The Resolute Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

Device Description

The Resolute Facet Screw System is comprised of various sized single-use, non-sterile facet screws that are designed to provide bilateral transfacet fixation of the lumbar facet joints. The system consists of titanium alloy (6AL-4v-EU per ASTM F136) screws in fully threaded and partially threaded designs, both of which are cannulated.

AI/ML Overview

This document describes the Resolute™ Facet Screw System, a medical device designed for spinal stabilization, and its regulatory submission (510(k)). The provided text does not describe an AI/ML powered medical device, an imaging device, or a study that uses acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).

Instead, this is a 510(k) summary for a traditional medical implant (facet screw system) where "acceptance criteria" and "performance data" refer to mechanical and material testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested fields regarding AI/ML device performance, reader studies, ground truth establishment, and training sets are not applicable.

Here's an analysis of the provided information in the context of the device:

1. A table of acceptance criteria and the reported device performance:

The document states: "Cantilever testing and engineering analysis was completed on the Resolute Facet Screw System." and "No new technical characteristics are being introduced with this product."

This implies that the acceptance criteria for the Resolute™ Facet Screw System would be to meet or exceed the mechanical performance (e.g., stiffness, strength) of the predicate devices (Spineology® Capture™ Facet Screw System (K092464) and NuVasive® Triad® Facet Screw System (K020411)) as demonstrated through cantilever testing and engineering analysis. The specific numerical acceptance criteria (e.g., minimum loads, deflections, fatigue cycles) are not provided in this summary but would have been part of the full submission.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Mechanical performance (e.g., stiffness, strength, fatigue resistance) equivalent to or better than predicate devices, as demonstrated by cantilever testing and engineering analysis.	"Cantilever testing and engineering analysis was completed on the Resolute Facet Screw System." Conclusion: "The overall technology characteristics and mechanical performance data lead to the conclusion that Resolute Facet Screw System is substantially equivalent to the predicate devices."
Material properties (titanium alloy 6AL-4v-ELI per ASTM F136) equivalent to predicate devices.	"The Resolute Facet Screw System screws are manufactured from titanium alloy (6AL-4v-ELI per ASTM F136), similar to the referenced predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

For a mechanical device like this, the "test set" would refer to the number of screws or test constructs used in the mechanical testing. This information is not provided in the given 510(k) summary. Data provenance is not applicable for this type of mechanical testing, as it's performed in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This question is not applicable. The "ground truth" for a mechanical device is established by physical laws and engineering standards, not expert clinical consensus. The testing would be conducted by engineers in a lab.

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

This question is not applicable. Adjudication methods are used for clinical or diagnostic data, not for mechanical testing of an orthopedic implant.

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:

This question is not applicable. This device is a surgical implant, not an imaging or diagnostic AI device. No reader studies would be performed.

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

This question is not applicable as this is a mechanical medical device, not an AI/ML algorithm.

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

The "ground truth" for this device's performance is based on engineering principles, material science, and relevant ASTM standards for mechanical testing of spinal implants. It's not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This question is not applicable. There is no "training set" for a mechanical medical device in the context of the provided information.

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

This question is not applicable for the same reason as above.

Summary

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5. 510(k) Summary

OCT 2 3 2012

Image /page/0/Picture/3 description: The image shows the logo for Neurostructures. The logo consists of a square divided into four smaller squares, with the top left square being solid black and the other three squares being grayscale. To the right of the square is the word "NEURO" in large, bold, sans-serif font, with the letters slightly spaced apart. Below "NEURO" is the word "STRUCTURES" in a smaller, sans-serif font, and above the "O" in "NEURO" is the trademark symbol.

Submitter's Name:	NeuroStructures
Submitter's Address:	63 Bovet Road, Suite 135San Mateo, CA 94402
Submitter's Telephone:	800-352-6103
Contact Name:	John Stephani
Date Summary was Prepared:	18 May 2012
Trade or Proprietary Name:	Resolute™ Facet Screw System
Common or Usual Name:	Screw, Fixation, Bone
Classification:	Unclassified
Product Codes:	MRW
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Device:	Spineology® Capture™ Facet Screw System (K092464)NuVasive® Triad® Facet Screw System (K020411)

Description of the Device Subject to Premarket Notification:

INDICATIONS FOR USE

Resolute Facet Screw System

Pg lo82

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Technical Characteristics

The Resolute Facet Screw System screws are manufactured from titanium alloy (6AL-4v-ELI per ASTM F136), similar to the referenced predicate devices. No new technical characteristics are being introduced with this product.

Performance Data

Cantilever testing and engineering analysis was completed on the Resolute Facet Screw System.

Conclusion

The overall technology characteristics and mechanical performance data lead to the conclusion that Resolute Facet Screw System is substantially equivalent to the predicate devices.

Resolute Facet Screw System

Pg 2002

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Neurostructures, LLC % Empirical Testing Corporation Ms. Meredith May, MS 4628 Northpark Drive Colorado Spring, Colorado 80918

Re: K121551

Trade/Device Name: Resolute Facet Screw System Regulatory Class: Unclassified Product Code: MRW Dated: September 06, 2012 Received: October 15, 2012

Dear Ms. May:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

OCT 23 2012

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Page 2 – Ms. Meredith May, MS

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

for
Melkerson

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

Enclosure

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K121551

4. Indications for Use Statement

Device Name: Resolute Facet Screw System

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Divisi Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

KIZISSI 510(k) Number_

Resolute Facet Screw System

Regulation Number and Section

N/A