The Spine Innovation Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Spine Innovation Interbody System is intended for use with autograft and is intended for use with supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Spine Innovation Interbody System.

Device Description

The Spine Innovation Interbody System is an interbody fusion device and corresponding instruments intended to stabilize the spinal segment to promote fusion. The Spine Innovation Interbody consists of PEEK walls, an autogenous material aperture, two titanium linkages that connect the PEEK walls, angular anti-migration teeth, and tantalum x-ray markers.

The Spine Innovation Interbody is available in various sizes to accommodate varying patient anatomy. The Spine Innovation Interbody is available in undeployed widths ranging from 8-12mm, heights ranging from 8-16mm, lengths of 26 or 30mm, and lordotic angles of 0° (parallel), 5°, 10° or 15°.

The Spine Innovation Interbody System implants are intended to be inserted posteriorly via an open or minimally invasive approach.

The Spine Innovation Interbody System is non-sterile and is to be sterilized by the end user.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the Spine Innovation Interbody System, a medical device for spinal fusion. As such, it describes the acceptance criteria for substantial equivalence to a predicate device, focusing on non-clinical performance testing and technological characteristics, rather than performance of an AI/ML device or a device with a human-in-the-loop component.

Therefore, many of the requested items (e.g., number of experts, adjudication methods, MRMC studies, standalone AI performance, training set details) are not applicable to this type of medical device submission.

Here's a breakdown of what is available and what is not:

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

The acceptance criteria here are based on demonstrating substantial equivalence to predicate devices through mechanical performance testing. The "reported device performance" is that the Spine Innovation Interbody System met these criteria.

Acceptance Criteria (Bench Tests)	Reported Device Performance
Static and Dynamic Axial Compression per ASTM F2077	Indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
Static and Dynamic Shear Compression per ASTM F2077	Indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
Custom Static Shear Compression Test	Indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
Subsidence per ASTM F2267	Indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
Expulsion per ASTM Draft Standard F04.25.02.02	Indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
Cadaveric testing for surgical technique validation	Validated the surgical technique.

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

Test Set Sample Size: This document doesn't specify the exact number of devices (sample size) for each mechanical test. The ASTM standards typically outline the minimum number of samples required for such tests.
Data Provenance: The tests are benchtop mechanical tests and cadaveric testing. The document does not specify the country of origin of the data or whether it's retrospective or prospective, as these terms are generally more relevant to clinical studies involving human subjects or AI/ML model development.

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)

Not Applicable. Ground truth, in the context of expert consensus, radiologists, etc., is not relevant to the mechanical bench testing of an interbody fusion device. The "ground truth" for these tests are the established ASTM standards and the performance of the predicate devices.

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

Not Applicable. Adjudication methods are not relevant to mechanical bench testing.

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 medical device, not an AI/ML product or a product 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 medical device, not an algorithm.

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

The "ground truth" for these tests are the established mechanical performance standards (ASTM) and the demonstrated performance of legally marketed predicate devices. The device is considered to meet acceptance criteria if its mechanical performance is substantially equivalent to these benchmarks.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set. The device manufacturing processes are subject to Good Manufacturing Practice (GMP) requirements.

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

Not Applicable. See point 8.

Summary

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Image /page/0/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 a caduceus, a traditional symbol of medicine, but with three lines instead of one.

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

January 14, 2016

Spine Innovation, LLC % Mr. Jude Paganelli Cor Medical Ventures, LLC 215 South Highway 101, Suite 200 Solana Beach, California 92075

Re: K153356

Trade/Device Name: Spine Innovation Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 19, 2015 Received: November 20, 2015

Dear Mr. Paganelli:

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 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.

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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/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 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.

Sincerely 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K153356

Device Name Spine Innovation Interbody 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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K153356 Page 1 of 1

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510(k) Summary

SUBMITTER:	Spine Innovation LLC215 S. Highway 101, Suite 200Solana Beach, CA 92075858-774-7891
CONTACT PERSON:	Jude Paganelli
DATE PREPARED:	November 19, 2015
TRADE NAME:	Spine Innovation Interbody System
COMMON NAME:	Intervertebral Body Fusion Device
CLASSIFICATION NAME:	Intervertebral Body Fusion Device (21 CFR 888.3080)
PRODUCT CODE:	MAX

SUBSTANTIAL EQUIVALENCE:

The Spine Innovation Interbody System is substantially equivalent to the competitive devices in all facets including: function, design, performance, material, and intended use.

Globus Medical LATIS™ Spacers (K123913) Primary Predicate Device:

Additional Predicate Devices: Eisertech PLIF Cage (K113478) Synthes OPAL Spacer (K072791) Alphatec Epicage (K130548) SeaSpine Pacifica™ (K082310)

No reference devices were used in this submission.

DEVICE DESCRIPTION:

The Spine Innovation Interbody System implants are intended to be inserted posteriorly via an open or minimally invasive approach.

The Spine Innovation Interbody System is non-sterile and is to be sterilized by the end user.

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MATERIALS:

The Spine Innovation Interbody is manufactured from polyetheretherketone (PEEK) per ASTM F2026 and contains titanium alloys (Ti-6Al-4V per ASTM F1472 and Ti-6Al-4V ELI per ASTM F136) and tantalum per ASTM F560.

INDICATIONS FOR USE:

The Spine Innovation Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiquous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Spine Innovation Interbody System is intended for use with autograft and is intended for use with supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Spine Innovation Interbody System.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The Spine Innovation Interbody System is substantially equivalent to the predicate devices in all facets including: function, design, performance, material, and intended use. This conclusion is supported by substantially equivalent results of non-clinical testing (listed below).

PERFORMANCE TESTING:

Spine Innovation conducted the following bench tests:

Static and Dynamic Axial Compression per ASTM F2077 ●
. Static and Dynamic Shear Compression per ASTM F2077, and a Custom Static Shear Compression Test
Subsidence per ASTM F2267
. Expulsion per ASTM Draft Standard F04.25.02.02

Additional cadaveric testing has been performed to validate the surgical technique.

In summary, mechanical testing of the Spine Innovation Interbody indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.

CONCLUSIONS:

The Spine Innovation Interbody System has shown to be substantially equivalent to legally marketed predicates based on indications for use, technological characteristics, performance testing and comparison to predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.