CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System S8 (V1.2.0), 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 of the anatomy.

Device Description

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures. The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with more CoreLink pedicle screws.

AI/ML Overview

The FDA document K220973 concerns the "CoreLink Navigation Instruments" and includes a brief summary of performance data. However, it does not contain the detailed information necessary to fully address all the points in your request regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" for an AI/device performance evaluation.

This 510(k) submission is for navigation instruments, which are described as non-sterile, re-usable manual surgical instruments designed to interface with a navigation system (Medtronic StealthStation® System S8). The performance data section states: "CoreLink, LLC has conducted an engineering analysis to demonstrate that the system modifications provide adequate and substantially equivalent accuracy for their intended use."

This implies a mechanical/engineering performance evaluation, not a study involving AI assistance for human readers, nor detailed clinical outcome data in the context of an AI-driven diagnostic or prognostic device. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance (Based on provided text)

The document primarily focuses on demonstrating substantial equivalence to predicate devices through an engineering analysis, rather than setting specific quantitative acceptance criteria for a new AI application.

Acceptance Criteria	Reported Device Performance
Accuracy for Intended Use	Demonstrated through engineering analysis to provide "adequate and substantially equivalent accuracy for their intended use." (Specific quantitative metrics for accuracy are not detailed in this summary.)
Technological Characteristics	"Nearly identical technological characteristics" to predicate devices, with "minor differences [that] do not raise any new issues of safety and effectiveness." This includes identical indications for use, materials of manufacture, and principles of operation.

Study Details (Based on provided text)

Most of the requested study details are not applicable or not provided in this 510(k) summary, as it describes an engineering analysis for mechanical instruments, not an AI performance study.

Sample size used for the test set and the data provenance: Not explicitly stated for performance testing; the "engineering analysis" suggests bench testing or simulations rather than a clinical dataset in the context of AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth establishment as typically understood in AI studies (e.g., for image interpretation) is not relevant for this device's type of performance evaluation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic or prognostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual surgical instrument intended to be used by a surgeon in conjunction with a navigation system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical accuracy, ground truth would typically refer to known physical measurements or engineering specifications against which the instrument's performance is compared. Details are not provided in this summary.
The sample size for the training set: Not applicable for this type of device and performance evaluation.
How the ground truth for the training set was established: Not applicable.

In summary:

The provided FDA letter and 510(k) summary pertain to a Class II surgical instrument (CoreLink Navigation Instruments) used with a separate navigation system. The "performance data" mentioned refers to an "engineering analysis" to demonstrate mechanical accuracy and substantial equivalence to existing devices, not the performance of an AI algorithm based on clinical data. Therefore, the detailed questions about AI study design, ground truth establishment, reader studies, and training/test sets are outside the scope of the information provided in this regulatory document.

Summary

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June 1, 2022

CoreLink, LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K220973

Trade/Device Name: CoreLink Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 1, 2022 Received: April 4, 2022

Dear Nathan Wright:

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K220973

Device Name CoreLink Navigation Instruments

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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K220973 510(k) SUMMARY

Submitter's Name:	CoreLink, LLC
Submitter's Address:	2072 Fenton Logistics ParkSt. Louis, Missouri 63026
Submitter's Telephone:	888-349-7808
Contact Person:	Nathan Wright MSEmpirical Testing Corp.719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	April 1, 2022
Trade or Proprietary Name:	CoreLink Navigation Instruments
Common or Usual Name:	Orthopedic Stereotaxic Instruments
Classification:	Class II per 21 CFR §882.4560
Product Code:	OLO
Classification Panel:	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with more CoreLink pedicle screws.

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

Indications for use ●
Materials of manufacture
Principles of operation ●

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Predicate Devices
Page 2 of
510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K212825	CoreLink Navigation Instruments	CoreLink, LLC	Primary
K161210/K170679	Medtronic Navigated Reusable Instruments	Medtronic Sofamor Danek	Additional
K210539	CoreLink Midline Fixation System	CoreLink, LLC	Reference

PERFORMANCE DATA

In support of this Traditional 510(k) submission, CoreLink, LLC has conducted an engineering analysis to demonstrate that the system modifications provide adequate and substantially equivalent accuracy for their intended use.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the CoreLink Navigation Instruments are substantially equivalent to the predicate device.

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).