedicle screws, hooks, 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 and titanium unalloyed (T40) that conforms to ASTM F67.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PASSmed Spinal System:

Based on the provided text, the acceptance criteria and study information are quite limited, typical for a Special 510(k) submission which focuses on modifications to an already cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of a clinical study with patients or specific data. Instead, it refers to mechanical testing.

• Sample Size: Not specified for the mechanical tests, beyond the implication that "additional components" were tested.
• Data Provenance: The tests were performed in accordance with ASTM F1717 or ASTM F1798, which are standardized mechanical testing methods for spinal implant systems. This implies lab-based mechanical testing, not human or animal data. There is no information on country of origin of the data as it pertains to clinical data, as no clinical data is presented.
• Retrospective/Prospective: Not applicable, as no clinical data is referenced.

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

Not applicable. The "ground truth" here is mechanical soundness, established by specified ASTM standards, not by expert medical opinion on clinical data.

4. Adjudication Method for the Test Set

Not applicable. There's no clinical "test set" requiring adjudication. Mechanical testing against a standard does not involve adjudication.

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

No. This is a medical device (spinal implant) that undergoes mechanical testing and relies on substantial equivalence to predicate devices, not a diagnostic AI system requiring an MRMC study.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used is the mechanical performance standards outlined in ASTM F1717 or ASTM F1798. These standards define the acceptable mechanical properties for spinal implant systems.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

Summary of the Study:

The "study" described is a series of mechanical performance tests conducted on the additional components of the PASSmed Spinal System (specifically the Ø6mm rod and connectors). These tests were performed in accordance with established ASTM (American Society for Testing and Materials) standards: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) or ASTM F1798 (Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants).

The purpose of these tests was to demonstrate the mechanical equivalence of the modified components to the previously cleared PASSmed devices. The reported outcome states that these tests indicate that the products are as mechanically sound as other PASSmed devices commercially available. This serves as the evidence for meeting the acceptance criteria of mechanical soundness. The reliance on these standardized tests and the comparison to predicate devices is a typical approach for Special 510(k) submissions where the changes are limited and primarily mechanical.

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