The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.

Device Description

The Cavetto®-SA Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026, titanium per ASTM F560, and tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Cavetto®-SA Cervical Cage System, an intervertebral body fusion device. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold format for each test. Instead, it states that the "results of this non-clinical testing show that the strength of the Cavetto®-SA Cervical Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

This implies that the acceptance criterion for each test was to meet or exceed the performance of the legally marketed predicate devices. The specific performance values for the predicate devices are not provided in this summary.

Acceptance Criterion (Implied)	Reported Device Performance
Strength sufficient for intended use and substantially equivalent to legally marketed predicate devices for each test mode below.	Strength of the Cavetto®-SA Cervical Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Static axial compression per ASTM F2077	(Results not numerically detailed, but stated to meet criterion)
Static compressive shear per ASTM F2077	(Results not numerically detailed, but stated to meet criterion)
Static torsion per ASTM F2077	(Results not numerically detailed, but stated to meet criterion)
Dynamic axial compression per ASTM F2077	(Results not numerically detailed, but stated to meet criterion)
Dynamic compressive shear per ASTM F2077	(Results not numerically detailed, but stated to meet criterion)
Dynamic torsion per ASTM F2077	(Results not numerically detailed, but stated to meet criterion)
Static subsidence per ASTM F2267	(Results not numerically detailed, but stated to meet criterion)
Expulsion per ASTM F-04.25.02.02	(Results not numerically detailed, but stated to meet criterion)

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

Sample Size: The document does not specify the number of samples or units tested for each non-clinical performance test (e.g., how many cages were subjected to static axial compression).
Data Provenance: The data is from non-clinical testing (mechanical testing), not human or animal studies. Therefore, concepts like country of origin for human data or retrospective/prospective don't apply in the same way. The testing was conducted to established ASTM standards.

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

Not applicable. This submission relies on non-clinical, mechanical performance data, not expert-derived ground truth based on interpreting medical images or clinical outcomes. The "ground truth" here is the physical measurement of the device's mechanical properties according to established engineering standards (ASTM).

4. Adjudication Method for the Test Set:

Not applicable. As the data is purely mechanical testing against engineering standards, there's no "adjudication" in the sense of reconciling differing expert opinions. The tests are performed and measured objectively.

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

No. This document describes a 510(k) submission based on non-clinical bench testing for a physical implantable device (a cervical cage). MRMC studies evaluate the performance of diagnostic algorithms or imaging techniques, often involving human readers. This type of study is not relevant to the evaluation of the Cavetto®-SA Cervical Cage System as presented here.

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

Not applicable. This device is a physical medical implant, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. The Type of Ground Truth Used:

For the non-clinical performance tests, the "ground truth" is established by adherence to published ASTM standards and the expected mechanical properties for devices of this type for their intended use. The comparison is made to predicate devices which have already demonstrated safety and effectiveness through their regulatory clearance based on similar mechanical and material properties.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of this 510(k) submission. This is a physical medical device, not a machine learning model that requires training data.

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

Not applicable. As there is no training set, this question is not relevant.

In summary, the provided document focuses on demonstrating the substantial equivalence of a physical medical implant (intervertebral cage) through non-clinical mechanical testing, rather than evaluating the performance of a diagnostic algorithm or AI system. Therefore, many of the requested categories (expert ground truth, MRMC studies, training sets) are not applicable to this type of regulatory submission. The core of the "proof" is that the device's mechanical properties, tested against recognized ASTM standards, are sufficient for its intended use and comparable to already cleared predicate devices.

Summary

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February 23, 2018

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

Re: K173077

Trade/Device Name: Cavetto®-SA Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: January 19, 2018 Received: January 22, 2018

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

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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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173077 Device Name Cavetto®-SA Cervical 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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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
Submitter's Telephone:	Kathleen Wongkw@neurostructures.com949.370.4497
Contact Person:	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874kmaxwell@empiricalconsulting.com
Date Summary was Prepared:	20 February 2018
Trade or Proprietary Name:	Cavetto®-SA Cervical Cage System
Common or Usual Name:	Intervertebral Fusion Device With Integrated Fixation, Cervical
Classification:	Class II per 21 CFR §888.3080
Product Code:	OVE
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS

The Cavetto®-SA Cervical Cage System and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and

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effectiveness. Specifically the following characteristics are identical between the subject and predicates:

. Indications for Use
Principle of operation ●
Implant material PEEK ●
Implant material titanium ●
Screw implant diameter and length ●
Structural support mechanism .
. Cage implant sizes

Table 5-1: Predicate Devices

510kNumber	Trade or Proprietaryor Model Name	Manufacturer	PredicateType
K132894	Optio-CTM	Zimmer Spine	Primary
K153250	Tesera	Renovis	Additional
K150053	STALIF C®	Centinel Spine	Additional
K152515	TOMCAT™	Choice Spine	Additional
K102606	AVS Anchor-C	Stryker Spine	Additional

PERFORMANCE DATA

The Cavetto®-SA Cervical Cage System has been tested in the following test modes:

Static axial compression per ASTM F2077 ●
Static compressive shear per ASTM F2077 .
Static torsion per ASTM F2077 ●
Dynamic axial compression per ASTM F2077 .
Dynamic compressive shear per ASTM F2077 .
Dynamic torsion per ASTM F2077 ●
Static subsidence per ASTM F2267 .
Expulsion per ASTM F-04.25.02.02 ●

The results of this non-clinical testing show that the strength of the Cavetto®-SA Cervical 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 Cavetto@-SA Cervical Cage System is substantially equivalent to the predicate device.

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.