(222 days)
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
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Static and dynamic compression as per ASTM F2077-11 | Met pre-determined acceptance criteria for all tests. |
| Static and dynamic compression shear as per ASTM F2077-11 | Met pre-determined acceptance criteria for all tests. |
| Static and dynamic torsion as per ASTM F2077-11 | Met pre-determined acceptance criteria for all tests. |
| Subsidence testing as per ASTM F2267-04(2011) | Met pre-determined acceptance criteria for all tests. |
| Material conformance (PEEK) | PEEK OPTIMA™ LT-1 conforms to ASTM F2026. |
| Material conformance (Titanium alloy) | Ti-6Al-4V ELI conforms to ASTM F136 standards. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.