The CTL Amedica Navigation Instrument System is intended to be used during the preparation and placement of CTL Amedica screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The CTL Amedica Navigation Instrument System is specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Device Description

The CTL Amedica Navigation Instrument System are manual surgical instruments for use with the Medtronic® StealthStation™ Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of this navigation system provides the surgeon access to real-time, multiplane 3D images (and 2D images) providing confirmation of hardware placement.

The Navigation Instruments include the following:

Drivers
Taps
Awls
Probes

Use of the Navigated Instrument System is limited to Taps ranging in sizes from 4.5mm to 8.5mm in diameter. The Navigation Instruments are to be used with the following CTL Amedica Systems but not limited to:

RAPHAELTM Pedicle Screw System Family
PICASSO II™ MIS Spinal System Family
TAURUS™ Pedicle Screw System Family

The CTL Amedica Navigation Instruments are designed for use only with the hardware and software of the Medtronic StealthStation Navigation System.

The CTL Amedica Navigation Instruments are manufactured from Stainless Steel and Aluminum. All of these materials conform to ASTM F899.

AI/ML Overview

The provided text describes the CTL Amedica Navigation Instrument System, but it does not contain any specific numerical acceptance criteria or performance results from a study that proves the device meets those criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (K172115 and K153442) for 510(k) clearance. This means the manufacturer is asserting their device is as safe and effective as a legally marketed device, rather than providing new, independent performance metrics against specific acceptance thresholds.

Therefore, many of the requested sections regarding detailed study information cannot be answered from the provided document.

Here's a breakdown of what can be inferred or explicitly stated based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicit: The document does not state specific numerical acceptance criteria (e.g., accuracy +/- X mm, or specific pass/fail rates). The criteria are implicitly tied to the performance of the predicate devices.	Compatibility, Accuracy, Function, and Performance: The non-clinical testing demonstrated that the subject instruments registered successfully with the StealthStation system and are substantially equivalent to the predicate devices with regards to compatibility, accuracy, function, and performance in a simulated surgical navigation use environment.

Study Information (Based on the provided text):

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

Sample Size: Not specified. The document mentions "all subject instruments" for compatibility testing and "both the predicate devices and subject devices" for dimensional analysis, but no specific count is given for the test set.
Data Provenance: Not explicitly stated, but the testing was conducted as part of the regulatory submission process for the CTL Amedica Navigation Instrument System, implying it was conducted by or for the manufacturer. It is a non-clinical, controlled environment (simulated surgical navigation use environment) rather than clinical data.

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

Not Applicable. The ground truth in this non-clinical testing appears to be based on engineering analysis, dimensional comparisons, and the successful registration and function with the predicate Medtronic StealthStation system. There is no mention of human experts establishing a 'ground truth' for specific anatomical localization or diagnostic outcomes.

4. Adjudication method for the test set

Not Applicable/Not Specified. Since there's no mention of human experts establishing ground truth or evaluating outcomes in a subjective manner, an adjudication method like 2+1 or 3+1 is not relevant to the described testing.

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. The document explicitly states "Clinical Tests: o N/A". This is a premarket notification for a medical instrument system, not an AI-powered diagnostic device, and therefore this type of study is not applicable or performed as part of this submission. The device is an instrument used with a navigation system.

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

Partially. The testing described is primarily standalone device performance (how the instruments themselves function with the navigation system). It's "algorithm only" in the sense that the instruments interface with the "Medtronic StealthStation System" software, and their compatibility/accuracy with that system's function is assessed. However, this is not an "AI algorithm" in the typical sense of a diagnostic or predictive model. The assessment of "accuracy, function and performance in a simulated surgical navigation use environment" primarily focuses on the instrument's interaction with the navigation system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this non-clinical testing is based on:
- Successful registration and compatibility with the Medtronic StealthStation system.
- Dimensional measurements and geometrical comparisons against predicate devices (for dimensional comparison and rigidity).
- Expected function and performance in a simulated environment as defined by the capabilities of the StealthStation system and the purpose of the surgical instruments.
- Essentially, the ground truth is the expected engineering and functional performance when integrated with the existing, cleared navigation system.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set in the conventional sense. The device is a set of physical surgical instruments.

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

Not Applicable. (See point 8)

Summary

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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

May 12, 2022

CTL Medical Corporation % Dhaval Saraiya Regulatory/Quality Consultant Omni Strategic Solutions, LLC 700 Pennsylvania Ave SE 2nd Floor Washington, District of Columbia 20003

Re: K213491

Trade/Device Name: CTL Amedica Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 8, 2022 Received: April 12, 2022

Dear Dhaval Saraiya:

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.

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

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Indications for Use

510(k) Number (if known) K213491

Device Name

CTL Amedica Navigation Instrument System

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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510(k) Summary

In accordance with 21 CFR $807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the CTL Amedica Navigation Instrument System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.

Sponsor:	CTL Medical CorporationSean Suh4550 Excel PkwySte 300Addison, TX 75001
Contact Person:	Dhaval S.Omni Strategic Solutions, LLC.Regulatory/Quality ConsultantEmail: omniregsolutions@gmail.comTel: 213-400-2576
Date:	11 May 2022
Subject Device:	Trade Name: CTL Amedica Navigation Instrument SystemCommon Name: Orthopedic Stereotaxic InstrumentClassification Name: OLO – Stereotaxic Instrument (21 CFR 882.4560)
Predicate Device(s):
Primary	K172115	Navigated Instrument System	Orthofix Inc.
	K153442	Medtronic NavigatedManual ReusableInstruments for Use withStealthStation	Medtronic
Purpose andDevice Description:	The purpose of this submission is to request clearance for the newCTL Amedica Navigation Instrument System.The CTL Amedica Navigation Instrument System are manualsurgical instruments for use with the Medtronic® StealthStation™Navigation System to assist surgeons in precisely locating

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anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of this navigation system provides the surgeon access to real-time, multiplane 3D images (and 2D images) providing confirmation of hardware placement.

The Navigation Instruments include the following:

Drivers ●
. Taps
Awls
Probes .

RAPHAELTM Pedicle Screw System Family
PICASSO II™ MIS Spinal System Family
TAURUS™ Pedicle Screw System Family

The CTL Amedica Navigation Instruments are designed for use only with the hardware and software of the Medtronic StealthStation Navigation System.

The CTL Amedica Navigation Instruments are manufactured from Stainless Steel and Aluminum. All of these materials conform to ASTM F899.

Intended Use and Indications for Use:

The CTL Amedica Navigation Instrument System is intended to be used during the preparation and placement of CTL Amedica screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The CTL Amedica Navigation Instrument System is specifically designed for use with the Medtronic StealthStation System, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Summary of Technological

Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

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Intended Use: The intended use is similar to the intended use ● cleared in K172115 and K153442.
. Indications for Use: The indications for use are similar to the indications for use cleared in K172115 and K153442.
. Materials: The CTL Amedica Navigation Instrument System are manufactured from Stainless Steel (per ASTM F899) and Aluminum (per ASTM B221) which are commonly used materials in orthopedic instruments and similar to materials used in K172115 and K153442.
Design Features: The design features for the CTL Amedica ● Navigation Instrument System is similar to those in currently marketed devices cleared in K172115 and K153442. The design differences have not identified any issues that would impact the safety and effectiveness of the device.
Sterilization: The CTL Amedica Navigation Instrument System are offered to the user in the non-sterile configuration. The non-sterile instruments will be required to be steam sterilized by the user prior to use is similar to the devices cleared in K172115 and K153442.

Summary of Performance Data (Nonclinical and/or Clinical):

Non-Clinical Tests: ●

Compatibility Testing Testing included physical testing with all subject instruments to demonstrate that the subject instruments can be regsitered with the StealthStation system and are compatible with the StealthStation system software in terms of accuracy, function and performance in a simulated surgical navigation use environment
o Dimensional Comparison Engineering analysis and tolerance analysis included dimensional measurements and geometrical comparisons of both the predicate devices and subject devices
o Rigidity Comparison Testing to demonstrate that the NavLock engagement feature on the subject instruments is equivalent to the predicate engagement feature

The non-clinical testing demonstrated that the subject instruments registered successfully with the StealthStation system and are substantially equivalent to the predicate devices with regards to compatibility, accuracy, function and performance. Therefore, it can be concluded that the compatibility, accuracy, function, and performance of the subject devices are substantially equivalent to the predicate devices.

Clinical Tests: ●
o N/A

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Substantial Equivalence Conclusion:

The CTL Amedica Navigation Instrument System has shown to be substantially equivalent to the predicate device with regards to indications, design, technology, funcitionality and performance. Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.

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).