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The Vertebral Body Replacement (VBR) Spinal Systems are indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The VBR Spinal Systems are also indicated for treating fractures of the thoracic and lumbar spine.

The VBR Spinal Systems 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.

The VBR Spinal Systems are intended for use with DePuy Spine supplemental internal fixation.

The BENGAL System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation products may be used.

The BENGAL System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation products.

The CONCORDE, CONCORDE Inline, CONCORDE Curve, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (CONCORDE, CONCORDE Inline) or TLIF (CONCORDE, CONCORDE Inline, CONCORDE Curve, DEVEX, LEOPARD) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.

The CONCORDE. CONCORDE Inline. CONCORDE Curve. DEVEX. and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems 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. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation products.

The CONCORDE Bullet and COUGAR Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally the CONCORDE Bullet and COUGAR Systems can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF or TLIF approach (CONCORDE Bullet) or an anterior approach (COUGAR) using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products.

The CONCORDE Bullet and COUGAR Systems are indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems 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. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation products.

The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation.

The COUGAR LS Lateral Cage System is also indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Additionally, the COUGAR LS Lateral Cage System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six mon-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and may be implanted via an open or a minimally invasive lateral approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

The DePuy PULSE Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. The DePuy PULSE Cervical Cage System implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. DePuy PULSE Cervical Cage System implants are intended to be used with supplemental internal fixation systems.

The DePuy PULSE Lumbar Cage System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.

The Lumbar I/F Cage System is indicated for an open posterior approach using autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1 whose condition requires the use of interbody fusion combined with posterolateral fusion (360° fusion) and posterior pedicle screw fixation. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The X-MESH Expandable Cage System is designed to restore biomechanical integrity throughout the thoracic and lumbar spine following vertebrectomy or corpectomy for patients with spine tumors or fractures. The system is available in many heights, and different endplate shapes, sizes and angles. The surgeons have the option to place the standard or angled endplates. The spikes on the endplates help anchor the device.

The OCELOT Stackable Cage System consists of one or more stackable vertebral body replacement components and a supplemental internal fixation system. One or more OCELOT Stackable Cage System implants may be stacked to the desired height, as determined by the surgeon. A titanium alloy screw can be passed through a center hole in the cages and with a nut provide a rigid and compressed assembly.

The Stackable Cage System is designed to restore biomechanical integrity throughout the thoracic and lumbar spine following vertebrectomy or corpectomy. A Stackable Cage construct consists of one or more cages that are stacked to the desired height, as determined by the surgeon. Ridges or teeth allow the cages to be assembled, and a locking screw and nut secure the components as a construct.

The Surgical Titanium Mesh System is designed to restore biomechanical integrity throughout the thoracic and lumbar spine following vertebrectomy or corpectomy for patients with spine tumors or fractures. The system consists of various shapes and sizes of mesh, standard or angled rings and screws, endplates, and endcaps. The surgeons have the option to place the standard or angled rings and screws, endplates and endcaps within the mesh. These interface devices may be used to provide increased surface area at the mesh/bone interface, which provides additional support and increased resistance to subsidence.

The BENGAL Stackable Cage System consists of both one piece (monolithic) and twoto three-piece (stackable) vertebral body replacement components and a supplemental internal fixation system that offer a variety of size options to allow surgeons to achieve a desired height. The two- or three-piece (stackable) construct can be assembled from a variety of different sized components. A titanium alloy screw is then passed through a hole in the cages and with a nut provides a rigid and compressed assembly.

The BENGAL, CONCORDE, CONCORDE Bullet, CONCORDE Inline, CONCORDE Curve, COUGAR, DEVEX and LEOPARD Systems consist of polymer/carbon fiber composite or titanium cages and implantation instrumentation. Cages are available in varying shape and size configurations to match patient anatomy. The polymer/carbon fiber cage structure is radiolucent with tantalum x-ray markers so that healing can be assessed by normal radiographic methods. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft.

The DePuy PULSE Cervical Cage System is designed for use as a cervical intervertebral body fusion device and consists of polymer cages and implantation instrumentation. The cages are available in various geometries and sizes to accommodate patient anatomy. The polymer cage structure is radiolucent with tantalum x-ray markers so that healing can be assessed by normal radiographic methods. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft.

The DePuy PULSE Lumbar Cage System is designed for use as a lumbar intervertebral body fusion device and consists of polymer cages and implantation instrumentation. The cages are available in various geometries and sizes to accommodate patient anatomy. The polymer cage structure is radiolucent with tantalum x-ray markers so that healing can be assessed by normal radiographic methods. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft.

The LUMBAR I/F CAGE is made of a polymer/carbon fiber composite material, is radiolucent, and available is two designs: the Jaguar I/F Cage and the Saber I/F Cage. The Jaguar I/F Cage is a rectangular cage with ridged teeth to resist implant pullout. The Saber I/F Cage, also a rectangular cage, has a curved lateral wall and rounded edges with pyramidal teeth to resist implant pullout. Each of these designs has both parallel and wedged configurations.

This document, a 510(k) summary, details the submission for clearance of magnetic resonance compatibility labeling for a multitude of spinal implant systems. It does not contain information about acceptance criteria or a study proving the device meets said criteria related to clinical efficacy or performance beyond MR compatibility. The document is primarily focused on demonstrating substantial equivalence to predicate devices and providing performance data for MR compatibility.

Here's an analysis based on the provided text for what is present regarding MR compatibility:

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

The document does not explicitly provide a table of acceptance criteria and reported device performance in the format requested for general device performance. However, for MR compatibility, it refers to industry standards which implicitly contain acceptance criteria. The "Performance Data" section states that "Results demonstrated compatibility conditions of the subject devices in the MR environment," which serves as the reported performance, indicating the devices met the criteria defined by the listed ASTM standards.

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

The document does not specify the sample size for the test set used for the MR compatibility studies. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. This is typical for preclinical testing data referenced in a 510(k) submission, where the focus is often on adherence to recognized standards rather than clinical trial details.

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)

This information is not applicable to the non-clinical MR compatibility testing described in the document. Ground truth as typically established by experts (e.g., radiologists interpreting images) is not relevant for in-vitro engineering tests like those for MR compatibility.

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

This information is not applicable to the non-clinical MR compatibility testing described in the document. Adjudication methods are relevant for clinical studies involving human interpretation or assessment, not for standardized engineering 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

This is not applicable as the document describes spinal implants (hardware), not an AI-powered diagnostic device or software. Therefore, no MRMC study or AI assistance is mentioned or relevant.

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

This is not applicable as the document describes spinal implants (hardware), not an algorithm or software.

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

For the MR compatibility testing, the "ground truth" would be the biophysical properties and behavior of the devices as measured against the specified ASTM standards. These are objective measurements rather than subjective assessments like expert consensus or pathology. No clinical outcomes data are presented for MR compatibility.

8. The sample size for the training set

This is not applicable as the document describes spinal implants (hardware) and non-clinical testing, not a machine learning model requiring a training set.

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

This is not applicable as the document describes spinal implants (hardware) and non-clinical testing, not a machine learning model requiring a training set.

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The Blackstone Medical Surgical Titanium Mesh System is indicated for use in the thoraco-lumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Surgical Titanium mesh is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. It is recommended to pack bone graft material inside the mesh cage prior to implantation.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Surgical Titanium Mesh System is the Blackstone Medical Spinal Fixation System.

The Blackstone Medical, Inc. Surgical Titanium Mesh System is comprised of a hollow cylindrical tube made from commercially pure (CP) titanium conforming to ASTM F-67. The walls of the tube are perforated with evenly spaced diamond-shaped openings. These openings and the hollow core allow grafting material to be placed inside the device to help achieve solid fusion. Because of the construction, the angle and the length of the mesh can be reduced incrementally to adjust it to individual anatomical conditions. The end rings, standard ring and screws of the device are made of titanium alloy (6AL-4V ELI, per ASTM F136). The end rings, which are placed onto each end of the tube, feature spikes on the exterior sides that help prevent lateral movement of the device.

The provided text is a 510(k) summary for a medical device (Blackstone™ Surgical Titanium Mesh System Angled End Rings) and does not contain information about acceptance criteria or a study proving device performance.

510(k) submissions, particularly for devices like spinal implants, typically demonstrate substantial equivalence to a predicate device rather than conducting new clinical trials or detailed performance studies using AI/software. The "Basis of Substantial Equivalence" section in the document explicitly states this: "The Blackstone™ Surgical Titanium Mesh System Angled End Rings are substantially equivalent to the Blackstone Surgical Titanium Mesh System (K030744), which has been cleared by FDA for use in patients with tumor, trauma or fractures."

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance through substantial equivalence, not on a specific performance study with acceptance criteria for an AI or software component.

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The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).

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The provided text describes the regulatory clearance for the "Surgical Titanium Mesh™ System" as a medical device, focusing on its intended use and general performance data (biomechanical testing). It does NOT contain information about acceptance criteria for device performance, a study to prove it meets those criteria, sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established.

Therefore, most of the requested information cannot be extracted from the given text.

Here's what can be extracted based on the provided document:

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

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. This document pertains to a 510(k) submission for a medical device and typically such submissions detail testing protocols and results, but this specific excerpt doesn't provide those details.

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 as this is a physical medical device (implant) and not related to AI or diagnostic image analysis where expert-established ground truth for a test set would be relevant.

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

• Not applicable for a physical medical device.

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

• Not applicable. This is a physical medical device, not an AI diagnostic tool.

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

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

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

• Not applicable. Performance for this device would be based on engineering and biomechanical standards, not a clinical "ground truth" as typically defined for diagnostic AI. The "performance data" mentioned is biomechanical testing.

8. The sample size for the training set

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

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

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

Ask a specific question about this device

The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX and Profile).

Not Found

The Surgical Titanium Mesh™ System is a medical device and thus does not include AI/ML components for which a test set would be used to establish device performance. The performance data section of the provided text indicates that:

• Biomechanical testing, including static axial compression and dynamic axial compression, were conducted.

Without additional information on acceptance criteria and the specific results of these biomechanical tests, it's not possible to populate the full table or answer all the detailed questions provided in the request. The 510(k) summary focuses on the device's intended use, materials, and substantial equivalence to predicate devices, rather than detailed performance metrics that would be associated with AI/ML diagnostic or predictive tools.

However, I can provide a general structure based on the available information and explicitly state what is missing:

1. 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)

• Sample Size: Not applicable. The "test set" in this context refers to physical prototypes or samples of the device undergoing biomechanical testing, not a dataset for an AI/ML model. The specific number of physical test samples used for static and dynamic axial compression is not stated in the provided text.
• Data Provenance: Not applicable in the traditional sense of clinical data. The tests were biomechanical in nature, likely performed in a lab setting rather than involving human subjects or clinical data in the context of an AI/ML model.

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. As this is a medical device (implant) and not an AI/ML diagnostic tool, external human experts are not typically used to establish "ground truth" for biomechanical tests in the same way they would be for image interpretation or disease diagnosis. The "ground truth" for biomechanical performance is derived from physical measurements and engineering standards.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data (e.g., for AI/ML performance evaluation) by resolving disagreements among human readers. Biomechanical testing relies on objective physical measurements and engineering analysis.

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

• Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are irrelevant to this device.

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

• Not applicable. This device is a physical surgical implant, not an algorithm or software. Its performance is inherent in its physical and mechanical properties.

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

• For biomechanical testing, the "ground truth" is established by engineering standards and physical measurements. For example, the load at which a device fails or deforms beyond a specified limit is an objective physical measurement, not an expert consensus or pathology report.

8. The sample size for the training set

• Not applicable. This device is a physical product, not an AI/ML model that requires a training set.

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

• Not applicable. There is no training set for a physical surgical implant.

Ask a specific question about this device

The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended to be packed inside of the mesh cage prior to implantation.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX and Profile).

Not Found

The provided text describes a medical device, the "Surgical Titanium Mesh™ System," and its intended use, materials, and performance data, as submitted in a 510(k) summary to the FDA. However, the document does not contain the level of detail required to answer all the questions about acceptance criteria and a specific study proving the device meets those criteria, particularly for an AI/algorithm-based device as implied by the questions asking for "standalone" performance, MRMC studies, or training/test set details.

This document describes a physical medical implant, not an AI or software device. Therefore, many of the questions are not applicable to the information provided.

Here's an analysis based on the provided text, addressing what can be answered and clearly stating what cannot:

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

The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics of the device itself. It mentions "Biomechanical testing, including static axial compression and dynamic axial compression," were conducted, and that "Clinical data were provided to demonstrate the performance of the device in patients with spine tumors."

However, no specific numerical acceptance thresholds or the results against those thresholds are provided. The FDA's 510(k) clearance process determined "substantial equivalence" to predicate devices, which implies the device's performance was deemed acceptable relative to established standards for similar devices already on the market.

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 in the 510(k) summary. It only states that "Clinical data were provided."

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)

This information is not provided. The term "ground truth" is typically associated with AI/ML model validation, which is not applicable to a physical implant in this context. The clinical data would have been evaluated by medical professionals as part of standard clinical practice and regulatory review.

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

This information is not provided. Adjudication methods are usually relevant for expert reviews in image analysis or similar diagnostic tasks, not physical device performance in biomechanical or clinical studies as described 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 study was not done, as this is a physical implant, not an AI or diagnostic imaging device that requires 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, as this is a physical implant, not an algorithm or AI.

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

For biomechanical testing, the "ground truth" would be the measured physical properties and fatigue life under specified loads, measured against engineering standards. For clinical data, the "ground truth" would be patient outcomes, such as successful spinal stabilization, fusion (if applicable), pain reduction, neurological improvement, and absence of device-related complications, as documented in medical records. The document only generally states "Clinical data were provided to demonstrate the performance of the device in patients with spine tumors."

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device.

Summary of what is provided in the document related to "acceptance criteria" and "study":

The document states that the performance data included:

• Biomechanical testing: "static axial compression and dynamic axial compression." This testing likely involved established engineering standards for spinal implants to assess their strength and durability. The acceptance criteria would be defined by these standards (e.g., ability to withstand a certain number of load cycles at a specified force without failure, or a minimum static strength). The reported performance would be the results of these tests, demonstrating compliance. However, the specific numerical criteria and results are not detailed in this summary.
• Clinical data: "Clinical data were provided to demonstrate the performance of the device in patients with spine tumors." This data would show the safety and effectiveness of the device in a real-world setting. The acceptance criteria for clinical data would typically involve demonstrating favorable patient outcomes (e.g., spinal stabilization, successful tumor resection with hardware in place, acceptable complication rates) comparable to predicate devices or established treatment methods. Again, specific details of this clinical data or its full methodology are not included in this 510(k) summary.

In conclusion, based solely on the provided text, it is impossible to complete a detailed table of acceptance criteria and reported device performance with specific quantitative figures, nor can most of the questions relating to AI/algorithm development and validation be answered, as the document describes a physical medical implant.

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