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When used as a single-level partial vertebral body replacement device, the Galileo™ devices are indicated for use in the cervical spine (C2-T1) of skeletally mature patients for the partial replacement (i.e., partial vertebrectomy) of a vertebral body resected or excised for the treatment of tumors. or trauma/fracture, or osteomvelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The device is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. When the Galleo ™ device is used as a single-level, partial vertebral body replacement device, supplemental fixation may be used.

The Galileo Vertebral Body Replacement device is a surgical grade titanium (Ti- 6A1-4V) device and is available in various widths and heights. It has openings of various sizes to allow for the placement of bone graft and for the free flow of cells between the bone graft and the bone of the patient. It is intended for partial vertebral body replacement in a single vertebra and to hold bone graft material.

The provided text is a 510(k) premarket notification for the "Galileo Vertebral Body Replacement Device". This document primarily focuses on establishing substantial equivalence to a predicate device based on mechanical performance, rather than evaluating an AI/ML powered device. As such, many of the requested criteria for AI/ML device studies (such as sample sizes for test/training sets, expert ground truth development, MRMC studies, standalone performance, etc.) are not applicable or detailed in this type of submission.

However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets those criteria, specifically for its mechanical performance.

Acceptance Criteria and Device Performance (Mechanical)

Study Details (Mechanical Performance):

• Sample size used for the test set and the data provenance: Not specified in the document. The testing would involve physical samples of the device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is typically defined by established engineering standards (ASTM F2077 in this case) and measured by testing equipment.
• Adjudication method: Not applicable for mechanical tests.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is a mechanical device, not an AI/ML diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
• The type of ground truth used: Mechanical performance standards defined by ASTM F2077.
• The sample size for the training set: Not applicable. This is a mechanical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

Additional Information from the Document:

• Device: Galileo Vertebral Body Replacement Device
• Predicate Device: Galileo Vertebral Body Replacement Device (K192145)
• Reason for new submission (K221542): The Galileo VBR has additional sizes (7mm, 8mm, 9mm, 10mm widths and heights, all 12mm depth) compared to the predicate.
• Changes: No changes were made to the device design, materials, or manufacturing method, only additional sizes were introduced.
• Conclusion: The device is substantially equivalent to the predicate device, and the new device sizes do not raise new questions of safety and effectiveness, based on the required design verification and validation activities (mechanical performance tests). No clinical tests were required or performed for this submission.

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When used as a single-level partial vertebral body replacement devices are indicated for use in the cervical spine (C2-T1) of skeletally mature patial replacement (i.e., partial vertebrectomy) of a vertebral body resected or excised for the treatment of tumors, or traumaffracture, or osteomyelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The device is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. When the Galileo™ device is used as a single-level, partial vertebral body replacement device, supplemental fixation may be used.

The Galileo Vertebral Body Replacement device is a surgical grade titanium (Ti-6A1-4V) device and is available in various widths and heights. It has openings of various sizes to allow for the placement of bone graft and for the free flow of cells between the bone graft and the bone of the patient. It is intended for partial vertebral body replacement in a single vertebra and to hold bone graft material.

The provided document does not describe the acceptance criteria and study that proves a device (Galileo Vertebral Body Replacement Device) meets the acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a physical medical device: a vertebral body replacement. The studies described are non-clinical mechanical performance tests (ASTM F2077 and ASTM F2267) to demonstrate the device's structural integrity and resistance to subsidence and expulsion. These are standard engineering tests for implantable devices, not AI/ML performance evaluation studies.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria, performance, sample sizes, expert ground truth adjudication, MRMC studies, or training set details, as this information is not present in the provided text.

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When used as a cervical intervertebral body fusion device, the Galileo™ Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Galileo™ Spinal Spacer System is to be used with a supplemental fixation system.

The Bright Spine Galileo™ Spinal Spacer System is an implantable device manufactured from titanium alloy

The provided document is a 510(k) summary for the Bright Spine Galileo™ Spinal Spacer System, which is a cervical intervertebral body fusion device. This type of device is an implantable medical device and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance characteristics commonly found in AI/ML device studies.

Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable to this type of traditional medical device submission.

Here's an adaptation of your request based on the available information:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not applicable. This device's performance was evaluated through mechanical testing against ASTM standards and comparison to a predicate device, not through a clinical "test set" of patients or data in the way AI/ML algorithms are.
• Data Provenance: Not applicable. The performance data comes from mechanical testing, not retrospective or prospective patient data from a specific country.

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

• Not applicable. Ground truth, in this context, would be established by the engineering standards themselves (ASTM F2077-03 and ASTM F2267-04) and by the FDA's assessment of substantial equivalence based on the provided technical documentation, not by expert consensus on clinical cases.

4. Adjudication method for the test set

• Not applicable. There was no clinical "test set" requiring adjudication. The assessment was based on comparison to a predicate device and compliance with established engineering standards.

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 no MRMC study was performed.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used

• Ground Truth: For performance, the "ground truth" is defined by the acceptance criteria specified in the ASTM F2077-03 and ASTM F2267-04 standards. For the overall approval, the "ground truth" is the demonstration of substantial equivalence to the predicate device (Alphatec Spine, Inc. Novel® Spinal Spacer System K081730). This is based on material, dimensional, and functional similarity, as well as adherence to performance standards.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, and no training set was used.

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

• Not applicable. This is not an AI/ML device.

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