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The DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in sketally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The DIVERGENCE™ stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCE™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody fusion device with internal screw fixation. The DIVERGENCE™ Anterior Cervical Fusion System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. This system is indicated for single-level use only in the C2-T1 anterior spine. The system is comprised of a PEEK interbody cage and screws.

The DIVERGENCE™ anterior cervical cages are provided in 0 and 6 degrees of lordosis, 5-12mm heights, 15-20mm widths and 12-16mm depths. This device is intended to be radiolucent, and the interior space of the product is to be used with autogenous bone graft. The DIVERGENCE™ stand-alone cervical interbody device is manufactured from medical grade polyetheretherketone (PEEK) and contains radiopaque markers made from medical grade titanium alloy. The PEEK interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism.

The bone screws used with this device are provided in self-drilling and self-tapping options and are manufactured from medical grade titanium alloy. The bone screws are provided in 3.5mm and 4.0mm diameters and 9-17mm lengths.

The PEEK material (PEEK OPTIMA™ LT-1) used conforms to ASTM F2026 and the titanium alloy material (Ti-6Al-4V ELI) used conforms to ASTM F136 standards. These devices are offered in sterile form.

The provided text describes a 510(k) premarket notification for the DIVERGENCE™ Anterior Cervical Fusion System. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than clinical studies or AI performance data. Therefore, many of the requested points related to AI or extensive clinical trials cannot be found in this document.

Here's an analysis based on the available information:

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

Specific numerical values for acceptance criteria and test results are not provided in this summary document.

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

The document describes non-clinical (mechanical) testing of the device. It does not refer to sample sizes of human subjects or data provenance in the context of clinical studies. The "test set" here refers to the physical devices subjected to mechanical tests. The sample size for these tests is not explicitly stated in this summary.

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)

This is not applicable to the provided document. The ground truth for mechanical testing is established by engineering standards (ASTM) defining robust and safe performance of the device. There are no human experts "establishing ground truth" in the way a radiologist would for medical imaging.

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

This is not applicable as the document describes non-clinical mechanical testing, not a clinical trial requiring adjudication of patient outcomes or expert consensus.

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

This is not applicable. The document describes a medical device (an intervertebral body fusion device), not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The document describes a physical medical device, not an algorithm.

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

For the non-clinical tests described, the "ground truth" is defined by established engineering standards (ASTM F2077-11 and ASTM F2267-04(2011)) that set performance benchmarks for intervertebral body fusion devices. Meeting these standards demonstrates the device's mechanical integrity and safety.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device and its mechanical testing, not an AI system that requires a training set.

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

This is not applicable for the same reason as point 8.

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The DIVERGENCE™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudoarthrosis, and/or 6) failed previous fusions.

The DIVERGENCE™ anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non-operative treatment. The DIVERGENCE™ cage must be used with supplemental fixation. The DIVERGENCE™ cage is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

When used together, the DIVERGENCE™ components can be used only to treat cervical disc disease.

The DIVERGENCE™ Anterior Cervical Fusion System consists of temporary implants (plates and bone screws) intended for anterior screw fixation, and fusion devices (interbody cages) intended to stabilize and promote bone fusion during the normal healing process following surgical correction of disorders of the spine.

The DIVERGENCE™ anterior cervical plates and bone screws are available in broad range of size offerings that are intended for anterior screw fixation intended for stabilization use during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The DIVERGENCE™ anterior cervical plate and bone screws are made from titanium alloy and are provided sterile.

The DIVERGENCE™ anterior cervical cages available in various widths and heights can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These implants must be used with supplemental fixation. The device is made from medical grade polyetheretherketone (PEEK OPTIMA™ LT1), contains titanium alloy wire markers and is provided sterile.

The associated accessories include:

• Guides
• Inserters
• Trials

The purpose of this submission is to introduce new implant trials into the DIVERGENCE™ Anterior Cervical Fusion System.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted using the device. The document is a 510(k) premarket notification for a medical device (DIVERGENCE™ Anterior Cervical Fusion System) and primarily focuses on establishing substantial equivalence to a predicate device.

The document discusses:

• The device's indications for use.
• A comparison of the new device's technology characteristics with a predicate device.
• A brief mention of a risk analysis and validation labs of design modifications, but no specific performance data or study results are provided in detail.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for either test or training sets.

Ask a specific question about this device