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The MOSS® MIAMI Spine System 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 (pseudarthrosis).

The MOSS® MIAMI Spine Systems is also indicated for pedicle screw fixation 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.

The MOSS® MIAMI Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MOSS® MIAM! Spine Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The EXPEDIUM® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM® Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Moss® Miami and Expedium® Spine Systems consists of rods, hooks, pedicle screws, and other components. A subset of the Moss Miami and Expedium systems, which is the basis of this submission, includes titanium pedicle screws and rods that are now sterilized via gamma radiation. Previously, these devices were commercialized as clean, but non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain pedicle screws and rods will be packaged in sterile multi-packs for customer convenience.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or diagnostic ability.

Instead, the document is a 510(k) summary for a medical device (Moss® Miami and Expedium® Spine Systems) that describes a change in sterilization method (from non-sterile to terminally sterilized via gamma radiation). The key aspect of this submission is demonstrating substantial equivalence to predicate devices.

Here's a breakdown of why the requested information isn't present in this document:

• "Acceptance criteria and the reported device performance": This document does not outline numerical performance criteria (e.g., "The device must achieve X% sensitivity and Y% specificity"). The "performance" being discussed is the effect of the new sterilization method.
• "Study that proves the device meets the acceptance criteria": There isn't a clinical or analytical performance study in this document that would measure diagnostic accuracy or similar metrics. The focus is on demonstrating that the sterilization change does not alter the fundamental characteristics or safety/effectiveness of the device compared to its non-sterile predecessors.
• "Sample size used for the test set and the data provenance": Not applicable, as there's no diagnostic test set being evaluated.
• "Number of experts used to establish the ground truth... and qualifications": Not applicable.
• "Adjudication method": Not applicable.
• "Multi reader multi case (MRMC) comparative effectiveness study": Not applicable. Such studies are typically for diagnostic imaging devices or AI-powered algorithms where human reader performance is a key metric.
• "Standalone (i.e. algorithm only without human-in-the-loop performance) was done": Not applicable, as this device (spinal fixation system) is not an algorithm.
• "Type of ground truth used": Not applicable.
• "Sample size for the training set": Not applicable.
• "How the ground truth for the training set was established": Not applicable.

What the document does state regarding the "study" for acceptance:

The document explains that the sterilization process itself was conducted in compliance with a standard:

• Study described: The gamma sterilization is performed in compliance with ISO 11137:2006 (VDMax method).
• "Acceptance Criteria" implicitly met: By complying with ISO 11137:2006, the device is accepted to achieve a predefined sterility assurance level (SAL), which is the primary "acceptance criterion" for the sterilization process. The "performance" is that the device is now terminally sterilized to this recognized standard.

Conclusion from the document:

The final conclusion is that the "Substantial Equivalence Justification demonstrates that the device is as safe, as effective, and performs as well as the predicate device." This means the change in sterilization method did not negatively impact the device's safety, effectiveness, or performance, which were already established for the predicate devices.

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