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.

Device Description

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.

AI/ML Overview

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.

Summary

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January 13, 2023

Bright Spine % Bahram Parvinian Founder & Principal Consultant Lighthouse Regulatory Consulting Group 5801 Nicholson Lane, Apt. 1705 North Bethesda, Maryland 20852

Re: K221542

Trade/Device Name: Galileo Vertebral Body Replacement Device Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR Dated: December 14, 2022 Received: December 19, 2022

Dear Bahram Parvinian:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Katherine D. Kavlock -S

for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K221542

Device Name

Galileo Vertebral Body Replacement Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared	May 5, 2022
Submitted By	Bright Spine LLCRobert Simonsont 561-289-9378r@brightspine.com
Primary Contact	Bahram Parvinian PhD,Founder and Principal ConsultantLighthouse Regulatory Consulting Group LLC(301)938-7669Bahram@lighthouseregulatory.com
Trade Name	Galileo Vertebral Body Replacement Device
Common Name	Vertebral body replacement device
ClassificationName	Spinal intervertebral body fixation orthosis
Class	II
Product Code	PLR
CFR Section	21 CFR section 888.3060
Device Panel	Orthopedic
PrimaryPredicate Device	Galileo Vertebral Body Replacement Device (K192145)
DeviceDescription	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 ofvarious sizes to allow for the placement of bone graft and for the free flow of cellsbetween the bone graft and the bone of the patient. It is intended for partial vertebralbody replacement in a single vertebra and to hold bone graft material.
Materials	Titanium (Ti-6A1-4V)
Intended Use	Partial cervical vertebral body replacement

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SubstantialEquivalenceClaimed toPredicate Device	Galileo VBR is substantially equivalent to the predicate device in terms of intendeduse, design, materials used, mechanical safety and performances.
Indications for Use	When used as a single-level vertebral body replacement device, the Galileo™devices are indicated for use in the cervical spine (C2-T1) of skeletally maturepatients for the partial replacement (i.e., partial vertebrectomy) of a vertebral bodyresected or excised for the treatment of tumors, or trauma/fracture, or osteomyelitis,or to achieve decompression of the spinal cord and neural tissues in cervicaldegenerative disorders. The device is intended for use with autograft or allogenicbone graft comprising cancellous and/or corticocancellous bone graft. When theGalileo™ device is used as a single-level, partial vertebral body replacement device,supplemental fixation may be used
Summary of thetechnologicalcharacteristicscompared topredicate	Galileo VBR has the same intended use and Indications For Use as K192145. TheGalileo VBR includes four additional sizes:
	A (width) B (height) C (depth) 7 mm 7 mm 12 mm 8 mm 8 mm 12 mm 9 mm 9 mm 12 mm 10 mm 10 mm 12 mm
	There were no changes made to the device design, materials, or manufacturingmethod.
Non-clinical TestSummary	Mechanical performance tests were conducted following the ASTM F2077 (Testmethods for intervertebral body fusion devices). All tests were passed.
Clinical TestSummary	Not Applicable
SE conclusion	The intended use and technological characteristics of Galileo VBR is the sameas the identified predicate. The Galileo VBR has additional sizes compared tothe predicate; however, these new device sizes do not result in new questionsof safety and effectiveness. Based on the required design verification andvalidation activities, Galileo VBR is substantially equivalent to the identifiedpredicate.

Regulation Number and Section

§ 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.