The Opticage™ Expandable Interbody Fusion Device is a 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 Expandable Interbody Fusion Device can be implanted via posterior, transforaminal, or lateral 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 a six month course 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 Devices, Model Series 9070 are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. The devices are fabricated from titanium alloy (Ti-6AI-4V) as per ASTM Fl36. Each device consists of an upper and lower titanium plate, two titanium wedges and a central shaft. The two titanium wedges are connected by the central shaft. The shaft can be rotated to move the wedges toward the center of the device thereby increasing the distance (i.e. height) between the upper and lower titanium plates. Alternatively, the shaft can be rotated in the opposite direction to move the wedges away from the center of the device causing the distance (i.e. height) between the upper and lower plates to decrease. In this manner, the height of the construct can be continuously adjusted. The devices are available in a several footprint sizes. The top and bottom of the devices are fenestrated and each contain windows to enhance bony in growth. A cavity internal to each device is intended to hold autogenous bone graft.

The Opticage Expandable Interbody Fusion Devices in Model Series 9070 are provided in both sterile and non-sterile versions.

AI/ML Overview

This document (K140716) is a 510(k) premarket notification for a medical device called the Opticage™ Expandable Interbody Fusion Device. As such, it focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a primary clinical study.

The FDA 510(k) pathway does not typically require clinical trials in the same way a PMA (Premarket Approval) does, especially for Class II devices like this one. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device performance metrics (like sensitivity, specificity, etc., with associated sample sizes, ground truths, and reader studies) is not directly applicable or present in this 510(k) submission.

However, I can extract the information related to the performance data provided to support the claim of substantial equivalence. This "performance data" serves the purpose of demonstrating that the new device functions similarly and is as safe as the predicate devices.

Here's a breakdown based on the provided document, addressing the closest analogues to your request:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there aren't "acceptance criteria" in the traditional sense of a diagnostic performance study (e.g., minimum sensitivity). Instead, the performance claims are based on meeting established standards for intervertebral body fusion devices, and demonstrating comparable performance to predicate devices.

Acceptance Criteria (Standards Met)	Reported Device Performance (Summary from Document)
ASTM F2077-03	All necessary performance testing completed for Opticage™ Model Series 9070, including: - Static compression - Dynamic compression - Static compression shear - Dynamic compression shear - Static torsional - Dynamic torsional
ASTM F2267	Subsidence testing completed for Opticage™ Model Series 9070.
ISO 17853	Evaluation of wear debris/particulates completed for Opticage™ Model Series 9070.
ASTM F1877	Evaluation of wear debris/particulates completed for Opticage™ Model Series 9070.
Not explicitly listed, but implied	Expulsion testing completed for Opticage™ Model Series 9070.
Not explicitly listed, but implied	Finite Element Analysis (FEA) conducted to confirm worst-case performance configuration.
Overall Comparison to Predicates	"Test performance data demonstrated substantial equivalence to the predicate devices." (Specifically Caliber® Spacer (K123231), L-Varlock Lumbar Cages (K080537), Caliber™ Spacer (K102293), and referenced Opticage models (K113527, K132479, K133583)). The device has similar size, shape, and material composition (Ti-6AL-4V) to predicates, with similar operational characteristics.

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

This document describes mechanical and material testing, not clinical or diagnostic performance testing with human subjects. Therefore, the concept of a "test set" in terms clinical data or patient images (as would be relevant for an AI device) does not apply. The "samples" would be the physical devices or components tested according to the ASTM and ISO standards. The document does not specify the number of devices or components tested, nor their manufacturing origin (country). This type of testing is generally performed in a lab setting by the manufacturer or contracted labs.

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

Not applicable.

For mechanical and material testing, ground truth is established by the physical properties and performance characteristics of the materials and device components as measured against established engineering standards (ASTM, ISO). There are no "experts" establishing a "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set

Not applicable.

There is no "adjudication" in the context of mechanical device testing; the results are typically quantitative and objective measurements against predefined criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable.

This is a mechanical implant device, not a diagnostic imaging device or an AI algorithm intended to assist human readers. Therefore, an MRMC study is outside the scope of this submission.

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

Not applicable.

This device is a physical implant for spinal fusion, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established engineering and material science standards (e.g., ASTM F2077-03, ASTM F2267, ISO 17853, ASTM F1877) that dictate acceptable performance ranges for intervertebral body fusion devices. The device's performance against these standards, and its similarity to predicate devices, forms the basis for demonstrating safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable.

There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

No training set exists for this type of device submission.

Summary

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

November 24, 2014

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

Re: K140716

Trade/Device Name: Opticage™ Expandable Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 20, 2014 Received: October 23, 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 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.

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Page 2 - Ms. Jane Metcalf

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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours, Lori A. Wiggins -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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Indications for Use

510(k) Number (if known) K140716

Device Name

Opticage™ Expandable Interbody Fusion Device

Indications for Use (Describe)

The Opticage™ Expandable Interbody Fusion Device is a 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 at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Candidates for surgery should be skeletally mature and have had a six month course 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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APPLICANT:	Interventional Spine, Inc.
DATE PREPARED:	November 24, 2014
CONTACT PERSON:	Jane Metcalf13700 Alton Parkway, STE 160Irvine, CA 92618Phone: 949.525.1493Fax: 949.472.0016
TRADE NAME:	Opticage™ Expandable Interbody Fusion Device,
COMMON NAME:	Spinal Implant
CLASSIFICATIONNAME:	Intervertebral Body Fusion Device
DEVICECLASSIFICATION:	Class II
REGULATIONNUMBER	888.3080 (product code: MAX)
PRIMARYPREDICATE:	• Caliber® Spacer (K123231)
SECONDARYPREDICATES:	• L-Varlock Lumbar Cages (K080537)• Caliber™ Spacer (K102293)
REFERENCEDEVICES:	• Opticage Interbody Fusion Device (K113527)• Opticage™ Interbody Fusion Device, Model, Sterile (K132479)• Opticage™ Expandable Interbody Fusion Device, Model Series 9070 (K133583)

Purpose of Submission

There are two purposes for this 510(k) submission. The first is to modify the Indication for Use Statement to include the word "lateral". The second is to achieve market clearance for additional larger sizes of the Opticage Expandable Interbody Device, Model Series 9070.

Substantially Equivalent To

The Opticage Expandable Interbody Fusion Device, Model Series 9070 is substantially equivalent in intended use, principal of operation and technological characteristics to the primary predicate, Caliber® Spacer (K123231).

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Device Description

The Opticage Expandable Interbody Fusion Devices, Model Series 9070 are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. The devices are fabricated from titanium alloy (Ti-6AI-4V) as per ASTM Fl36. Each device consists of an upper and lower titanium plate, two titanium wedges and a central shaft. The two titanium wedges are connected by the central shaft. The shaft can be rotated to move the wedges toward the center of the device thereby increasing the distance (i.e. height) between the upper and lower titanium plates. Alternatively, the shaft can be rotated in the opposite direction to move the wedges away from the center of the device causing the distance (i.e. height) between the upper and lower plates to decrease. In this manner, the height of the construct can be continuously adjusted. The devices are available in a several footprint sizes. The top and bottom of the devices are fenestrated and each contain windows to enhance bony in growth. A cavity internal to each device is intended to hold autogenous bone graft.

The Opticage Expandable Interbody Fusion Devices in Model Series 9070 are provided in both sterile and non-sterile versions.

Indication for Use

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Technical Characteristics

The Opticage Expandable Interbody Fusion Devices in Model Series 9070 have similar size, shape and material composition as the predicates, although the Caliber predicates (K102293 and K12332) also contain PEEK material that is not contained in the Opticage devices. Operational characteristics of all of the predicates are similar to the Opticage in than they can be expanded in situ via a special tool designed to interface with the expansion mechanism of the device. Graft material may be added to the internal cavity of all of the devices and all of the devices have windows in the top/bottom to allow the graft material to interface with the upper and lower vertebral endplates. Fenestrations are used on the top and bottom of all the devices to provide stability in the intervertebral space.

Performance Data

All necessary performance testing, has been completed for the Opticage Expandable Interbody Fusion Device, Model Series 9070 including loading paradigms identified in ASTM F2077-03 (static and dynamic compression, static and dynamic compression shear, static and dynamic torsional), subsidence per ASTM F2267, expulsion, and evaluation of wear debris/particulates per ISO 17853 and ASTM F1877. Finite element analysis (FEA) has been conducted to confirm worst case performance configuration.

Test performance data demonstrated substantial equivalence to the predicate devices.

Basis for Determination of Substantial Equivalence

Upon reviewing the performance data provided in this submission and comparing intended use, design, materials, principle of operation and overall technological characteristics, the Opticage Expandable Interbody Fusion Device, Model Series 9070 is determined by Interventional Spine, to be substantially equivalent to existing legally marketed 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.