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The MOSS Miami Spinal System is intended for non-cervical use in the spine. When used with anterior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to turnor, spinal stenosis, spondylolisthesis, a previously failed back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw attachment are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

The MOSS MIAMI System is available in either Stainless Steel or Titanium. The following components are available in Stainless Steel: 4mm and 5mm diameter longitudinal rods, 5-7mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors and staple washers. The following components are available in Titanium: 5.5mm diameter longitudinal rods, 5-8mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors, washers and staple washers.

This is a 510(k) summary for a spinal system, specifically for additional screws to an already cleared device. This document does not describe a study that uses acceptance criteria and reports device performance in terms of diagnostic accuracy or similar metrics. Instead, it focuses on demonstrating substantial equivalence to a previously cleared device.

Therefore, many of the requested categories for acceptance criteria and study details cannot be filled as they are not applicable to this type of regulatory submission.

Here's an attempt to address the prompt based on the provided text, highlighting what information is available and what is not:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This submission focuses on substantial equivalence based on material, intended use, and design comparisons, not a clinical test set for diagnostic accuracy with a specific sample size or data provenance. The "test set" here refers to the actual physical components being compared for equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. "Ground truth" in the context of device design and material equivalence is typically established by engineering specifications, material standards, and regulatory guidance, rather than expert consensus on a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There is no "test set" in the sense of clinical data requiring adjudication.

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

• Not applicable. This submission is for a spinal implant system (screws), not an AI diagnostic device.

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

• Not applicable. This submission is for a spinal implant system (screws), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for demonstrating substantial equivalence relies on:
  • Material specifications: Conformance to material standards (e.g., Titanium).
  • Engineering design specifications: Comparison of dimensions (e.g., thread length, diameter), and overall design principles.
  • Regulatory definitions: Conformance to the intended use as defined by current regulations and prior clearances.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of device submission.

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

• Not applicable. There is no "training set" for this type of device submission.

Summary of why many fields are Not Applicable:

This document is a 510(k) summary demonstrating substantial equivalence for minor modifications (additional screw sizes) to an already cleared spinal system. It relies on comparing the new components to previously cleared components based on materials, intended use, and design. It does not present a clinical study with diagnostic accuracy metrics, test sets, or expert ground truth adjudication as would be relevant for a diagnostic or AI-powered medical device.

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