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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 Modulus ALIF System is indicated for spinal fusion procedures in skeletally mature patients. These devices are intended to be used with bone screws, anchoring blades, or a combination of the two. When used with Modulus ALIF bone screws, the Modulus ALIF System 10° 20° lordotic cages may be used as a standalone system. When used with Modulus ALIF anchoring blades, the Modulus ALIF Interfixated System must be used with supplemental internal spinal fixation systems (e.q., posterior pedicle screw and rod system) that are cleared for use in the lumbar spine. When used with either the Modulus ALIF bone screws or the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated system 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems that are cleared for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive Modulus ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (e.g., radiographs, CT scan, MRI scan). The Modulus ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolistheses and spinal stenosis at one or two adjacent levels, the Modulus ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by FDA for use in the lumbar spine in addition to the integrated screws/anchoring blades.

The subject NuVasive Modulus ALIF System interbody implants are manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration of the device. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. When used with the Modulus ALIF bone screws, the Modulus ALIF Interfixated System 10°- 20° lordotic cages may be used as a standalone system. When used with the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared for use in the lumbar spine. When used with either the Modulus ALIF bone screws or the Modulus ALIF anchoring blades, the Modulus ALIF Interfixated system 25°- 30° lordotic cages must be used with supplemental internal spinal fixation systems that are cleared for use in the lumbar spine.

The purpose of this submission is to introduce the Modulus ALIF anchoring blades (blades), which are a new in-line fixation option, provided sterile and non-sterile, for the NuVasive Modulus ALIF System.

The provided text is a 510(k) summary for the NuVasive Modulus ALIF System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, material composition, function, and range of sizes, supported by mechanical performance testing.

Therefore, it does not contain the specific information requested regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, or the results of a multi-reader multi-case (MRMC) study. The NuVasive Modulus ALIF System is an intervertebral body fusion device and is not an AI/ML powered medical device.

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The surgical instruments are specifically designed for use with the Pulse System, which enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate.

When used with a Pulse Navigation system, the patient reference hardware is intended to provide a reference to a rigid anatomical structure that can be identified relative to the acquired image of the anatomy.

The subject NuVasive Rod Registration Frame is introducing modifications based on the design of existing patient reference hardware, the Spinous Process Clamp (Pulse System K210574). The Rod Registration Frame was designed to offer surgeons more flexibility during the registration process of Pulse Navigation by providing an additional patient reference hardware design option for attaching the existing Patient Reference Array to the patient. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device Rod Registration Frame is substantially equivalent to the predicate as demonstrated by verification and validation testing performed using well established and previously cleared test methods.

The NuVasive Rod Registration Frame is a surgical instrument designed for use with the Pulse System, enabling computer-assisted navigation for spinal surgical procedures. The device provides a reference to a rigid anatomical structure that can be identified relative to an acquired image of the anatomy when used with a Pulse Navigation system. The device is a modification of an existing patient reference hardware (Spinous Process Clamp, K210574), with updated distal and proximal connection features and removal of radiographic markers (as it is used only for non-fiducial registration).

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes non-clinical testing to demonstrate substantial equivalence, rather than a direct table of specific numerical acceptance criteria and performance for a new, independent claim of efficacy. The core acceptance criterion is that the Rod Registration Frame performs equivalently to its predicate device (Spinous Process Clamp K210574).

2. Sample size used for the test set and the data provenance:

• The document states that "non-clinical testing was performed." However, it does not specify the sample size for the test sets used in System Level Accuracy Testing, Cadaver Verification, Design Validation, Tolerance Analysis, or Usability Validation.
• The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated in this summary. Given that it's non-clinical testing for a U.S. FDA submission, it's highly probable the testing was conducted in a controlled lab environment and likely within the U.S. or by a recognized testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the summary. For non-clinical performance testing of a medical device, ground truth is typically established through engineering measurements, biomechanical modeling, and cadaveric studies where anatomical landmarks might serve as a reference. The "design validation" and "cadaver verification" sections imply that expert evaluation (e.g., of surgical applicability) would have been involved, but details on their number or qualifications are not given.

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

• This information is not provided as the testing described is non-clinical performance and validation testing, not a clinical study involving human reader assessments requiring adjudication.

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:

• No MRMC study was done. The device (Rod Registration Frame) is a physical surgical instrument used for navigation, not an AI or imaging diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not applicable. The document explicitly states: "No clinical studies were conducted."

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

• This question is not applicable as the device is a physical surgical instrument, not an algorithm or AI system.

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

• For the performance data mentioned (System Level Accuracy, Design Validation, Tolerance Analysis), the ground truth would be based on engineering specifications, physical measurements, and established performance criteria for navigation devices.
• For Cadaver Verification, the ground truth would involve anatomical landmarks and verified instrument placement/registration accuracy against known anatomical points. This would likely involve precise measurement tools and potentially expert anatomical assessment.

8. The sample size for the training set:

• This question is not applicable as the device is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI algorithms.

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

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

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When used as a pedicle screw fixation system in skeletally mature patients, the NuVasive Reline System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

The Nu Vasive Reline System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthrosis
7. Tumor resection and/or
8. Failed previous fusion

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System is indicated as an adjunct to fusion to treat:

1. adolescent idiopathic scoliosis.
2. progressive spinal deformities (i.e., scoliosis, or lordosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis,
3. spondylolisthesis,
4. spondylolysis,
5. pseudarthrosis,
6. failed prior fusion and
7. fracture caused by tumor and/or trauma in pediatric patients.

Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

In order to achieve additional levels of fixation, the NuVasive Reline System rods may be connected to the Armada System.

The NuVasive Reline System is a pedicle screw system that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to introduce "Dual-Headed Modular Connectors" which will be included in the NuVasive Reline System. Additionally, this submission is intended to specify pediatric progressive deformities in the indications for use statement for NuVasive Reline System. Lastly, this submission is intended to add minor labeling changes to address compatibility updates to the NuVasive Reline system.

The provided document describes the NuVasive Reline System, a pedicle screw system, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria in the context of diagnostic accuracy or clinical outcomes.

The "Performance Data" section (G) on page 6 refers to nonclinical testing, which are engineering tests to assess the physical properties and mechanical performance of the device. These are distinct from clinical studies designed to evaluate diagnostic accuracy or the effectiveness of AI algorithms.

Therefore, I cannot fulfill the request as the document does not provide the necessary information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study related to meeting such criteria.

The information provided is focused on demonstrating substantial equivalence for a medical device (pedicle screw system), primarily through design comparison, material composition, and mechanical testing according to established ASTM standards.

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The Nu Vasive Cohere ALF System Intervertebral Body Fusion Device is indicated for spinal fusion procedures in skeletally mature patients. The Cohere ALIF System Interverebird Body Fusion Device 10-200 lordotic cages may be used as a standalone system. The System Intervetebral Body Fusion Device 25-30° lordotic cages may be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneis bone graft, intervertebral hody fraise to corticocancellous bone graft, or a bone void filler as cleared by FDA, for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had alleast sim onths of non-operative treatment.

The NuVasive Cohere ALLF System Intervertebral Body Fusion Device is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectory in the trestment of symptomatic degenerative disc disease (DD) or degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disconfirmed by history and radiographic studies. The Cohere ALFE System Intervertebral Body Fusion Device implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative spondylolisthanis as saind the used in these patients at multiple levels at multiple levels and for patients with degenerative spondylolisthesis or spinal stenosis at one or two adjacent levels, the Cohere ALIF System Intervetebrah Body Fusion Device must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the internal spillal fixal.

The Cohere ALIF System Intervertebral Body Fusion Device is inclusive of sterile, single use interbody implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights. Each device within the Cohere ALIF System Intervertebral Body Fusion Devce is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. In addition to PEEK, the device assembly contains radiolucent markets to enable visibility under x-ray in vivo. The implants are available in a variety of sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The Cohere ALIF System Intervertebral Body Fusion Device 10°-20° lordotic cages may be used as a standalone system. The Cohere ALIF System Intervertebral Body Fusion Device 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

This document describes the NuVasive® Cohere® ALIF System Intervertebral Body Fusion Device, which is an implant made of PEEK material for spinal fusion procedures. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each mechanical test. The tests were non-clinical, implying in-vitro or bench testing. The data provenance is implied to be from the manufacturer's internal testing facilities, as no external data sources (e.g., country of origin, retrospective/prospective) are mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a non-clinical, mechanical testing study to assess device performance against established standards and predicate devices, not a study involving human expert judgment for ground truth.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation or subjective assessments. This study involved objective mechanical testing against defined ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states that "No clinical studies were conducted." This study focuses on the physical and mechanical properties of the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical intervertebral body fusion device and does not involve any algorithms or software that would have standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study is established by:

• ASTM Standards: Specifically ASTM F2077, F1714, and F1877, which provide benchmark performance requirements for intervertebral body fusion devices and material properties.
• Predicate Device Performance: The subject device's performance was compared to that of legally marketed predicate devices to demonstrate substantial equivalence, meaning the predicate devices' established performance serves as a comparative "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model. Therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth, and hence no establishment process for it relevant to this context.

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The NuVasive Reline Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Reline Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Reline Cervical System may be connected to the NuVasive SpheRx Spinal System, Precept Spinal System, Armada Spinal System, Reline 4.5-5.0 System va the rod to rod connectors or transition rods.

The NuVasive Reline Cervical System is an occipito-cervico-thoracic posterior system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537. The Reline Cervical System consists of a variety of components including screws, rods, offset connectors, rod to rod connectors, set screws, cross connectors, hooks, eyelets, and occipital plates which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

The provided text is a 510(k) summary for the NuVasive Reline Cervical System. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study that proves the device meets such criteria in the context of diagnostic or AI-augmented medical imaging.

Instead, this document details the regulatory approval process for a spinal implant system by demonstrating its substantial equivalence to previously cleared predicate devices. The "performance data" mentioned refers to non-clinical mechanical testing of the implant's strength and durability, not diagnostic accuracy or clinical outcomes in human subjects in the way an AI medical device would be evaluated.

Therefore, I cannot extract the information required for your request from this document. The questions you've asked are typically relevant to the evaluation of AI/ML-based medical devices or diagnostic tools.

To answer your request, I would need a document describing the evaluation of a diagnostic device or an AI-based system.

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The NuVasive MOD-EX XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. When used with or without the MOD-EX XLIF internal fixation, the system is intended for allogencis and or allogeneic bone graft comprised of cancellous and/or cortiocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for >20° lordosis is needed, the plated MOD-EX XLIF Interbody must be used along with additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive MOD-EX XLIF Plated 2.0 Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is intended for use with autogeneic bone graft comprised of cancellous and/or corticocancellous bone graft or a bone void filler as cleared by FDA for use in intervertebral body fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The MOD-EX XLIF Interbody System and MOD-EX XLIF Plated 2.0 Interbody System are interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degenerative spondylolisthess at one or two adjacent levels, including thoracy disc hemiation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NaVasive MOD-EX XLF Interbody System and NuVasive MOD-EX XLIF Plated 2.0 Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive MOD-EX XLIF Interbody System and NuVasive MOD-EX XLIF Plated 2.0 Interbody System are an expandable interbody system, additively manufactured from Grade 23 titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C and traditionally manufactured from titanium alloy (Ti-6V-4A1 ELI) per ASTM F136 or ISO 5832-3. The NuVasive MOD-EX XLIF Interbody System also includes Nickel-Cobalt-Chromium-Molybdenum (MP35N) conforming to ASTM F562. The NuVasive MOD-EX XLF and NuVasive MOD-EX XLIF Plated 2.0 interbodies are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The system is designed to address thoracolumbar pathologies utilizing interbody placement through a standard lateral (XLIF) approach. The device features independent threaded drive and wedge mechanisms to allow for independent expansion of the anterior and posterior aspect of the implant. The superior and inferior endplate components are solid and porous structures manufactured simultaneously using a powder bed fusion method. The microporous, textured surfaces on the superior and inferior ends of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The NuVasive MOD-EX XLIF and NuVasive MOD-EX XLIF Plated 2.0 Interbody System interbodies have superior and inferior graft apertures, allowing for packaging of graft to aid in the promotion of a solid fusion.

The provided text is a 510(k) Premarket Notification from the FDA regarding an Intervertebral Body Fusion Device. It details the device name, indications for use, device description, and performance data used to establish substantial equivalence to predicate devices.

However, the content of this document does not describe a study that proves a device meets acceptance criteria in the context of an AI/ML-driven medical device, nor does it provide a table of acceptance criteria and reported device performance related to such a study.

The performance data section (G) in the document refers to:

• Nonclinical testing for a physical medical device (NuVasive MOD-EX XLIF Plated 2.0 Interbody System), including:
  • Dynamic Axial Compression testing
  • Dynamic torsion testing
  • Gravimetric and Particulate analysis
  • Screw push-out analysis
  • Subsidence analysis
• MRI compatibility testing for the physical device, in accordance with FDA guidance for passive implants in the MR environment, covering:
  • Magnetically induced displacement force
  • Magnetically induced torque
  • Radiofrequency (RF) induced heating
  • MR image artifact

These tests are standard for a physical implantable device to demonstrate its mechanical properties, material properties, and compatibility with MRI. They do not involve acceptance criteria or studies related to AI/ML device performance, such as:

1. A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, accuracy, etc.)
2. Sample sizes for test sets (in terms of patient cases or images)
3. Ground truth establishment by experts (radiologists, pathologists)
4. Adjudication methods
5. Multi-reader multi-case (MRMC) studies
6. Standalone algorithm performance
7. Types of ground truth (e.g., pathology, outcomes data)
8. Training set sample size
9. Ground truth establishment for the training set

Therefore, I cannot extract the requested information from the provided document as it pertains to a different type of medical device (a mechanical implant) and not an AI/ML-driven device.

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The NuVasive Reline Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Reline Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Reline Cervical System may be connected to the NuVasive SpheRx Spinal System, Precept Spinal System, Armada Spinal System and Reline 4.5-5.0 System via the rod to rod connectors or transition rods.

The NuVasive Reline Cervical System is an occipito-cervico-thoracic posterior system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537. The Reline Cervical System consists of a variety of components including screws, rods, offset connectors, rod to rod connectors, set screws, cross connectors, hooks, eyelets, and occipital plates which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

The provided text describes a 510(k) premarket notification for the NuVasive® Reline® Cervical System, a spinal implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices through material and mechanical performance testing, rather than a study involving human or image-based AI performance.

Therefore, the document does not contain the information required to answer questions 1-9 regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI or diagnostic performance.

The performance data section (G) specifically mentions:

• Nonclinical testing was performed to demonstrate that the subject NuVasive Reline Cervical System is substantially equivalent to the predicate device.
• The following testing was performed:
  • Dynamic Compression Bending per ASTM F1717
  • Static Torsion per ASTM F1717
  • Static My per ASTM F1798
  • Static Fz per ASTM F1798
• The results demonstrate that the subject NuVasive Reline Cervical System is substantially equivalent to the predicate.

This indicates mechanical testing of the physical implant components against established ASTM standards for spinal implants, not a clinical study on diagnostic accuracy or AI performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth was established, as this information is not present in the provided text.

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The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The Nu Vasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of the implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. Additionally, the three-hale version of the implant system may be appropriate only for patients with large vertebral bodies, and is particularly suited for use following corpectomies for the treatment of tumors and burst fractures.

The NuVasive SmartPlate Gradient Plus System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

The NuVasive HELIX Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

The NuVasive Anterior Cervical Plate Systems are anterior cervical plating systems that consist of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject devices components are from titanium (Ti-6A1-4V) conforming to ASTM F1472/F136 and ISO 5832-3, (titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 or ISO 5832-3, and nickel-cobalt-chromium-molybdenum alloy (MP35N) per ASTM F562.

This document pertains to the 510(k) premarket notification for the NuVasive® Anterior Cervical Plate Systems, identifying them as substantially equivalent to legally marketed predicate devices. The information provided focuses on the regulatory clearance process for a medical device and describes the types of testing conducted to demonstrate safety and substantial equivalence to predicate devices, rather than a study proving an AI/software device meets specific performance criteria against a ground truth.

Therefore, the requested information for an AI/software device's acceptance criteria and study proving performance (e.g., sample size, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth sources) cannot be extracted from this document. This document describes the mechanical, material, and MRI compatibility testing for a physical implant system.

However, I can extract the acceptance criteria and the types of studies conducted for this physical medical device based on the provided text:

Acceptance Criteria and Device Performance (for a physical medical device)

Information Not Applicable or Not Found in the Document (for an AI/Software Device Context):

• Sample size used for the test set and the data provenance: Not applicable, as this is a physical medical device. The document mentions an evaluation (e.g., comparing material properties), not a test on a "data set."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant would typically be engineering specifications, material standards, and biomechanical performance metrics, not expert consensus on images.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is not an AI/software device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this specific device, "ground truth" would be established by validated engineering test methods against industry standards (ASTM, ISO), material properties, and potentially biomechanical testing. The document explicitly lists the ASTM standards used for MRI compatibility.
• The sample size for the training set: Not applicable. This is not an AI/software device that undergoes "training."
• How the ground truth for the training set was established: Not applicable.

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