Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.

Device Description

Spineology Navigation Instruments are non-sterile, reusable instruments; including awls, bone taps, drills, and screwdrivers that are operated manually. These instruments are manufactured from stainless steel in accordance with ASTM F899 and are intended to be used within the context and limitations of the indications for use for Spineology's FDA-cleared Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation® System S7 (v2.1.0).

AI/ML Overview

The provided text describes the 510(k) premarket notification for Spineology Navigation Instruments. This document demonstrates the substantial equivalence of the new instruments to a legally marketed predicate device, rather than proving a device meets specific clinical acceptance criteria through a standalone study.

Therefore, many of the requested details regarding acceptance criteria, device performance, sample size, ground truth, and expert involvement are not applicable as this is a regulatory submission for substantial equivalence based on technological characteristics and non-clinical testing, not a clinical effectiveness study.

Here's what can be extracted from the provided text based on your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a typical clinical study. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device. The performance is assessed through non-clinical testing focused on compatibility and accuracy within the context of the Medtronic StealthStation System.

Acceptance Criteria (Implied)	Reported Device Performance
Instrument Mating: Connection between the Medtronic NavLock Tracker Array and Spineology Navigation Instruments is functional.	Testing evaluated the connection, implying successful mating.
Registration: Spineology Navigation Instruments can be registered with the Medtronic StealthStation System.	Testing ensured instruments can be registered, implying successful registration.
Accuracy: Accuracy equivalent to Medtronic Navigation Instruments when used with the Medtronic StealthStation System.	Side-by-side comparison with equivalent Medtronic instruments was performed, implying comparable accuracy.
Safety and Effectiveness: No new issues of safety or effectiveness are introduced compared to the predicate device.	Risk assessment conducted to confirm no new issues.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of numerical count for instruments or specific test scenarios. The non-clinical testing generally refers to "Spineology Navigation Instruments."
- Data Provenance: The "Non-Clinical Testing" section describes in-house design verification activities performed by Spineology Inc. No specific country of origin for data is mentioned, and the testing is described as internal verification rather than external data collection. The tests are retrospective in the sense that they are internal design verification activities.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The "ground truth" for non-clinical engineering tests (like instrument mating, registration, and accuracy) is typically established by engineering specifications, validated measurement systems, and comparison to known good standards or predicate device performance, not by clinical experts establishing ground truth in the way it's done for diagnostic AI. The document does not mention external experts or their qualifications for establishing ground truth in these non-clinical tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments. The non-clinical tests described (instrument mating, registration, accuracy comparison) would involve objective measurements and comparisons against established metrics or predicate device performance, not clinical adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This document pertains to the clearance of surgical navigation instruments, not an AI-assisted diagnostic or interpretative device. Therefore, there is no mention of human readers, AI assistance, or effect sizes in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device (Spineology Navigation Instruments) is a physical surgical instrument intended for use with the Medtronic StealthStation System and by a surgeon (human-in-the-loop). It is not an algorithm that operates in a standalone capacity.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests described, the "ground truth" would be based on:
  - Engineering Specifications: For instrument mating and registration, the "ground truth" is that the instruments must correctly connect and register according to pre-defined engineering standards for the Medtronic StealthStation System.
  - Predicate Device Performance: For accuracy, the "ground truth" is the established accuracy of the equivalent Medtronic Navigation Instruments, to which the new Spineology instruments were compared.
- This is not clinical ground truth like pathology or outcomes data.
The sample size for the training set:
- This information is not applicable. There is no mention of a "training set" because this device is a physical instrument, not an AI or machine learning model that requires training data.
How the ground truth for the training set was established:
- This information is not applicable as there is no training set mentioned or implied for this device.

Summary

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May 2, 2018

Spineology Inc. % Jacqueline Hauge Regulatory Affairs Manager Spineology, Inc. 7800 3rd Street North, Suite 600 St. Paul, Minnesota 55128

Re: K180796

Trade/Device Name: Spineology Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 26, 2018 Received: March 27, 2018

Dear Jacqueline Hauge:

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. 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);

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ic product radiation control provisions (Sections 531-542 of the Act): 21 CFR

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 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)

K180796

Device Name Spineology Navigation Instruments

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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Date Prepared:	March 26, 2018
Submitter:	Spineology Inc.7800 3rd Street North, Suite 600Saint Paul, MN 55128
	Establishment Registration Number: 2135156
Contact Person:	Jacqueline A. HaugeRegulatory Affairs Manager
	Phone: 651.256.8534Fax: 651.256.8505Email: jhauge@spineology.com

Device Name and Classification

Trade Name:	Spineology Navigation Instruments
Common Name:	Orthopedic Stereotaxic instrument
Classification Name:	Stereotaxic Instrument
Product Codes:	OLO
Regulatory Class:	Class II
Regulation Number:	21 CFR 882.4560
Panel:	Orthopedic

Predicate Device

Spineology Navigation Instruments (Spineology Inc.) K172518

Purpose 1.

The purpose of this Premarket Notification is to obtain FDA clearance for the addition of Spineology Navigation Instruments to Spineology's FDA cleared Navigation Instrument set.

2. Device Description

A. Spineology Navigation Instruments

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B. Spineology Pedicular Fixation Systems

Spineology Fortress, Threshold V2, and Palisade Pedicular Fixation Systems consist of screws, curved and straight rods, and Connector devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. All screws are available with or without a hydroxyapatite coating. These systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.

3. Indications for Use

Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.

Technological Characteristics 4.

When compared to the predicate device, Spineology Navigation Instruments have the same intended use and equivalent technological characteristics, including:

Primary Design Features, including but not limited to, critical dimensions, distal (functional) end features (i.e., implant/inserter interface), and proximal end mating features (i.e., Medtronic NavLock Tracker Array interface)
Materials of Construction
. Fundamental Scientific Technology
Function/Performance
. Use with Medtronic StealthStation System
. Principle of Operation

5. Non-Clinical Testing

Spineology performed design verification activities to demonstrate that the design outputs of the subject Spineology Navigation Instruments met the design input requirements. Due to the substantial equivalence of the primary technological characteristics of the subject Spineology Navigation Instruments as compared to the predicate device, existing verification and validation testing previously provided to FDA was used to support the safety and effectiveness of the subject devices. Previously conducted testing included, but was not limited to, the following:

. Instrument mating testing which evaluated the connection between the Medtronic NavLock Tracker Array and Spineology Navigation Instruments.
. Registration testing which ensured that Spineology Navigation Instruments can be registered to the Medtronic StealthStation System.

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. Accuracy testing which included side-by-side comparison of Spineology Navigation Instruments to equivalent Medtronic Navigation Instruments intended for use with the Medtronic StealthStation System.
In addition to design verification, Spineology conducted a risk assessment to confirm that the subject Spineology Navigation Instruments do not introduce new issues of safety or effectiveness.

6. Clinical Testing

Clinical testing was not performed or required to establish the substantial equivalence of Spineology Navigation Instruments to the predicate device.

7. Conclusion

Spineology has demonstrated the substantial equivalence of the subject Spineology Navigation Instruments through the comparison of these devices to the legally marketed predicate device and confirmed that the intended use is the same and any difference in technological characteristics between the subject and predicate device do not raise new issues of safety and effectiveness.

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).