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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 use with autogenous and/or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. When ≥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 MOD-EX XLIF 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 is intended for use 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 thoracy 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 MOD-EX XLIF Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis and sagittal deformity.

The NuVasive MOD-EX XLIF Interbody System is 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 both titanium alloy (Ti-6V-4A1 ELI) per ASTM F136 or ISO 5832-3 and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. MOD-EX XLIF 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 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) Pre-market Notification for the NuVasive® MOD-EX XLIF Interbody System. This document focuses on demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices, rather than performing a clinical study to establish acceptance criteria based on human expert performance or clinical outcomes.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance against those criteria, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types in the context of an AI/software device.

The "Performance Data" section (Page 4, Section G) refers to non-clinical mechanical testing performed to demonstrate substantial equivalence to predicate devices, not clinical performance metrics relevant to AI algorithms or human reading tasks.

• Acceptance Criteria and Reported Device Performance: This information is not present. The document focuses on mechanical testing demonstrating substantial equivalence to predicate devices, not on pre-defined clinical acceptance metrics.
• Sample size used for the test set and the data provenance: Not applicable, as this is a mechanical engineering equivalence study, not an AI/clinical performance study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study was not performed or referenced.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device for spinal fusion, not an AI algorithm.
• The type of ground truth used: Not applicable. The "ground truth" here would be established mechanical engineering standards.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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The NuVasive CoRoent Thoracolumbar 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 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 Nu Vasive 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) 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 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 non-operative treatment.

The NuVasive CoRoent XL Interfixated System implants are interbody fusions in the lumbar spine, from L2 to L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis 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 Nu Vasive 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 Hyperlorio 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 allogeneic 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 discectorny in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis 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, 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) or degenerative spondylolisthesis 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 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 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 interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis 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, 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 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 nonoperative treatment.

The Coalesce Thoracolumbar Interbody Fusion System is 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) 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 Coalesce Thoracolumbar Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The 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 Cohere Thoracolumbar Interbody System is 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) 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 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) 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 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) 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 Modulus TLIF Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Nu Vasive 3DP Interfixated ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The 3DP Interfixated ALIF System 10°-20° lordotic cages may be used as a standalone system. The 3DP Interfixated 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 3DP Interfixated ALIF System used with less than 3 bolts 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 Nu Vasive 3DP Interfixated ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis 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 3DP Interfixated 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, the 3DP Interfixated 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 (Ti6Al4V 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.

The provided text describes a 510(k) premarket notification for various intervertebral body fusion devices. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not typically part of a 510(k) summary for these types of Class II spinal implants.

However, I can extract and infer some information based on the document's content.

Here's a breakdown of the requested information:

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

The document does not provide a table of explicit acceptance criteria or quantitative performance metrics in the way one would see for an AI/CADe device or a new technology requiring de novo clearance. For spinal implants cleared via 510(k), "acceptance criteria" are generally tied to demonstrating substantial equivalence in terms of:

• Intended Use: The device performs the same function for the same condition.
• Technological Characteristics: The materials, design, and operating principles are similar or equivalent, and any differences do not raise new questions of safety or effectiveness.
• Performance: The device performs as safely and effectively as the predicate, often demonstrated through non-clinical (e.g., mechanical, biocompatibility) testing.

The "performance" reported here is a qualitative assessment of substantial equivalence.

Implants are manufactured from PEEK-Optima® LT-1 or Titanium alloy (Ti6Al4V ELI). Interfixated implants include Titanium alloy screws. (Similar to predicate materials). |
| Safety and Effectiveness Equivalence: Demonstrated through established clinical use and/or non-clinical testing. | "Based on the clinical data, it was determined that the NuVasive Thoracolumbar Interbody Systems used in the treatment of thoracolumbar sagittal deformities has a safety and effectiveness profile similar to the predicate device."

"No new NuVasive Thoracolumbar Interbody Systems implant designs are being introduced... minor design modifications were made... 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."

"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." |

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. This submission primarily relies on demonstrating equivalence to existing cleared devices, particularly for a broadened indication (multilevel degenerative scoliosis and sagittal deformity). The document states, "A clinical literature analysis of thoracolumbar sagittal deformities treated with the subject device was performed." This refers to a literature review, not a new clinical study with a prospectively defined test set of patients for device performance evaluation.
• Data Provenance: The nature of the "clinical literature analysis" means the data provenance would be from published studies, which could originate from various countries and be retrospective or prospective depending on the individual studies included in the analysis. The document does not specify.

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

• Not applicable. As no new clinical study was conducted with a defined "test set" requiring ground truth establishment by experts for specific outcomes, this information is not provided. The determination of "substantial equivalence" is made by the FDA based on the provided technical and comparative information and literature review.

4. Adjudication method for the test set:

• Not applicable. There was no specific test set requiring adjudication in the context of this 510(k) submission.

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 a submission for spinal implants, not an AI or imaging diagnostic device.

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

• Not applicable. This is a physical implant device, not an algorithm.

7. The type of ground truth used:

• For this 510(k) submission, the "ground truth" for the new indication (multilevel degenerative scoliosis and sagittal deformity) is established through clinical literature analysis. This means the safety and effectiveness profile of using these types of devices for this condition, as reported in existing peer-reviewed literature, serves as the basis for enabling expanded indications. The FDA relies on the predicate devices' established safety and effectiveness and the literature supporting the similar safety and effectiveness for the expanded use.

8. The sample size for the training set:

• Not applicable. No "training set" in the machine learning sense was used, as this is a physical medical device. The "training" for the device's design and use comes from existing medical knowledge, biomechanical principles, and the history of predicate devices.

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

• Not applicable. As above, no machine learning training set was used. The basis for the device's design and function comes from established clinical practice, biomechanical data from prior predicate devices, and manufacturing standards for medical implants.

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Peridot Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one 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 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Peridot Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Peridot Intervertebral Body Fusion System is intervertebral body fixation devices intended for use as an aid in spinal fixation. The Peridot Intervertebral fusion system is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. And some cage holders are made of titanium alloy as per ASTM F136.

X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment.

The device is available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.

The device is supplied non-sterile.

The device consists of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages.

The device is supplied with their specific instrument. The specific instrument is supplied dedicated tray and non-sterile. The device and instrument are supplied separately.

The device must be used in combination with the dedicated instrument supplied.

The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system.

This document is a 510(k) premarket notification for a medical device called the "Peridot Intervertebral body fusion system." It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study presenting the performance of an AI/ML powered device against acceptance criteria.

The document does not contain any information about acceptance criteria or a study proving that an AI/ML powered device meets those criteria.

Instead, it describes the device, its intended use, and compares it to existing predicate devices to show substantial equivalence for regulatory clearance. It focuses on mechanical testing of the physical implant according to ASTM standards, not on the performance of a software algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them based on the provided text.

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The Calix® Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 – S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The X-spine Calix® Lumbar Spinal Implant System is an intervertebral fusion device for use with bone graft, designed for surgical placement between adjacent vertebrae of the lumbar spine as an adjunct to fusion.

The X-spine Calix® Lumbar Spinal Implant System is a generally hollow box or oval shaped device manufactured from Invibio PEEK-Optima™ LT1 per ASTM F2026. The device contains an array of holes located throughout its geometry as well as teeth on the superior and inferior surfaces to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without a medical grade commercially pure titanium (CP Ti) plasma coating (per ASTM F1580) on the superior and inferior surfaces of the device.

The hollow center of the implant allows the device to be packed with bone graft: autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft,

The single use implants are supplied in several width, height and lordosis options to accommodate variations in patient anatomy and differing pathologies. The devices contain radiographic markers made from tantalum per ASTM F560 to aid in final placement verification. Plasma coated implants are provided clean and sterile. Nonplasma coated implants and instruments are provided non-sterile. All implants are intended for single use only, and should not be reused under any circumstances.

The system does not contain software/firmware.

The provided text describes a 510(k) premarket notification for a medical device (Calix® Lumbar Spinal Implant System), which is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device. This type of submission primarily relies on non-clinical performance data (mechanical and material testing) to demonstrate that the new device performs as well as or better than the predicate, especially when modifications are made.

The document does not describe an AI/ML-driven device or diagnostic tool that would require a study involving human readers, ground truth establishment through expert consensus (radiologists), or MRMC/standalone performance metrics typical of AI models. Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.

The acceptance criteria and proof of performance for this particular device (a spinal implant) are based on mechanical and material testing as per established ASTM standards and FDA recommendations for intervertebral body fusion devices.

Here's a breakdown of the relevant information from the provided text, addressing the points where applicable and noting when information is not present or relevant:

Acceptance Criteria and Device Performance (for a spinal implant)

The acceptance criteria for this medical device are primarily based on demonstrating mechanical equivalence and safety to predicate devices, adhering to recognized standards. The "performance" here refers to the physical and functional integrity of the implant, not diagnostic accuracy.

Table of Acceptance Criteria and Reported Device Performance

Detailed Information as per Request (with applicability notes):

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

   • See table above. The acceptance criteria are largely adherence to specified ASTM standards and demonstrating that the modifications (titanium coating, allograft use) do not negatively impact performance compared to the predicate.

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

   • N/A. For this type of device (spinal implant), "sample size" refers to the number of physical devices or material samples tested in a lab, not a population of patients or images. The document does not specify the exact number of implants tested for each mechanical test, which is common for 510(k) summaries where the methodology typically follows established engineering test standards.
   • Data Provenance: The data originates from the manufacturer's (X-spine Systems, Inc.) internal testing, conducted in their facilities or contracted labs. This is not clinical data, so terms like "retrospective" or "prospective" are not applicable.

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)

   • N/A. "Ground truth" in the context of this spinal implant device is established through physical mechanical testing and material characterization according to validated engineering standards (ASTM). It does not involve expert clinical assessment or image interpretation for establishing a "ground truth" diagnosis.

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

   • N/A. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-reader studies (e.g., in diagnostic imaging). This regulatory submission is for a physical implant, not a diagnostic AI 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

   • N/A. An MRMC study is designed to evaluate the performance of diagnostic devices, particularly AI-assisted ones, by comparing human reader performance with and without AI assistance. This submission is for an orthopedic implant and does not involve AI or human readers for diagnosis.

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

   • N/A. This refers to the standalone performance of an AI algorithm. The device is a physical implant, not an algorithm.

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

   • The "ground truth" for this device's performance is based on engineering standards and established physical properties. For example, the acceptable load-bearing capacity, expulsion resistance, and material characteristics determined by industry-standard mechanical testing are the "ground truth" for its functional performance.
   • For the Indications for Use, the "ground truth" for degenerative disc disease (DDD) is defined clinically: "back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies." This is a clinical definition for patient selection, not a ground truth for testing the device itself.

8. The sample size for the training set

   • N/A. There is no "training set" as this is not an AI/ML device.

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

   • N/A. No training set exists for this device.

Summary of Acceptance and Performance:

The Calix® Lumbar Spinal Implant System's acceptance and demonstrated performance hinge on its ability to meet or exceed the performance characteristics of its predicate device, the Calix® Lumbar Spinal Implant System (K131350), and other reference devices. The key elements of its "proof" are:

• Mechanical Testing: Demonstrating compliance with ASTM F2077 (for static/dynamic compression/shear) and ASTM F2267 (for subsidence) and FDA-recommended expulsion testing. The critical finding is that the new titanium plasma coating "does not present a new worst case, and does not impact the performance of the implants."
• Material Characterization: Showing the properties of the new CP Ti plasma coating via ASTM F1877.
• Indications for Use Expansion: Justifying that the addition of allograft use "does not impact the mechanical performance" and "does not introduce new risks," citing that allograft has been cleared for many other spinal implants.
• Substantial Equivalence: Ultimately, the study (mechanical and material testing) served to prove that the modified device is substantially equivalent to legally marketed predicate devices in terms of safety and effectiveness, despite the added coating and expanded graft options.

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

The Monolith Corpectomy System is a vertebral body replacement system manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The Monolith Corpectomy System is made up of two primary components: a core and a set of endcaps. The core is offered in a variety of shapes and sizes to suit individual pathology and anatomical conditions of the patient. The modular endcaps are offered in multiple footprints and lordosis options.

The device contains 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 to serve as radiopaque markers. The Monolith Corpectomy System is provided non-sterile to be sterilized by the user before each use.

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets them in the format requested.

The document is a 510(k) Premarket Notification for the NuVasive® Monolith Corpectomy System. It primarily focuses on demonstrating substantial equivalence to already marketed predicate devices.

Here's what the document does say regarding performance:

• Performance Data: Nonclinical testing was performed to demonstrate substantial equivalence. The following tests were mentioned:
  • Static Axial compression and torsion per ASTM F2077
  • Push-out Analysis
  • Subsidence Analysis
  • MR Compatibility Analysis
• Additional Analysis: Finite Elemental Analysis (FEA) and engineering rationale were provided.
• Conclusion: The results of the testing and FEA demonstrate that the subject Monolith Corpectomy System is substantially equivalent to predicate devices.
• Crucially: "No non-clinical or clinical studies were conducted."

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance (specific numerical acceptance criteria are not detailed, nor are the specific numerical results of the tests).
2. Sample size for the test set or data provenance (as no clinical studies were performed).
3. Number of experts or their qualifications, or adjudication method (as no studies requiring expert review were performed).
4. Information on MRMC or standalone studies (as no clinical studies were performed).
5. Type of ground truth used (not applicable here, as it's a mechanical device tested against engineering standards, not diagnostic performance).
6. Sample size for the training set or how ground truth was established for it (not applicable here, as this is not an AI/machine learning device).

The document is about demonstrating the mechanical and material equivalence of a medical implant to existing devices through engineering tests, not about the performance characteristics of an AI or diagnostic device that would typically involve the criteria you've asked for.

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