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The Coupler-ATM and Coupler-LTM Lumbar Plate Systems are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the vessels or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies):

• · Pseudoarthrosis;
• · Spondylolysis;
• · Spondylolisthesis;
• · Spinal stenosis;
• Tumors;
• · Trauma (i.e. Fractures or Dislocation)
• · Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
• · Failed Previous Fusion

The Coupler-ATM and Coupler-L™ Lumbar Plate Systems provide stabilization to the lumbar spine during spinal fusion. These systems include plates, screws, and an instrument set used in the surgical insertion of the implants. The implants are composed of Ti6Al4V ELI Titanium per ASTM F136. The screws are inserted into the vertebral body through corresponding holes in the plate to achieve fixation. A screw locking system is incorporated in the plate allowing the surgeon to lock the screws into place with cam screws after insertion. The plates are available in multiple lengths to allow for utilization in fusion operations across L1 to S1 of the lumbar spine. The system instrumentation is manufactured from surgical grade stainless steel and other surgical grade materials. The instrumentation is used in the placement and fixing of the device.

This document describes the Omnia Medical Coupler-A™ Anterior Lumbar Plate System and Omnia Medical Coupler-L™ Lateral Lumbar Plate System, which are spinal intervertebral body fixation orthoses. The document primarily focuses on demonstrating the substantial equivalence of these devices to a predicate device (Stryker LITe® Plate System K221728) through mechanical testing.

Here's the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided text. The mechanical testing refers to "subject device" and "predicate device," implying samples of both were tested, but no specific number of units or tests is given.
• Data Provenance: Not explicitly stated. Mechanical testing is generally conducted in a laboratory setting. There is no indication of country of origin for this data or if it's retrospective or prospective.

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

• This information is not applicable as the study described is mechanical testing of medical devices, not a clinical study involving ground truth established by expert consensus. The "ground truth" here is the physical performance of the devices under specific forces, measured by laboratory equipment against industry standards (ASTM F1717).

4. Adjudication Method for the Test Set

• This information is not applicable as the study is mechanical testing and does not involve human interpretation or 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

• No, a MRMC comparative effectiveness study was not done. This document pertains to the mechanical safety and performance of spinal implants, not an AI-assisted diagnostic tool.

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

• No, this is not an algorithm. This document describes the mechanical testing of a physical medical device (spinal plates and screws).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" in this context is established by engineering standards and physical measurements. Specifically, the performance of the devices is evaluated against ASTM F1717, an industry standard for "Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model." The acceptance criteria are implicitly derived from the performance of the legally marketed predicate device and the requirements of this standard.

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" as this is not an AI/machine learning study.

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

• This information is not applicable. There is no "training set" or corresponding ground truth establishment process for a mechanical testing study of this nature.

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