The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative 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 titanium per ASTM F136. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies.

AI/ML Overview

The provided text is a 510(k) summary for the Cavetto®-SA Cervical Cage System, which is an intervertebral fusion device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets acceptance criteria for a new AI/ML-driven medical device.

Therefore, many of the requested categories for acceptance criteria and study details (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set) are not applicable to this submission as it describes a traditional medical device (implantable cage and screws) that typically undergoes mechanical testing rather than AI/ML performance evaluation.

Based on the provided text, here's what can be extracted and what information is not available due to the nature of the device:

1. A table of acceptance criteria and the reported device performance:

The document mentions "Performance Data" but specifies that it was a "comparison of the previously cleared device material and the subject device material was completed in lieu of mechanical testing." This suggests that the acceptance criteria would be related to material properties and substantial equivalence to the predicate device's materials, rather than a clinical performance metric. Specific quantitative acceptance criteria and reported performance metrics in a table format are not provided in this document. The conclusion states "The overall technology and material characteristics lead to the conclusion that the Cavetto®-SA Cervical Cage System is substantially equivalent to the predicate device." This "substantial equivalence" is the primary performance claim rather than a separate set of performance criteria.

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

Not Applicable. The document describes a traditional implantable medical device, not a diagnostic or AI/ML device that would use test sets of patient data in this manner. The performance data mentioned refers to material comparison, not clinical trial data with patient samples.

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

Not Applicable. This is not relevant for the type of device described. Ground truth for an AI/ML diagnosis is established by expert consensus or other definitive methods, which is not what is being evaluated here.

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

Not Applicable. See point 3.

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. An MRMC study is relevant for AI-assisted diagnostic devices. This is a physical implantable device.

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

Not Applicable. This device does not involve an algorithm.

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

Not Applicable. The "performance data" mentioned focuses on material comparison to a predicate device, not establishing clinical ground truth for diagnosis/prognosis.

8. The sample size for the training set:

Not Applicable. This device does not utilize a training set in the context of machine learning.

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

Not Applicable. See point 8.

In summary, the provided document is a 510(k) summary for a physical medical implant (intervertebral fusion device). It asserts substantial equivalence to a predicate device based on technological characteristics and material comparisons, rather than providing the detailed performance study information typically associated with AI/ML-driven diagnostic or prognostic devices as requested in your prompt.

Summary

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September 24, 2020

NeuroStructures, Inc. % Mr. Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K200115

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: August 26, 2020 Received: August 27, 2020

Dear Mr. Wright:

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. Although this letter refers to your product as a device, please be aware 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200115

Device Name Cavetto(R)-SA Cervical Cage System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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K200115 - 510(K) SUMMARY

Submitter's Name:	NeuroStructures, Inc.
Submitter's Address:	199 Technology Drive, Suite 110Irvine, CA 92618
Submitter's Telephone:	800-352-6103
Company Contact Person	Moti Altarac
Contact Person:	Nathan WrightEmpirical Testing Corp.nwright@empiricaltech.com719-337-7579
Date Summary was Prepared:	January 15, 2020
Trade or Proprietary Name:	Cavetto®-SA Cervical Cage System
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, CervicalIntervertebral 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

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.

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 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 ●

510kNumber	Trade or Proprietaryor Model Name	Manufacturer	PredicateType
K173077	Cavetto-SA CervicalCage System	NeuroStructures	Primary
K172064	Ti-Diagon ObliqueTLIF	Camber SpineTechnologies	Reference
K172320	Cavetto® CervicalCage System	NeuroStructures,Inc.	Reference
K142041	PorOsteon PhusionMetal Cervical Cage	PorOsteon, Inc.	Reference
K153097	Belvedere™ LateralPlating System	Neurostructures	Reference

Table 5-1: Predicate Devices

PERFORMANCE DATA

A comparison of the previously cleared device material and the subject device material was completed in lieu of mechanical testing.

CONCLUSION

The overall technology and material characteristics 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.