The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Device Description

The Curiteva Porous PEEK Cervical Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally boxshaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense central ring with a porous structure lining the vertical graft corridor and on the superior and inferior surfaces of the construct. Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick. The Curiteva Porous PEEK Cervical Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136).

AI/ML Overview

This document is a 510(k) summary for a medical device called the "Curiteva Porous PEEK Cervical Interbody Fusion System." This type of document is used to demonstrate substantial equivalence to previously cleared devices rather than providing a study that proves the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it demonstrates the device's functional and safety equivalence through non-clinical performance data.

Therefore, many of the requested elements pertaining to clinical study design, ground truth, expert adjudication, and AI performance metrics are not applicable to this type of regulatory submission. I will address the relevant sections based on the provided text.

Here's a breakdown of the requested information based on the provided 510(k) Summary:

Acceptance Criteria and Device Performance Study

The "Curiteva Porous PEEK Cervical Interbody Fusion System" is a medical implant, and its regulatory clearance process (510(k)) focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than meeting specific performance acceptance criteria related to AI/ML or diagnostic accuracy, which would typically involve clinical studies with human readers and ground truth.

For this device, the "acceptance criteria" are implicitly met by demonstrating that the device performs equivalently to the predicates when subjected to a battery of non-clinical (mechanical) tests. The "study that proves the device meets the acceptance criteria" refers to these non-clinical performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The concept of explicit quantitative "acceptance criteria" with a pass/fail threshold, as might be found for a diagnostic AI, is not detailed in this type of 510(k) summary for a spinal implant. Instead, the performance is demonstrated by showing the device withstands stresses comparable to predicate devices and industry standards. The reported device performance is that the device meets or is sufficient for its intended use and is substantially equivalent to the predicate devices. The specific numerical results of these tests are not included in the summary.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance: - Axial compression strength	Sufficient for intended use, substantially equivalent to predicate devices.
- Compression-shear strength	Sufficient for intended use, substantially equivalent to predicate devices.
- Torsion strength	Sufficient for intended use, substantially equivalent to predicate devices.
- Subsidence resistance	Sufficient for intended use, substantially equivalent to predicate devices.
- Wear debris characteristics	Sufficient for intended use, substantially equivalent to predicate devices.
- (Additional tests like expulsion, impaction)	Sufficient for intended use, substantially equivalent to predicate devices.
Material Compatibility: - Biocompatibility (implied)	PEEK (ASTM F2026) with Titanium alloy markers (ASTM F136), HA coating.

2. Sample size used for the test set and the data provenance

The "test set" in this context refers to the physical samples of the Curiteva Porous PEEK Cervical Interbody Fusion System that underwent mechanical testing. The specific number of samples tested for each mechanical test is not provided in the summary.

Data Provenance: The data comes from non-clinical (laboratory) testing conducted on the manufactured device models. There is no mention of country of origin of the data or whether it's retrospective/prospective, as these terms are generally applicable to clinical human data.

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

This question is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for imaging devices) is relevant for diagnostic performance studies. For an intervertebral body fusion device, mechanical properties are evaluated against engineering standards and comparison to predicate devices, not against expert interpretation of patient data.

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

This question is not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to establish a consensus "ground truth" among multiple readers. For mechanical testing of an implant, the results are derived from physical measurements and engineering analyses, not from human interpretation requiring adjudication.

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

This question is not applicable. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret medical images, often with or without AI assistance. This submission pertains to a physical spinal implant.

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

This question is not applicable. This refers to AI algorithm performance. The Curiteva Porous PEEK Cervical Interbody Fusion System is a physical medical implant, not an algorithm.

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

This question is not applicable in the traditional sense of clinical "ground truth." For mechanical tests, the "ground truth" is defined by established engineering principles, ASTM (American Society for Testing and Materials) standards (e.g., ASTM F2077, ASTM F2267, ASTM F1877), and the performance characteristics of previously cleared predicate devices. The device's performance is compared against these engineering benchmarks and predicate device data.

8. The sample size for the training set

This question is not applicable. A "training set" refers to data used to train an AI/ML algorithm. This device is a physical implant and does not involve AI/ML.

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

This question is not applicable. As there is no AI/ML training set, there is no ground truth established for it.

Summary

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February 13, 2023

Curiteva, Inc. % Meredith May, MS, RAC Director of Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K213030

Trade/Device Name: Curiteva Porous PEEK Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: January 11, 2023 Received: January 11, 2023

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 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.

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

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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 -S

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) K213030

Device Name

Curiteva Porous PEEK Cervical Interbody Fusion System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary - K213030

A. Submitter Information

Submitter:	Curiteva, Inc.25127 Will McComb Drive, Suite 100Tanner, AL 35671Phone: (256) 213-1057Fax: (256) 213-1058
Submitter Contact:	Eric LinderChief Technology Officer
Regulatory Contact:	Meredith May MS, RACEmpirical Testing Corp.Phone: (719) 337-7579mpvanderbilt@empiricaltech.com
Date Prepared:	February 9, 2023

B. Device Information

Trade Name:	Curiteva Porous PEEK Cervical Interbody Fusion System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Fusion Device With Bone Graft, Cervical
Device Classification:	Class II (per 21 CFR 888.3080)
Product Code:	ODP
Classification Panel:	Division of Orthopedic Devices
Predicate Device(s):	Primary: Curiteva Cervical Interbody Fusion System – K181261Additional: Astura Medical ALTA Anterior Cervical InterbodySpacer - K173324Additional: Cutting Edge Spine, LLC EVOL SI Joint FusionSystem - K190025

C. Device Description

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the superior and inferior surfaces of the construct. Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The Curiteva Porous PEEK Cervical Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136).

D. Indications for Use

The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT. MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

E. Comparison of Technological Characteristics

As was established in this submission, the subject Curiteva Porous PEEK Cervical Interbody Fusion System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and to have similar technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

F. Performance Data

Non-clinical testing performed on the Curiteva Porous PEEK Cervical Interbody Fusion System supports substantial equivalence to predicate devices. The following testing was performed:

Axial compression per ASTM F2077
Compression-shear per ASTM F2077 ●
Torsion per ASTM F2077 ●
Subsidence per ASTM F2267
Wear debris characterization per ASTM F1877

Additional testing (e.g. expulsion, impaction) was performed to further support substantial equivalence. The results of non-clinical testing demonstrate that the strength and performance of the Curiteva Porous PEEK Cervical Interbody Fusion System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

G. Conclusion

Based on the indications for use, technological characteristics, non-clinical performance testing, and comparison to predicate devices, the subject Curiteva Porous PEEK Cervical Interbody Fusion System has been shown to be substantially equivalent to legally marketed 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.