Dark Star Navigated Instrument System is intended to be used during the preparation and placement of Dark Star 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, 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

The Republic Spine, LLC Dark Star Navigation Instrument System consists of reusable surgical instruments intended for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.

The Dark Star Navigation Instrument System includes taps, awls, probes, and drivers. The Dark Star Navigation Instrument System is to be used with the Dark Star Spinal System.

The instruments are made from stainless steel. The Dark Star Navigation Instrument System is not compatible with implants from other manufacturers and is designed for use only with Medtronic StealthStation Navigation System hardware and software.

AI/ML Overview

The provided text describes the "Dark Star Navigation Instrument System," a medical device intended to assist surgeons in spinal surgery by precisely locating anatomical structures. The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Medtronic Navigated Reusable Manual Instruments).

However, the provided document does not contain any information about an AI/Algorithm component or any studies that would involve AI performance metrics, such as accuracy (sensitivity, specificity, AUC), or a multi-reader multi-case (MRMC) study. The performance data section explicitly states that the device was tested per "ASTM F2554-18, 'Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.'" This standard focuses on the positional accuracy of computer-assisted surgical systems, which relates to the hardware and software's ability to accurately track and display instrument positions, not the performance of an AI algorithm in interpreting medical images or providing diagnostic assistance.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI evaluation, ground truth, and expert adjudication cannot be extracted from this document as they are not relevant to the type of device and testing described.

Based on the provided text, here is what can be inferred:

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

The document states: "The Dark Star Navigation Instrument System has been tested per ASTM F2554-18, 'Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.' The results of this non-clinical testing show that performance of the Dark Star Navigation Instrument System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The specific numeric acceptance criteria for positional accuracy and the reported performance values from the ASTM F2554-18 testing are not detailed in this document. The document only states that the performance was "sufficient for its intended use."

Acceptance Criteria (from ASTM F2554-18)	Reported Device Performance
Not specified in this document	"Sufficient for its intended use"; Specific numeric results not provided

Regarding AI/Algorithm-specific criteria, there are none mentioned.

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

As the performance testing was for the "positional accuracy of computer assisted surgical systems" (hardware/software integration), rather than an image-based AI algorithm, the concept of a "test set" for data provenance (e.g., country of origin, retrospective/prospective) is not applicable in the typical sense for AI studies. The testing would have involved physical measurements and evaluations of the system's accuracy. The sample size for such non-clinical testing (e.g., number of measurements taken, number of test subjects/simulations) is not specified in the document.

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

This information is not applicable as the evaluation is not for an AI algorithm's diagnostic or interpretive performance on medical images. The ground truth for positional accuracy would be established by the physical testing methodology described in ASTM F2554-18.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the type of testing described (positional accuracy).

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

There is no indication that an MRMC study was performed or that an AI component for human reader assistance exists in this device.

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

There is no indication of an AI algorithm in the device that would require standalone performance testing.

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

The ground truth for the device's performance is based on measurements against the "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems" (ASTM F2554-18). It is a technical measurement ground truth, not a clinical or pathological one.

8. The sample size for the training set

There is no mention of a training set, as the document does not describe an AI/machine learning component.

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

There is no mention of a training set or ground truth establishment relevant to AI.

Summary

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September 27, 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 and 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.

Republic Spine, LLC James Doulgeris Director of Product Development and Quality Systems 2424 N Federal HW, Suite 257 Boca Raton, Florida 33431

Re: K212028

Trade/Device Name: Dark Star Navigation Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 28, 2021 Received: June 29, 2021

Dear James Doulgeris:

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

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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, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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	DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
	Food and Drug AdministrationExpiration Date: 06/30/2020
	Indications for Use	See PRA Statement on last page.

510(k) Number (if known)	K212028
Device Name	Dark Star Navigation Instrument System
Indications for Use (Describe)	Dark Star Navigated Instrument System is intended to be used during the preparation and placement of Dark Star 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, 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.

510(k) Number (if known)

K212028

Device Name

Dark Star 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)
-------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)	Page 1 of 1	PSC Publishing Services (301) 443-6740 EF
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510(K) SUMMARY

Submitter's Name:	Republic Spine, LLC
Submitter's Address:	2424 North Federal Hwy, Suite 257Boca Raton, FL 33431
Submitter's Telephone:	561-334-2421
Contact Person:	James Doulgeris727-512-5461James@rspine.com
Date Summary was Prepared:	06/28/2021
Trade or Proprietary Name:	Dark Star Navigation Instrument System
Common or Usual Name:	Orthopedic Stereotaxic Instrument
Classification:	Class II per 21 CFR §882.4560
Product Code:	OLO
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Dark Star Navigation Instrument System includes taps, awls, probes, and drivers. The Dark Star Navigation Instrument System is to be used with the Dark Star Spinal System.

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS

Republic Spine, LLC Dark Star Navigation Instrument System

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

Indications for Use ●
Materials of manufacture ●
Principles of Operation ●
Sizes ●

Table 5-1 Predicate Devices

510kNumber	Trade or Proprietary or Model Name	Manufacturer	ProductCode	PredicateType
K161210	Medtronic Navigated Reusable ManualInstruments for Use with the StealthStation™and IPCT™ Powerease™ Systems	MedtronicSofamorDanek	OLO	Primary
K201420	Dark Star Spinal System	RepublicSpine, LLC	NKB,KWP	Reference

PERFORMANCE DATA

The Dark Star Navigation Instrument System has been tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems."

The results of this non-clinical testing show that performance of the Dark Star Navigation Instrument System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Dark Star Navigation Instrument System is 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).