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.

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 a 510(k) premarket notification for Spineology Navigation Instruments, specifically concerning the addition of an Adapter to an existing cleared instrument set.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

This document does NOT describe the performance of an AI-powered device or a study with specific performance metrics (like sensitivity, specificity, AUC, etc.) typically associated with AI/ML systems. Instead, it describes a medical device (surgical instruments) cleared under the 510(k) pathway, where the primary demonstration of safety and effectiveness relies on "substantial equivalence" to a predicate device.

Therefore, many of the requested items (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance, training set details) are not applicable in the context of this specific regulatory submission. The "study" described is primarily non-clinical testing focused on design verification and risk assessment for the adapter, rather than clinical performance of an AI algorithm.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of device clearance:

Acceptance Criteria and Device Performance (as demonstrated for this type of device):

The "acceptance criteria" for a 510(k) submission for a non-AI medical device like this are primarily demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety/effectiveness.

Acceptance Criteria (for 510(k) based on substantial equivalence)	Reported Device Performance (as demonstrated by Spineology)
Intended Use Equivalence: Same indications for use as predicate.	Spineology Navigation Instruments have the same intended use as the predicate device. They are intended for use during preparation and placement of pedicle screws in spinal surgery to assist in locating anatomical structures, designed for use with the Medtronic StealthStation® System.
Technological Characteristics Equivalence: Key features (design, materials, function, principle of operation) are substantially equivalent. Any differences do not raise new issues of safety or effectiveness.	The device has the same primary design features (includes critical dimensions, distal/proximal end features), materials of construction (stainless steel per ASTM F899), fundamental scientific technology, function/performance, and principle of operation as the predicate device. It also maintains use with the Medtronic StealthStation System.
Safety and Effectiveness: Demonstrated through non-clinical testing and risk assessment for any changes (e.g., the adapter).	Non-Clinical Testing: Design verification activities were performed to ensure design outputs met input requirements. Testing of the Adapter included assessment of instrument mating and confirmation that performance of Spineology Navigation Instruments is unaffected by use of the Adapter. Risk Assessment: A risk assessment was conducted to confirm the Adapter does not introduce new safety or effectiveness issues.
No New Issues of Safety or Effectiveness: Clearances are based on not introducing new risks.	Differences in technological characteristics between the subject and predicate device do not raise new issues of safety and effectiveness.

Detailed Study Information (largely N/A for this 510(k) submission):

Sample size used for the test set and the data provenance:
- N/A. This clearance is for surgical instruments, not an AI model evaluated on a "test set" of patient data. The "testing" involved non-clinical design verification (e.g., instrument mating, performance confirmation) for the adapter. The exact sample size for these non-clinical tests is not specified in the summary, but it would typically involve a sufficient number of units to demonstrate design integrity, not a patient data sample.
- Data Provenance: N/A. No patient data provenance specified as clinical data was not required.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth establishment by experts for a test set of patient data is not relevant to this submission, as no clinical study evaluating interpretation or diagnosis was performed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not applicable, as there was no test set requiring expert 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:
- N/A. This device is a set of surgical instruments, not an AI or imaging diagnostic aid. No MRMC study was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. Not applicable, as this is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No ground truth from patient data was established or used, as no clinical performance study was conducted. The "ground truth" for the non-clinical testing was based on design specifications and engineering requirements.
The sample size for the training set:
- N/A. This device does not involve a "training set" in the context of machine learning or artificial intelligence.
How the ground truth for the training set was established:
- N/A. Not applicable.

Summary of the "Study" (Non-Clinical Testing for Substantial Equivalence):

The "study" conducted for this 510(k) submission was a series of non-clinical design verification activities focused on the newly added Adapter to the Spineology Navigation Instruments.

Purpose: To demonstrate that the design outputs of the subject Spineology Navigation Instruments (with the adapter) met the design input requirements and that the adapter did not introduce new issues of safety or effectiveness.
Methods:
- Assessment of instrument mating (how the adapter fits with other instruments).
- Confirmation that the performance of Spineology Navigation Instruments is unaffected by the use of the Adapter.
- A risk assessment to confirm no new safety or effectiveness issues.
Conclusion: Spineology demonstrated substantial equivalence to the predicate device, confirming the same intended use and that any differences in technological characteristics (specifically the addition of the adapter) did not raise new issues of safety and effectiveness.
Clinical Testing: Explicitly stated as "Clinical testing was not performed or required to establish the substantial equivalence of Spineology Navigation Instruments to the predicate device."

Summary

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September 21, 2018

Spineology Inc Karen Roche VP, Operations & Technologies 7800 Third Street N., Suite 600 St. Paul, Minnesota 55128

Re: K182345

Trade/Device Name: Spineology Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 27, 2018 Received: August 28, 2018

Dear Karen Roche:

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.

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182345

Device Name Spineology Navigation Instruments

Indications for Use (Describe)

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 indical 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.

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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Spineology ***

510(k) Summary

Date Prepared:	September 18, 2018
Submitter:	Spineology Inc.7800 3rd Street North, Suite 600Saint Paul, MN 55128
Establishment Registration Number:	2135156
Contact Person:	Karen RocheVice President, Operations & Technology
	Phone: 651.256.8513Fax: 651.256.8505Email: kroche@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

Predicate Device

K180796, K172518 Spineology Navigation Instruments (Spineology Inc.)

Orthopedic

Purpose 1.

Panel:

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

Device Description 2.

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 Connex 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

4. Technological Characteristics

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
. 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. Testing of the Adapter included, but was not limited to, assessment of instrument mating and confirmation that performance of Spineology Navigation Instruments is unaffected by use of the Adapter.

Spineology conducted a risk assessment to confirm that the subject Adapter for Spineology Navigation Instruments does 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.

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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 differences 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).