INNOVERSE Navigation Instruments are intended to be used during the preparation and placement of INNOVERSE Spinal System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in spinal procedures. These instruments are designed for use with the stereotactic navigation system Medtronic® StealthStation™, 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

The INNOVERSE Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation™ Navigation System to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of pedicle screw implants.

The INNOVERSE Navigation Instruments include awls, probes, taps, and drivers and are to be used with the INNOVERSE Spinal System.

All instruments are made from Stainless Steel per ASTM F899. The INNOVERSE Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation™ Navigation System hardware and software.

AI/ML Overview

The provided text is a 510(k) Summary for the "INNOVERSE Navigation Instruments." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and, in this case, a single performance test. It does not contain information about a study designed to prove the device meets specific acceptance criteria in the way one might expect for an AI algorithm or diagnostic tool.

Instead, the performance data section of this document describes non-clinical testing for positional accuracy of the instruments themselves, not a clinical study involving human-in-the-loop performance or AI-driven diagnostic capabilities.

Therefore, many of the requested categories for the description of "the study that proves the device meets the acceptance criteria" are not applicable to the information provided.

Here's an attempt to answer based on the available text, with significant caveats where information is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document only explicitly mentions one performance test and its results.

Acceptance Criteria	Reported Device Performance
Positional Accuracy	The results of non-clinical testing show that the performance of the INNOVERSE Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (The specific numerical acceptance criteria and the actual measured positional accuracy are not provided in this summary, only the qualitative statement of sufficiency and substantial equivalence.)

Acceptance Criteria

Reported Device Performance

Positional Accuracy

The results of non-clinical testing show that the performance of the INNOVERSE Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (The specific numerical acceptance criteria and the actual measured positional accuracy are not provided in this summary, only the qualitative statement of sufficiency and substantial equivalence.)

2. Sample Size Used for the Test Set and Data Provenance

The document describes "non-clinical testing" for positional accuracy (per ASTM F2554-18). This typically involves testing the instruments in a laboratory setting, not on a "test set" of patient data.

Sample size for the test set: Not applicable in the context of patient data for an algorithm. The "sample" would refer to the number of instruments tested or the number of measurements taken, which is not specified.
Data provenance: Not applicable. The testing is non-clinical, likely performed in a lab.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for positional accuracy would be established by precision measurement equipment in a laboratory setting, not by human experts interpreting data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for human interpretation or multi-expert assessment, which is not described here. Positional accuracy is typically measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on the instruments themselves and their positional accuracy, not on human reader performance with or without AI assistance.

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

No, this is not a study of an algorithm's standalone performance. The device is a set of surgical instruments, not an AI or imaging algorithm.

7. The Type of Ground Truth Used

The ground truth for the single mentioned performance test (positional accuracy) would be based on precise physical measurements using calibrated equipment, as per the ASTM F2554-18 standard. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is a set of physical surgical instruments and does not involved a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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June 14, 2024

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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

Innosys Co., Ltd. % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K241082

Trade/Device Name: INNOVERSE Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 19, 2024 Received: April 19, 2024

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 (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" (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).

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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 QS 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.

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

Sincerely,

Eileen
Digitally signed by
Eileen Cadel -S
Date: 2024.06.14
Cadel -S 11:33:10-04'00'

for

Colin O'Neill, MBE Assistant Director DHT6B: Division of Spinal 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

Submission Number (if known)

K241082

Device Name

INNOVERSE Navigation Instruments

Indications for Use (Describe)

INNOVERSE Navigation Instruments are intended to be used during the preparation and placement of INNOVERSE Spinal System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in spinal procedures. These instruments are designed for use with the stereotactic navigation system Medtronic StealthStation™, 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

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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K241082 Page 1 of 1

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510(K) SUMMARY

Submitter's Name:	Innosys Co., Ltd.
Submitter's Address:	20, Sandan-Ro 76beon-Gil(Rd)Uijeongbu-Si, South Korea 11781
Submitter's Telephone:	+82 31-860-6839
Contact Person:	Nathan Wright, MS, RACEmpirical Technologies1-719-351-0248nwright@empiricaltech.comImage: Empirical Technologies Logo
Date Summary was Prepared:	April 19, 2024
Trade or Proprietary Name:	INNOVERSE Navigation Instruments
Device Classification Name:	Orthopedic Steretaxic Instrument
Classification & Regulation #:	Class II per 21 CFR §882.4560
Product Code:	OLO
Classification Panel:	Restorative, Repair and Trauma Devices (DHT6C)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The INNOVERSE Navigation Instruments include awls, probes, taps, and drivers and are to be used with the INNOVERSE Spinal System.

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
Intended Use and Function ●
Materials of manufacture ●
Manufacturing and Biocompatibility ●

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Sterilization and Packaging

510k Number	Trade or Proprietary or Model Name	Manufacturer	Product Code	Predicate Type
K223494	Navigated Reusable Instruments for use withStealthStation™ and IPCT™ Powerease™ Systems	Medtronic®	OLO	Primary
K233960	INNOVERSE Spinal System	Innosys Co., Ltd.	NKB	Reference

Predicate Devices

PERFORMANCE DATA

The INNOVERSE Navigation Instruments have been tested for positional accuracy 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 INNOVERSE Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and performance testing data lead to the conclusion that the INNOVERSE Navigation Instruments are 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).