The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (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 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

The Aurora Spine ZIPIM MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical 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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "ZIP™ MIS Interspinous Fusion System" by Aurora Spine, Incorporated. It describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices.

Based on the provided text, the device is a mechanical implant, not an AI/ML-driven device or an imaging device, and therefore the concepts of acceptance criteria regarding accuracy, precision, sensitivity, specificity, MRMC studies, or standalone algorithm performance are not applicable in the way they would be for AI-based diagnostic tools.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical and biological performance of the implant and its substantial equivalence to a predicate device.

Here's an attempt to answer the questions based on what is available and extrapolate where necessary, acknowledging the nature of the device:

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

The document does not explicitly present a discrete table of acceptance criteria with corresponding performance metrics in a format typical for AI/ML device evaluations. Instead, the acceptance criterion is implicitly "substantial equivalence" to a predicate device in terms of safety and effectiveness.

Acceptance Criteria (Implied)	Reported Device Performance
Material Properties & Biocompatibility: Equivalent to predicate device.	The device's nature (interspinous fusion system) implies use of biocompatible materials. The document states "no changes to the intended use of the device or its fundamental scientific technology," and mentions materials as a comparative factor ("materials" in predicate comparison section), suggesting equivalence implicitly accepted.
Mechanical Performance (Strength, Durability, Fixation): Equivalent to predicate device.	Non-Clinical Testing: Finite Element Analysis (FEA) testing was conducted. "FEA testing showed the additional geometries of the subject device do not offer a worst-case scenario as compared to the predicate ZIP™ MIS Interspinous Fusion System components." This implies the new geometries meet or exceed the performance of the predicate.
Functional Equivalence: Performs the same function as the predicate device.	"The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device... intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion." "No changes to the intended use of the device or its fundamental scientific technology."
Biomechanical Stability / Supplemental Fusion: Provides similar stability and promotes fusion as predicate device.	"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 FEA testing likely supports this.
Safety Profile: No new safety concerns compared to predicate.	No new safety concerns are mentioned. The substantial equivalence claim is based on "indications, design, function, performance and materials" being equivalent to the predicate.

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

Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial test set for software. The primary "test set" for this submission was the CAD models used for Finite Element Analysis (FEA) of the device's mechanical properties. The document does not specify the number of FEA models or simulations.
Data Provenance: The FEA testing would be computational and likely performed by the manufacturer or a contract lab. Country of origin of data is not specified but would be related to the location of the FEA execution. This is a non-clinical study.

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)

Ground Truth Experts: Not explicitly stated. For a mechanical device being evaluated via FEA, the "ground truth" for the FEA would be based on engineering principles, materials science data, and established biomechanical models. The expertise would lie with the engineers and scientists who designed the FEA models and interpreted the results. This doesn't involve medical experts in the way AI image analysis would.

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

Adjudication Method: Not applicable. This concept is typically for resolving discrepancies in human expert interpretations of ground truth for diagnostic tests. For FEA, the results are computational and typically verified through engineering checks and comparisons to known benchmarks or predicate device performance.

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

MRMC Study: No. This type of study is completely irrelevant for a mechanical interspinous fusion system. MRMC studies are for evaluating the diagnostic performance of AI algorithms, particularly in imaging.

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

Standalone Performance: Not applicable. This device is a surgical implant, not an algorithm. Its performance is physical and biological, not computational in a diagnostic sense.

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

Type of Ground Truth: For the non-clinical testing, the "ground truth" for the FEA simulations would be based on:
- Engineering principles and material properties: Known physical laws and validated material data.
- Predicate device performance data: The performance of the previously cleared predicate device serves as the benchmark against which the modified device is compared to establish substantial equivalence.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not use machine learning, so there is no "training set."

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary, this 510(k) submission is for a modification to a mechanical surgical implant. The "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device, primarily through non-clinical mechanical testing (Finite Element Analysis) rather than clinical studies or evaluations of AI performance.

Summary

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

November 17, 2014

Aurora Spine. Incorporated % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K141317

Trade/Device Name: 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 17, 2014 Received: September 18, 2014

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, 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 (reporting of medical device-related 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Sincerelv vours.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141317

Device Name ZIPTM MIS Interspinous Fusion System

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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Contact:	Justin EggletonDirector, Spine Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800jeggleton@mcra.com
Date Prepared:	November 17, 2014
Device Trade Name:	ZIP™ MIS ULTRA Interspinous Fusion SystemZIP™ 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

Summary of Technological Characteristics:

The purpose of this Special 510(k) is to introduce a line extension (ZIP™ Flared) to the Aurora Spine ZIP™ MIS Interspinous Fusion System that accommodates spinal level between T1 and S1 with greater lordosis. There have been no changes to the intended use of the device or its fundamental scientific technology.

Indications For Use:

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-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 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.

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Device Description:

Predicate Device:

The modified Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K140715, K133091) with respect to indications, design, function, performance and materials.

Non-Clinical Testing:

Finite Element Analysis (FEA) testing was provided to demonstrate substantial equivalence of the modified components compared to the predicate ZIP™ MIS system. FEA testing showed the additional geometries of the subject device do not offer a worst-case scenario as compared to the predicate ZIPTM MIS Interspinous Fusion System components.

Conclusion:

The Aurora Spine ZIP™ MIS Interspinous Fusion System has been modified to include modified spinous process fusion plates with different angles and spike orientations to accommodate varying degrees of lordosis. Substantial equivalence has been demonstrates to predicate ZIP™ MIS Interspinous Fusion System 510(k)s.

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.