The Curiteva Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.

Device Description

The Curiteva Anterior Cervical Plate System consists of screws and plates. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy. All implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Curiteva Anterior Cervical Plate System." It confirms that the device is substantially equivalent to legally marketed predicate devices.

Let's break down the information provided in the context of acceptance criteria and a study proving the device meets them:

Critique of the Provided Document Regarding Acceptance Criteria and Study:

The provided document is an FDA 510(k) clearance letter and a 510(k) Summary. It does NOT contain the detailed information typically found in a clinical study report or a pre-defined set of acceptance criteria for algorithm performance.

This document is for a mechanical medical device (spinal plate system), not an AI/ML software or diagnostic device. Therefore, the "acceptance criteria" and "study" described in the prompt are referring to mechanical and material performance testing, not AI performance metrics like sensitivity, specificity, or AUC, nor are they clinical trials with human readers.

The prompt's questions are geared towards the evaluation of an AI/ML-based medical device. My response will highlight how the provided document addresses, or doesn't address, these questions in the context of a mechanical device clearance.

Here's an attempt to answer your questions based solely on the provided text, interpreting "acceptance criteria" and "study" within the context of mechanical device testing:

Based on the provided FDA 510(k) clearance letter and summary for the Curiteva Anterior Cervical Plate System, the "acceptance criteria" and "study" refer to the mechanical and material performance testing required for this type of implantable device, rather than the AI/ML performance metrics that your questions typically relate to.

Acceptance Criteria and Device Performance (Mechanical Device Context)

Acceptance Criteria Category (Implied)	Reported Device Performance (from "Performance Data")
Mechanical Strength & Durability	The Curiteva Anterior Cervical Plate System was mechanically tested in the following test modes: static and dynamic compression bend per ASTM F1717, static torsion per ASTM F1717, and axial screw pushout. The results of this non-clinical testing show that the strength and performance of the Curiteva Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (Exact numerical thresholds or specific pass/fail values are not provided in this summary, but would have been defined in the underlying test protocols.)
Biocompatibility	(Implicitly met as the material is Titanium alloy (Ti-6Al-4V) conforming to ASTM F136, a standard for implantable materials. No specific test results are detailed in this summary.)
Dimensional & Design Equivalence	The subject device was shown to be substantially equivalent and to have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

Study Details (Interpreted for a Mechanical Device)

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of plates/screws tested. For mechanical testing, samples are usually a representative number of units per size/configuration tested to ISO/ASTM standards.
- Data Provenance: The testing was "non-clinical testing," implying it was conducted in a laboratory setting (e.g., in vitro mechanical testing), not on human subjects. The location (country) of the testing is not specified, but it would have been conducted by the manufacturer or a certified testing lab. This would be considered "prospective" for the purpose of demonstrating device performance against pre-defined test protocols.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of mechanical device testing. "Ground truth" for mechanical testing is established by adhering to widely accepted international standards (e.g., ASTM F1717) and engineering principles. The "experts" would be the engineers and technicians performing and interpreting the mechanical tests according to these standards.
Adjudication Method for the Test Set:
- Not applicable. Mechanical testing results are objectively measured (e.g., force, displacement, cycles to failure). There is no "adjudication" in the sense of reconciling human interpretations.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and their performance might be enhanced by an AI tool. This device is a surgical implant, not a diagnostic tool requiring human interpretation for its function.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, in a way relevant to a mechanical device. The "performance data" presented is effectively "standalone" performance of the device itself under specified mechanical stress conditions, without human interaction during the test. There is no algorithm here; it's a physical product.
The Type of Ground Truth Used:
- For mechanical testing, the "ground truth" is defined by established engineering standards (e.g., ASTM F1717) and the physical properties and failure points of the materials and designs under controlled loads. The comparison to predicate devices also serves as a benchmark for acceptable performance.
The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML product that undergoes a "training set" process. It's a manufactured medical device.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no "training set" or "ground truth" establishment in the AI/ML sense for this mechanical device. Design validation and verification are based on engineering principles and compliance with standards.

Summary in relation to your prompt's original intent (AI/ML):

This document pertains to a traditional Class II mechanical implantable medical device. Therefore, the specific questions regarding AI/ML performance metrics (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI) are not directly addressed or applicable in the context of this 510(k) submission. The "study" described is entirely focused on demonstrating the physical and mechanical equivalence and safety of the implant compared to existing cleared devices through bench testing.

Summary

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August 2, 2018

Curiteva, LLC Mr. Eric Linder Chief Operating Officer 25127 Will McComb Drive, Suite 100 Tanner, Alabama 35671

Re: K181562

Trade/Device Name: Curiteva Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 13, 2018 Received: June 14, 2018

Dear Mr. Linder:

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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,

Ronald P. Jean -S

for 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) K181562

Device Name

Curiteva Anterior Cervical Plate System

Indications for Use (Describe)

The Curiteva Anterior Cervical Plate System is interior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.

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

A. Submitter Information

Submitter:	Curiteva, LLC25127 Will McComb Drive, Suite 100Tanner, AL 35671Phone: (256) 213-1057Fax: (256) 213-1058
Contact Person:	Eric Linderregulatory@curiteva.com
Date Prepared:	August 2, 2018

B. Device Information

Trade Name:	Curiteva Anterior Cervical Plate System
Common Name:	Anterior Cervical Plate System
Classification Name:	Appliance, Fixation, Spinal Intervertebral Body
Device Classification:	Class II (per 21 CFR 888.3060)
Product Code:	KWQ
Classification Panel:	Division of Orthopedic Devices
Predicate Device(s):	Primary: Synthes Anterior CSLP System - K030866Additional: DeGen Medical Hyper-C Anterior Cervical PlateSystem -- K150759

C. Device Description

D. Indications for Use

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history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.

E. Technological Characteristics

As was established in this submission, the subject Curiteva Anterior Cervical Plate 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 the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

F. Performance Data

The Curiteva Anterior Cervical Plate System was mechanically tested in the following test modes: static and dynamic compression bend per ASTM F1717, static torsion per ASTM F1717, and axial screw pushout.

The results of this non-clinical testing show that the strength and performance of the Curiteva Anterior Cervical Plate 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, performance testing, and comparison to predicate devices, the subject Curiteva Anterior Cervical Plate System has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.