The NeoOrtho NEOPLATE Spine Anterior Fixation System is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma, (including fractures), 3) tumors, 4) deformity (defined by kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Note: this device system is intended for anterior cervical intervertebral body fusions only.

Device Description

The NeoOrtho NEOPLATE Spine Anterior Fixation System consists of a variety of shapes and sizes of bone plates, screws and instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the NEOPLATE Spine Anterior Fixation System, structured to address your specific points:

The provided document describes a 510(k) premarket notification for the NEOPLATE Spine Anterior Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or setting performance criteria for diagnostic accuracy. Therefore, many of your requested points pertain to diagnostic AI/medical imaging systems and are not applicable to this type of device (a surgical implant).

This document outlines the mechanical performance testing conducted to demonstrate substantial equivalence, not to establish specific clinical acceptance criteria or evaluate the performance of an AI algorithm.

Description of Acceptance Criteria and Study: NEOPLATE Spine Anterior Fixation System

The NEOPLATE Spine Anterior Fixation System is a surgical implant. The "acceptance criteria" in this context refer to demonstrating substantial equivalence to a predicate device, primarily through material characterization and mechanical performance testing, rather than clinical efficacy or diagnostic accuracy.

The study conducted was a mechanical testing study performed according to ASTM F1717, a recognized standard for testing spinal implant constructs. The purpose was to show that the device's mechanical properties are equivalent to or better than those of a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (for Substantial Equivalence)	Reported Device Performance / Evaluation Method
Material Composition	Manufactured from titanium alloy (ASTM F136), same as predicate.
Basic Design	Plate and screw system, same as predicate.
Size/Dimensions	Dimensions are within the ranges of the predicate device.
Mechanical Performance	Mechanical testing (ASTM F1717) demonstrated substantial equivalence to predicate.
- Compression Testing	Performed according to ASTM F1717. (Specific numerical results not provided in summary)
- Fatigue Testing	Performed according to ASTM F1717. (Specific numerical results not provided in summary)
- Static Torsional Testing	Performed according to ASTM F1717. (Specific numerical results not provided in summary)
Indications for Use	Same as predicate device (anterior interbody screw/plate fixation of the cervical spine).

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

Test Set Sample Size: The document does not specify a "sample size" in the context of patients or clinical data. The "test set" here refers to the number of physical device units or components that underwent mechanical testing. This information (e.g., number of plates/screws tested for each mechanical test) is not provided in the summary.
Data Provenance: The mechanical testing was likely conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility. The country of origin of this testing data is not explicitly stated, but the manufacturer is based in Brazil. This is not a retrospective or prospective clinical study on human patients.

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

Not Applicable. This device is a mechanical implant, not an AI or diagnostic imaging system. There was no "ground truth" established by experts in the context of diagnostic interpretation (e.g., radiologists interpreting images). The "ground truth" for mechanical testing is derived from engineering principles and the passed/failed status against pre-defined load/cycle specifications in the ASTM standard.

4. Adjudication Method for the Test Set

Not Applicable. There was no adjudication method used for a "test set" in the sense of expert consensus on clinical or diagnostic outcomes. The mechanical tests have objective pass/fail criteria based on the ASTM F1717 standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is designed for evaluating the diagnostic performance of systems, often comparing human readers with and without AI assistance to interpret medical images. This is not relevant for a spinal fixation implant, which is evaluated based on its mechanical integrity and substantial equivalence.

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

Not Applicable. This device is a physical surgical implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing was the engineering specifications and pass/fail criteria defined by the ASTM F1717 standard and compared against the performance of the predicate device. This is a mechanical/performance ground truth, not a clinical or pathological ground truth.

8. The Sample Size for the Training Set

Not Applicable. This device did not involve the use of machine learning or AI, and therefore no "training set" was used.

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

Not Applicable. As there was no training set (no AI/ML involved), there was no ground truth for a training set.

In summary, the provided document details a 510(k) submission for a surgical implant, not a diagnostic AI device. The "study" described is mechanical performance testing, and the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device in terms of material, design, dimensions, and mechanical integrity, as opposed to clinical efficacy or diagnostic accuracy.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "NEOORTHO". The logo consists of a black square with a white curved shape inside, followed by the word "NEOORTHO" in black, bold, sans-serif font. The letters are slightly rounded, giving the logo a modern and professional appearance.

510(k) Summary	MAY 1 4 2014
Proprietary Name	NEOPLATE Spine Anterior Fixation System
510(K) Number	K132653
Date Prepared	May 12, 2014
Submitter	NEOORTHO Produtos Ortopedicos S/ARua Angelo Domingos Durigan 607,CascatinhaCuritiba-PR, Brazil 82020-340
	Telephone: +55 41 3535-1033Fax: +55 41 3535-1018
Official Contact	Tara ConradTechLink International Consulting18851 NE 29th Avenue Suite 720Aventura, FL 33180TEL- (305) 377-0077
Common NameTrade NameRegulatory ClassProduct CodeClassification PanelRegulation NumbersPredicate Device	Appliance, fixation, spinal Intervertebral bodyNEOPLATE Spine Anterior Fixation SystemClass IIKWQOrthopedic21 CFR § 888.3060K030327 Zephir Anterior Cervical System byMedtronic Sofamor Danek

Device Description

Indications for Use Statement

Note: this device system is intended for anterior cervical intervertebral body fusions only.

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Image /page/1/Picture/0 description: The image shows the logo for "NEOORTHO". The logo consists of a stylized, abstract symbol on the left, resembling a curved shape within a square. To the right of the symbol is the word "NEOORTHO" in bold, sans-serif font. The overall design is simple and modern.

Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Material

The NEOPLATE is manufactured from titanium alloy as described in ASTM F136.

Performance Data

Mechanical testing was performed according to ASTM F1717. The specific tests performed were:

Compression Testing .
Fatique Testing .
Static Torsional Testing .

The mechanical testing results demonstrate substantial equivalence to other legally marketed devices.

Technological Characteristics

The NEOPLATE System possesses the same technological characteristics as the predicate device. These include:

Performance (described above) .
. Basic design (plate and screw system)
Material (titanium alloy) .
. Size (dimensions are within the ranges of the predicate)

Therefore the fundamental scientific technology of the NEOPLATE System is the same as the previously cleared device.

Conclusion

The subject device and predicate device share the same indications for use, primary implant design and equivalent material of manufacture. In conclusion, the information provided and performance testing conducted demonstrate that the subject device is substantially equivalent to other legally marketed devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, with three curved lines representing the body and a base that suggests movement or support.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 14, 2014

NEOORTHO Produtos Orthopedicos S/A % TechLink International Consulting Ms. Tara Conrad Regulatory Affairs Manager 18851 Northeast 29th Avenue, Suite 720 Aventura, Florida 33180

Re: K132653

Trade/Device Name: NEOPLATE Spine Anterior Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 4, 2014 Received: April 11, 2014

Dear Ms. Conrad:

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.

1f 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Tara Conrad

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132653

Device Name

NEOPLATE Spine Anterior Fixation System

Indications for Use (Describe)

The NeoOrtho NEOPLATE Spine Anterior Fixation System is interior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is incdicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma, (including fractures), 3) tumors, 4)deformity (defined by kyphosis, or scoliosis), 5) nseudarthrosis, and/or 6) failed previous fusions. Note: this device system is intended for anterior cervical intervertebral body fusions only.

Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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.