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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.

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Intervertebral Body Fusion Device: The Atlas Spine Spacer is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 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) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Atlas Spinc 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 (TI-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of turnors 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 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 Spacer is a rectangular, radiolucent device in various sizes. 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) summary describes a medical device, the Atlas Spine Spacer, which is an intervertebral body fusion device and a vertebral body replacement. It is a traditional medical device, not an AI/ML software device. Therefore, the questions related to AI/ML software performance criteria, ground truth establishment, sample sizes for training/test sets, and expert involvement are not applicable here.

The document indicates that the device's acceptance criteria and performance were established through pre-clinical data per ASTM F2077, demonstrating substantial equivalence to previously cleared devices.

Here's a breakdown of the provided information, focusing on the relevant parts for a non-AI/ML device:

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)

• Not Applicable (N/A) for an AI/ML device. The performance data cited is pre-clinical (likely mechanical and material testing), not related to clinical or imaging test sets.

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 (N/A) for an AI/ML device. Ground truth for device performance is established through engineering and material testing standards (ASTM F2077), not expert consensus on diagnostic interpretations.

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

• Not Applicable (N/A) for an AI/ML device. Adjudication methods are typically for clinical diagnostic outcomes or image interpretation, not for mechanical device performance.

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 (N/A). This refers to AI/ML software studies. The Atlas Spine Spacer is a physical implant.

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

• Not Applicable (N/A). This refers to AI/ML software studies.

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

• For the physical device, the "ground truth" for demonstrating performance is derived from engineering and material testing standards (ASTM F2077), ensuring the device meets predefined mechanical and material properties necessary for its intended use and is comparable to predicate devices. This is not a clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

• Not Applicable (N/A). This refers to AI/ML software development.

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

• Not Applicable (N/A). This refers to AI/ML software development.

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