Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The NAUTILUS Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the NAUTILUS Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

Device Description

The NAUTILUS Spinal System consists of an assortment of rods, screws, and cross connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Spinal System screw assembly component. The cross connectors are also assembled during manufacturing. Do not use any of the NAUTILUS Spinal System components with the components from any other system or manufacturer.

AI/ML Overview

The NAUTILUS Spinal System is a medical device and its "acceptance criteria" and "study that proves the device meets the acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, rather than clinical performance metrics typical of AI/software devices. Therefore, the questions related to AI/software performance metrics (like sample size for test set, experts for ground truth, MRMC study, standalone performance) are not applicable in this context.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Substantial Equivalence)	Reported Device Performance (Means of Demonstration)
Design Substantial Equivalence	Same basic design principle (pedicle screw system for posterior spinal fixation).
Material Substantial Equivalence	Manufactured from 6AL-4V-ELI titanium according to ASTM F136; variety of non-sterile, single-use components.
Indications for Use Substantial Equivalence	Intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients as an adjunct to fusion, for conditions like degenerative disc disease, trauma, curvatures, spinal tumor, failed previous fusion, pseudarthrosis, spinal stenosis, and spondylolisthesis. This perfectly matches the predicate devices.
Sizing Substantial Equivalence	Not explicitly detailed, but stated as being substantially equivalent in sizing to predicate systems. Implies similar range and types of components.
Performance (Mechanical) Substantial Equivalence	Static compression, static torsion, and dynamic compression testing per ASTM F1717 presented. These tests demonstrate substantial equivalency to the mechanical performance of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable: This is a mechanical device, not an AI/software device. There is no "test set" in the context of image analysis or algorithm performance. The data provenance would relate to the mechanical testing, which is performed in a laboratory setting. The document only states "Static compression, static torsion, and dynamic compression testing per ASTM F1717 was presented". The specific number of samples for each test type is not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not Applicable: There is no "ground truth" in the clinical or image analysis sense for this type of device submission. Substantial equivalence is established through comparison of design, materials, indications, and mechanical testing against recognized standards (ASTM F1717) and predicate devices.

4. Adjudication Method for the Test Set

Not Applicable: See point 3.

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 a physical spinal system, not an AI or software device that assists human readers.

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

Not Applicable: This is a physical spinal system; there is no algorithm or standalone performance in the context of AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not Applicable (in the conventional sense): The "ground truth" for this device's acceptance is its compliance with recognized mechanical testing standards (ASTM F1717) and its similarity in design, materials, and indications for use to already legally marketed predicate devices (CONQUEST Spinal System K080767, Pilot Spinal System K063601, ARX Spinal System K061600). The "truth" is established by showing it performs comparably and is structurally similar to devices already deemed safe and effective.

8. The Sample Size for the Training Set

Not Applicable: There is no "training set" for this type of medical device submission.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: See point 8.

Summary

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510(k) Summary NAUTILUS Spinal System

7 2012 AUG

Submitted By:

Life Spine, Inc. 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118

510(k) Contact:

Randy Lewis Life Spine 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118

Date Prepared:

Trade Name:

Common Name:

Classification:

NKB, CFR 888.3070, Class III MNH, CFR 888.3070, Class II MNI, CFR 888.3070, Class II

NAUTILUS Spinal System

Pedicle Screw Spinal System

July 6th, 2011

· Predicate Device:

CONQUEST Spinal System (K080767), Pilot Spinal System (K063601), ARX Spinal System (K061600)

Device Description:

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Intended Use of the Device:

Technological Characteristics:

The NAUTILUS Spinal System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

Material:

The NAUTILUS Spinal System is 6AL-4V-ELI titanium manufactured according to ASTM F136. The device is comprised of a variety of non-sterile titanium, single use components.

Performance Data:

Static compression, static torsion, and dynamic compression testing per ASTM F1717 was presented to demonstrate the substantial equivalency of the NAUTILUS Spinal System.

Conclusion:

The information presented demonstrates the substantial equivalency of the Nautilus Spinal System

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight. The symbol is composed of three curved lines that converge and then separate, creating a sense of movement and dynamism.

AUG

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

7 2012

Regulatory Affairs, Quality Assurance Manager 2401 West Hassell Road, Suite 1535

Re: K111953

Life Spine, Incorporated % Mr. Randy Lewis

Hoffman Estates, Illinois 60169

Trade/Device Name: NAUTILUS Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: July 06, 2012 Received: July 09, 2012

Dear Mr. Lewis:

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

{3}------------------------------------------------

Page 2 - Mr. Randy Lewis

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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Indications for Use

510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: NAUTILUS Spinal System

When used as a posterior spine thoracic/lumbar system, the NAUTILUS Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

Prescription Use x (Part 21 CFR 801 Subpart D) And/Or

Over-the-Counter Use (21 CFR 807 Subpart C)

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

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.