The Aurora Spine ZIPTM MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T)-SI). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIPTM MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

Device Description

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Aurora Spine ZIP™ MIS Interspinous Fusion System is manufactured from titanium alloy (Ti-6A1-4V ELI in accordance with ASTM F136 or ISO 5832-3).

AI/ML Overview

This document describes a 510(k) submission for a medical device called the Aurora Spine ZIP™ MIS Interspinous Fusion System. It is a spinal implant, not an AI/ML device, and therefore the standard AI/ML device performance criteria, such as those related to accuracy, sensitivity, and specificity, are not applicable here.

Instead, the acceptance criteria for this type of device focus on substantial equivalence to existing legally marketed predicate devices, primarily demonstrated through biocompatibility, mechanical performance, and materials testing.

Here's an analysis based on the provided text, aligning with the spirit of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Testing
Material Equivalence	The device's material composition should be identical or substantially equivalent to that of predicate devices, with established history of safe use in the human body.	Manufactured from titanium alloy (Ti-6A1-4V ELI) in accordance with ASTM F136 or ISO 5832-3. This material is widely used and accepted in spinal implants, matching the expectations for predicate devices.
Biocompatibility	The device material must be biocompatible, meaning it does not produce adverse biological responses (e.g., cytotoxicity, sensitization, irritation) when in contact with tissues. (Although not explicitly detailed, this is an inherent requirement for all implantable devices).	Implicitly met through the use of Ti-6A1-4V ELI, a well-established biocompatible material for implantable devices. Further specific biocompatibility testing (e.g., ISO 10993 series) would have been performed and reviewed by the FDA, even if not explicitly summarized in this public document.
Mechanical Performance	The device must demonstrate mechanical strength and fatigue resistance suitable for its intended use, comparable to predicate devices. This includes static and dynamic loading scenarios to simulate physiological conditions. Specifically, performance against ASTM F1717 standards is mentioned for interspinous process distraction devices.	"Testing performed on this device indicates that the Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to predicate devices. ASTM F1717 performance standards were adhered to and all applicable requirements were met. This testing included static compression bending, static torsion, dynamic compression bending, and disassociation testing in UHMWPE test blocks." Results are stated to meet the standards, implying they are comparable or superior to the predicate devices.
Design and Function	The device's design and functional principles should be substantially equivalent to predicate devices to achieve the stated indications for use.	"The Aurora Spine ZIP™ MIS Interspinous Fusion System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used." It is described as a "bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes," consistent with the function of interspinous fusion devices.
Indications for Use	The device's intended clinical applications must be substantially equivalent to those of the predicate devices.	The text explicitly states the device "has the same indications for use" as the predicate devices. The specific indications for use are detailed in the "Indications For Use" section, covering degenerative disc disease, spondylolisthesis, trauma, and/or tumor, for supplemental fusion with bone graft material at single non-cervical levels.

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

Sample Size for Test Set: The document describes bench testing (mechanical testing), not a clinical study with patient samples. The "test set" here refers to the number of physical devices and test rigs used for mechanical evaluation. The exact number of devices tested for each mechanical test (static compression bending, static torsion, dynamic compression bending, and disassociation testing) is not specified in the provided 510(k) summary. However, such testing typically involves a statistically relevant number of samples to ensure reproducibility and reliability of results, as specified by the ASTM F1717 standard.
Data Provenance: The data provenance for this bench testing is the manufacturer's internal testing facilities or a contracted testing laboratory. There's no mention of patient data or clinical trials, as this is a 510(k) submission primarily relying on substantial equivalence to predicates through non-clinical data. The data is prospective in the sense that the tests were conducted specifically for this submission to demonstrate compliance.

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

This question is not applicable to this type of medical device submission. Ground truth, in the context of AI/ML or diagnostic devices, refers to a definitive diagnosis or outcome confirmed by human experts or other gold standards. For a spinal implant, "ground truth" is established by adherence to engineering standards (like ASTM F1717) and regulatory requirements, not by expert consensus on clinical cases. The "experts" in this context would be:
- Engineers and material scientists conducting and interpreting the mechanical tests based on established standards.
- FDA reviewers with expertise in orthopedic devices, biomechanics, and regulatory science, who evaluate the submitted data against compliance criteria. Their qualifications are not specified in the document but are inherent to their roles at the FDA.

4. Adjudication Method for the Test Set

This question is not applicable to this type of medical device. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies or expert review panels to resolve discrepancies in diagnoses or interpretations, typically for diagnostic or imaging devices. For mechanical performance testing, the "adjudication" is met by demonstrating that the test results satisfy the quantitative criteria defined by the ASTM F1717 standard. If there were discrepancies in test results, they would be handled through repeat testing, error analysis, or re-design, rather than an expert adjudication process as understood in clinical evaluation.

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. An MRMC study is relevant for diagnostic imaging AI/ML devices where the performance of human readers (e.g., radiologists) is compared with and without AI assistance. The Aurora Spine ZIP™ MIS Interspinous Fusion System is a surgical implant for spinal fusion and does not involve "human readers" or "AI assistance" in its direct function or evaluation for this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is a concept that does not apply here.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its 510(k) clearance, is demonstrated adherence to recognized consensus standards for mechanical performance (ASTM F1717) and material properties.
- It is not expert consensus on clinical cases, pathology, or outcomes data, as these are typically part of a higher-level regulatory pathway (PMA) or post-market surveillance for novel devices. For a 510(k), the "ground truth" for showing substantial equivalence rests on demonstrating that the device meets established engineering and material specifications that are known to be safe and effective for similar predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this device. Training sets are used to develop and refine AI/ML algorithms. This device is a manufactured physical good, not a software algorithm.

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

This question is not applicable for the same reasons as #8.

Summary

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510(k) Summary

Contact:	Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800	NOV 27 2013
Date Prepared:	November 26, 2013
Device Trade Name:	Aurora Spine ZIPTM MIS Interspinous Fusion System
Manufacturer:	Aurora Spine, Inc.1920 Palomar Point WayCarlsbad, CA 92008
Common Name:	Interspinous Fusion Device
Classification:	21 CFR §888.3050; Spinal interlaminal fixation orthosis
Class:	II
Product Code:	PEK

Indications For Use:

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T)-SI). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

Device Description:

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Predicate Device(s):

The Aurora Spine ZIP™ MIS Interspinous Fusion System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. These devices include the Lanx Spinous Process Fusion Plate (K071877) and the NuVasive Affix (K073278).

Performance Standards:

Testing performed on this device indicates that the Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to predicate devices. ASTM F1717 performance standards were adhered to and all applicable requirements were met. This testing included static compression bending, static torsion, dynamic compression bending, and disassociation testing in UHMWPE test blocks.

Conclusion:

The Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to predicate devices with respect to safety and effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the top half of the circle. Inside the circle is a stylized symbol resembling three abstract human figures or forms, with flowing lines suggesting movement or connection. The symbol is black, contrasting with the white background.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 27, 2013 Aurora Spine. Incorporated % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

Re: K133091

Trade/Device Name: Aurora Spine ZIP™ MIS Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: September 27, 2013 Received: September 30. 2013

Dear Mr. Eggleton:

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. Iisting 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 (reporting of medical device-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Justin Eggleton

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

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/ResourcesforYou/Industry/default.htm.

Sincercly yours,

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): K133091

Device Name: Aurora Spine ZIPTM MIS Interspinous Fusion System

The Aurora Spine ZIPTM MIS Interspinous Fusion is a posterior, non-pedicie supplemental fixation device, intended for use at a single level in the non-cervical spinc (TI-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with deveneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.c., fracture or dislocation), and/or tumor. The Aurora Spine ZIPTM MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

Prescription Usc (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)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133091

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.