The Neurostructures Cavetto® [MAX] Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Neurostructures Cavetto® [MAX] Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. The Neurostructures Cavetto® [MAX] Cervical Cage System is intended to be used with supplemental fixation.

Device Description

The Cavetto® [MAX] Cervical Cage System is an intervertebral fusion device made from medical grade titanium per ASTM F136. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® [MAX] Cervical Cage System is offered in parallel and lordotic styles in heights of 4-10mm, widths of 13-19mm, and lengths of 11-16mm.

AI/ML Overview

This document (K181590) describes a 510(k) premarket notification for a medical device called the "Neurostructures Cavetto® [MAX] Cervical Cage System." The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about a study that proves the device meets acceptance criteria in the way typically associated with AI/ML device performance studies (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement).

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices based on:

Technological characteristics: Similarities in indications for use, principles of operations, implant material, sterility, surgical approach, and structural support mechanism.
Performance data: An engineering comparison of material showing mechanical equivalence to the primary predicate device, and bacterial endotoxin testing.

Therefore, it's not possible to fulfill the request for information on acceptance criteria and study details related to a device's performance in terms of diagnostic accuracy or comparative effectiveness with human readers, as this type of information is not present in the provided document.

To directly answer your specific points based only on the provided text:

A table of acceptance criteria and the reported device performance:
- Not applicable. The document does not describe performance criteria or results in terms of diagnostic accuracy, sensitivity, specificity, or other metrics typical for AI/ML devices. The "performance data" mentioned refers to mechanical equivalence and endotoxin testing, not clinical or diagnostic performance against a ground truth.
Sample sizes used for the test set and the data provenance:
- Not applicable. No test set of clinical data is described. The "performance data" refers to engineering comparisons and lab testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment by experts is mentioned, as there is no test set for clinical performance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set is described.
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. No MRMC study or AI assistance is mentioned. This device is an intervertebral fusion device, not a diagnostic AI tool.
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.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth for clinical performance is described. The "ground truth" for the mechanical comparison would be the established properties of the primary predicate device.
The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm.

Summary

{0}------------------------------------------------

November 8, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

NeuroStructures, Inc. % Ms. Meredith May VP. Empirical Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K181590

Trade/Device Name: Neurostructures Cavetto® [MAX] Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: October 10, 2018 Received: October 12, 2018

Dear Ms. May:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.

David Hwang -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

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

K181590

Page 1 of 1

510(k) Number (if known) K181590

Device Name

Neurostructures Cavetto® [MAX] 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

5.510(K) SUMMARY

Submitter's Name	Neurostructures, Inc.
Submitter's Address	199 Technology Drive, Suite 110Irvine, CA 92618
Company Contact Person	Kathleen Wongkw@neurostructures.com949.370.4497
Contact Person	Meredith L. May MS, RACEmpirical Consulting719-337-7579MMay@EmpiricalConsulting.com
Date Summary wasPrepared	30 May 2018
Trade or Proprietary Name	Neurostructures Cavetto® [MAX] Cervical Cage System
Common or Usual Name	Intervertebral Fusion Device With Bone Graft, Cervical
Classification	Class II per 21 CFR §888.3080
Product Code	ODP
Classification Panel	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The indications for use for the Cavetto® [MAX] Cervical Cage System is similar to that of the predicates in Table 5-1: Predicate Devices.

{4}------------------------------------------------

TECHNOLOGICAL CHARACTERISTICS

The Cavetto® [MAX] Cervical Cage System 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 similar between the subject and predicates:

Indications for use
Principles of operations ●
Implant material ●
Sterility ●
Surgical approach ●
Structural support mechanism ●

Table 5-1: Predicate Devices

510k Number	Trade or Proprietary or ModelName	Manufacturer	PredicateType
K172320	Cavetto® Cervical Cage System	NeuroStructures	Primary
K172064	Ti-Diagon Oblique TLIF	Camber SpineTechnologies	Reference
K142041	PorOsteon Phusion Metal CervicalCage	PorOsteon, Inc.	Reference

PERFORMANCE DATA

An engineering comparison of the material used to manufacture the previously cleared device and the subject device material was completed in lieu of mechanical testing, showing that the subject device is mechanically equivalent to the primary predicate device. Bacterial endotoxin (LAL) testing was conducted and met endotoxin limit specifications.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Cavetto® [MAX] 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.