Search Results

The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.

The Atlas Spine VBR 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 of time. The interior of the Atlas Spine VBR can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The Atlas Spine VBR is generally rectangular in shape with anterior and posterior walls that are concentric arcs. The device is available in various sizes with an anterior height ranging from 10mm to 18mm and anterior width of 28mm while providing 0 or 5 degrees of lordosis. The posterior aspect is tapered, or bulleted, for ease of insertion. All devices are 20.0mm in length. The device design includes four radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.

This document describes a 510(k) premarket notification for the Atlas Spine Vertebral Body Replacement (VBR) device. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials or detailed performance studies to establish acceptance criteria for novel device performance.

Therefore, many of the requested elements for a study proving device performance (such as acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not typically present or required in a 510(k) submission for a device demonstrating substantial equivalence. The primary "study" is often a comparison of the new device's design, materials, and intended use against a legally marketed predicate device.

Based on the provided text, here's what can be extracted and what cannot:

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

This information is not provided in the document. A 510(k) for substantial equivalence usually doesn't specify new, quantifiable acceptance criteria for device performance beyond meeting the characteristics of the predicate device. The "performance" demonstrated is that the device is 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):

This information is not provided because a specific "test set" in the context of a new performance study (e.g., clinical trial) is not described. The submission relies on a comparison to a predicate device.

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. Ground truth established by experts is not relevant in this 510(k) context.

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

This information is not provided.

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 information is not provided. An MRMC study is not relevant to this type of device and submission. The device is a physical spinal implant, not an AI diagnostic tool.

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

This information is not provided. This refers to AI algorithms, which is not applicable here.

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

This information is not provided.

8. The sample size for the training set:

This information is not provided. Training sets are generally associated with machine learning models, which are not applicable to this physical device submission.

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

This information is not provided.

Summary of what is present in the document relevant to how the device meets "acceptance criteria" (understood here as "criteria for substantial equivalence"):

The document argues that the Atlas Spine VBR meets the acceptance criteria for substantial equivalence through a comparison to its predicate device, Atlas Spine Vertebral Body Replacement (K063464).

Here's how the "study" (the 510(k) submission) proves the device meets these criteria:

• Intended Use: The intended use of the Atlas Spine VBR is directly compared and found to be "substantially the same" as the predicate device. Both are for use in the thoracolumbar spine (T1-L5) for partial or complete replacement of a diseased vertebral body (tumors, fractures) to achieve decompression, restore height, and maintain biomechanical integrity. Both are intended to be used with supplemental spinal fixation systems and packed with bone.
• Design: The device's design (generally rectangular, anterior and posterior walls with concentric arcs, various sizes: 10mm-18mm anterior height, 28mm anterior width, 0 or 5 degrees lordosis, 20.0mm length, tapered posterior aspect, four radiopaque markers) is presented and compared against the predicate as being "substantially the same" in design principles.
• Materials: Both the subject device and the predicate devices are made from implantable PEEK (polyetheretherketone) polymer, establishing material equivalence.
• Functional Characteristics: It is stated that the "functional characteristics... are substantially the same." Both systems provide support after resection/removal of a damaged/collapsed/unstable vertebral body and are complemented by supplemental internal fixation.

Conclusion from the document:

The FDA reviewed the 510(k) submission (K071497) and determined that the Atlas Spine Vertebral Body Replacement is substantially equivalent to legally marketed predicate devices, thereby allowing it to be marketed. This determination implies that the device "meets the acceptance criteria" as defined by the 510(k) process for substantial equivalence.

Ask a specific question about this device

The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.

The Atlas Spine VBR 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 of time. The interior of the Atlas Spine VBR can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The Atlas Spine VBR is a rectangular, radiolucent vertebral body replacement device designed to replace, in whole or in part, a thoracic or lumbar vertebral body after complete or partial vertebrectomy.

The device design includes four radiopaque markers, two on the superior surface and two on the inferior surface, in opposing corners, that allow postoperative radiographic confirmation of the device position and orientation.

This 510(k) premarket notification for the Atlas Spine Vertebral Body Replacement (VBR) does not describe a study involving acceptance criteria and device performance in the way typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices. This is a common pathway for medical devices that are similar in design, materials, and intended use to products already on the market.

Therefore, many of the requested categories (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, there are no explicit "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for an AI algorithm. The primary "acceptance criterion" for this 510(k) was that the device demonstrates substantial equivalence to predicate devices, meaning it has similar intended use, design, materials, and functional characteristics.

The "reported device performance" is framed in terms of its similarity to predicates:

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 submission did not involve a "test set" of data for performance evaluation in the context of an AI algorithm. Substantial equivalence is determined through a comparison of the device's characteristics to those of predicate devices.

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. No "ground truth" was established by experts in the context of a dataset for performance evaluation. The FDA reviewed the company's detailed comparison of its device to predicates to determine substantial equivalence.

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

Not applicable. No "test set" or adjudication method was used for performance evaluation.

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 implantable device, not an AI/software device. There were no "human readers" interpreting data with or without AI assistance.

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

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

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

Not applicable. The "ground truth" for this type of submission is essentially the legally marketed predicate devices and their known characteristics, safety, and effectiveness. The FDA's determination of substantial equivalence relies on comparing the new device's features, materials, and intended use against these established predicates.

8. The sample size for the training set

Not applicable. This is a physical implantable device; it does not involve a training set for an algorithm.

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

Not applicable. See point 8.

Ask a specific question about this device

The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectorny) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.

The Atlas Spine VBR 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 of time. The interior of the Atlas Spine VBR can be packed with bone. The device must be used with supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5).

The Atlas Spine VBR is a rectangular, radiolucent vertebral body replacement device designed to replace, in whole or in part, a thoracic or lumber vertebral body after complete or partial vertebrectomy.

The device design includes radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.

The provided text is a 510(k) summary for the Atlas Spine Vertebral Body Replacement device, which is a medical implant. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study design for performance evaluation.

Therefore, the document does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria as typically expected for a diagnostic AI/ML device or a device requiring new clinical performance data.

The device, the Atlas Spine Vertebral Body Replacement (VBR), is a physical implant, not a diagnostic or AI-driven system. Its clearance is based on substantial equivalence to predicate devices. This means that its safety and effectiveness are established by demonstrating that it is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

Here's a breakdown based on the categories you requested, highlighting why most of the information is not applicable to this type of submission:

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

   • N/A. The submission does not define specific performance acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, etc., nor does it report performance in that manner. The "performance" is implicitly deemed equivalent to the predicate devices through design, material, and intended use comparison.

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

   • N/A. There is no "test set" in the context of evaluating performance for a new diagnostic algorithm or a device requiring specific clinical performance data. The device's safety and effectiveness are assessed through its substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • N/A. No ground truth establishment by experts is described as this is not a diagnostic device and no new clinical performance study requiring such ground truth is mentioned.

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

   • N/A. Not applicable, as there is no test set or clinical performance study described.

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 device is a physical spinal implant, not an AI-assisted diagnostic tool.

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

   • N/A. This device is a physical spinal implant, not an algorithm.

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

   • N/A. No ground truth is established or used in this submission beyond the demonstration that the device's design, materials, and intended use are substantially equivalent to a predicate device.

8. The sample size for the training set:

   • N/A. This is not an AI/ML device, so there is no training set mentioned or applicable.

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

   • N/A. Not applicable, as there is no training set.

In summary, the provided 510(k) summary for the Atlas Spine Vertebral Body Replacement device focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than presenting a performance study with acceptance criteria, test sets, or ground truth as would be relevant for a diagnostic or AI-driven medical device undergoing a different type of review.

Ask a specific question about this device