The EGPS Navigated Instruments are indicated for use during the preparation and placement of Astura Medical screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The EGPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for precisely locating anatomical structures and for the special position of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. Use of the EGPS Navigated Instrument System is limited to use only with the Olympic and Masada spinal fixation systems (Olympic K153446, Olympic MIS K182239, Masada K231694).

Device Description

Astura Medical EGPS Navigated Instruments are non-sterile, reusable instruments including a drill and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of associated Astura Medical screw implants. The instruments are manufactured from stainless steel per ASTM F899.

AI/ML Overview

The provided text is a 510(k) summary for the Astura Medical EGPS Navigated Instruments. It does not describe a study involving an AI/Machine Learning device or a diagnostic device that would have typical acceptance criteria and a study design as outlined in your request.

Instead, this document pertains to a Class II surgical instrument (Stereotaxic Instrument) that is intended for use with a pre-existing robotic navigation platform. The FDA's review for this type of device typically focuses on substantial equivalence to a predicate device, which involves demonstrating similar performance, design, materials, and indications for use.

Therefore, most of the specific points in your request regarding acceptance criteria for device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable to this submission, as it's not a diagnostic AI/ML device.

However, I can extract the relevant information concerning the non-clinical tests that were performed to demonstrate substantial equivalence for this surgical instrument.

Here's the closest interpretation of your request based on the provided text:

Device: EGPS Navigated Instruments

Device Type: Surgical Instrument (Stereotaxic Instrument) for spinal surgery, used with a robotic navigation platform.

Nature of FDA Submission: 510(k) Premarket Notification, seeking substantial equivalence to a predicate device.

Absence of AI/ML Study Data: The document explicitly states "No clinical studies were performed" and the "Non-clinical Test Summary" only lists "Comparative dimensional analysis of subject instruments with predicate." This indicates that the device's acceptance was based on non-clinical engineering and design verification, not on clinical performance metrics typically associated with AI/ML or diagnostic devices.

1. A table of acceptance criteria and the reported device performance

The document does not present specific quantitative acceptance criteria or detailed performance metrics in the format of a clinical performance study for an AI/ML device. Instead, it relies on demonstrating equivalence through design and material comparisons.

Acceptance Criteria Category	Description (as inferred from the document)	Reported Device Performance/Conclusion
Material Equivalence	Materials of construction are equivalent to predicate.	Manufactured from stainless steel per ASTM F899, same as predicate.
Design/Dimensional Equivalence	Dimensions and design should be comparable to the predicate device to ensure compatibility and safe function with the robotic navigation platform.	"Comparative dimensional analysis of subject instruments with predicate" was conducted. The conclusion states "similarities in geometry, principles of operation, technology".
Intended Use Equivalence	The intended use must be substantially equivalent to the predicate device.	The Indications for Use are listed and stated to be substantially equivalent.
Mechanical Safety	The instrument must meet mechanical safety standards.	Stated that the device is substantially equivalent in "mechanical safety and performance." Though specific tests aren't detailed, compliance with relevant standards and the successful dimensional analysis would contribute to this.

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

Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The non-clinical test involved "Comparative dimensional analysis," which refers to comparing the manufactured subject instruments to the specifications or dimensions of the predicate, likely involving engineering measurements rather than a "sample set" of patient data.
Data Provenance: Not applicable. The "data" here would be engineering measurements and material specifications, not patient data from a specific country or collected retrospectively/prospectively.

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 the context of AI/ML, refers to validated clinical outcomes or expert labels. For a surgical instrument, "ground truth" would relate to engineering specifications and manufacturing tolerances, which are established by design engineers and quality control personnel, not typically clinical experts for labeling.

4. Adjudication method for the test set

Not applicable. There was no "test set" of clinical data requiring expert adjudication.

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

No. This is a surgical instrument, not an AI/ML diagnostic or assistive technology that would be subject to an MRMC study.

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

Not applicable. This device is not an algorithm. It is a physical instrument intended for use by a surgeon, assisted by a separate robotic navigation platform.

7. The type of ground truth used

The "ground truth" for this device's acceptance is based on engineering specifications, material standards (ASTM F899), and documented design equivalence to the predicate device. There is no clinical "ground truth" in the typical sense of pathology or outcomes data for this specific submission.

8. The sample size for the training set

Not applicable. There is no AI/ML training set involved.

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

Not applicable. There is no AI/ML training set involved.

In summary, this 510(k) submission for the EGPS Navigated Instruments is for a physical surgical device, not a software-based AI/ML diagnostic tool. Therefore, the questions related to clinical study design for AI/ML devices are not relevant to this document. The manufacturer demonstrated substantial equivalence primarily through non-clinical comparative analysis of the instrument's design, materials, and intended use with its predicate.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.

October 17, 2024

Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063

Re: K240160

Trade/Device Name: EGPS Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 13, 2024 Received: September 13, 2024

Dear Mr. Kelch:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

{1}------------------------------------------------

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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

{2}------------------------------------------------

by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/2/Picture/3 description: The image shows the name "Shumaya Ali -S" in a large, clear font. The text is likely part of a document or presentation. The name is written in a simple, sans-serif typeface, making it easily readable.

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

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K240160

Device Name EGPS Navigated Instruments

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary: Astura EGPS Navigated Instruments

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

Date Prepared	October 14, 2024
Submitted By	Astura Medical
	4949 W Royal Ln
	Irving, TX 75063
Contact	Parker Kelch
	4949 W Royal Ln
	Irving, TX 75063
	Phone: 469-501-5530 x503
	Email: parker@asturamedical.com
Trade Name	EGPS Navigated Instruments
Common Name	Stereotaxic Instrument
Classification Name	Orthopedic Stereotaxic Instrument
Class	II
Product Code	OLO
CFR Section	21 CFR section 882.4560
Device Panel	Orthopedic
Predicate Device	Globus EXCELSIUS GPS (K171651)
Device Description	Astura Medical EGPS Navigated Instruments are non-sterile, reusable
	instruments including a drill and drivers that can be operated manually.
	These instruments are intended to be used with the Globus Medical
	Excelsius GPS® Robotic Navigation Platform to aid in implantation of
	associated Astura Medical screw implants. The instruments are
	manufactured from stainless steel per ASTM F899.
Materials	Stainless Steel ASTM F899
Substantial EquivalenceClaimed to PredicateDevice	The EGPS Navigated instruments are substantially equivalent to thepredicate device in terms of intended use, design, mechanical safety andperformance.
Indications for Use	The EGPS Navigated Instruments are indicated for use during thepreparation and placement of Astura Medical screws during spinalsurgery to assist the surgeon in precisely locating anatomical structures ineither open or minimally invasive procedures. The EGPS NavigatedInstruments are reusable and are specifically designed for use with theGlobus Medical Excelsius GPS® Robotic Navigation Platform which isintended for use as an aid for precisely locating anatomical structures andfor the special positioning and orientation of an instrument holder orguide tube to be used by surgeons for navigating and/or guidingcompatible surgical instruments in open or percutaneous proceduresprovided that the required fiducial markers and rigid patient anatomy canbe identified on CT scans or fluoroscopy. Use of the EGPS Navigated
	Instrument System is limited to use only with the Olympic and Masadaspinal fixation systems (Olympic K153446, Olympic MIS K182239, MasadaK231694).
Non-clinical TestSummary	The following analyses were conducted:
	Comparative dimensional analysis of subject instruments with predicate
Clinical Test Summary	No clinical studies were performed
Conclusions: Non-Clinicaland Clinical	Astura Medical considers the EGPS Navigated Instruments to besubstantially equivalent to the predicate device listed above. Thisconclusion is based upon the devices' similarities in geometry, principlesof operation, technology, and indications for use.

{5}------------------------------------------------

K240160 Page 2 of 2

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).