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When used as an anterior, thoracic/lumbar screw fixation system, the MOSS Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MOSS Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MOSS Spinal System is also indicated for pedicle screw fixation in skeletally mature 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 fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

The MOS'S Spinal System is available in Stainless Steel. The following components are included in the system: threaded rods, monoaxial and polyaxial screws, hexnut, washers, and transverse rod stabilizers. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.

The provided text describes a 510(k) submission for the DePuy AcroMed MOSS Spinal System. This submission focuses on establishing substantial equivalence to existing predicate devices, rather than conducting a de novo study with acceptance criteria and direct performance evaluation. Therefore, the device meets acceptance criteria by demonstrating it is as safe and effective as legally marketed predicate devices, not through a study proving specific performance metrics against a predefined set of criteria.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically applied to a de novo study (e.g., sensitivity, specificity, accuracy) is not directly applicable here because this is a 510(k) submission based on substantial equivalence. The "acceptance criteria" for a 510(k) are met by demonstrating that the new device is as safe and effective as a predicate device.

Acceptance Criteria (for 510(k) Substantial Equivalence): The device is substantially equivalent to legally marketed predicate devices in terms of:

• Intended use
• Technological characteristics (materials, design, performance)
• Safety and effectiveness

Reported Device Performance: The submission states:

The basis of substantial equivalence is explicitly stated as: "The components of the MOSS Spinal System are identical to the components of the other MOSS Spinal Systems which have been cleared by FDA for certain anterior and posterior uses and for pedicle fixation use indications."

This means the "performance" demonstrated is that its components and functionality are equivalent to previously cleared devices.

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

Not applicable. This 510(k) relies on demonstrating substantial equivalence to existing predicate devices rather than a new study with a "test set" of patients or data. The "data provenance" would refer to the regulatory history and technical specifications of the predicate devices.

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

Not applicable. No "test set" requiring expert ground truth establishment for performance metrics was used in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication was used.

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 device is a spinal implant system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a spinal implant system, not an algorithm.

7. The Type of Ground Truth Used

For a 510(k) based on substantial equivalence, the "ground truth" is effectively the regulatory history and established safety and effectiveness of the predicate devices. The ground truth is that the predicate devices have been deemed safe and effective for their indicated uses by the FDA. The new device is then compared against this established "ground truth" of the predicate.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this 510(k) submission for a spinal implant. This is not an AI/machine learning device.

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

Not applicable. No "training set" was used.

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