CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons for navigating compatible surgical instruments in open or percutaneous pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on O-arm or C-arm.

Device Description

The CUVIS-spine is a mobile system mainly comprising the robotic arm, the main console and the staff console as an option. The robotic arm is positioned on the floor near the side of the surgical table. The location of the main console or the staff console is appropriately determined considering the user preference and the environments.

The CUVIS-spine is a pedicle screw guide system which consists of Robotic Arm, Main Console, Staff Console, Guide bush, Source Calibrator, Registration Tool, Registration Tool Adapter, Robotic Arm Drape, Tool Drape, Detector Drape, Marker Ball, Patient Marker, Marker Driver, Detector Calibrator, Dilator, Serration-tip Dilator, Drill Bit, Tapper, Stylet Tapper, Screwdriver, Instrument Container.

AI/ML Overview

The provided text describes the CUVIS-spine device, a robotic-assisted pedicle screw placement system. It includes information on its regulatory classification, indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or an explicit study proving that the device meets defined acceptance criteria in the format requested.

The Performance Data section mentions non-clinical tests for "pose accuracy and repeatability" and a "cadaveric study" for robotic-assisted pedicle screw placement. It also touches on biocompatibility, electromagnetic compatibility, electrical safety, risk management, and usability. However, it does not provide details on the acceptance criteria for these tests, nor the results in a quantified manner that directly addresses the prompt's request for a table of acceptance criteria and reported device performance.

Therefore, I cannot fully complete the requested table or describe a detailed acceptance criterion study based on the provided text.

Here's a breakdown of what can be extracted and what is missing:

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

Acceptance Criteria	Reported Device Performance
Pose Accuracy	"tested and validated" (No specific numerical criterion or reported value provided)
Repeatability	"tested and validated" (No specific numerical criterion or reported value provided)
Biocompatibility (in vitro cytotoxicity)	"tested and evaluated according to the FDA-recognized consensus standard, ISO 10993-5." (No specific result provided, only adherence to standard)
Biocompatibility (irritation, skin sensitization, intracutaneous reactivity)	"tested and evaluated according to the FDA-recognized consensus standard, ISO 10993-10." (No specific result provided, only adherence to standard)
Electrical Safety	"tested and evaluated according to the FDA-recognized consensus standard, ES 60601-1." (No specific result provided, only adherence to standard)
Electromagnetic Compatibility	"tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2." (No specific result provided, only adherence to standard)
Risk Management	"recorded by referring to ISO 14971." (No specific outcome or acceptance level provided)
Usability	"documented by referring to IEC 60601-1-6." (No specific outcome or acceptance level provided)
Robotic-assisted pedicle screw placement (cadaveric study)	"performed" (No specific performance metrics like accuracy, success rate, or error margins, nor acceptance criteria for these, are provided)

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

Sample size for non-clinical tests (pose accuracy, repeatability): Not specified.
Sample size for cadaveric study: Not specified (referred to as "A cadaveric study").
Data provenance: Not specified. The studies are referred to generally as "non-clinical tests" and "A cadaveric study," without details on the origin or nature (retrospective/prospective) of the data.

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

This information is not provided in the text. The document refers to "testing and validation" and a "cadaveric study" but does not detail the methodology for establishing ground truth or the involvement/qualifications of experts.

4. Adjudication method for the test set

This information is not provided in the text.

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

This information is not provided in the text. The CUVIS-spine is described as a robotic-assisted system for surgical instrument guidance, not an AI software for interpretation by human readers. Therefore, an MRMC study related to human reading improvement with AI assistance would not be applicable in this context.

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

The document implies a standalone performance component for the robotic system in its "pose accuracy and repeatability" tests and the cadaveric study, as these would assess the device's technical performance. However, it does not explicitly state "standalone performance study" or provide results that isolate the algorithm's performance without human interaction during operation. The system's indication for use is "as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons," implying human interaction is part of its intended use.

7. The type of ground truth used

For the cadaveric study, the implied ground truth would likely be based on post-insertion imaging (e.g., CT scans) or physical dissection to verify screw placement accuracy relative to the surgical plan. However, this is not explicitly stated.
For pose accuracy and repeatability, the ground truth would be precise measurements of the robotic arm's position and orientation using metrology equipment.
For biocompatibility and electrical safety/EMC, the "ground truth" is adherence to the specified ISO/IEC consensus standards.

8. The sample size for the training set

This information is not provided in the text. The CUVIS-spine is a robotic system, not explicitly an AI model trained on a dataset of images in the conventional sense for diagnostic AI. While it uses software, the text does not describe a training set for machine learning.

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

As a training set is not explicitly mentioned for a machine learning model, this information is not applicable based on the provided text.

Summary

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May 19, 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.

Curexo, Inc. % Do Hyun Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, 06210 Republic of Korea

Re: K201569

Trade/Device Name: CUVIS-spine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 16, 2021 Received: April 19, 2021

Dear Do Hyun Kim:

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

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

Sincerely,

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

Enclosure

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Indications for Use

510(k) Number (if known) K201569

Device Name CUVIS-spine

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

Submitter/Applicant:	CUREXO, INC.
Address:	577, Gangnam-Daero, Seocho-GuSeoul, 06530, Republic of KoreaTel: +82-31-788-7935Jungeun PARKQuality Management RepresentativeEmail: jepark@curexo.com
Applicant correspondent:	Do Hyun Kim, BT Solutions, Inc.
Address:	Unit 904, Eonju-ro 86gil 5, Gangnam-guSeoul 06210, Korea.Tel: +82-2-538-9140Email: ceo@btsolutions.co.kr
Preparation Date:	May 20, 2021

Device Name and Code

Device Trade Name:	CUVIS-spine
Common Name:	Pedicle Screw Guide System
Classification Name:	Stereotaxic instrument
Product Code:	OLO
Regulation Number:	21 CFR 882.4560
Classification:	II
Review Panel:	Orthopedic

Predicate Device

CUVIS-spine is substantially equivalent to the following legally marketed predicate devices Table 1 Primary Predicate device

Applicant	Device Name	510(k) Number
Globus Medical Inc.	Excelsius GPSTM	K171651

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Device Description

Indications / Intended Use

CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on O-arm or C-arm.

Technical Characteristics in Comparison to Predicate Devices

	Subject Device	Predicate Device
	CUVIS-spine(K201569)	Excelsius GPSTM (K171651)
Manufacturer	CUREXO, INC.	Globus Medical Inc.
Classification	Class II	Class II
Product Code	OLO	OLO
Regulation No.	882.4560	882.4560
	Subject Device	Predicate Device
	CUVIS-spine(K201569)	Excelsius GPSTM (K171651)
General Devicedescription	The CUVIS-spine is a mobilesystem mainly comprising therobotic arm, the main console andthe staff console as an option. Therobotic arm is positioned on thefloor near the side of the surgicaltable. The location of the mainconsole or the staff console isappropriately determinedconsidering the user preference andthe environments.	The EXCELSIUS GPSTM is aRobotic Positioning System thatincludes a computer controlledrobotic arm, hardware, and softwarethat enables real time surgicalnavigation and robotic guidanceusing radiological patientimages(preoperative CT,intraoperative CT and fluoroscopy),using a dynamic reference base andpositioning camera.
Indicationsfor use	CUVIS-spine is intended for use asan aid for precisely locatinganatomical structures and for thespatial positioning and orientationof guide bush to be used bysurgeons for navigating and/orguiding compatible surgicalinstruments in open or percutaneouspedicle screw placement providedthat the required markers and rigidpatient anatomy can be identified onO-arm or C-arm.	The EXCELSIUS GPSTM isintended for use as an aid forprecisely locating anatomicalstructures and for the spatialpositioning and orientation of aninstrument holder or guide tube tobe used by surgeons for navigatingand/or guiding compatible surgicalinstruments in open or percutaneousprocedures provided that therequired fiducial markers and rigidpatient anatomy can be identified onCT scans or fluoroscopy. Thesystem is indicated for theplacement of spinal and orthopaedicbone screws.
Technical Characteristics
Principle ofoperation	- Intraoperative images- Patient registration- Surgical planning- Real-time tracking of navigatedinstruments- Guidance of instruments	- Intraoperative/preoperativeimages- Patient registration- Surgical planning- Real-time tracking of navigatedinstruments- Guidance of instruments
Image	O-arm, C-arm	O-arm, C-arm, CT
	Subject Device	Predicate Device
	CUVIS-spine(K201569)	Excelsius GPS TM (K171651)
Input Images	- 3D intra-operative exam- 2D intra-operative exam	- 3D pre-operative exam- 3D intra-operative exam- 2D intra-operative exam
Tracker	Optical Tracking System	Optical Tracking System
Guide	Dilator and Tapper	Dilator and Tapper
TargetTracking	YES	YES
IntegratedSoftware	- SRC (Control Software)- SPN (Planner Software)	Excelsius GPS Planning andNavigation Application Software
Save/loadPlanning	YES	YES
Merge imagesfunctionality	YES	YES
Trajectoryplanningparameters	- Entry point- Target point- Instrument length/diameter	- Entry point- Target point- Instrument length/diameter
Localizationmeans	Optical system (infrared camera)	Optical system (infrared camera)
Image-guided	YES	YES
Controller	Forced-controlled movementallowing robot arm positioning(called hand guide function)	Force-controlled movementallowing robotic arm positioning
Patientregistrationmethod	- Intra-op CT: Registration tool- Fluoroscopy: Source calibrator	- Pre-op CT: Fluoroscopic to pre-opCT merge- Intra-op CT: Registration fixture- Fluoroscopy: Registration fixture
Real timedisplay ofinstrumentposition	YES	YES
Accessories	- Registration instruments- Patient reference instruments- Surgical instruments	- Registration instruments- Patient reference instruments- Surgical instruments- End effector
Performance data
ElectricalSafety andElectromagenti	- IEC60601-1- IEC60601-1-2	- IEC60601-1- IEC60601-1-2
	Subject Device	Predicate Device
	CUVIS-spine(K201569)	Excelsius GPS TM (K171651)
c compatibilityAccuracyverification onanatomicallandmarks	Yes	Yes
Biocompatibility	The biocompatibility evaluation forthe patient marker has beenconducted in accordance with ENISO 10993 standards.	The biocompatibility evaluation forEXCELSIUS GPSTM has beenconducted in accordance with ISO10993 standards.
Parts ofContact withPatient	Patient marker	Patient reference instruments(Patient marker)
Nature ofBody Contact	Implant device / bone	Implant device / bone
Patient Fixation	Reference is fixed to patient's bonystructure for tracking system	Reference is fixed to patient's bonystructure for tracking system

CUVIS-spine is substantially equivalent to the following legally marketed predicate devices

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Performance Data

Non-clinical tests: Pose accuracy and Repeatability of the CUVIS-spine were tested and validated. A cadaveric study of the proposed device had been performed for the robotic-assisted pedicle screw placement.

Biocompatibility were tested using following consensus standards:

-Tests for in vitro cytotoxicity were tested and evaluated according to the FDArecognized consensus standard, ISO 10993-5.
-Tests for irritation, skin sensitization and intracutaneous reactivity were tested and evaluated according to the FDA-recognized consensus standard, ISO 10993-10.

Electromagnetic compatibility and electrical safety, etc, were tested using following consensus standards:

-Basic safety and essential performance of the CUVIS-spine is tested and evaluated according to the FDA-recognized consensus standard, ES 60601-1.
-Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2.
Risk management was recorded by referring to ISO 14971. -

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-Usability was documented by referring to IEC 60601-1-6.

Substantial Equivalence

CUVIS-spine is not based on a new technology. The technological characteristics of the subject device is comparable to the predicate device for comparable indications for use. Thus, subject device CUVIS-spine is concluded to be substantially equivalent to the predicate device.

Conclusions

On the basis of the information provided in this Summary, CUREXO, INC. believes that CUVIS-spine is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.

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).