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).

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The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The NuVasive 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, 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 NuVasive CoRoent Small Interbody System is a hollow interbody cage manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026. The implant contains a hollow core or graft aperture which allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft material 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 includes marker pins composed of titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782. The pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation.

The implants are available in flat or contoured endplates, and come in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The purpose of this 510(k) is to expand the indications for use to include the treatment of multilevel cervical disc degeneration and/or cervical instability at up to four contiguous levels.

The provided text describes a 510(k) premarket notification for a medical device called the NuVasive® CoRoent® Small Interbody System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data from a retrospective clinical study and clinical literature analysis.

However, the document does not contain the following information typically found in a study proving a device meets specific acceptance criteria, especially for AI/ML-based medical devices:

• A table of acceptance criteria and reported device performance: This document doesn't define quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, precision, recall) or provide numerical results for such metrics.
• Sample size used for the test set and data provenance: While a "retrospective clinical study" is mentioned, details about the test set size or data provenance (country of origin, specific demographics) are not provided.
• Number of experts used to establish ground truth and their qualifications: No information is given about expert involvement in establishing ground truth.
• Adjudication method: There is no mention of an adjudication process.
• MRMC comparative effectiveness study: This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
• Standalone performance: The text describes a "clinical study" and "clinical literature analysis" to support safety and effectiveness, but it doesn't present performance as a standalone algorithm in the way an AI/ML device would.
• Type of ground truth used: The clinical data determined safety and effectiveness for cervical disc degeneration, but the specific method of establishing "ground truth" (e.g., pathology, long-term outcomes, expert consensus on imaging) is not detailed.
• Sample size for the training set: This is not an AI/ML device, so a "training set" in that context is not relevant and not mentioned.
• How ground truth for the training set was established: Again, not applicable for this type of device.

What the document does state and imply:

The document describes the NuVasive® CoRoent® Small Interbody System and its intended use for intervertebral body fusion.
The primary purpose of this 510(k) is to expand the indications for use to include the treatment of multilevel cervical disc degeneration and/or cervical instability at up to four contiguous levels.

F. Technological Characteristics:

• Subject device: PEEK-Optima® LT-1 hollow interbody cage with a graft aperture, teeth to resist migration, and radiopaque marker pins (titanium alloy or tantalum).
• Substantial equivalence: The device is considered substantially equivalent to other predicate devices cleared by the FDA, including the primary predicate NuVasive CoRoent Small Interbody System (K150362). The equivalence is based on similar design, intended use, material composition, and function.
• No software or electrical equipment: This confirms it's not an AI/ML device.

G. Performance Data:

• Study Design: A retrospective clinical study was conducted.
• Study Population: Patients with cervical spondylosis including cervical disc degeneration, herniated nucleus pulposus (HNP), stenosis, deformity, and/or instability were treated with the subject device.
• Findings: "Based on the clinical data, it was determined that the CoRoent Small Interbody System used in the treatment of 3- and 4-level cervical disc degeneration has a safety and effectiveness profile similar to the predicate device."
• Supplementary Data: A clinical literature analysis of multilevel anterior cervical discectomy and fusion (ACDF) was performed to support the use of the subject device at 3 and 4 cervical levels.
• No new nonclinical testing: No new nonclinical testing was performed because no other changes were made to the interbodies since their previous clearance.

In summary, as this is a traditional medical device (not AI/ML), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of demonstrating substantial equivalence to a predicate device for an expanded indication for use. The key "proof" is that the retrospective clinical study and literature review showed a similar safety and effectiveness profile for the expanded indications compared to the previously cleared predicate device.

The document does not provide the specific quantitative performance metrics (like sensitivity, specificity, etc.) or detailed methodological breakdowns characteristic of AI/ML device evaluations.

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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 disease (DDD) at up to two 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 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 Interbody System is a hollow interbody cage manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026. 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 includes marker pins composed of titanium alloy conforming to ASTM F136 and ISO 5832-3 or ASTM F1472 or tantalum conforming to ASTM F560 or ISO 13782. The pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation. The implants are available in flat or contoured endplates, and come in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device will be packaged and initially provided non-sterile, and is designed to be sterilized by the user before each use.

This document refers to a 510(k) premarket notification for the NuVasive® CoRoent® Small Interbody System, an intervertebral body fusion device. The purpose of this submission is to modify the Indications for Use to include two-level cervical applications. As such, the presented information focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the expanded indications.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state "acceptance criteria" in terms of numerical thresholds for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance is assessed through a clinical literature review for the expanded two-level indication.

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

• Test Set Sample Size: Not explicitly stated as a defined "test set" with a specific sample size. The performance is based on a clinical literature review. This means the "sample size" would depend on the number of patients and studies included within that review.
• Data Provenance: The document does not specify the country of origin of the data within the clinical literature review, nor does it explicitly state whether the studies were retrospective or prospective. It only mentions "published clinical literature review."

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 this submission. The "ground truth" for the modified indication is established through existing published clinical literature, not a new expert review for this specific submission. The FDA reviews the submitted literature and its interpretation.

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

This is not applicable. There was no new "test set" created that would require an adjudication method. The clinical literature review inherently relies on the adjudication and peer-review processes of the original studies it incorporates.

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. This device is an intervertebral body fusion system, not an AI software/medical imaging device. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or described.

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

This is not applicable. This device is a physical implant, not an algorithm, so standalone performance is not relevant in this context.

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

The "ground truth" for the safety and effectiveness for the expanded indication is based on published clinical outcomes data and findings from the clinical literature review.

8. The sample size for the training set

This is not applicable. This is a 510(k) submission for a physical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set" as it relates to AI. The device's design and materials are based on established engineering principles and prior validated devices.

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

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

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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 disease (DDD) at one level 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 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 Interbody System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, and titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided document is a 510(k) premarket notification for a medical device, the NuVasive® CoRoent® Small Interbody System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a new study.

Therefore, the document does not contain the kind of information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, or AI performance metrics.

Specifically, the document states:

• No new studies were performed: "No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional nonclinical testing was required or performed."
• Performance data relied on existing literature: "A systemic literature analysis of published clinical data for cervical interbody fusion devices similar to the CoRoent Small Interbody System was provided as performance data to support the expanded Indications for Use."

As such, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided, as no new performance data was generated.
2. Sample sized used for the test set and the data provenance: Not applicable, as no new test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: 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, as this device does not contain software or electrical equipment and is not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for the reasons above.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable for the reasons above.
9. How the ground truth for the training set was established: Not applicable for the reasons above.

In summary, this document is a regulatory submission demonstrating substantial equivalence based on existing device characteristics and a literature review, not a new study with acceptance criteria and measured performance.

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Intervertebral Body Fusion

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 degenerative disc disease (DDD) at one level 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 designed for use with autogenous 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.

Partial Vertebral Body Replacement

The NuVasive CoRoent Small Interbody System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

The NuVasive CoRoent Small Interbody System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, and titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission describes the NuVasive CoRoent® Small Interbody System, which is an intervertebral body fusion device and a partial vertebral body replacement device. Since this is a medical implant, the "performance" is measured by its mechanical integrity and functional equivalence to predicate devices, rather than typical AI/software performance metrics like accuracy, sensitivity, or specificity.

2. Sample Size Used for the Test Set and Data Provenance

This submission does not involve a "test set" in the context of AI or software performance evaluation. The "testing" refers to non-clinical mechanical and material properties testing. The submission does not specify a distinct "sample size" for specific mechanical tests beyond the implication of standard testing methodologies per the referenced ASTM and ISO standards. The data provenance is derived from these non-clinical laboratory tests.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. This is a medical device (spinal implant) submission, not an AI/software submission. Ground truth for mechanical performance is established through standardized engineering tests, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device (spinal implant) submission, not an AI/software submission requiring adjudication of expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a medical device (spinal implant) submission. There is no AI component, and thus, no human readers or AI assistance to compare.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This is a medical device (spinal implant) submission. The device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for this device's "performance" is based on engineering standards and specifications. This includes:

• Material specifications: ASTM F2026, ASTM F136, ISO 5832-3, ASTM F560, ISO 13782 for the PEEK-Optima LT-1, titanium alloy, and tantalum components.
• Mechanical testing standards: ASTM F2077 for static and dynamic axial compression and torsion, and ASTM F2267 for subsidence analysis.
• Comparative analysis: Demonstrated substantial equivalence to the performance of legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is a medical device (spinal implant) submission, not an AI/software submission. There is no "training set" for an algorithm. The design and manufacturing processes are informed by existing biomechanical knowledge, engineering principles, and the performance characteristics of predicate devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set as this is not an AI/software device. The underlying principles for the device's design and expected performance are established through decades of biomedical engineering research, material science, and clinical experience with similar devices, as well as adherence to recognized industry standards (ASTM, ISO).

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