The Remex Spine Surgery Navigation instrument is designed for use with Anatase Spine Surgery Navigation System(K230783) and Remex Spine Surgery Navigation System II(K233513). The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include: Posterior-approach spinal implant procedures, such as pedicle screw placement, with the lumbar region.

Device Description

The Remex Spine Surgery Navigation Instrument is designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513).
The Remex Spine Surgery Navigation Instrument consists of the Nav Awl, Nav Drill Guide, Nav Tap, Nav Screwdriver and Nav Handle.

Nav Awl: The subject device is intended to support the surgeon to create an entry point before implanting the screw.
Nav Drill Guide: The subject device is intended to assist in drilling holes to a desired depth and ensuring proper orientation.
Nav Tap: The subject device is intended to create screw threads.
Nav Screwdriver: The subject device is intended to driver the screw into the vertebra.
Nav Handle: The subject device is intended to connected with Nav Awl, Nav Tap or Nav Screwdriver for navigation tracking purpose.

AI/ML Overview

This document is focused on the Remex Spine Surgery Navigation Instrument and its substantial equivalence to predicate devices (K233513, K230783). It primarily addresses the design and functional aspects of the instrument itself, rather than presenting a performance study of an AI-powered diagnostic device or a navigation system that relies on sophisticated algorithms validated with clinical outcomes.

Therefore, the provided text does not contain the detailed information required to answer many of the specific questions regarding acceptance criteria and a study proving device performance as typically understood for an AI/ML-driven diagnostic or image analysis device. The "Performance Data" section discusses general design verification, software verification (in accordance with general FDA guidance and IEC 62304), risk assessment (ISO 14971), and biocompatibility (ISO 10993). It states that "[a]ll the results are passed" but doesn't provide specific numerical acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, or reader improvement.

Based on the provided text, I can extract the following limited information:

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

The document doesn't provide specific numerical acceptance criteria in the format of a table with quantitative performance metrics for a diagnostic device (e.g., accuracy, sensitivity, specificity). Instead, it lists general verification and validation activities designed to demonstrate that the instrument performs safely and effectively.

Test Category	Acceptance Criteria (General)	Reported Performance
Software	Verified and validated in accordance with FDA guidance for software in medical devices and IEC 62304.	"[A]ll the results are passed." (Implies software met requirements for functionality, reliability, and safety based on its intended use within the navigation system, but no specific performance metrics like latency, throughput, or accuracy of algorithmic output are given for an AI component).
Risk Assessment	Effectiveness of all risk control measures verified in accordance with ISO 14971.	"[A]ll the results are passed." (Implies risks were identified, evaluated, and mitigated to an acceptable level).
Design Verification	Design output fulfills all design input requirements.	"[A]ll the results are passed." (Implies the physical components of the instrument meet their design specifications).
Biocompatibility Evaluation	No rejection, allergic, and adverse reactions, evaluated in accordance with FDA guidance (ISO 10993-1).	"[A]ll the results are passed." (Implies the materials used in the instrument are biologically safe for human contact as intended).

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

Sample Size: Not specified. The document refers to "verification and validation activities" and "performance tests" but does not detail the sample size (e.g., number of instruments tested, number of patients/cases used for a clinical performance study if one were relevant to this specific instrument).
Data Provenance: Not specified. (e.g., country of origin, retrospective or prospective).

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

Number of Experts: Not applicable/not specified. The testing described is primarily engineering and materials verification for a physical medical instrument, not a study requiring expert readers to establish ground truth for image interpretation or diagnosis.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication method for the test set:

Adjudication Method: Not applicable/not specified. This type of detailed adjudication process (e.g., 2+1, 3+1) is typically relevant to studies involving human reading of medical images where ground truth is established by consensus, which is not the subject of this document.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not done, or at least not described in this document. This document pertains to a physical surgical instrument, not an AI-assisted diagnostic or image analysis system that would typically undergo such a study.

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

Standalone Performance: Not applicable. This document describes a surgical instrument. While it works with navigation systems (K230783, K233513) that likely have software components, the focus here is the physical instrument itself, not an AI algorithm whose standalone performance needs to be measured.

7. The type of ground truth used:

Type of Ground Truth: Not applicable in the conventional sense of clinical ground truth (pathology, outcomes data, expert consensus). For a surgical instrument, "ground truth" would relate to engineering specifications, material properties, and functional performance (e.g., precision of fit, sterility, tracking accuracy within the navigation system). Measurements and observations against these pre-defined specifications serve as the "ground truth" for verification.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This document describes a physical medical device (surgical instrument), not an AI/ML algorithm that would undergo training on a data set.

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

Ground Truth Establishment for Training Set: Not applicable. There is no mention of an AI/ML training set in this document.

In summary: The provided document is an FDA 510(k) clearance letter and synopsis for a medical instrument (Remex Spine Surgery Navigation Instrument), which is a physical device used with existing navigation systems. It is not a submission for an AI/ML-driven diagnostic or image analysis device. Therefore, the detailed performance study and acceptance criteria questions related to artificial intelligence and clinical diagnostic performance are largely not applicable to the content provided. The "performance data" section focuses on standard engineering and biocompatibility testing to ensure the instrument's safety and effectiveness.

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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 13, 2024

Remex Medical Corp. Cheng-Hsiung Wang Quality Representative I 4F, No.9, Jingke Road, Nantun District Taichung, 408209 Taiwan

Re: K243560

Trade/Device Name: Remex Spine Surgery Navigation Instrument Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 11, 2024 Received: November 18, 2024

Dear Cheng-Hsiung Wang:

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"

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(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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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 (QS) 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 Rue"). 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-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-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

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

Sincerely,

Shumaya Ali -S

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) K243560

Device Name Remex Spine Surgery Navigation Instrument

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)

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Image /page/4/Picture/0 description: The image shows the word "REMEX" in a sans-serif font. The letters are gray, except for a green parallelogram in the lower-left corner of the "R". The letters are large and bold, taking up most of the image space. The background is white.

510(k) Summary

Submitted By	REMEX MEDICAL CORP.4F., No.9 Jingke Rd., Nantun District, Taichung, TW 408209Tel. +886-4-23595336Fax.+886-4-23598875
Contact Person	Cheng-Hsiung WangKevin816@mail.intai.com.tw
Date Prepared	October 11th, 2024
Device Name	Remex Spine Surgery Navigation Instrument
Classification Name	Stereotaxic instrument
Regulation Number	882.4560
Product Codes	OLO
Device Class	Class II
Predicate DevicesInformation	K233513, Remex Spine Surgery Navigation System II (primary)K230783, Anatase Spine Surgery Navigation System
Device Description	The Remex Spine Surgery Navigation Instrument is designed for use withAnatase Spine Surgery Navigation System (K230783) and Remex Spine SurgeryNavigation System II (K233513).The Remex Spine Surgery Navigation Instrument consists of the Nav Awl, NavDrill Guide, Nav Tap, Nav Screwdriver and Nav Handle.1. Nav Awl: The subject device is intended to support the surgeon to create anentry point before implanting the screw.2. Nav Drill Guide: The subject device is intended to assist in drilling holes to adesired depth and ensuring proper orientation.3. Nav Tap: The subject device is intended to create screw threads.4. Nav Screwdriver: The subject device is intended to driver the screw into thevertebra.Nav Handle: The subject device is intended to connected with Nav Awl, Nav Tapor Nav Screwdriver for navigation tracking purpose.
Indications for Use	The Remex Spine Surgery Navigation Instrument is designed for use withAnatase Spine Surgery Navigation System (K230783) and Remex Spine SurgeryNavigation System II (K233513).The Anatase Spine Surgery Navigation System and Remex Spine SurgeryNavigation System II, are indicated for precise positioning of surgicalinstruments or spinal implants during general spinal surgery when reference to arigid anatomical structure, such as the vertebra, can be identified relative to apatient's fluoroscopic or CT imagery. It is intended as a planning andintraoperative guidance system to enable open or percutaneous image guided
surgery by means of registering intraoperative 2D fluoroscopic projections to
pre-operative 3D CT imagery.
Example procedures include:
Posterior-approach spinal implant procedures, such as pedicle screw placement,
within the lumbar region.
TechnologicalCharacteristics	The subject devices have the same intended use, same indications for use, samesterilization method, same fundamental technology, and similar materials, similardesign as the predicate devices, Anatase Spine Surgery Navigation System(K230783) and Remex Spine Surgery Navigation System II (K233513).
	The difference between the subject devices and the predicate devices are theupgrade of the system software version, and new instruments for correspondingcompatible devices. However, these modifications share same function andfundamental technology with the predicate devices.
Performance Data	Verification and validation activities have been completed to provide sufficientassurance that the subject device meets the performance requirements under itsindications for use conditions. Below is a summary of all performance tests whichshould carried out on the subject device to demonstrated that the subject deviceperforms as safely and effectively as the predicate device.
	Test	Description
	Software	Software is verified and validated in accordance with FDAguidance for the content of premarket submissions forsoftware contained in medical devices and IEC 62304.
	Risk Assessment	The effectiveness of all risk control measures is verified inaccordance with ISO 14971.
	DesignVerification	The design output fulfills all design input requirements.
	BiocompatibilityEvaluation	The materials that contact with human tissue, blood orbone must be considered for biocompatibility to ensure norejection, allergic and adverse reactions occur. The subjectdevice is evaluated in accordance with FDA guidance forthe use of international standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation andtesting within a risk management process" and ISO 10993-1.
	The intended use and fundamental technology of the device are identical to thepredicate device, and could share the same testing methods as the predicatedevices. All the results are passed. Therefore, REMEX believes the testingdemonstrated that the subject devices are as safe and effective as the predicatedevices.
Conclusion	The Remex Spine Surgery Navigation Instrument and the predicate devices havethe same intended use and have the same or similar technological characteristics.Moreover, the information contained in this submission demonstrates that anydifferences in their technological characteristics do not raise new issues of safety

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Image /page/5/Picture/0 description: The image shows the word "REMEX" in a sans-serif font. The letters are gray, except for a green leaf-like shape that replaces the bottom left portion of the "R". The word is presented in a clear and legible manner, with a modern and professional aesthetic.

Remex Medical Corporation 4F, No. 9, Jingke Road, Nantun District, Taichung City408209, Taiwan

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Image /page/6/Picture/0 description: The image shows the word "REMEX" in a sans-serif font. The letters are gray, except for a green leaf-like shape in the lower-left corner of the "R". The text is centered and appears to be a logo or brand name.

Remex Medical Corporation 4F, No. 9, Jingke Road, Nantun District, Taichung City408209, Taiwan

or effectiveness. Hence, The Remex Spine Surgery Navigation Instrument is
substantially equivalent to the predicate devices.

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).