Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

Integrity Implants Navigated Instruments are specifically designed for use with Medtronic's 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, finages, or digitized landmarks of the anatomy.

Device Description

The Integrity Implants Navigated Instruments include non-sterile screw drivers, cannulated and solid taps (4.0 - 10.5 mm), probes, and awls designed to function with the Medtronic StealthStation® System and NavLock® Tracker. The subject devices are for use with the Integrity Implants LineSider® Spinal System (K190360 and K203367). The instruments are manufactured from stainless steel and Radel.

AI/ML Overview

The provided text is a 510(k) summary for the Integrity Implants Navigated Instruments. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for performance as an AI/ML-driven diagnostic or prognostic device.

However, I can extract information related to performance testing and acceptance criteria as much as possible from the provided text, while acknowledging that it's not a typical study report for acceptance criteria in the sense of accuracy, sensitivity, or specificity for AI/ML.

Here's a breakdown of the information based on your request, with limitations due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Reported Device Performance (from text)
Functionality & Compatibility	"Performance testing of the subject devices, including accuracy testing in accordance with ASTM F2554-18, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems, was completed to ensure the functionality and compatibility of the Integrity Implants Navigated Instruments with the Medtronic StealthStation® Surgical System and the NavLock® Tracker."
Registration with StealthStation System	"Registration testing was performed to ensure the instruments can be registered with the StealthStation System."
Dimensional Equivalence	"A dimensional analysis was conducted to demonstrate that the subject devices are substantially equivalent to the predicate devices."
Cleaning and Sterilization Validation	"Cleaning and sterilization validation data from K190360 were leveraged in support of the substantial equivalence determination."
Safety and Effectiveness	"The information provided above supports that the Integrity Implants Navigated Instruments are as safe and effective as the predicate device."

Limitations: The document does not provide specific quantitative acceptance criteria (e.g., "positional accuracy must be within X mm") or specific quantitative results for each test. It states that tests were "completed to ensure" functionality and compatibility and that the devices are "as safe and effective" as the predicate, implying that acceptance criteria were met, but without detailing them.

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

The document does not specify a "test set sample size" or "data provenance" in the context of typical AI/ML performance studies (e.g., number of images, patient demographics). The performance data cited refers to:

Accuracy testing: Performed in accordance with ASTM F2554-18. This standard likely dictates the setup and number of measurements, but the specific details (e.g., number of physical instruments tested, number of measurement points per instrument) are not provided.
Registration testing: Details on the sample size (e.g., number of instruments registered, number of registration attempts) are not provided.
Dimensional analysis: This likely involved comparing instrument dimensions, but the "sample size" here refers to the number of device types/models evaluated, which can be inferred from Section IV and the comparison table.
Cleaning and sterilization validation data: Leveraged from a previous 510(k) (K190360). This implies prior validation studies were conducted, but their specific sample sizes are not detailed in this 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 and not provided in the document. This device is a surgical instrument intended for use with a navigation system, not a diagnostic or prognostic AI/ML device that generates clinical findings requiring expert ground truth for a test set. The "ground truth" for its performance would be engineering measurements and physical tests.

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

Not applicable, as this is not an AI/ML diagnostic/prognostic device relying on human expert review for ground truth.

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

Not applicable. This is not an AI-assisted diagnostic or prognostic device that involves human readers interpreting output. It's a navigated surgical instrument.

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

This concept is somewhat applicable in the sense that the navigational system's accuracy and the instrument's compatibility with it can be tested independently of a surgeon's clinical use. The "accuracy testing in accordance with ASTM F2554-18" and "registration testing" would fall under this category of standalone performance assessment of the instrument's interaction with the navigation system. The document does not, however, detail specific performance metrics or results from these standalone tests beyond stating they were performed.

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

For the type of device described, the "ground truth" would be established through:

Physical measurements and engineering standards: For accuracy (e.g., comparing navigated position to physically measured position in a test setup per ASTM F2554-18).
Functional tests: To confirm proper registration and compatibility with the StealthStation system.
Dimensional specifications: For dimensional analysis.

It is not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a "training set" process.

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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December 23, 2021

Integrity Implants Inc. % Roshana Ahmed Sr. Regulatory Specialist TELOS Partners, LLC 571 Christina Lake Drive Lakeland, Florida 33813

Re: K212088

Trade/Device Name: Integrity Implants Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 22, 2021 Received: November 24, 2021

Dear Roshana Ahmed:

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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Indications for Use

510(k) Number (if known) K212088

Device Name

Integrity Implants Navigated Instruments

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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510(k) Summary

I. Submitter

Integrity Implants Inc. 354 Hiatt Drive Palm Beach Gardens, FL 33418 Phone: 561-529-3861

Contact Person: Roshana Ahmed, M.A., RAC, Senior Regulatory Specialist, Telos Partners LLC Secondary Contact Person: Lauren Kamer, Sr. Director of Reg Affairs, Integrity Implants Inc.

Date Prepared: December 22, 2021

II. Device

Device Proprietary Name:	Integrity Implants Navigated Instruments
Common or Usual Name:	Navigation Instruments
Classification Name:	Stereotaxic Instruments
Regulation Number:	21 CFR 882.4560
Product Code:	OLO
Device Classification:	II

III. Predicate Device

Substantial equivalence is claimed to the following primary predicate devices:

Navigated CD Horizon Solera Screwdriver/Taps, K140454, Medtronic Sofamor Danek ● USA, Inc.
The following secondary predicate devices are cited within the submission:
LineSider® Spinal System, K190360, Integrity Implants, Inc. ●
LineSider® Spinal System, K203367, Integrity Implants, Inc. ●

IV. Device Description

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V. Indications for Use

VI. Comparison of Technological Characteristics

The navigated instruments are identical to the predicate navigated instruments in that they are both intended to be used during the preparation and placement of implants during spinal surgery. incorporate the same design features to ensure navigation and compatibility with the Medtronic StealthStation® System and NavLock® Tracker to precisely locate anatomical structures, are made from the same materials, and utilize the same sterilization methods. The devices are equivalent in dimensions to the predicate instruments.

The table below compare the indications for use and key technological features between the subject and predicate device.

Parameter	Subject Device	Navigated CD HorizonSolera Screwdriver/Taps(K140454)	Analysis
Manufacturer	Integrity Implants Inc.	Medtronic Sofamor DanekUSA, Inc.	N/A
Indications for Use	Integrity Implants NavigatedInstruments are intended to beused during the preparationand placement of IntegrityImplants spinal implantsduring spinal surgery to assistthe surgeon in preciselylocating anatomical structuresin either open or minimallyinvasive procedures.Integrity Implants NavigatedInstruments are specifically	Medtronic NavigatedReusable Instruments areintended to be used during thepreparation and placement ofMedtronic screws duringspinal surgery to assist thesurgeon in precisely locatinganatomical structures in eitheropen or minimally invasiveprocedures.Medtronic NavigatedReusable Instruments are	SubstantiallyEquivalent
Parameter	Subject Device		Navigated CD HorizonSolera Screwdriver/Taps(K140454)	Analysis
Probes andAwls		designed for use withMedtronic's StealthStationSystem, which is indicatedfor any medical condition inwhich the use of stereotacticsurgery may be appropriate,and where reference to a rigidanatomical structure, such asvertebra, can be identifiedrelative to a CT or MR-basedmodel, fluoroscopy images,or digitized landmarks of theanatomy.	specifically designed for usewith the StealthStation®System, which is indicatedfor any medical condition inwhich the use of stereotacticsurgery may be appropriate,and where reference to a rigidanatomical structure, such asa skull, a long bone, orvertebra, can be identifiedrelative to a CT or MR basedmodel, fluoroscopy images,or digitized landmarks of theanatomy.Medtronic NavigatedReusable Instruments are alsocompatible with the IPC®POWEREASET™ System.
	TipGeometry	Trocar tip (Awl)Tapered Straight ProbeDuckbilled Straight Probe	Trocar tip (Awl),Tapered (aka Thoracic) ProbeDuckbilled (aka Lumber)Probe	Substantiallyequivalent
	Materials	Stainless Steel	Stainless Steel
Taps	Diameter	4.0 - 8.5 mm	3.75 - 8.5 mm	Substantiallyequivalent
	Design	Solid or cannulatedDual Lead, Quad Lead	Solid or cannulatedDual Lead
	Materials	Stainless Steel	Stainless Steel
Drivers	Diameter	5.5 - 6.0 mm	5.5 - 6.0 mm	Substantiallyequivalent
	Materials	Stainless Steel and Radel	Stainless Steel	Substantiallyequivalent
Sterilization		Non-Sterile	Non-Sterile	Substantiallyequivalent

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VII. Performance Data

Performance testing of the subject devices, including accuracy testing in accordance with ASTM F2554-18, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems, was completed to ensure the functionality and compatibility of the Integrity Implants Navigated Instruments with the Medtronic StealthStation® Surgical System and the NavLock® Tracker.

Registration testing was performed to ensure the instruments can be registered with the StealthStation System.

A dimensional analysis was conducted to demonstrate that the subject devices are substantially equivalent to the predicate devices.

Cleaning and sterilization validation data from K190360 were leveraged in support of the substantial equivalence determination.

VIII. Conclusion

The information provided above supports that the Integrity Implants Navigated Instruments are as safe and effective as the predicate device. Although minor differences in design and technology exist between the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the Integrity Implants Navigated 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).