(231 days)
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)
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Adherence to ASTM F2077 (Test methods for intervertebral body fusion devices) | All tests were passed. The device demonstrated substantial equivalence to the predicate in terms of mechanical safety and performance. |
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.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.