Search Results

The NuVasive® Thoracolumbar Interbody Systems are indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems that are 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 NuVasive CoRoent Thoracolumbar System (XL platform) implants are intended for use in interbody fusions in the thoracic spine, from T1 to T12, and at the thoracolumbar junction (T12-L1), and the CoRoent Thoracolumbar System (XL and L platforms) implants are intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy 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 NuVasive CoRoent Thoracolumbar System (XL and L platforms) can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive CoRoent XL Interfixated System implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of nonoperative treatment.

The NuVasive CoRoent XL Interfixated System implants are intended for use in interbody fusions in the lumbar spine, from L2 to L5, 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 radiographic studies. The NuVasive CoRoent XL Interfixated System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angles of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Brigade 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 radiographic studies. The Brigade System platform 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 spondylolisthesis and spinal stenosis at one or two adjacent levels, the Brigade System platform 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 integrated screws.

The Brigade Lateral System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Lateral System 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 in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Brigade Lateral 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 radiographic studies. The Brigade Lateral System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The BASE Interfixated Titanium System is indicated for spinal fusion procedures in skeletally mature patients. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e., 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 and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The BASE Interfixated Titanium 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 radiographic studies. The BASE Interfixated 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 spondylolisthesis and spinal stenosis at one or two adjacent levels, the BASE Interfixated Titanium System 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 integrated screws.

The NuVasive Coalesce Thoracolumbar Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate 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 NuVasive Coalesce Thoracolumbar Interbody Fusion System is intended for use in 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 degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy 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 NuVasive Coalesce Thoracolumbar Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive Cohere Thoracolumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without the Cohere XLIF internal fixation, the system is indicated for use with supplemental 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 NuVasive Cohere Thoracolumbar Interbody System is intended for use in interbody fusions in the thoracic spine, from T1 to T12, and at the thoracolumbar junction (T12-L1), and in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy 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 NuVasive Cohere Thoracolumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive Modulus XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without Modulus XLIF internal fixation, the system is intended for use with supplemental spinal fixation system 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 NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and for use in the lumbar spine from L1 to S1, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy 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 NuVasive Modulus XLIF Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive Modulus TLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate 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 nonoperative treatment.

The NuVasive Modulus TLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and for use in the lumbar spine from L1 to S1, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy 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 NuVasive Modulus TLIF Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive Modulus ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The Modulus ALIF System 10°-20° lordotic cages may be used as a standalone system. The Modulus ALIF System 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. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft 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 radiographic studies. 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 spondylolisthesis 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 the FDA for use in the lumbar spine in addition to the integrated screws.

The NuVasive Thoracolumbar Interbody Systems are intervertebral body fusion devices, interfixated and non-interfixated. Implants are manufactured of either PEEK-Optima® LT-1 (Polyether-ether-ketone) conforming to ASTM F2026 or Titanium alloy (Ti6Al4V ELI) conforming to ASTM F136/ISO 5832-3. PEEK implants include radiographic markers made of Titanium (Ti) conforming to ASTM F136/ISO 5832-3 or ASTM F1472, or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. Interfixated implants include Titanium alloy (Ti6A14V ELI) screws conforming to ASTM F136/ISO 5832-3, and in addition, CoRoent Thoracolumbar Interfixated implants include canted coil locking mechanism of Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562.

CoRoent Thoracolumbar System: The subject NuVasive CoRoent Thoracolumbar System are interbodies manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6A1-4V) conforming to ASTM F136. The PEEK devices contain titanium alloy radiographic markers conforming to ASTM F136 or ASTM F1472 or tantalum markers conforming to ASTM 560 or ISO 13782. The device's hollow core or graft aperture allows for packing of autograft to help promote a solid fusion. Small spikes or teeth on each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion 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. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

CoRoent XL Interfixated System and Brigade Hyperlordotic System: The subject CoRoent Thoracolumbar System (Interfixated) and Brigade Hyperlordotic System are interbodies manufactured from PEEK-Optima LT-1 conforming to ASTM F2026 PEEK-Optima® LT-1, with radiographic markers manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136, and CoRoent Thoracolumbar Interfixated implants include canted coil locking mechanism of Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562. The devices all contain integrated screws made of titanium alloy, and include a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. The subject implants contain small spikes or teeth on each end of the device, which serve to grip the adjacent vertebrae to resist migration and expulsion. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. In addition to the integrated screws, the CoRoent XL-F System and Brigade Hyperlordotic System devices are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

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

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

Brigade Standalone System: The NuVasive Brigade Hyperlordotic System is an interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Hyperlordotic System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Hyperlordotic intervertebral fusion device is a device composed of a PEEK interbody implant containing radiographic titanium alloy markers, and-four (4) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK OPTIMA LTI) conforming to ASTM F-2026 and titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and 150 5832-3.

Brigade Lateral System: The NuVasive® Brigade® Lateral System is an interfixated interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Lateral System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Lateral System intervertebral fusion device is composed of a PEEK interbody implant containing radiographic titanium alloy markers, and two (2) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK-OPTIMAL LT1) conforming to ASTM F2026 and titanium alloy (Ti-6A-4V ELI) conforming to ASTM F136 and ISO 5832-3 or (Ti-6A-4V) conforming to ASTM F1472.

Base Interfixated Titanium System: The NuVasive BASE Interfixated Titanium System is an interfixated interbody system manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3. The NuVasive BASE Interfixated Titanium System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The BASE Interfixated Titanium System consists of a titanium alloy interbody and three (3) titanium alloy bone screws. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

Modulus XLIF: The subject NuVasive Modulus XLIF Interbody System are interbody implants manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. 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 and expulsion of the device. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Modulus TLIF: The subject NuVasive Modulus TLIF Interbody System are interbody implants manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. 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 and expulsion of the device. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Modulus ALIF System: The subject NuVasive Modulus ALIF System, previously cleared as 3DP Interfixated System, are interbody implants manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. 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. The Modulus ALIF System 10°-20° lordotic cages may be used as a standalone system. The Modulus ALIF System 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.

The provided document pertains to a 510(k) premarket notification for a medical device (NuVasive Thoracolumbar Interbody Systems) and as such, it does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML medical device.

The document describes various intervertebral body fusion devices, their indications for use, technological characteristics, and a comparison to predicate devices to establish substantial equivalence. It explicitly states in Section G, "Performance Data": "No new NuVasive Thoracolumbar Interbody Systems implant designs are being introduced... Nevertheless, minor design modifications were made to certain devices... We include the confirmatory mechanical testing that shows that the minor design modifications do not create a new worst case that would require new or additional testing. Since spinal stenosis use does not change the biomechanical stresses placed upon the individual implants, additional non-clinical testing is unwarranted. Therefore, no performance testing was performed for this 510(k) submission and the worst case devices included with the subject system were tested and cleared in predicate 510(k) submissions. Only previously cleared devices are the subject of this submission, i.e., there is no new worst case device."

It also states in Section F, "Technological Characteristics": "This device does not contain software or electrical equipment."

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML performance studies is not applicable to this document. This submission focuses on demonstrating substantial equivalence for an existing class of physical implants based on mechanical testing and a clinical literature analysis, not on the performance of a novel AI/ML algorithm.

Ask a specific question about this device

The NuVasive Cohere Thoracolumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate 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 NuVasive Cohere Thoracolumbar Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12, at the thoracolumbar junction (T12-L1), and in the lumbar spine from L1 to S1 for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy 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 NuVasive Cohere Thoracolumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The NuVasive Cohere Thoracolumbar Interbody System comprises of sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the thoracolumbar spinal column in thoracolumbar intervertebral body fusion procedures.

Each device within the Cohere Thoracolumbar Interbody System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. In addition to PEEK, the device assembly may contain two or more radiolucent markers, depending on footprint, to enable visibility under x-ray in vivo.

The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The provided document is an FDA 510(k) clearance letter for the NuVasive® Cohere® Thoracolumbar Interbody System. This document does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it concerns a physical intervertebral body fusion device.

Therefore, most of the requested information regarding acceptance criteria, study design for a diagnostic device, sample size, experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable (N/A) to this document's content.

However, I can extract information related to the device's performance data and the basis for its clearance, which can be interpreted in the context of "acceptance criteria" for a physical medical device.

Here's what can be extracted from the provided text:

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

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

• Sample size: Not specified as N/A in the context of a physical device. Performance was assessed through non-clinical (mechanical) testing, not patient data.
• Data provenance: N/A. The testing was non-clinical engineering testing.

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

• Number of experts: N/A. Ground truth was established through engineering standards (ASTM) and comparison to predicate devices, not expert human evaluation of typical diagnostic outputs.
• Qualifications of experts: N/A.

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

• Adjudication method: N/A. This concept is for clinical or diagnostic studies. The evaluation here was based on specified engineering tests and comparison to a predicate device.

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:

• MRMC study: No. This is a physical device, not an AI/diagnostic software.
• Effect size: N/A.

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

• Standalone performance: N/A. This is a physical device, not an algorithm.

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

• Type of ground truth: The "ground truth" for this device's performance is adherence to established engineering standards (ASTM) and demonstration of substantial equivalence to already cleared predicate devices based on design, materials, and functional testing.

8. The sample size for the training set:

• Training set sample size: N/A. This device does not involve machine learning or a "training set."

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

• Ground truth establishment for training set: N/A.

In summary, the document describes the clearance of a physical medical device based on non-clinical engineering testing and substantial equivalence to predicate devices, rather than a diagnostic AI/ML system. Therefore, many of the questions are not applicable to the content provided.

Ask a specific question about this device

The ACRON™ TLIF System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ACRON™ TLIF System is to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The ACRON™ TLIF System is an implant system for a unilateral posterior transforaminal approach (TLIF). It is specially designed for small incision (minimally invasive), resulting in a relatively atraumatic operation for the patient. Implants, used with supplemental fixation and autogenous bone graft, provide improved stability, height restoration and lordosis to optimize fusion. The system is comprised of implantable cages and stainless steel surgical instruments, both general and system specific.

The ACRON™ TLIF System cages are manufactured from radiolucent polymer PEEK-OPTIMA® Optima LT1 (Polyether-ether-ketone) conforming to ASTM standard F2026, to allow for clear assessment of bone fusion. Two radiopaque markers constructed from Tantalum conforming to ASTM standard F560 allow for radiographic visualization of the implant orientation and placement.

The implants have a convex shape and are offered in 4 sizes, in 2mm increments, ranging in height from 7mm to 13mm with lordotic angle of 8°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Teeth on the superior and inferior surfaces help the implant to resist expulsion and migration. The geometry includes openings to allow for the packing of autogenous bone graft into the axial canal.

Apologies, but the provided text from the FDA 510(k) K171151 letter for the ACRON™ TLIF System does not contain information about the acceptance criteria and study that proves a device meets acceptance criteria for an AI/ML-based medical device.

The document describes a traditional intervertebral body fusion device (implants and instruments) and focuses on demonstrating substantial equivalence to predicate devices through nonclinical testing (static/dynamic compression, subsidence testing). It explicitly states: "No clinical studies were conducted."

Therefore, I cannot provide the requested information, as it pertains to a different type of device (AI/ML) and study methodology than what is described in the provided text.

If you have a document describing the acceptance criteria and study for an AI/ML medical device, please provide that text, and I will do my best to extract the relevant information.

Ask a specific question about this device

When used as an interbody fusion device, the ProLift® Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift® Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONL Y and should not be reused under any circumstances. Do not use any of the ProLift® Expandable System components with components from any other system or manufacturer. The ProLift® Expandable System components should never be reused under any circumstances.

The provided document is a 510(k) premarket notification for a medical device called the ProLift® Expandable System, an intervertebral body fusion device. This type of regulatory filing focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving efficacy or safety through clinical trials with defined acceptance criteria for a device's performance.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth establishment relevant to AI/algorithm performance.

Instead, the "Performance Data" section (page 4) refers to:

• Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077. This is mechanical testing to demonstrate the structural integrity and equivalence of the device to predicate devices, not performance related to clinical outcomes or diagnostic accuracy for an AI system.

The document explicitly states: "The ProLift® Expandable System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance." This underlines that the focus is on equivalence in physical and mechanical properties and intended use, not on a performance study comparing diagnostic accuracy or clinical effectiveness against specific acceptance criteria.

Ask a specific question about this device

The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. The hyperlordotic CASCADIA lumbar implants (i.e., ≥ 20°) should be used with anterior supplemental fixation (e.g., an anterior lumbar plate).

The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.

The implants consist of hollow tube structures additively manufactured from titanium allov. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional lumbar implant sizes into the system.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.

I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the context of device performance metrics such as accuracy, sensitivity, specificity, AUC, human reader improvement, or FROC analysis.

The document is a 510(k) premarket notification from the FDA for the Cascadia Interbody System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing detailed acceptance criteria and performance study results for a new or significantly re-engineered AI/imaging device.

Here's what the document does mention in relation to performance and comparison:

• Non-Clinical Performance Evaluation:
  • It states that "The worst case implants for the Cascadia Interbody System were previously tested and performed equally to or better than the predicate devices in static compression, dynamic compression (ASTM F2077), subsidence (ASTM F2267) and expulsion."
  • It also mentions "Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of

Ask a specific question about this device

The ELSA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

ELSA™ Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance.

ELSA™ Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and include an internal component manufactured from radiolucent PEEK polymer, as specified in ASTM F2026. The screws used with ELSA™ are manufactured from titanium allov, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

The provided text describes a medical device, the ELSA™ Spacer, which is an intervertebral body fusion device. The document is a 510(k) premarket notification summary submitted to the FDA. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices.

However, the provided text does not include information about acceptance criteria for a device's performance (such as a diagnostic algorithm or AI system) or a study that specifically proves the device meets such criteria in terms of clinical accuracy or effectiveness. Instead, it describes mechanical and material performance testing for the physical implant itself, aimed at demonstrating functional equivalence to existing devices.

Therefore, many of the requested categories about acceptance criteria, clinical study design, ground truth establishment, and AI performance metrics cannot be answered from the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

The document lists performance tests conducted for the physical device, not for a diagnostic algorithm's accuracy. The "acceptance criteria" here relate to the mechanical integrity and safety of the implant itself, aligning with established ASTM standards for intervertebral fusion devices.

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

• Not applicable. This document describes mechanical and material testing of a physical implant, not a clinical study involving a test set of patient data or images. The "samples" would refer to the number of devices subjected to various mechanical stress tests, which is not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth establishment by clinical experts is relevant for diagnostic or AI devices, not for the mechanical testing of an interbody fusion device.

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

• Not applicable. This pertains to clinical studies for diagnostic accuracy, not mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is for AI-assisted diagnostic devices. The ELSA™ Spacer is a physical implant.

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

• Not applicable. There is no algorithm or AI component described for the ELSA™ Spacer.

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

• Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM and FDA guidance) for device strength, durability, and biocompatibility.

8. The sample size for the training set

• Not applicable. There is no AI training set mentioned for this physical device.

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

• Not applicable. No training set or ground truth in the AI context are relevant to this document.

Summary of Device and Study Type:

The ELSA™ Spacer is an interbody fusion device, a physical implant used in spinal surgery. The "study" described in this document is a series of mechanical and material performance tests (e.g., static and dynamic compression, subsidence, expulsion, bacterial endotoxin) conducted in accordance with established ASTM standards and FDA guidance. The purpose of these tests is to demonstrate the substantial equivalence of the ELSA™ Spacer to legally marketed predicate devices in terms of safety, function, and mechanical integrity, rather than clinical diagnostic performance or AI accuracy.

Ask a specific question about this device

The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone and supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Amendia Interbody Fusion Devices consist of multiple components comprised of nonsterile, single-use implants fabricated from Invibio PEEK-Optima® LT1 or Solvay Advanced Polymers Zeniva™ ZA-500 PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The Amendia Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The provided document is a 510(k) premarket notification for Amendia Interbody Fusion Devices, which are medical devices used in spinal fusion procedures. This type of regulatory document focuses on establishing substantial equivalence to existing legally marketed devices, rather than proving efficacy or meeting specific diagnostic performance criteria through clinical studies in the same way a diagnostic AI device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data specific to an AI/diagnostic device is not applicable to this document.

This document describes a medical device (surgical implants) and its intended use, material composition, and mechanical performance testing (engineering analysis and ASTM standards) to demonstrate equivalence to predicate devices, not the diagnostic performance of a software algorithm.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document assesses substantial equivalence based on intended use, indications, material, and mechanical performance (engineering analysis, ASTM F2077, ASTM F1877), not diagnostic accuracy metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance: Not applicable. There is no diagnostic "test set" in the context of an interbody fusion device. The document refers to "performance testing" based on engineering analysis and ASTM standards, which would involve physical specimens of the device, not a dataset of patient images or information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for an interbody fusion device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is for resolving discrepancies in diagnostic interpretation, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for diagnostic accuracy is not relevant.
8. The sample size for the training set: Not applicable. There is no training set for a physical implant.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) and does not contain the type of information requested about acceptance criteria and studies typical for AI/diagnostic software performance.

Ask a specific question about this device