The GALILEO™ Spine Alignment Monitoring System is intended to provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes.

The GALILEO™ Spine Alignment Monitoring System is indicated for patients undergoing orthopedic spine surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid spinal anatomical structure, such as a vertebral body, can be identified relative to the anatomy. The system aids the surgeon in controlling spinal sagittal alignment.

Example spine surgical procedures include:

Spinal deformity correction
Spinal fusion

Device Description

The GALILEO™ Spine Alignment Monitoring System provides intra-operative real-time measurement of sagittal plane spine alignment parameters such as Lordosis and Kyphosis. The system consists of Orientation Sensing Modules (OSM) that are attached to vertebrae of interest with the patient in prone position. The OSM's are battery-powered devices containing inertial sensors that measure vertebral alignment changes and communicate the information wirelessly to a computer. The computer software calculates sagittal plane spinal alignment parameters in real-time based on the OSM measurements and displays the information on a touch screen tablet.

AI/ML Overview

The provided text describes the GALILEO™ Spine Alignment Monitoring System, but it does not contain the specific details regarding acceptance criteria and the comprehensive study results that would be necessary to fully answer your request.

Here's an analysis of what information is available and what is missing:

Information Present:

Device Name: GALILEO™ Spine Alignment Monitoring System
Intended Use/Indications for Use: To provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes, during orthopedic spine surgery (e.g., spinal deformity correction, spinal fusion) to aid in controlling spinal sagittal alignment.
Types of Performance Data Performed:
1. Performance tests under simulated bench conditions to verify software algorithms and overall system accuracy for calibration, sagittal plane registration, vertebral registration, and sagittal plane spine alignment measurements.
2. Simulated use testing (sawbones and cadaver) to verify and validate overall system performance and compare measurements with clinically accepted standardized radiographic measurements.
3. Electrical, electromagnetic compatibility, and wireless telecommunication tests (IEC 60601-1-2, FCC 47 CFR part 15).
4. Software tests for functionalities and features.
5. Biocompatibility testing (using materials with established biocompatibility).
6. Sterilization and packaging validation (ISO 14937, ISO 11607 for SAL of 10-9).

Missing Information (Crucial for your request):

Specific Acceptance Criteria: While performance tests are mentioned, the actual numerical or qualitative acceptance criteria are not provided. For example, what was the acceptable margin of error for sagittal plane alignment measurements?
Reported Device Performance (Quantitative): The document states that "The results demonstrated that the GALILEO™ Spine Alignment Monitoring System satisfied all user needs and intended use requirements," but it does not provide the actual measured performance values (e.g., accuracy, precision) from the tests.
Sample Size for Test Set: The number of sawbones or cadaver specimens used for simulated use testing is not specified.
Data Provenance (Country, Retrospective/Prospective): Not mentioned for any of the performance data.
Number of Experts & Qualifications for Ground Truth: Not mentioned.
Adjudication Method: Not mentioned.
MRMC Comparative Effectiveness Study: The document does not describe any study comparing human readers with and without AI assistance, nor does it mention an effect size.
Standalone Performance Study: While "Performance tests were performed...to verify the implementation of the software algorithms and overall system accuracy," it's not explicitly stated as a standalone performance study with detailed results for the algorithm only.
Type of Ground Truth Used: The text mentions comparing system measurements with "clinically accepted standardized radiographic measurements" for simulated use testing, which implies an external reference standard. However, the exact nature (e.g., expert consensus on radiographs, direct physical measurements) is not fully elaborated.
Sample Size for Training Set: Not mentioned. The device is described as having "inertial sensors" and "computer software calculates sagittal plane spinal alignment parameters," suggesting an algorithm, but training data details are absent.
How Ground Truth for Training Set Was Established: Not mentioned.

Based on the available information, here's what can be provided with the significant gaps highlighted:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric/Test	Acceptance Criteria	Reported Device Performance
System Accuracy (Bench testing)	Not specified in document	"verified the implementation of the software algorithms and overall system accuracy"
Overall System Performance (Simulated use)	Not specified in document	"satisfied all user needs and intended use requirements" and "compare system measurements with clinically accepted standardized radiographic measurements"
Software Functionality	Not specified in document	"ensure that the required functionalities and features were implemented without the introduction of hazardous anomalies"
Electrical, EMC, Wireless	Compliance to IEC 60601-1-2 and FCC 47 CFR part 15	"demonstrate compliance to IEC 60601-1-2, and FCC 47 CFR part 15"
Biocompatibility	Using materials with established biocompatibility	"achieved by using materials with established biocompatibility"
Sterilization & Packaging	Compliance with ISO 14937 and ISO 11607 to ensure a SAL of 10-9	"performed for single-use components in compliance with ISO 14937 and ISO 11607 to ensure a SAL of 10-9 over the shelf life of the product."

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

Test Set Sample Size: Not specified. The document only mentions "simulated use testing involving sawbones and cadaver specimen." The number of sawbones or cadavers is not provided.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
- Implicit: The ground truth for simulated use testing was compared to "clinically accepted standardized radiographic measurements," implying that these measurements would typically be interpreted or confirmed by radiology or orthopedic specialists, but the specific role and number of experts are not detailed.

4. Adjudication method for the test set

Adjudication Method: Not specified.

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

MRMC Study: No, the document does not describe a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance. The device is described as providing intra-operative measurements to a surgeon, not as an AI-assisted diagnostic tool for human readers in the traditional sense of image interpretation.

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

Standalone Performance: Yes, in part. The "Performance tests were performed under simulated bench test conditions to verify the implementation of the software algorithms and overall system accuracy covering all functional steps." These tests would likely assess the algorithm's performance in isolation from a human surgeon interacting with it, focusing on the accuracy of the measurements it produces. However, quantitative results of this standalone accuracy are not provided.

7. The type of ground truth used

For the simulated use testing, the ground truth was "clinically accepted standardized radiographic measurements." This suggests that the device's output was compared against established radiographic parameters that are considered the standard.

8. The sample size for the training set

Training Set Sample Size: Not specified. The document describes the device as containing "inertial sensors that measure vertebral alignment changes and communicate the information wirelessly to a computer. The computer software calculates sagittal plane spinal alignment parameters," implying an algorithm, but details about training data are absent.

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

Ground Truth for Training Set: Not specified.

Summary

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June 15, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

MiRus, LLC Jordan Bauman Director of Regulatory Affairs and Quality 2150 Newmarket Parkway Suite 108 Marietta, Georgia 30067

Re: K182524

Trade/Device Name: GALILEO Spine Alignment Monitoring System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO

Dear Jordan Bauman:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 17, 2019. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shumaya Ali, M.P.H., OHT6: Office of Orthopedic Devices, (301) 796-2356, Shumaya.Ali(@fda.hhs.gov.

Sincerely,

Jesse Muir -S

For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 18, 2019

MiRus, LLC Jordan Bauman Director of Regulatory Affairs and Ouality 2150 Newmarket Parkway Suite 108 Marietta, Georgia 30067

Re: K182524

Trade/Device Name: GALILEO Spine Alignment Monitoring System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 13, 2019 Received: May 16, 2019

Dear Jordan Bauman:

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.

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

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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.

Jesse Muir-S

For; Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

See PRA Statement below.

510(k) Number (if known)

K182524

Device Name

GALILEO™ Spine Alignment Monitoring System

Indications for Use (Describe)

Example spine surgical procedures include:

Spinal deformity correction
Spinal fusion

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)
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510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

I. SUBMITTER	MiRus, LLC2150 Newmarket ParkwaySuite 108Marietta, Georgia 30067Tel: (844) 367-0078Fax: (844) 367-2348
II. OFFICIAL CORRESPONDENT	Jordan BaumanDirector of Regulatory Affairs and QualityMiRus, LLC2150 Newmarket ParkwaySuite 108Marietta, Georgia 30067Tel: (844) 367-0078Fax: (844) 367-2348
III. DATE PREPARED	May 13, 2019
IV. DEVICE
Name of DeviceCommon NameClassification NameRegulatory ClassProduct CodesSubmission Type	GALILEO™ Spine Alignment Monitoring SystemOrthopedic Stereotaxic Instrument21 CFR §882.4560Class IIOLOTraditional 510(k)
V. PREDICATE DEVICE	Primary:Intellijoint HIP™ System (K133759)Reference:Zimmer iASSIST® Knee System (K122326)

VI. DEVICE DESCRIPTION

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VII. INTENDED USE/ INDICATIONS FOR USE:

Example spine surgical procedures include:

Spinal deformity correction
Spinal fusion

VIII. TECHNOLOGICAL COMPARISONS TO THE PREDICATE

Both the predicate and subject devices provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components. Differences in tracking technology between the subject and predicate do not raise any new questions of safety and effectiveness. The reference device - iASSIST® Knee System (K122326) - is a legally marketed device that utilizes similar battery-powered inertial sensing technology as the subject device to track the orientation of instruments and anatomy.

IX. PERFORMANCE DATA

The following performance data supports the safety and substantial equivalence of the GALILEO™ Spine Alianment Monitoring System.

1. Performance tests were performed under simulated bench test conditions to verify the implementation of the software algorithms and overall system accuracy covering all functional steps including: calibration, sagittal plane registration, vertebral registration, and sagittal plane spine alignment measurements.
1. Simulated use testing involving sawbones and cadaver specimen were performed to verify and validate the overall system performance and to compare system measurements with clinically accepted standardized radiographic measurements. The results demonstrated that the GALILEO™ Spine Alignment Monitoring System satisfied all user needs and intended use requirements.
1. Electrical, electromagnetic compatibility, and wireless telecommunication tests were performed to demonstrate compliance to IEC 60601-1-2, and FCC 47 CFR part 15.
1. Software tests were performed to ensure that the required functionalities and features were implemented without the introduction of hazardous anomalies.
1. Biocompatibility was achieved by using materials with established biocompatibility for characteristics for all patient contacting instruments and components.
1. Sterilization and packaging validation tests were performed for single-use components in compliance with ISO 14937 and ISO 11607 to ensure a SAL of 10-9 over the shelf life of the product.

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X. CONCLUSION

Based on the intended use, performance testing, and comparison to the predicate device, the GALILEO™ Spine Alignment Monitoring System has been shown to be substantially equivalent to the legally marketed predicate device and does not present any new questions of safety and effectiveness.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).