Search Results

Intervertebral Body Fusion Device: The Atlas Spine Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Vertebral Body Replacement: When used as a vertebral body replacement, the Atlas Spine Spacer 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 Spacer is also indicated for treating fractures of the thoracic and lumbar spine.

The Atlas Spine Spacer 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 Spacer can be packed with autograft and/or allograft. 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 Spacer is a rectangular, radiolucent device provided in various sizes. The device design includes six radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.

The provided text describes a 510(k) premarket notification for the Atlas Spine Spacer, a medical device. However, it does not contain information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria in the way a diagnostic AI device submission would.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared devices. It states:

• "The Atlas Spine Spacer was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function and material."
• "Pre-clinical data per ASTM F2077 have been submitted to characterize the Atlas Spine Spacer."

This is typical for a 510(k) submission where the primary goal is to show that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific clinical endpoints or diagnostic accuracy metrics with a comprehensive study involving human subjects and ground truth.

Therefore, I cannot provide the requested table and details because the information is not present in the given text. The document indicates pre-clinical data per ASTM F2077 was submitted, which would involve mechanical testing to characterize the device's physical properties, but not performance in a clinical diagnostic sense.

Ask a specific question about this device

The Atlas Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Atlas Spine Pedicle Screw System is a titanium alloy (6Al-4V ELI per ASTM F136) device consisting of a variety of non-sterile, single use components. The system consists of an assortment of polyaxial and monoaxial screws, cross connectors, rods, collar assemblies, offset receptacle bases and straight receptacle bases.

The provided document is a 510(k) summary for the Atlas Spine Pedicle Screw System. It describes a medical device, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain any information about acceptance criteria, device performance, a specific study proving acceptance criteria, sample sizes, ground truth establishment, or expert involvement for AI/device performance assessment.

The "Performance Data" section merely states: "Data were submitted to characterize the Atlas Spine Pedicle Screw System." without providing any details of what that data was or what it showed. This suggests the data primarily related to mechanical testing to ensure the device met engineering standards rather than clinical performance based on a study with a test set, ground truth, or human-in-the-loop assessments as typically found for AI/imaging devices.

Therefore, I cannot fulfill the request for a table of acceptance criteria and device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or details on training/test sets and ground truth. This type of information is not present in the provided 510(k) summary.

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