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The NEX-D2 Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pediatic patients, the NEX-D2 Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft to facilitate fusion.

The Next Orthosurgical NEX-D2 Posterior Fixation System is a non-cervical pedicle screw system that consists of pedicle screws, rods, connectors, and set screws. All components are available in a variety of sizes to match patient anatomy. All components are manufactured from Ti-6AI-4V ELI per ASTM F136, commercially pure titanium per ASTM F67, and cobalt chrome allov per ASTM F1537, These components are supplied either sterile or non-sterile.

The provided document is a 510(k) summary for the NEX-D2 Posterior Fixation System, which is a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through novel acceptance criteria and studies.

Therefore, the information typically requested in your prompt regarding acceptance criteria, device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for a novel AI/medical device with new performance claims is not applicable to this document.

Instead, the document focuses on non-clinical mechanical testing to demonstrate that the new device components are substantially equivalent to existing, cleared devices.

Here's how to interpret the available information in the context of your request:

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

• Acceptance Criteria: The document states, "The subject devices met the pre-determined acceptance criteria." It implies these criteria are derived from the performance of the predicate devices according to the listed ASTM standards. However, the specific numerical acceptance criteria (e.g., minimum bending strength, maximum deflection) are not detailed in this summary. They would typically be found in the full 510(k) submission, referencing the specific ASTM standard requirements for such devices.
• Reported Device Performance: The document generally states, "Testing results demonstrate that the NEX-D2 Posterior Fixation System is substantially equivalent to the predicate devices." It does not provide specific numerical performance results for the NEX-D2 system (e.g., exact values for static compression bending strength, fatigue life cycles). This level of detail is also usually present in the full submission, comparing the subject device's performance directly to the predicate or to the ASTM standard's requirements.

2. Sample sized used for the test set and the data provenance

• For the non-clinical mechanical tests, the sample sizes are not specified in this summary. These quantities would be defined by the relevant ASTM standards for the specific tests performed (e.g., a certain number of constructs for fatigue testing).
• Data Provenance: The tests were conducted internally by Next OrthoSurgical or a contracted lab to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a mechanical device, and "ground truth" in this context refers to the specified performance requirements of industry standards (ASTM) rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

• Not Applicable. Mechanical testing results are objective measurements against established standards, not subject to expert adjudication of subjective assessments.

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 surgical implant (pedicle screw system), not an AI-powered diagnostic or assistive tool. No human reader studies were performed.

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

• Not Applicable. This is a mechanical surgical implant, not an algorithm.

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

• The "ground truth" for this device's performance acceptance is based on adherence to recognized industry standards (ASTM F1717, ASTM F1798, ASTM F543, ANSI/AAMI ST72) and demonstrating performance comparable to previously cleared predicate devices.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not Applicable.

In summary, for the NEX-D2 Posterior Fixation System, the primary "study" is a series of non-clinical mechanical tests demonstrating compliance with recognized ASTM standards and substantial equivalence to predicate devices, rather than a clinical trial or AI performance study with human-in-the-loop assessments.

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