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The Vertera Spine™ Cohere® Cervical Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Vertera Spine Cervical Interbody Fusion Device is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion

The subject Vertera Spine Cohere Cervical Interbody Fusion Device, previously cleared as predicate Vertera Hedgehog Cervical Interbody Fusion Device (K143685), is an interbody fusion device comprised of a single, continuous piece of PEEK Scoria®, which is formed into a final product shape. The subject device remains solid with an extruded porous layer on the superior and inferior surfaces of the implant body. The porous surface is derived directly from the implant body and is not a sintered or otherwise additive coating. The hollow core or graft aperture allows for packing of autograft or allograft to help promote a solid fusion. The PEEK cage contains two marker bands made of tantalum conforming to ASTM F560 R05200, which serve as radiopaque markers so the location and orientation of the device may be seen radiographically, during and after the procedure for position confirmation. The Vertera Spine Cohere Cervical Interbody Fusion Device comes in a variety of sizes and geometries to suit the individual pathology and anatomical conditions of the patient. The devices are provided sterile, with the accessory surgical instruments packaged as non-sterile to be sterilized by the end user. The Vertera Spine Cohere Cervical Interbody Fusion Device is intended to be used with supplemental fixation.

This document is a 510(k) summary for the Vertera Spine™ Cohere® Cervical Interbody Fusion Device. It focuses on establishing substantial equivalence to previously cleared devices and expanding the indications for use. As such, it does not contain the acceptance criteria or a study demonstrating the device meets those criteria, as typically found for AI/ML-based devices.

The submission is for a physical medical device (intervertebral body fusion device) and not a software or AI/ML device that would require performance metric-based acceptance criteria and a study to prove meeting them in the way described in the prompt. Therefore, most of the requested information (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, etc.) is not applicable to this type of device submission.

Here's a breakdown of what is available and why other requested items are not:

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

• Not applicable for this type of device. This document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, AUC) or performance metrics for an AI/ML algorithm. Instead, it refers to establishing "substantial equivalence" to predicate devices based on design, intended use, material composition, and function. The "performance data" mentioned is mechanical testing data for the physical device, described in previous submissions (K143685), not new data for this 510(k).

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

• Not applicable. There is no "test set" in the context of an AI/ML algorithm being evaluated for its diagnostic or predictive performance.

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)

• Not applicable. There is no "ground truth" establishment process for a test set as described for AI/ML algorithms.

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

• Not applicable.

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 physical implant, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This device is not an algorithm.

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

• Not applicable.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of physical device.

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

• Not applicable.

Summary of relevant information from the document (as it pertains to a traditional medical device submission):

• Device Name: Vertera Spine™ Cohere® Cervical Interbody Fusion Device
• Purpose of current 510(k): To expand indications for use to include:
  • Use with allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion.
  • Treatment of multilevel cervical disc degeneration and/or cervical spinal instability at multiple levels (C2 - T1).
• Predicate Devices:
  • Primary: Vertera Hedgehog Cervical Interbody Fusion Device (K143685)
  • Additional: NuVasive CoRoent Small Interbody System (K163491)
• Substantial Equivalence Basis: Comparison in design, intended use, material composition, and function to predicate devices.
• Performance Data: Mechanical performance testing data was provided in previous submissions (specifically K143685) to establish substantial equivalence. No new mechanical testing was performed for this 510(k) submission because no design changes were made.
• Device Characteristics: Comprised of a single piece of PEEK Scoria® with an extruded porous layer on superior and inferior surfaces. Contains radiopaque tantalum marker bands. Intended for use with supplemental fixation and autogenous and/or allogeneic bone graft. Does not contain software or electrical equipment.

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The Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the lumbar spine (L2 to S1), and are intended to be used with autogenous bone graft and supplemental fixation systems that have been cleared by the FDA for use in the lumbar spine.

The proposed devices within the Coalesce™ Lumbar Interbody Fusion System are sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the lumbar spinal column in lumbar intervertebral body fusion procedures. Each device within the Coalesce™ System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the device assembly may contain two or more tantalum markers, depending on footprint, to enable visibility under x-ray in vivo.

The provided text describes a medical device, the Coalesce™ Lumbar Interbody Fusion System, and its clearance process with the FDA. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. The "testing" mentioned is primarily performance testing against engineering standards for intervertebral body fusion devices, not clinical studies with human participants or evaluation of algorithm performance in an AI context.

Therefore, I cannot provide the requested information. The text does not report:

1. A table of acceptance criteria and reported device performance related to diagnostic or evaluative metrics.
2. Sample sizes for test sets, data provenance, or details about training sets.
3. Number or qualifications of experts to establish ground truth.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth used in a clinical or AI context.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Non-Clinical Testing" section (I) describes:

• Functional performance testing: static and dynamic compression, compression shear, subsidence, and expulsion.
• Standards referenced: (ASTM) F2077-14, (ASTM) F2267-04, and (ASTM) F1877-16.
• Conclusion: "Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices."

This indicates that the device met the requirements of these engineering standards, which likely have their own defined acceptance criteria (e.g., maximum deformation under load, minimum load to failure). However, these specific criteria and the detailed results showing compliance are not included in the summary.

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