The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

Device Description

The Opticage™ Expandable Interbody Fusion Device, Model Series 9070 is composed of lumbar intervertebral body fusion implants manufactured from implant grade titanium alloy and ranging in widths from 9 mm x 12 mm and lengths from 21 x 30 mm. Each implant consists of an upper and lower titanium plate and two titanium wedges that interact to change the height of the construct from a minimum of 9 mm to a maximum of 14 mm. The top and bottom plates are fenestrated and contain a window to enhance bony in-growth. A cavity internal to the device is intended to hold autogenous bone graft.

AI/ML Overview

Here's an analysis of the provided text regarding the Opticage™ Expandable Interbody Fusion Device, Model Series 9070, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the device is being cleared for additional sizes of an already cleared product. Therefore, the "study" described is a demonstration of substantial equivalence for these new sizes, rather than a clinical trial for a novel device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance for New Sizes (Equivalency to Predicate Devices)	A Finite Element Analysis (FEA) model was developed and validated. This FEA model demonstrated that the additional sizes perform at least equivalently to the previously cleared devices (K113527 and K132479).
Material Composition	Manufactured from implant grade titanium alloy.
Indications for Use (for new sizes)	Consistent with predicate devices: Posterior lumbar intervertebral body fusion with autogenous bone graft for DDD (up to Grade I spondylolisthesis/retrolisthesis) at 1-2 contiguous levels from L2-S1. Must be used with supplemental internal spinal fixation.
Technological Characteristics	The "additional sizes" maintain the same technology as the predicate: designed to hold bone graft, expand after implantation, and allow bony ingrowth. Expansion by rotating a central shaft.

Study Details

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

Test Set Sample Size: Not applicable in the traditional sense of a clinical trial with patient data. The "test set" here refers to the parameters and simulations run within the Finite Element Analysis (FEA) model. The specific number of simulations or variations tested within the FEA is not disclosed.
Data Provenance: The FEA model itself is a computational model, not based on human patient data for this submission. The validation of the FEA model would ideally refer to correlations with physical testing data of the predicate devices, but the details of this validation are not provided. There is no mention of country of origin as no patient data was used for this part of the submission. It is a prospective analytical study using computational modeling.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in this context, would relate to the accuracy and validity of the FEA model. This would typically be established by engineers and biomechanics experts, but no specific number or qualifications are mentioned for the development or validation of the FEA model.

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

Not applicable. Adjudication methods are relevant for human interpretation of data, like radiology reads. For an FEA, the "adjudication" would be in the rigorous validation of the model's assumptions and results against established engineering principles and possibly physical test data, but no specific adjudication method is described.

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 device is an implant, not an AI diagnostic or assistive tool. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. The FEA model can be considered a "standalone" computational analysis, but it's not an algorithm in the AI sense, nor does it have human-in-the-loop performance implications described here.

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

The "ground truth" for the FEA model would be its ability to accurately predict the mechanical behavior of the physical device. This would typically be established by comparing FEA predictions against:
- Physical bench testing data (e.g., compression, torsion, fatigue testing) of the predicate devices.
- Established engineering principles and material properties.
  The document states the FEA model was "developed and validated," implying such comparisons were made, but specific details of this validation are not provided.

8. The sample size for the training set

Not applicable in the context of machine learning. If "training set" refers to the data used to validate the FEA model, it would be the data from physical mechanical tests of the predicate devices. The size of this dataset is not specified.

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

Not applicable for a "training set" in the machine learning sense. For the validation of the FEA model, the ground truth would have been established through physical mechanical testing of the previously cleared Opticage devices (K113527 and K132479) and adherence to recognized engineering standards for medical devices.

Summary

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510(k) SUMMARY

FEB 1 0 2014

Submitter Information

Address:	Interventional Spine, Inc.13600 Alton Parkway, Ste. 160Irvine, CA 92618
Telephone:	(949) 472-0006
Contact Person:	Jane Metcalf
Date prepared:	November 19, 2013

Name of Device

Trade name:	Opticage™ Expandable Interbody Fusion Device, ModelSeries 9070
Common name:	Intervertebral Body Fusion Device
Classification:	Class II (Special Controls) per 21 CFR 888.3080
Product Code:	MAX

Purpose of Submission

The purpose of this submission is to gain market clearance for additional sizes of implants utilizing the technology of the Opticage Expandable Interbody Fusion Device, Model Series 9070.

Substantially Equivalent To

The additional sizes described in this submission are substantially equivalent to the Opticage Expandable Interbody Fusion Device, Model Series 9070, cleared under K113527 and K132479.

Description of the Device Subject to Premarket Notification

The Opticage Expandable Interbody Fusion Device, Model Series 9070 is composed of lumbar intervertebral body fusion implants manufactured from implant grade titanium alloy and ranging in widths from 9 mm x 12 mm and lengths from 21 x 30 mm. Each implant consists of an upper and lower titanium plate and two titanium wedges that interact to change the height of the construct from a minimum of 9 mm to a maximum of 14 mm. The top and bottom plates are fenestrated and contain a window to enhance bony in-growth. A cavity internal to the device is intended to hold autogenous bone graft.

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510(k) SUMMARY (continued)

Indication for Use

Technical Characteristics

The Opticage Expandable Interbody Fusion Device, Model Series 9070 is designed to hold bone graft, to be expanded after implantation, and to allow bony ingrowth through-out the device. Expansion of the device is accomplished by rotating a central shaft that moves the side wedges inward, increasing the distance between the top and bottom plates.

Performance Data

All necessary performance testing was completed for the previously cleared Opticage Expandable Interbody Fusion Devices in Model Series 9070. A Finite Element Analysis (FEA) model was developed and validated to show that the additional sizes perform at least equivalently to the previously cleared devices.

Basis for Determination of Substantial Equivalence

The additional sizes of the Opticage Expandable Interbody Fusion Device, Model Series 9070, are determined to be substantially equivalent to the Opticage Expandable Interbody Fusion Devices from Model Series 9070, previously cleared under K113527 and K132479 based on comparisons to device design, indications for use, technological characteristics, and FEA analysis.

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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 stylized eagle with its wings spread, and three lines representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

February 10, 2014

Interventional Spine, Incorporated Ms. Jane Metcalf Vice President, Quality Assurance, Regulatory and Clinical Affairs 13700 Alton Parkway, Suite 160 Irvine, California 92618

Re: K133583

Trade/Device Name: Opticage™ Expandable Interbody Fusion Device. Model Series 9070 Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 11, 2014 Received: January 13, 2014

Dear Ms. Metcalf

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 - Ms. Jane Metcalf

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/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 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.

Sincerely yours,

Vincent JiDevlin -S

for

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) K133583

Device Name

Opticage(TM) Expandable Interbody Fusion Device, Model Series 9070

Indications for Use (Describe)

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sudies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

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)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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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.