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The ELITE™ L Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in sketetally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-L5. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.

The Elite™ L is a titanium alloy (Ti6Al4V-ELI) implant that is designed to provide mechanical support of the intradiscal space while biologic fusion occurs. The device is available in a variety of footprints, all of which are inserted in the unexpanded state and are expanded in situ. There are various heights to accommodate varied patients' anatomy. The implants are available in parallel and lordotic angles, with the implant end plates being bi-convex to optimize contact with the vertebral body end plates. All implants are made from medical grade titanium alloy. Implants have a locking mechanism to hold the implant in the expanded position once deployed.

This document is a 510(k) summary for the ELITE™ L Expandable Lumbar Fusion System, which is an intervertebral body fusion device. The purpose of this submission is to add devices to be implanted from the lateral surgical approach.

Unfortunately, the provided text does not contain explicit acceptance criteria or details of a study that proves the device meets specific performance criteria in the way you've outlined for statistical performance of an AI/ML device.

This document describes a medical device and its substantial equivalence to a predicate device, which is a common pathway for FDA clearance for certain medical devices. The "performance testing" mentioned refers to mechanical and functional testing of the physical implant, not performance in terms of diagnostic accuracy or clinical outcomes of an AI/ML system.

Therefore, I cannot populate your requested table and study details. The information provided is for a physical medical implant and focuses on:

• Mechanical Testing: According to ASTM F2077 (Static and dynamic axial compression, subsidence resistance, and expulsion resistance of an intervertebral body fusion device) and ASTM F2267 (Standard Test Method for Measuring Load-Displacement Properties of Spine Implants Under Compression or Shear).
• Finite Element Analysis (FEA): Used to compare the new device (Elite™ L) to the primary predicate device (Elite Expandable Interbody Fusion Device) and demonstrated "greater strength and durability to static and dynamic forces."

The criteria for this type of device are primarily related to its mechanical properties and biocompatibility, ensuring it can perform its intended function of supporting the intradiscal space and facilitating fusion without failure. The "acceptance criteria" here would implicitly be that the device performs at least as well as, or better than, the predicate device in these mechanical tests and that its materials, dimensions, and function are substantially equivalent to legally marketed predicate devices.

To directly answer your numbered points based on the provided text, I must state that most of the requested information regarding AI/ML device performance is not available.

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical implants, not data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Gor mechanical testing, ground truth is established by engineering standards and measurements.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

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

7. The type of ground truth used: For mechanical testing, the "ground truth" would be the direct measurements obtained from standardized physical tests and the results of Finite Element Analysis.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, the provided document describes the mechanical and functional characteristics of a physical medical device and asserts its substantial equivalence to a predicate device based on standardized mechanical testing and FEA. It does not involve any AI/ML components or studies of diagnostic accuracy in the way your questions are framed.

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The NuVasive CoRoent Small Contoured Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Contoured Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - TI. The System is intended to be used with supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The NuVasive CoRoent Small Contoured Interbody System is a hollow interbody cage manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026. The implant contains a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The device includes marker pins composed of titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782. The pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation.

The implants are available in flat or contoured endplates, and come in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device will be packaged and initially provided non-sterile, and is designed to be sterilized by the user before each use.

This document describes the NuVasive CoRoent Small Contoured Interbody System, an intervertebral body fusion device. While it contains information about the device's intended use and performance data, it does not describe an AI/ML device or a study that evaluates its performance against specific acceptance criteria in the context of AI/ML.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or ground truth as typically associated with AI/ML device evaluations.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and a clinical literature review for a medical implant, not an AI-powered diagnostic or assistive tool.

Specifically, the document states:

• "This device does not contain software or electrical equipment." (Page 4, Section F) This explicitly confirms it is not an AI/ML device.

Therefore, a table of acceptance criteria and reported device performance for an AI/ML device cannot be extracted from this document, nor can the details of an AI/ML study.

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Intervertebral Body Fusion

The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is designed for use with autogenous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

Partial Vertebral Body Replacement

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. Type of Ground Truth Used

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

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

8. Sample Size for the Training Set

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

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

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

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When used as an intervertebral body fusion device, the InterForm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The InterForm PLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm PLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior approach and used with supplemental fixation and autogenous bone graft.

The InterForm TLIF Interbody Fusion Implants consists of cage footprints widths of 9, 11, 13mm , lengths of 22, 24, 26, 28, 30, 32mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm TLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm OTLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30, 32, 34mm, ranging in height from 7mm to 14mm with lordosis of 0°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm OTLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior or transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm LLIF Interbody Fusion Implants consists of cage footprint widths of 18, 20, 22, 24mm, lengths of 40, 45, 50, 55, 60mm, ranging in height from 8mm to 18mm with lordosis of 0° or 7°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm LLIF Interbody Fusion devices are intended to be implant via a lateral approach and used with supplemental fixation and autogenous bone graft.

The InterForm ALIF Interbody Fusion Implants consists of cage footprints of 30x24mm, and 39x30mm (DxW), ranging in height from 10mm to 20mm with lordosis of 0°, 7° or 12° which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm ALIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, anterior approach and used with supplemental fixation and autogenous bone graft.

All implants are packaged non-sterile to be sterilized at the hospital.

Materials:

PEEK Optima LT1 conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:

Maintain adequate disc space until fusion occurs.

The InterForm Interbody Cage System is intended for spinal fusion procedures.
Here's a breakdown of the acceptance criteria and the study done:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The documentation explicitly states that the device is considered "substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances." The acceptance criteria, while not explicitly numerical, are therefore met by demonstrating performance comparable to the already legally marketed predicate devices. The study concludes that the results indicate the InterForm Interbody Cage System is equivalent.

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

This information is not provided in the document. The studies listed are non-clinical tests (mechanical testing), not studies involving human or animal subjects that would generate a "test set" of data in the typical sense of evaluating AI or clinical outcomes. The provenance of the samples (e.g., specific batches of PEEK and tantalum used in testing) is not detailed, nor is it relevant given the mechanical nature of the tests.

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

This information is not applicable as the studies are non-clinical mechanical tests, not clinical evaluations requiring expert interpretation or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical mechanical tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This device is a physical medical implant, not an AI or imaging device that would typically involve human reader studies.

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

This information is not applicable as the device is a physical medical implant and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established mechanical properties and performance standards outlined in the ASTM F2077 and ASTM F2267 standards, and the performance characteristics of the predicate devices. For mechanical tests, the ground truth is objectively measured physical properties and behaviors of the material and device under specific conditions.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical implant and would not have a "training set" in the context of machine learning or AI. For mechanical testing, the "samples" would be the manufactured devices or materials subjected to the tests. The exact number of units tested for each non-clinical test (static compression, dynamic compression, subsidence, expulsion) is not specified, but it would typically be a statistically significant number of physical samples to ensure reliability and reproducibility of the results according to the ASTM standards.

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

This information is not applicable for the same reasons as #8. The "ground truth" for material and device properties in mechanical testing is established through standardized testing procedures and validated measurement techniques, as defined by organizations like ASTM.

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