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The Jemo Spine, LLC, DELTA™, Spinal Fusion System, a posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 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.

In addition, the Jemo Spine, LLC, DELTA™, Spinal Fusion System is 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).

When used as an posterior screw fixation system such as a sacral/iliac screw fixation system, the Jemo Spine, LLC, DELTA™, Spinal Fusion System is indicated for patients with severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

The Jemo Spine, LLC, DELTA™, Spinal Fusion System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, cap/set screws, and a transverse (cross) linking mechanism. The Jemo Spine, LLC, DELTA™, Spinal Fusion System implant components are fabricated from titanium allov (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.

The Jemo Spine, LLC, DELTA™, Spinal Fusion System can be used in the posterior plane providing unilateral and bilateral modes of fixation.

The Jemo Spine, LLC, DELTA™, Spinal Fusion System design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a preassembled bi-polar cup and internal saddle in the housing component between the screw and the rod which tightens against the head of the pedicle screw upon interface of the cap/set screw assembly with the rod.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Jemo Spine, LLC, DELTA™, Spinal Fusion System implants.

Here's an analysis of the provided 510(k) summary regarding the Jemo Spine, LLC, DELTA™ Spinal Fusion System, focusing on acceptance criteria and the study conducted to prove device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any particular "test set." The mechanical testing refers to "established requirements," implying a standardized testing protocol that would define the number of samples. For the dimensional comparison, it's a comparison of specifications rather than a statistical sample size from production.
• Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The testing described is pre-market non-clinical (mechanical and dimensional comparison).

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

• Not Applicable. This submission is for a spinal implant, which is a physical device, not an AI or diagnostic device that requires expert ground truth for interpretation of images or patient data. The "ground truth" for this device relates to manufacturing specifications, material properties, and mechanical performance under standardized tests.

4. Adjudication Method for the Test Set

• Not Applicable. As noted above, this type of device does not involve human interpretation or subjective assessments that would require an adjudication method. Performance is measured against objective standards (e.g., ASTM standards, dimensional comparisons).

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, an MRMC study was NOT done. This is a hardware medical device (spinal implant), not an AI-assisted diagnostic or interpretation system. Therefore, MRMC studies are not relevant.

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

• Not Applicable. This is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

• For mechanical testing, the "ground truth" is defined by the ASTM F 1717-04 standard specifications for spinal implant constructs.
• For material composition, the "ground truth" is adherence to the ASTM F 136 standard for titanium alloys.
• For dimensional characteristics, the "ground truth" is the design specifications of the device itself and its comparison to the predicate device.
• For safety and effectiveness, the "ground truth" is demonstrated through substantial equivalence to a predicate device that has already been deemed safe and effective by the FDA, based on similar design, materials, indications, and non-clinical performance data.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI or machine learning device that requires a training set. The "training" for such devices involves adherence to design controls, manufacturing processes, and testing protocols.

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

• Not Applicable. As per point 8, there is no training set for this type of device.

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