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The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent Ti-C System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The NuVasive® CoRoent Ti-C System is manufactured from PEEK-OPTIMA® (Polyetherether-ketone) conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580, Ti-6Al-4V ELI conforming to ASTM F136/1472 or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided document is a 510(k) premarket notification for a medical device (CoRoent Ti-C System), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical or performance study results for achieving specific acceptance criteria.

Therefore, the document does not contain the information requested for acceptance criteria and the study proving the device meets those criteria, specifically:

• A table of acceptance criteria and the reported device performance: This information is not provided. The document states "no new worst-case for performance testing" but does not detail specific performance thresholds or results against them.
• Sample sized used for the test set and the data provenance: No test set is described in the context of clinical performance.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable as no clinical test set/ground truth is discussed.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states, "No non-clinical or clinical studies were conducted."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant, not a software/algorithm device.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as no training set for an algorithm is described.
• How the ground truth for the training set was established: Not applicable.

The performance data mentioned in the document (Section G, Page 4) is limited to nonclinical testing primarily for demonstrating equivalence to predicate devices:

• Static and dynamic axial compression and compression shear per ASTM F2077
• Wear debris testing per ASTM F2077, ASTM F1714 and ASTM F1877

The conclusion drawn from this testing is that "the subject CoRoent Ti-C System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate." However, specific acceptance criteria values and the device's numerical performance against those values are not detailed in this submission.

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The Endoskeleton® TL IBD is indicated for use in spinal 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. Patients should have received 6 months of non-operative treatment with the devices. This device is intended for use supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients with non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone.

The Endoskeleton® TL Interbody Fusion Device (IBD) implants are available in a various sizes with a variety of lordotic angles (0, 7 or 12 degrees), to accommodate patient anatomy. Lengths range from 40 to 60mm, widths from 18 to 26m and heights range from 8 to 16mm. Endoskeleton® TL IBD implants are intended for treatment in Lateral Lumbar Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a farge hollow region in the center to house bone graft material. The new bone formation through the implant is intended to provide long-term structural support and biologic fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone. An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the interbody space. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-AV-ELI).

Here's an analysis of the provided text regarding the Endoskeleton® TL Interbody Fusion Device, focusing on acceptance criteria and supporting studies:

It's important to note that this document is a 510(k) Summary for a medical device seeking clearance, not a detailed research paper. Therefore, the depth of information regarding clinical studies, ground truth establishment, and expert qualifications is much less than what would be found in a peer-reviewed publication. The focus of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "test set" in the context of human subjects or clinical data. The performance testing described (mechanical testing) likely used device prototypes or manufactured samples. The number of samples for each mechanical test is not provided.
• Data Provenance: Not applicable in the context of a clinical test set. The mechanical testing was performed in vitro, presumably by Titan Spine, LLC or a contracted lab. There is no mention of country of origin for clinical data, as no clinical study is detailed.
• Retrospective/Prospective: Not applicable, as no clinical study is described. The mechanical tests are inherently retrospective in the sense that they are performed on manufactured devices.

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

• This information is not provided in the document. For mechanical testing, the "ground truth" is typically defined by the test standards (ASTM F2077, ASTM F2267) and the performance of the predicate device. There were no human experts establishing a clinical ground truth for this type of submission.

4. Adjudication Method for the Test Set

• This information is not provided and is not applicable to the type of mechanical performance testing described. Adjudication methods are typically used in clinical studies for interpreting ambiguous findings, which is not the case 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

• No, an MRMC comparative effectiveness study was not done. This device is a physical intervertebral fusion device, not an AI software or diagnostic imaging tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone performance study was not done. This refers to AI algorithms. The device is a physical implant.

7. The Type of Ground Truth Used

• For the mechanical testing, the "ground truth" was established by established ASTM standards (F2077, F2267) and the performance characteristics of the legally marketed predicate devices. The goal was to demonstrate that the subject device met or exceeded the performance of the predicates under these standardized conditions.

8. The Sample Size for the Training Set

• This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical implant, and the submission does not involve AI or machine learning.

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

• This information is not applicable. As there is no AI component, there is no training set or associated ground truth.

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When used as a vertebral body replacement, the TASMIN® R devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumaffracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.

When used as an intervertebral fusion device, the TASMIN® R devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

The basic shape of the TASMIN® R devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open with peaked teeth that assist in anchoring and seating the implant between the vertebral bodies. There are lateral fenestrations for bony in-growth. The device is available in a variety of sizes and angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

The TASMIN® R device is a spinal intervertebral body fixation orthosis and intervertebral body fusion device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The documentation refers to "worst case TETRIS™ and TASMIN® R devices" for finite element analysis and "worst case TASMIN® R devices" for physical testing. It does not specify the exact number of devices or scenarios considered. It is implied that representative "worst-case" configurations were selected for the evaluation.
• Data Provenance: The studies are described as "Finite element analysis simulations" and "Static and dynamic compression testing." This indicates the data was generated from engineering analyses and laboratory bench testing performed by the sponsor, SIGNUS Medizintechnik GmbH. The country of origin of the data is not explicitly stated, but the sponsor is based in Germany. The data is prospective in the sense that it was generated specifically for the premarket submission.

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 performed were bench testing and finite element analysis, not clinical studies requiring expert consensus on patient data. The "ground truth" for these types of studies is established by adherence to recognized ASTM standards and engineering principles.

4. Adjudication Method for the Test Set

This information is not applicable for bench testing and finite element analysis. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of imaging or clinical outcomes.

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

An MRMC comparative effectiveness study was not conducted. The device is a medical implant, not an AI-assisted diagnostic or therapeutic tool.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies was derived from:

• Recognized Industry Standards: ASTM F2077 (for compression, torsion, compression-shear) and ASTM F2267 (for subsidence properties). These standards define the methodology and expected performance for intervertebral body fusion devices.
• Engineering Principles: Finite element analysis relies on established biomechanical and engineering principles to simulate mechanical behavior.
• Material Specifications: ASTM F2026 for PEEK-OPTIMA® LT1 and ASTM F560 for Tantalum, defining the accepted properties of the materials.

8. The Sample Size for the Training Set

This information is not applicable. The studies performed were bench testing and simulations, not machine learning studies that require a training set.

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

This information is not applicable as there was no training set for a machine learning algorithm. The "ground truth" for the device's performance was established by adherence to ASTM standards and engineering principles as described in point 7.

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The NuVasive CoRoent Single Tab System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent Single Tab System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to L5, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six months of non-operative treatment. The system is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle or facet screws) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screw.

The NuVasive CoRoent Single Tab System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, MP35N conforming to ASTM F562, and titanium alloy conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided document is a 510(k) summary for the NuVasive CoRoent Single Tab System, which is an intervertebral body fusion device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or setting acceptance criteria for device performance based on a new study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as well as details about sample sizes, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.

Here's why and what information is available:

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

• Not provided. The 510(k) pathway for this device relies on demonstrating substantial equivalence through bench testing, not on establishing and meeting new clinical performance acceptance criteria.
• The document states: "The results demonstrate that the subject CoRoent Single Tab System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate."

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/Not provided. No clinical test sets or patient data were used for this 510(k) submission. All testing was bench-based.

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

• Not applicable/Not provided. No human expert ground truth was established as there were no clinical studies.

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

• Not applicable/Not provided. No clinical test set.

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/Not provided. This is a physical medical device (intervertebral body fusion system) and does not involve AI, human readers, or image interpretation.

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

• Not applicable/Not provided. This device is a physical implant, not an algorithm. The document explicitly states: "This device does not contain software or electrical equipment."

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

• Not applicable/Not provided. Ground truth, in the clinical sense, was not established as there were no clinical studies. For bench testing, the "ground truth" is typically the established engineering and materials standards (e.g., ASTM standards).

8. The sample size for the training set:

• Not applicable/Not provided. No training set was used as this device does not involve machine learning or AI.

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

• Not applicable/Not provided. No training set was used.

Summary of available "Performance Data" from the document:

The device underwent bench testing to demonstrate substantial equivalence to predicate devices. The specific tests performed were:

• Static and dynamic axial compression and compression shear per ASTM F2077.
• Wear debris testing per ASTM F2077, ASTM F1714, and ASTM F1877.

The document explicitly states: "No animal or clinical studies were conducted."

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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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The NuVasive Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.

The Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Expandable Lumbar Interbody System. The Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems (e.g. pedicle screw/rod systems) that are cleared by the FDA for use in the lumbar spine.

The NuVasive Expandable Lumbar Interbody System is manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6A1-4V conforming to ASTM 1472, and Nitinol SE508 conforming to ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided document describes the NuVasive Expandable Lumbar Interbody System, a Class II medical device intended for intervertebral body fusion of the spine. The evaluation criteria for this device are based on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics for an AI system. Therefore, many of the requested categories related to AI model evaluation are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for individual tests. The document refers to various "testing" and "cadaver testing" without detailing the number of units or cadavers used.
• Data Provenance: Not explicitly stated. Nonclinical testing was performed, but the location or specific origin of materials/samples is not mentioned. This is a medical device, so the tests would be performed on engineered samples or cadaveric specimens, not retrospective or prospective patient data in the sense of an AI study.

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

• Not Applicable. This is a physical medical device clearance, not an AI or diagnostic tool where expert ground truth is established for a test set. The "ground truth" here is compliance with established ASTM standards and comparable performance to predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Testing involves objective measurements against established technical standards, not subjective expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• Not Applicable. This is not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI performance evaluation was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• Technical Standards and Predicate Device Performance: The "ground truth" for this device's performance evaluation is established by:
  • ASTM International Standards: F2077 (for static and dynamic mechanical testing), F2129 (for corrosion testing).
  • Performance of Legally Marketed Predicate Devices: The "substantial equivalence" claim is based on demonstrating that the new device performs comparably to the NuVasive CoRoent® System (K071795) and NLT Spine Ltd. Prow Fusion (K112359) without introducing new worst-case scenarios.

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve an AI model requiring a training set.

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

• Not Applicable. This device does not involve an AI model requiring ground truth for a training set.

Summary of the Study:

The study described is a nonclinical performance testing regimen designed to demonstrate the mechanical and material characteristics of the NuVasive Expandable Lumbar Interbody System. The methodologies employed are based on established ASTM standards for intervertebral body fusion devices. The primary objective was to show that the subject device performs similarly to or better than two specific predicate devices already on the market (NuVasive CoRoent® System (K071795) and NLT Spine Ltd. Prow Fusion (K112359)) across various mechanical and environmental tests. The conclusion states that the device presents "no new worst-case for performance testing," thereby establishing substantial equivalence to the predicate devices in terms of safety and effectiveness. This type of clearance (510(k)) relies on demonstrating similarity to existing legally marketed devices, rather than establishing de novo safety and effectiveness through extensive clinical trials for software performance.

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Intervertebral Body Fusion

The NuVasive CoRoent Titanium System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The CoRoent Titanium System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Partial Vertebral Body Replacement

The NuVasive CoRoent Titanium 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 Titanium System is a lumbar interbody system manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. The implants are available in a variety of sizes to suite 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.

The NuVasive CoRoent Titanium System is an intervertebral body fusion device and partial vertebral body replacement device. This 510(k) summary indicates that the device met acceptance criteria through Finite Element Analysis (FEA), which demonstrated its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a Finite Element Analysis (FEA).

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

The document does not specify a "test set" in the context of clinical or image-based data. Instead, the performance evaluation was based on Finite Element Analysis (FEA). FEA is a computational method that discretizes a structure into many small elements to analyze its behavior under various loads. The "sample size" for this type of analysis refers to the complexity of the model (e.g., number of elements, nodes) rather than a cohort of patients or images. The document does not provide details on the specific FEA model parameters or the provenance of any physical data used to validate the FEA model, if applicable.

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

This information is not applicable as the study described is a Finite Element Analysis (FEA) of the device's mechanical properties, not a study involving human interpretation of medical data where "ground truth" would be established by experts.

4. Adjudication Method for the Test Set:

This information is not applicable as the performance data is derived from Finite Element Analysis (FEA), which is a computational simulation, not a review process requiring human adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance data provided is based on Finite Element Analysis (FEA) of the device itself, not a study of human readers' performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The performance study described is a standalone evaluation of the device's mechanical properties through Finite Element Analysis (FEA). This is an "algorithm only" in the sense that it's a computational simulation of the device's behavior, without human intervention in the performance measurement itself (though humans design the FEA and interpret its results).

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the engineering principles and material properties that govern the behavior of the titanium alloy (Ti-6Al-4V) used in the device. The FEA simulates these physical laws to predict performance. There is no biological or clinical "ground truth" derived from pathology or outcomes data presented for this specific performance evaluation.

8. The Sample Size for the Training Set:

This information is not applicable. Finite Element Analysis (FEA) is a simulation method based on physical laws and material properties, not a machine learning model that requires a "training set" of data.

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

This information is not applicable as there is no "training set" in the context of a Finite Element Analysis (FEA). The "ground truth" for FEA is based on established physics, material science, and engineering standards.

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The CAPSTONE CONTROL™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of nonoperative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The CAPSTONE CONTROL™ Spinal System consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CAPSTONE CONTROL™ Spinal System implants will be available in heights of 8mm to 18mm, lengths of 22mm, 27, mm, and 32mm, and widths of 9mm or 10mm. In addition, the implants will be available with 0°, 6°, 12°, and 18° of lordosis.

The CAPSTONE CONTROL™ Spinal System is an intervertebral body fusion device.

Here's an analysis of the provided text in relation to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the test set. However, it indicates mechanical testing was conducted. For such devices, samples typically refer to individual devices or components tested according to the standards. The provenance of this mechanical performance data would be laboratory testing performed by Medtronic Sofamor Danek, USA Inc.

The document does not provide details on the geographical origin of the data or whether it was retrospective or prospective, as it pertains to engineering-focused mechanical tests rather than patient studies.

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

This information is not applicable as the studies described are mechanical engineering tests rather than clinical or observational studies requiring expert consensus for ground truth. The "ground truth" here is defined by established engineering standards (ASTM F2077-11 and ASTM F2267-04) and FDA guidance.

4. Adjudication Method for the Test Set

This information is also not applicable for the same reasons as above. Adjudication methods like "2+1" or "3+1" are typical for clinical trials or image interpretation studies to resolve discrepancies in expert opinions. For mechanical testing, the results are objectively measured against predefined pass/fail criteria based on the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an intervertebral body fusion device (an implantable medical device), not an Artificial Intelligence (AI) or diagnostic imaging system. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study was not done. As mentioned, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for demonstrating device performance was engineering standards and regulatory guidance. Specifically:

• ASTM F2077-11: Test Methods for Intervertebral Body Fusion Devices
• ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of the Intervertebral Body Fusion Device under Static Axial Compression
• FDA's Guidance document: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device issued June 12, 2007.

The "ground truth" for this submission is performance that meets the established mechanical requirements outlined in these standards and guidance documents.

8. The Sample Size for the Training Set

This information is not applicable. This submission describes the testing of a finished medical device against established standards, not the training of a machine learning algorithm.

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

This information is not applicable for the same reason as above. There is no training set mentioned in the context of this device submission for machine learning.

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When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical JBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

The Aleutian Spinal System consists of a hollow tube or horseshoe-shaped structures manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are 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.

Materials: The implants are manufactured from Invibio™ PEEK OPTIMA® LT1 per ASTM F2026. Tantalum beads/ rods are to be made of Grade UNS R05200, UNS R05400 according to ASTM F560.

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

The provided text describes a medical device submission (510(k)) for the Aleutian IBF System. It outlines the device's description, intended use, and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way an AI/ML device submission would.

This document pertains to a traditional medical device (an intervertebral body fusion device made of PEEK, Tantalum) and its substantial equivalence to other physically similar medical devices already on the market. The evaluation criteria for such a device are primarily based on material properties, mechanical testing, and comparison with predicate devices, not on performance metrics like accuracy, sensitivity, or specificity against a ground truth dataset, which would be typical for AI/ML devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to the information contained in this 510(k) summary for a physical implant.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This information is not provided. The study conducted was primarily mechanical testing and finite element analysis, not a clinical study with a "test set" of patients or data in the typical sense.

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 for this type of device and study. The ground truth for mechanical performance typically relies on established engineering principles, material standards (ASTM), and validated testing methods.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, as 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, as this is not an AI/ML device.

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

• The "ground truth" in this context is based on established engineering standards (ASTM F2077 for static compression and torsion testing) and the mechanical performance and material properties of the predicate devices. The finite element analysis (FEA) was validated against these physical tests.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this device and the provided study, which involves mechanical testing and FEA.

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

• Not applicable.

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InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The InFill™ intervertebral body fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill™ intervertebral body fusion device is provided sterile, for single use only.

The provided text describes the InFill™ Intervertebral Body Fusion Device, its intended use, and the regulatory pathway. However, it does not contain information about a study proving the device meets acceptance criteria in the way a diagnostic AI device would.

This document is a 510(k) summary for a medical implant (spinal fusion device), not a diagnostic AI/ML system. The "performance data" section refers to mechanical and material testing to ensure the device's physical integrity and equivalence to predicate devices, not clinical efficacy or diagnostic accuracy.

Therefore, many of the requested categories in your prompt (e.g., sample size for test set, data provenance, ground truth, experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and are not present in the provided text.

Here's an analysis based on the information that is available, and an explanation of why other requested information is absent:

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

For this device type, acceptance criteria are generally related to mechanical and material properties, demonstrating that the device is as safe and effective as previously cleared predicate devices. The document states:

Explanation: The document explicitly states that "All necessary performance testing, has been completed for the InFill™ intervertebral body fusion device including static/dynamic compression (ASTM F2077), static subsidence (ASTM F2267) and expulsion. to assure substantial equivalence to the predicate devices." The acceptance criteria for these tests would be defined in the standards themselves and by comparison to the predicate devices. The reported performance is that the device met these criteria, thus assuring substantial equivalence. Specific numerical performance values are not typically included in a 510(k) summary for this kind of mechanical device but would be in the full submission.

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 device is a passive implantable medical device, not a diagnostic or AI system that processes data from a "test set" of patient cases, images, or records. The "test set" for this device would refer to the physical units of the device subjected to mechanical testing. The number of physical units tested 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, in the context of diagnostic performance, is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and comparison to predicate devices, not expert human interpretation.

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

Not applicable. Adjudication methods are typically used in clinical trial settings or for establishing ground truth in diagnostic studies.

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. MRMC studies are used to evaluate the diagnostic performance of systems, often AI-powered ones, by comparing human readers' performance with and without assistance. This is a physical implant, not a diagnostic tool.

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

Not applicable. The device is a physical implant; there is no "algorithm" to run in a standalone fashion.

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

For the mechanical performance, the "ground truth" is adherence to established ASTM standards (F2077, F2267) and demonstrating equivalence to predicate devices which have been previously cleared based on similar standards. It does not involve expert clinical consensus, pathology, or outcomes data in the sense of a diagnostic device.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system that requires a "training set."

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary regarding the device and its compliance:

The InFill™ Intervertebral Body Fusion Device is a Class II medical device, which achieved 510(k) clearance by demonstrating "substantial equivalence" to predicate devices (NuVasive CoRoent System, K071795; Globus Medical Patriot Transcontinental LLIF Spacer K093242). This means that its intended use, principle of operation, technological characteristics, and safety/effectiveness profiles were found to be similar enough to already-marketed devices. The "study" mentioned refers to mechanical and material performance testing (static/dynamic compression, static subsidence, expulsion) conducted according to established ASTM standards (F2077, F2267). The device met these engineering performance criteria, allowing it to be deemed substantially equivalent.

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