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The Adaptix™ PEEK Interbody System with Nanotechnology devices and the Capstone Control™ PEEK Spinal System with Nanotechnology devices including those with macro-, micro- and nano-roughened surface textures are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s).
Additionally, Adaptix™ PEEK Interbody System with Nanotechnology and the Capstone Control™ PEEK Spinal System with Nanotechnology devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Adaptix™ PEEK and the Capstone Control™ PEEK devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures and may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.

The Adaptix™ PEEK Interbody System with Nanotechnology and Capstone Control™ PEEK Spinal System with Nanotechnology consist of interbody implants designed for restoration of sagittal alignment in the lumbar spine. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected pores averaging 523 μm, and pore interconnections averaging 229 μm in diameter. This product demonstrates the requirements for nanotechnology. The surface has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. The scaffold of the Adaptix™ PEEK and Capstone Control™ PEEK devices is electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface. The scaffold with nanotubes assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. The Adaptix™ PEEK and Capstone Control™ PEEK devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided text describes a medical device, the Adaptix™ PEEK Interbody System with Nanotechnology and Capstone Control™ PEEK Spinal System with Nanotechnology, and its 510(k) submission for substantial equivalence to predicate devices. It does not present acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.

The "Performance Data" section solely discusses mechanical and MR compatibility testing, which are standard for interbody fusion devices and not related to AI/ML performance.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving their fulfillment for an AI/ML device from the given document. The document pertains to a physical medical implant, not an AI/ML software.

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Anatomic PEEK™ Cervical Fusion System with Nanotechnology devices including those with macro-, micro-, and nano-roughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. These patients should have had at least six weeks of non-operative treatment. The Anatomic PEEK™ device is to be used with supplemental fixation; the hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. The Anatomic PEEK™ Cervical Fusion System with Nanotechnology is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate, and is to be implanted via an open anterior approach.

The Anatomic PEEK™ Cervical Fusion System with Nanotechnology consists of implants and instruments for implantation. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected pores averaging 523 µm, and pore interconnections averaging 229 µm in diameter. This product demonstrates the requirements for nanotechnology. The surface has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. The scaffold of the Anatomic PEEK™ devices is electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface. The scaffold with nanotubes assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. The Anatomic PEEK™ devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided text describes the 510(k) clearance for the Anatomic PEEK™ Cervical Fusion System with Nanotechnology, a medical device. This document is a regulatory submission demonstrating substantial equivalence to predicate devices, not a study evaluating human-in-the-loop AI performance or an AI-powered diagnostic device.

Therefore, the input text does not contain the information requested regarding acceptance criteria and a study proving an AI device meets those criteria. The acceptance criteria and study details for an AI-powered device (e.g., sample size, expert ground truth, MRMC study, standalone performance) are not present in this regulatory clearance document for a physical medical implant.

The "Performance Data" section in the provided document refers to mechanical testing of the implant and MR compatibility, not a study evaluating AI diagnostic performance or human reader improvement with AI assistance.

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The Nano FortiFix® System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the non-cervical spine for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion. The Nano FortiFix® System can be used in an open approach or a percutaneous approach with MIS instrumentation.

Nano FortiFix® is a posterior pedicle screw system consisting of rods, polyaxial and monoaxial pedicle screws, connectors and fasteners in a variety of sizes to accommodate differing anatomic requirements. The Nano FortiFix® pedicle screw shaft is available having a nanosurface. The Nano FortiFix® nano pedicle screw has a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the nano screw threads has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These threads are electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nano FortiFix® System:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • For mechanical testing (ASTM F1717), the text mentions "worst case construct" but does not specify the numerical sample size (e.g., number of constructs tested for each type of loading or the number of repetitions for each test).
  • For in vitro evaluations (mineralization), the text does not specify the numerical sample size (e.g., number of cell cultures, experimental replicates).
  • For bacterial endotoxin testing, the text does not specify the numerical sample size (e.g., number of samples tested).
• Data Provenance: The studies were conducted by the manufacturer as part of their 510(k) submission. The exact country of origin for the studies is not explicitly stated, but the sponsor's location (Nanovis Spine, LLC, Columbia City, Indiana, USA) suggests a U.S. origin. All studies appear to be prospective in nature, designed specifically to evaluate the Nano FortiFix® System.

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

• This information is not applicable to the type of studies described. The studies are primarily in vitro (cell culture and mechanical testing) and material/biological safety analyses (bacterial endotoxin). There is no "ground truth" derived from human experts in the context of diagnostic performance or clinical outcomes. The "ground truth" for these tests comes from adherence to established standards (ASTM F1717, AAMI ST72:2011) and scientific principles for cell culture and material properties.

4. Adjudication method for the test set

• This information is not applicable as the studies are not based on interpreting patient data where adjudication would be necessary. The results are quantitative measurements from laboratory 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a thoracolumbosacral pedicle screw system, an implantable medical device, not an AI-powered diagnostic or assistive tool for human readers.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

7. The type of ground truth used

• For mechanical testing: The ground truth is established by the specified performance requirements of the ASTM F1717 standard and the comparative performance of legally marketed predicate devices. The "truth" is whether the device meets or exceeds these established benchmarks.
• For nanotechnology/mineralization studies: The ground truth is the quantitative measurement of mineralization in cell cultures and the successful demonstration of the specified nanotopography. The comparison to "other surfaces" provides the baseline.
• For bacterial endotoxin testing: The ground truth is defined by the "specified testing limit" within the AAMI ST72:2011 standard.

8. The sample size for the training set

• Not applicable. This device is a physical implant, not a machine learning algorithm that requires a training set.

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

• Not applicable. As there is no training set for a machine learning model, there is no ground truth established for a training set.

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FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nano FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® lumbar devices are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, Nano FortiCore® lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Nano FortiCore® lumbar devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.

FortiCore® and Nano FortiCore® consist of implants and instruments for implantation. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected pores averaging 523 µm, and pore interconnections averaging 229 um in diameter. This product demonstrates the requirements for nanotechnology. The surface has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. The scaffold of the Nano FortiCore® devices is electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having an average pore size between 60-80 nanometers. Calcium and phosphate are incorporated into the nanotube surface. The scaffold with nanotubes assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. The FortiCore® and Nano FortiCore® devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided text describes a 510(k) premarket notification for two intervertebral body fusion devices, FortiCore® and Nano FortiCore®, and asserts their substantial equivalence to predicate devices. However, this document does not include information about acceptance criteria or a study proving that the device meets such criteria in terms of AI/algorithm performance.

The "Performance Data" section solely discusses mechanical testing of the devices according to ASTM F2077 and F2267, as well as in vitro evaluations related to nanotechnology and bacterial endotoxin testing. It concludes that "The mechanical test results demonstrate the FortiCore® and Nano FortiCore® device performance is substantially equivalent to the predicate devices."

Therefore, based only on the provided text, I cannot answer the questions regarding acceptance criteria and an AI/algorithm-related study. The document pertains to a physical medical device (intervertebral body fusion device) and its mechanical/material properties, not an AI or software as a medical device (SaMD).

To explicitly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses mechanical testing results in comparison to predicate devices, but doesn't present specific acceptance criteria in a table or quantitative performance metrics for an AI/algorithm.
2. Sample sizes used for the test set and the data provenance: Not applicable. The "test set" refers to physical devices undergoing mechanical tests, not a data set for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This concept is for AI/algorithm validation, not mechanical testing of a medical implant.
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. This is for AI-assisted diagnostic or interpretative devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here would be the physical properties and performance of the implant under mechanical stress, compared to established standards (ASTM).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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FortiCore® is intended for spinal fusion procedures in skeletally mature patients with disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, FortiCore® can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. FortiCore® devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.

FortiCore® consists of implants and instruments for implantation. The upper and lower aspects of the implant incorporate a three-dimensional titanium scaffold electrochemically treated to possess a controlled nanotopography composed of nanotube arrays with an average pore size between 60-80 nanometers, which assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. Calcium and phosphate are incorporated into the nanotube surface. Nanovis has not submitted data to show that phenomena, including chemical properties or biological effects are attributable to these features. The devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided text is a 510(k) summary for the FortiCore® intervertebral body fusion device. It does not contain information about acceptance criteria for a device's performance in terms of diagnostic accuracy or a study proving that the device meets such criteria for an AI/ML device.

Instead, the "Performance Data" section of the 510(k) summary (page 3) discusses mechanical testing related to the physical device itself:

• Acceptance Criteria and Reported Device Performance: This document describes mechanical performance testing, not clinical or diagnostic performance.
  • Acceptance Criteria (Implicit): That the device's mechanical performance (dynamic compression, static and dynamic compression shear) is "substantially equivalent to the predicate devices" according to ASTM F2077.
  • Reported Device Performance: Mechanical testing was performed on "worst case FortiCore® devices" according to ASTM F2077. The results "demonstrate that the FortiCore device performance is substantially equivalent to the predicate devices."

The following points refer to information typically found in studies for AI/ML devices, which are not present in this document as it's for a physical intervertebral fusion device, not a diagnostic AI/ML algorithm.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical FortiCore® devices subjected to mechanical testing, not a dataset of patient images or clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement, not expert opinion.
4. Adjudication method: 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 for a physical implant, not an AI assistance tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For this device, the "ground truth" for performance is compliance with mechanical testing standards (ASTM F2077) and comparison to predicate devices, demonstrating substantial equivalence in physical performance.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.

When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade I spondylolisthesis or retrolisthesis at the involved spinal level(s). Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

When used as a cervical intervertebral body fusion device, FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.

When used as a lumbar intervertebral body fusion device, FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

The Nanovis Intervertebral Body Fusion and FortiCore® Systems include PLIF implants and related instruments for implantation. The upper and lower aspects of the implants from both systems are open and have a central column to be packed with autogenous bone graft. The FortiCore® implants have an integrated titanium scaffold which assists in securing the implant in the intervertebral space. The PLIF devices from both systems are available in a variety of shapes and sizes to accommodate the individual patient anatomy. The Nanovis Intervertebral Body Fusion System and FortiCore® PLIF implants are offered as sterile.

The provided text describes a 510(k) premarket notification for the Nanovis Intervertebral Body Fusion System and FortiCore®. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance as would be expected for a novel AI/medical device.

Therefore, many of the requested categories related to AI/algorithm performance and clinical study details are not applicable to this submission. This is a common characteristic of 510(k) submissions for devices that are evolutionary rather than revolutionary, where the primary goal is to show similarity to existing, legally marketed products.

Here's the information extracted and, where applicable, noted as "N/A" for "Not Applicable" given the context of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified in terms of number of actual device units tested, but references "dimensional analyses of the modified Nanovis Intervertebral Body Fusion and FortiCore® devices".
• Data Provenance: N/A for clinical data, as this is a mechanical and material performance study, not a clinical trial. The study was conducted by the manufacturer to demonstrate substantial equivalence.

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

• N/A. Ground truth in this context refers to mechanical and material standards (ASTM and ANSI/AAMI), not expert clinical consensus.

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

• N/A. This is a technical performance study against specified standards, not a clinical study requiring human reader 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

• N/A. This document pertains to an intervertebral body fusion device, not an AI-assisted diagnostic or therapeutic tool.

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

• N/A. This document pertains to an intervertebral body fusion device, not an AI/algorithm-based device.

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

• The ground truth relies on established engineering standards (ASTM F2077 for mechanical testing, ANSI/AAMI ST-72:2011 for bacterial endotoxin testing) and comparison to the characteristics of legally marketed predicate devices.

8. The sample size for the training set

• N/A. No training set is relevant for this type of mechanical and material characteristics study.

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

• N/A. No training set is relevant for this type of mechanical and material characteristics study.

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When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System and FortiCore® are intended for spinal fusion procedures in skeletally mature patients with disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. The Nanovis Intervertebral Body Fusion System and FortiCore® implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.

When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System and FortiCore® are intended for spinal fusion procedures in skeletally mature patients with disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and or may have up to Grade 1 spondylolisthesis at the involved spinal level(s). The Nanovis Intervertebral Body Fusion System and FortiCore® implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

The Nanovis Intervertebral Body Fusion System and FortiCore® consist of implants and related instruments for implantation. The upper and lower aspects of the implants from both systems are open and have a central column to be packed with autogenous bone graft. The FortiCore® implants have an integrated titanium scaffold which assists in securing the implant in the intervertebral space. The devices from both systems are available in a variety of shapes and sizes to accommodate the individual patient anatomy.

This document is a 510(k) summary for the Nanovis Intervertebral Body Fusion System and FortiCore®. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to predicate devices. However, it does not contain a typical study design with acceptance criteria and performance metrics for an AI/ML device.

Instead, the performance data section describes engineering analyses for a physical medical device. Therefore, I cannot provide the information requested in your prompt as it pertains to an AI/ML device study.

Here's a breakdown of what the document does provide regarding performance and criteria for this non-AI/ML device:

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

The document describes performance data for the physical device, not an AI/ML algorithm.

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. The performance data section refers to "finite element and dimensional analyses" and a "Bacterial Endotoxins Test (BET)," which are engineering and laboratory tests, not clinical studies with human patient data or test sets in the context of AI/ML.

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. This is not an AI/ML study involving expert interpretation of data to establish ground truth.

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

Not applicable. This is not an AI/ML study involving adjudication of human or algorithmic outputs.

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, and therefore no MRMC study comparing human readers with and without AI assistance was performed.

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

Not applicable. This is a physical intervertebral body fusion system, not a software algorithm.

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

For the engineering analyses, the "ground truth" would be established by validated engineering principles and test standards. For the Bacterial Endotoxins Test, the "ground truth" is meeting the specified endotoxin limits as defined by ANSI/AAMI ST72.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set in this context.

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

Not applicable. This is not an AI/ML device; there is no training set ground truth to establish.

In summary: The provided document is for a physical medical device (intervertebral body fusion system) and the performance data presented relates to engineering analyses and laboratory testing, not the evaluation of an AI/ML algorithm. Therefore, many of the questions are not applicable to the content of this specific document.

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When used as a cervical intervertebral body fusion device, FortiCore™ is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore™ devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, FortiCore™ is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). FortiCore™ devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

FortiCore™ consists of implants and instruments for implantation.
The upper and lower aspects of the implant are open and have an integrated titanium scaffold which assists in securing the implant in the intervertebral space. The devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided document is a 510(k) premarket notification for a medical device called FortiCore™. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specified acceptance criteria and performance metrics. Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study design, expert involvement, or sample sizes related to clinical performance.

The "Performance Data" section (page 4) refers to mechanical testing of the device, not a study of its clinical performance in patients.

Here's a breakdown of what can be extracted from the document and why other information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated for clinical performance. The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing.
• Reported Device Performance: The document states: "The mechanical test results demonstrate that the FortiCore device performance is substantially equivalent to the predicate devices."
  • Mechanical Tests Performed:
    • Static and dynamic compression (according to ASTM F2077)
    • Static and dynamic torsion (according to ASTM F2077)
    • Subsidence testing (according to ASTM F2267)
    • Shear and tension testing (according to ASTM F1044 and F1147, respectively) to evaluate the metal-polymer interface.

This document does not contain information about:

2. Sample size used for the test set or its data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance. This is a medical implant, not an AI/software device.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

Reason for Missing Information:

The document is a 510(k) submission to the FDA. The primary purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" in terms of its intended use and technological characteristics to a legally marketed "predicate" device. This typically involves:

• Comparing indications for use.
• Comparing technological characteristics (materials, design, performance specifications).
• Conducting non-clinical performance testing (like the mechanical tests mentioned here) to show the new device performs at least as well as the predicate for relevant characteristics.

A 510(k) does not typically require extensive clinical trials with human subjects, setting acceptance criteria for clinical performance metrics (like sensitivity/specificity for diagnostic devices or specific clinical outcomes for therapeutic devices), or rigorous ground truth establishment as would be seen in studies designed to prove de novo safety and effectiveness or for AI/ML device evaluations. The mechanical testing described here is to ensure the device's physical properties are safe and comparable to established devices.

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The Nanovis Spinal System is intended for posterior, non-cervical (i.e., T1-S1) pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

The Nanovis Spinal System consists of rods, hooks, monoaxial and polyaxial screws with set screws, and crosslinks with fastening set screws. Rods are available either straight or pre-contoured in a variety of lengths. Hooks are offered in a variety shapes and sizes. Solid and cannulated monoaxial and polyaxial screws are available in standard and reduction versions in a variety of diameter-length combinations to accommodate differing patient anatomy.

The Nanovis Spinal System is a medical device and its approval is based on a demonstration of substantial equivalence to predicate devices rather than the typical performance study structure found in AI/ML device submissions. Therefore, many of the requested categories related to human-AI performance, sample sizes for training/test sets, and ground truth establishment are not applicable.

Here's the information extracted from the provided text regarding the Nanovis Spinal System:

Acceptance Criteria and Device Performance

The acceptance criteria for the Nanovis Spinal System are based on demonstrating mechanical performance that is "as well as or better than the predicate device" through ASTM F1717 testing.

Study Proving Device Meets Acceptance Criteria

The study conducted was a mechanical testing study performed according to ASTM F1717.

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

   • Sample Size: Not explicitly stated as a number of samples in the classic sense (e.g., cases, images). The testing refers to "the worst case Nanovis construct." This implies that specific configurations of the device were chosen for testing, likely representative samples of the manufactured components.
   • Data Provenance: Not applicable in the context of clinical data. This refers to mechanical testing performed on physical prototypes/products.

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

   • Not applicable. Mechanical testing uses engineering standards (ASTM F1717) and physical measurements as the 'ground truth,' not expert clinical opinion.

3. Adjudication method for the test set:

   • Not applicable. Adjudication is relevant for subjective assessments, typically in clinical studies or image review. Mechanical tests yield objective, quantifiable results.

4. 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. This is a mechanical device, not an AI/ML diagnostic or assistive tool.

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

   • Not applicable. This refers to a physical medical device (spinal implant system).

6. The type of ground truth used:

   • The "ground truth" for this device's performance evaluation was established by the specified mechanical testing protocols and acceptance criteria of ASTM F1717. This standard defines the methods for assessing the static and fatigue properties of metallic spinal implant constructs.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling.

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

   • Not applicable. As above, there is no "training set" in this context.

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When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.

When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

The Nanovis Intervertebral Body Fusion System consists of implants (cages) and related instruments intended to be used for intervertebral body fusion procedures involving the cervical (C2 - T1) and lumbar (L2 - S1) spine. The cages are available in a variety of shapes and sizes to accommodate the individual anatomic and clinical circumstances of each patient, and are available in two materials: polyetheretherketone (PEEK) and titanium alloy (Ti-6AI-4V ELI).

The provided text is a 510(k) Summary for the Nanovis Intervertebral Body Fusion System. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study report detailing clinical performance and acceptance criteria for a novel device against predetermined benchmarks.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance defined in terms of clinical accuracy metrics (e.g., sensitivity, specificity for a diagnostic device).
• Details about a "test set" for performance evaluation against ground truth (e.g., sample size, data provenance).
• Information on "experts" establishing ground truth or adjudication methods.
• A "multi-reader multi-case (MRMC) comparative effectiveness study" or its effect size.
• A "standalone (algorithm only without human-in-the-loop performance)" study.
• The "type of ground truth used" in the context of device performance metrics.
• Training set sample size or how ground truth was established for a training set.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Intended Use: The Nanovis system has the same intended use as the predicate devices for spinal fusion.
• Technological Characteristics: The device is made of the same materials (PEEK and titanium alloy), has similar overall shapes, and encompasses the same range of physical dimensions as the predicate devices.
• Performance Testing: While performance testing was done, it was focused on mechanical testing against engineering standards to confirm that the device's physical properties are comparable to the predicates, not on clinical performance metrics. The standards mentioned are:
  • ASTM F2077 (static and dynamic axial compression, and static and dynamic torsion)
  • ASTM F2267 (subsidence)
  • Draft standard ASTM F04.25.02.02 (expulsion)

The document explicitly states: "Any differences in technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy." This is the core argument for 510(k) clearance, not the achievement of specific clinical performance acceptance criteria.

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