The SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Device Description

The SeaSpine Navigation System reusable instruments are Class II, manual, surgical instruments for use with the Medtronic StealthStation Navigation System S7 (v.2.1.0) and NavLock Tracker, to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of SeaSpine implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. The instruments are manufactured from stainless steel per ASTM F899.

The SeaSpine Navigation Instruments include the following:

Taps .
Awl/Tap
Probe ●
Drills ●
Drill/Tap Guides

The SeaSpine Navigation Instruments are to be used with the following FDA cleared SeaSpine Spinal Systems:

Atoll
Coral/Coral MIS ●
Malibu Spinal System/Daytona ●
Malibu Spinal System
Daytona Small Stature ●
Mariner Spinal System
NewPort MIS ●
. Sierra

AI/ML Overview

This document describes the premarket notification (510(k)) for the SeaSpine Navigation System. Based on the provided text, the device is a set of reusable surgical instruments intended to assist surgeons in spinal surgery by precisely locating anatomical structures when used with the Medtronic StealthStation System.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of acceptance criteria and the reported device performance:

The document does not present explicit, quantitative acceptance criteria in a pass/fail table with numerical targets. Instead, the "Non-Clinical Testing" section describes a series of tests performed to ensure "compatibility, accuracy, function, and performance" of the SeaSpine Navigation System reusable instruments, aiming for substantial equivalence to predicate devices. The reported device performance is qualitative, stating that the tests were completed and "demonstrate that the SeaSpine Navigation System reusable instruments are substantially equivalent to the predicate."

Here's a summary of the tests and their qualitative outcomes as reported:

Test	Description	Reported Performance
Registration	Performed to ensure the SeaSpine Navigation Instruments can be registered to the StealthStation.	Testing was performed to ensure registration capability. (Implies successful registration)
Navigation Accuracy	Completed for comparison to the reference instruments.	Accuracy testing was completed. (Implies satisfactory accuracy compared to reference)
Anatomical Simulated Use	Confirmed instrument functionality under expected use conditions.	Confirmed instrument functionality under expected use conditions.
Navigation Simulated Use	Confirmed the SeaSpine Navigation System functionality under expected use conditions.	Confirmed the SeaSpine Navigation System functionality under expected use conditions.
CAD Model Evaluation	Verified the CAD models are accurately reflected in the application software.	Verified CAD models are accurately reflected.
Rigidity	Evaluated the connection between the tracker and the instruments.	Rigidity testing evaluated the connection. (Implies satisfactory rigidity)
Implant/Instruments Mating Conditions	Verified the instruments can be assembled with the appropriate devices according to their intended use.	Verified proper assembly according to intended use.
Compatibility with the Medtronic StealthStation Navigation System	Evaluated to ensure the SeaSpine Navigation Instruments are compatible with the Medtronic StealthStation Navigation System.	Compatibility has been evaluated to ensure compatibility.

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

The document describes "engineering analysis" and "non-clinical testing" which involve physical testing of instruments and CAD model evaluation. It does not refer to a "test set" in the context of patient data or clinical images. The data provenance is from the manufacturer's internal testing as part of their 510(k) submission. No information about country of origin of data or whether it's retrospective/prospective is provided as it's not a clinical study.

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

This is not applicable. The evaluations are engineering tests (e.g., dimensional measurements, rigidity, functional checks with the navigation system), not interpretations of clinical data requiring expert consensus or ground truth establishment by medical professionals.

4. Adjudication method for the test set:

Not applicable. There's no clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The device is a set of surgical instruments used with a navigation system, not an AI-powered diagnostic or assistive tool that would typically undergo an MRMC study. The submission focuses on substantial equivalence based on engineering and functional testing of the instruments themselves.

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

Not applicable. The device is a physical set of instruments, not a standalone algorithm. Its function is explicitly with human-in-the-loop (the surgeon) and with another medical device (Medtronic StealthStation System).

7. The type of ground truth used:

The "ground truth" for this device's evaluation is primarily based on:

Engineering specifications and measurements: For dimensional accuracy, rigidity, etc.
Functional performance criteria: Ensuring instruments register correctly, mate properly, and function as intended with the predicate navigation system.
Comparison to predicate devices: The goal is substantial equivalence, meaning the performance is comparable to already marketed devices.

It is not based on expert consensus, pathology, or outcomes data, as this is a device for surgical assistance, and the submission primarily relies on non-clinical performance data for substantial equivalence.

8. The sample size for the training set:

Not applicable. This device is a set of physical instruments engineered for specific functions. There isn't a "training set" in the machine learning context.

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

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

Summary

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May 11, 2018

SeaSpine Orthopedics Corporation Gina Flores Sr. Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008

Re: K172517

Trade/Device Name: SeaSpine Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 5, 2018 Received: April 6, 2018

Dear Gina Flores:

We have reviewed vour 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172517

Device Name

SeaSpine Navigation 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)

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510(k) Summary

K172517

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:Phone number:Fax number:	5770 Armada Drive, Carlsbad CA(760) 216-5136(760) 683-6874
Contact person:Email address:	Gina Flores, Sr. Regulatory Specialistgina.flores@seaspine.com
Date Prepared:	April 5, 2018
Device Name:
Trade Name:	SeaSpine Navigation System
Common Name:	Orthopedic Stereotaxic Instrument
Classification Name:	Stereotaxic Instrument
Class:	II
Product Code:	OLO

Legally Marketed Predicate Devices

510(k)	Product Code	Trade Name	Manufacturer
Number
PRIMARY PREDICATE Device
K124004 K140454	OLO, HBE	Navigated CD Horizon SoleraScrewdrivers and Taps	Medtronic SofamorDanek, USA Inc.
SECONDARY PREDICATE Devices
K143628	OLO	Navigated VERTEX SELECTInstruments	Medtronic SofamorDanek, USA Inc.
K153603	OLO	Alphatec NavigationInstruments	Alphatec Spine Inc.

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Device Description

The SeaSpine Navigation Instruments include the following:

Taps .
Awl/Tap
Probe ●
Drills ●
Drill/Tap Guides

The SeaSpine Navigation Instruments are to be used with the following FDA cleared SeaSpine Spinal Systems:

Atoll
Coral/Coral MIS ●
Malibu Spinal System/Daytona ●
Malibu Spinal System
Daytona Small Stature ●
Mariner Spinal System
NewPort MIS ●
. Sierra

Intended Use/Indications for use

The SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation System reusable instruments are specifically 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Summary of Technological Characteristics

The SeaSpine Navigation System is equivalent to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance.

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Non-Clinical Testing

Engineering analysis demonstrate that the subject SeaSpine Navigation System reusable instruments are substantially equivalent to the predicate in compatibility, accuracy, function, and performance. Engineering analysis includes dimensional measurements of both predicate and subject devices.

Test	Description
Registration	Registration testing was performed to ensure the SeaSpineNavigation Instruments can be registered to theStealthStation
Navigation Accuracy	Accuracy testing was completed for comparison to thereference instruments
Anatomical Simulated Use	Confirmed instrument functionality under expected useconditions
Navigation Simulated Use	Confirmed the SeaSpine Navigation System functionalityunder expected use conditions
CAD Model Evaluation	Verified the CAD models are accurately reflected in theapplication software
Rigidity	Rigidity testing evaluate the connection between thetracker and the instruments.
Implant/InstrumentsMating Conditions	Verified the instruments can be assembled with theappropriate devices according to their intended use
Compatibility with theMedtronic StealthStationNavigation System	Compatibility has been evaluated to ensure the SeaSpineNavigation Instruments are compatible with the MedtronicStealthStation Navigation System

Therefore, it can be concluded that the compatibility, accuracy, function, and performance of the subject SeaSpine Navigation System instruments are substantially equivalent to the predicate navigation instruments when used with the Medtronic StealthStation System.

Clinical Testing

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

Conclusions

The submitted data demonstrate that the SeaSpine Navigation System is substantially equivalent to the cited legally marketed predicate.

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).