Search Results

NuVasive CoRoent Small Interbody System:
The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System 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 CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of nonoperative treatment.

NuVasive CoRoent Small Contoured Interbody System:
The NuVasive CoRoent Small Contoured Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Contoured Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) 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 intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

NuVasive CoRoent Small Interlock System:
The CoRoent Small Interlock System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature 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 autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

NuVasive CoRoent Small Interlock II System:
The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) 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 CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or alloqenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to or a bone void filler as cleared by the FDA for use in intervertebral body fusion facilitate fusion. The cervical devices are to be used in patient who have had at least six weeks of non-operative treatment.

NuVasive CoRoent Small Ti-C System:
The NuVasive CoRoent Small Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Ti-C System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/ or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent Small interbody devices with lordotic angles of 10° or greater are required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

NuVasive Cohere Cervical Interbody System:
The Cohere® Cervical Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Vertera Spine Cohere 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 or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.

NuVasive CoRoent Small Interbody System:
The NuVasive CoRoent Small Interbody System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The CoRoent Small Interbody System implants are hollow devices manufactured from polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of either titanium alloy (Ti-6A1-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 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 CoRoent Small Interbody System and accessory surgical instruments will be packaged and provided both sterile and non-sterile implants are designed to be sterilized by the user before each use. The implantation technique does not differ from that performed for the predicate CoRoent Small offerings cleared in NuVasive CoRoent Small Interbody System (K163491). The CoRoent Small Interbody offerings are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The CoRoent Small Hyperlordotic offerings (lordotic angles of 10° to 30°) must be used with an anterior cervical plate. The CoRoent Small Interbody System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion.

NuVasive CoRoent Small Contoured Interbody System:
The NuVasive® CoRoent® Small Contoured Interbody System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The CoRoent Small Contoured Interbody System implants are hollow devices manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of either titanium alloy (Ti-6Al-4V) or tantalum serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation. Both the subject device and its accessory surgical instruments will be packaged and initially provided non-sterile and are designed to be sterilized by the user before each use. The implantation technique for the subject CoRoent Small Contoured Interbody System does not differ from that performed for the predicate CoRoent Small offerings cleared in CoRoent Small Interbody System (K163491). The CoRoent Small Interbody offerings are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The CoRoent Small Contoured Interbody System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion and to expand indications to include treatment of degenerative disc disease (DDD) of the cervical spine at multiple contiguous levels.

NuVasive CoRoent Small Interlock System:
The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature 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 autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of either titanium alloy (Ti-6Al-4V) or tantalum 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 NuVasive CoRoent Small Interlock System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The CoRoent Small Interlock offerings are intended to be standalone without supplemental fixation. ThThe CoRoent Small Interlock System implants will be packaged either sterile while accessory surgical instruments will be provided non-sterile and are designed to be sterilized by the user before each use. The implantation technique does not differ from that described in primary predicate CoRoent Small Interlock System (K192582). The CoRoent Small Interlock System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion.

NuVasive CoRoent Small Interlock II System:
The NuVasive CoRoent Small Interlock II System is an intervertebral body fusion device designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The System consists of various sizes of PEEK implants with tantalum radiographic markers, titanium alloy washers and bone screws. Additionally, a commercially pure titanium (CP Ti) coating is plasma sprayed to the superior and inferior surfaces of the interbody device. The implants are manufactured from Polyetheretherketone PEEKOPTIMA® LT1 conforming to ASTM F2026, commercially pure titanium coating conforming to ASTM F1580, with titanium alloy washers and bone screws conforming to ASTM F136, ASTM F1472 or ISO 5832-3. The hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of tantalum 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 implantation technique for the subject CoRoent Small Interlock II implants (including hyperlordotic offerings) does not differ from that performed for the predicate Interlock offerings cleared in CoRoent Small Interlock System (K192582). Both the subject PEEK only interbodies, screws and accessory surgical instruments will be packaged and initially provided non-sterile and are designed to be sterilized by the user before each use. Additionally, the subject PEEK with CP Ti coating implants will be provided sterile. Non-clinical testing demonstrates that the subject device meets performance requirements set by the Agency's guidance document and is substantially equivalent to the predicate NuVasive CoRoent Small Interlock II System (K170961) NuVasive CoRoent Small Interlock System (K192582), and other predicate devices cleared by the Agency. The CoRoent Small Interlock II System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion and to expand indications to include treatment of degenerative disc disease (DDD) of the cervical spine at multiple contiguous levels.

NuVasive CoRoent Small Ti-C System:
The NuVasive CoRoent Small Ti-C System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The subject CoRoent Small Ti-C System implants are hollow devices manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. A commercially pure titanium (CP Ti) coating is plasma sprayed to the superior and inferior surfaces of the device. The hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 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 CoRoent Small Ti-C System includes several variants within its offering. Within the subject system, the CoRoent Small Interbody offerings are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The CoRoent Small Hyperlordotic offerings (lordotic angles of 10° to 30°) must be used with an anterior cervical plate. The CoRoent Small Ti-C System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion and to expand indications to include treatment of degenerative disc disease (DDD) of the cervical spine at multiple contiguous levels. Overall, the subject NuVasive CoRoent Small Ti-C System device is substantially equivalent to predicates NuVasive CoRoent Small Interbody System (K163491), and NuVasive Ti-C System (K162138), as well as other predicate devices cleared by the Agency. The CoRoent Small Ti-C System will be provided sterile while its accessory general surgical instruments will be provided non-sterile and designed to be sterilized by the user before each use. The implantation technique does not differ from that performed for the predicate devices cleared in NuVasive CoRoent Small Interbody System (K163491).

NuVasive Cohere Cervical Interbody System:
The subject Cohere® Cervical Interbody Fusion Device (K173030) 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 autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft or a bone void filler as cleared by the FDA for use in intervertebral body fusion to help promote a solid fusion. The PEEK cage contains two marker bands made of tantalum R05200 conforming to ASTM F560, 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 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. All accessory instruments utilized with the subject system are the same as those referenced in K173030. A complete part number list of the Cohere Cervical Interbody Fusion Device implants is provided in this submission. This part number list is identical to the list submitted in K173030. The Cohere Cervical Interbody Fusion Device is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The Cohere Cervical Interbody System is identical to the primary predicate with respect to design, footprint, material composition, mechanical performance, labeling, intended use, and sterilization. The only difference is the expansion of indications to include use with a bone void filler as cleared by the FDA for use in intervertebral body fusion.

The provided text is a 510(k) summary for NuVasive's intervertebral body fusion devices. It's a regulatory document demonstrating substantial equivalence to previously cleared devices. It does not contain information about studies proving the device meets acceptance criteria in the context of an AI/ML medical device, particularly regarding performance metrics, sample sizes, expert involvement, or comparative effectiveness studies.

The document explicitly states: "Therefore, no performance testing was performed for this Special 510(k) submission." This means that for the purposes of this 510(k) clearance, the manufacturer did not conduct new performance studies. Instead, they relied on the substantial equivalence of their material composition, design, and mechanical performance to previously cleared predicate devices.

Therefore, I cannot extract the information required by your prompt, as the document does not describe a study that proves the device meets acceptance criteria in the manner you've outlined. The device being discussed is a physical surgical implant, not an AI/ML-based diagnostic or therapeutic software that would typically have the kind of acceptance criteria and performance studies you've asked about (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts).

Ask a specific question about this device

The NuVasive CoRoent Small Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Ti-C System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent Small interbody devices with lordotic angles of 10° or greater are required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/ or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The NuVasive CoRoent Small Ti-C System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The subject CoRoent Small Ti-C System implants are hollow devices manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. A commercially pure titanium (CP Ti) coating is plasma sprayed to the superior and inferior surfaces of the device. The implant contains a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 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 implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

This document is a 510(k) Premarket Notification from the FDA regarding the NuVasive® CoRoent® Small Ti-C System. It does not describe a study involving an AI/Machine Learning diagnostic device or provide acceptance criteria and performance data in the typical sense for such devices.

Therefore, most of the requested information regarding acceptance criteria, study design, expert qualifications, and AI-related details cannot be extracted from this document.

However, I can provide the non-clinical performance data that was conducted to demonstrate substantial equivalence to predicate devices for this intervertebral body fusion device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
This document discusses non-clinical (mechanical and biological) testing for a physical implantable device. The concept of a "test set" and "data provenance" in the context of clinical data or AI models is not applicable here. The testing was laboratory-based, not patient-data-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical implant, not an AI diagnostic tool that requires ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, for the same reasons as above.

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 is not an AI device or a diagnostic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the limits defined by the ASTM and ANSI/AAMI standards for biomechanical and biocompatibility performance.

8. The sample size for the training set
Not applicable. There is no AI algorithm being trained.

9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm being trained.

Ask a specific question about this device