The Cortina™ Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non- operative treatment.

Device Description

The Cortina™ Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK with titanium markers. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies.

AI/ML Overview

The provided text is a 510(k) summary for the Cortina™ Lumbar Cage System, a medical device. This type of document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of diagnostic or predictive AI/ML performance.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, ground truth establishment, and MRMC studies for an AI/ML device is not present in this document.

The document discusses mechanical performance data to demonstrate that the device's strength is sufficient for its intended use and is substantially equivalent to predicate devices.

Here's what can be extracted from the document in relation to performance data, although it doesn't align with the AI/ML focus of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or specific quantitative performance metrics as would be expected for an AI/ML device (e.g., sensitivity, specificity, F1-score). Instead, it lists the types of mechanical tests performed and a general conclusion.

Acceptance Criteria (Not explicitly stated as numerical targets; implied by equivalence to predicates)	Reported Device Performance (General Conclusion)
Sufficient strength for intended use (implied by comparison to predicate devices)	"The results of this non-clinical testing show that the strength of the Cortina™ Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Note: This is a qualitative statement of equivalence for mechanical properties, not a quantitative metric for diagnostic accuracy or similar AI/ML performance.

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

Not applicable. The document describes mechanical testing of physical devices, not a test set of data for an AI/ML algorithm.

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

Not applicable. The "ground truth" for mechanical testing is typically established by engineering standards and measurements, not expert consensus on medical images or clinical data.

4. Adjudication Method

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical intervertebral cage system.

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

No. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

For the mechanical tests, the "ground truth" implicitly refers to the physical properties and performance characteristics defined and measured by the ASTM standards mentioned (F2077-11, F2267-04, DRAFT F-04.25.02.02).

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML training set for this device.

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

Not applicable.

In summary: The provided document is for a physical medical device (intervertebral cage), not an AI/ML-driven device. Therefore, the information requested in the prompt, which is tailored to AI/ML device evaluation, cannot be found in this text. The "Performance Data" section solely addresses mechanical testing to establish substantial equivalence for safety and effectiveness.

Summary

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October 25, 2017

NeuroStructures, Inc. % Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K171914

Trade/Device Name: Cortina™ Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 10, 2017 Received: October 10, 2017

Dear Mr. Maxwell:

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 (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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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 (DICE) 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 (DICE) 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,

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) K171914

Device Name Cortina™ Lumbar Cage 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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510(K) SUMMARY

Submitter's Name	Neurostructures, Inc.
Submitter's Address	16 Technology Drive, Suite 165Irvine, CA 92618
Company Contact Person	Kathleen Wongkw@neurostructures.com949.370.4497
Contact Person	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874kmaxwell@empiricalconsulting.com
Date Summary wasPrepared	21 June 2017
Trade or Proprietary Name	Cortina™ Lumbar Cage System
Common or Usual Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification	Class II per 21 CFR §888.3080 Device Classification
Product Code	MAX
Classification Panel	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

INDICATIONS FOR USE

The indications for use for the Cortina™ Lumbar Cage System is similar to that of the predicates noted in Table 5-1: Predicate Devices.

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

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Principles of Operation ●
Indications for Use .
Implant Materials
Implant Sizes ●
Surgical Approach ●

510k Number	Trade or Proprietary or ModelName	Manufacturer	PredicateType
K113478	PLIF Cage	Eisertech	Primary
K072791	OPAL Spacer	Synthes	Additional
K141217	AccuLIF® TL and PL Cage	Stryker	Additional
K071724	Lucent Cage	Spinal Element	Additional
K112095	AccuLiF® TL-PEEK Cage and	CoAlign	Additional
K123281 K123752	AccuLiF® TL and P	Innovation	Additional

Table 5-1: Predicate Devices

Performance Data

The Cortina™ Lumbar Cage System has been tested in the following test modes:

Static axial compression per ASTM F2077-11 ●
. Dynamic axial compression per ASTM F2077-11
. Static subsidence per ASTM F2267-04
Static expulsion per ASTM DRAFT F-04.25.02.02 ●

The results of this non-clinical testing show that the strength of the Cortina™ Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Cortina™ Lumbar Cage System is substantially equivalent to the 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.