The PEEK Cage for the Vertebral Spine NeoSpace PLIF, TLIF, and ALIF devices are indicated for spinal fusion procedures at one or two contiguous levels from L2-S1, in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have Grade 1 Spondylolisthesis at involved levels. Patients must have undergone a regimen of six months of non-operative treatment prior to treatment in the lumbar spine. The PLIF devices may be used singularly or in pairs. All lumbar devices are to be used with supplemental fixation cleared for use in the lumbar spine.

The Cervical devices are indicated for spinal fusion procedures at one level in the cervical spine from C3 to T1 for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Patients must have undergone a regimen of six weeks of non-operative treatment prior to treatment in the cervical spine. One cervical device is used per intervertebral space. All cervical devices are to be used with supplemental fixation cleared for use in the cervical spine.

All lumbar and cervical devices are intended for use with autogenous bone graft.

Device Description

The PEEK CAGE FOR THE VERTEBRAL SPINE NEOSPACE is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK -Optima (per ASTM F2026).

AI/ML Overview

The provided document describes a medical device called the "PEEK CAGE FOR THE VERTEBRAL SPINE NEOSPACE," an intervertebral body fusion device. The document focuses on establishing substantial equivalence for this device to legally marketed predicate devices, primarily through performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance
Static Compression per ASTM F2077	Demonstrated substantially equivalent performance to predicate devices.
Static Compression-Shear per ASTM F2077	Demonstrated substantially equivalent performance to predicate devices.
Static Torsion per ASTM F2077	Demonstrated substantially equivalent performance to predicate devices.
Dynamic Compression per ASTM F2077	Demonstrated substantially equivalent performance to predicate devices.
Dynamic Compression-Shear per ASTM F2077	Demonstrated substantially equivalent performance to predicate devices.
Dynamic Torsion per ASTM F2077	Demonstrated substantially equivalent performance to predicate devices.
Subsidence Testing per ASTM F2267	Demonstrated substantially equivalent performance to predicate devices.

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

Sample Size: The document states that testing was performed on "worst case subject devices." However, it does not specify the exact number (sample size) of devices tested for each performance test.
Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. It only mentions the submitter is from Brazil.

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

This information is not applicable as the study described is a mechanical performance study of a device, not an AI or diagnostic study requiring expert ground truth for interpretation of outcomes. The 'ground truth' for this type of study is the physical measurement against established ASTM standards and comparison to predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable for a mechanical performance study. Adjudication methods are typically used in clinical or diagnostic studies to resolve discrepancies in expert interpretations or assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not mentioned or conducted. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the nature of this submission.
Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (algorithm only without human-in-the-loop performance) was not done. This submission is for a physical medical implant, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for this mechanical performance testing is based on established engineering standards (ASTM F2077 and ASTM F2267) and comparison to the performance of legally marketed predicate devices. It is not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.

8. Sample Size for the Training Set

This information is not applicable. The study is a mechanical performance test for a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable as there is no training set mentioned or required for this type of device submission.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for "NEOORTHO". The logo consists of a black square with a white swirl inside on the left, followed by the word "NEOORTHO" in black, bold, sans-serif font. The letters are closely spaced, giving the word a solid, unified appearance.

MAY 2 9 2014

SECTION 6
510(k) Summary
Proprietary Name		PEEK CAGE FOR THE VERTEBRALSPINE NEOSPACE
Date Prepared	May 28, 2014
510(K) Number	K132852
Submitter	NEOORTHO Produtos Ortopedicos S/ARua Angelo Domingos Durigan, 607CascatinhaCuritiba-PR, Brazil 82020-340Telephone: +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 Name		Intervertebral body fusion device
Regulation Number & Product Codes		MAX -21 CFR §888.3060ODP- 21 CFR §888.3080
Classification Panel		Orthopedic
Predicate Device Identification		K071983 Aesculap PEEK Spinal Implant SystemK082848 Nubic by Signus

Device Description

Indications for Use Statement

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

The Cervical devices are indicated for spinal fusion procedures at one level in the cervical --spine from C3 to T1 for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Patients must have undergone a regimen of six weeks of non-operative treatment prior to treatment in the cervical spine. One cervical device is used per intervertebral

space. All cervical devices are to be used with supplemental fixation cleared for use in the cervical spine.

All lumbar and cervical devices are intended for use with autogenous bone graft.

Substantial Equivalence

The fundamental scientific technology, design, and materials of the subject device are substantially equivalent to the legally marketed predicates.

Performance Testing

The following tests were performed on the worst case subject devices: static compression, static compression-sheer, static torsion, dynamic compression, dynamic compression-sheer and dynamic torsion testing per ASTM F2077 and subsidence testing per ASTM F2267. The testing demonstrated substantially equivalent performance of the subject device as compared the legally marketed predicate devices.

Conclusion .

The subject device and predicate devices share indications for use, primary implant design and equivalent material of manufacture.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person or a symbol of care and support. The logo is black and white.

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 29, 2014

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

Re: K132852

Trade/Device Name: PEEK Cage for the Vertebral Spine NeoSpace Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: April 25, 2014 Received: April 29, 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.

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

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

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/Resourcesfor You/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/McdicalDevices/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

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

Indications for Use

510(k) Number (if known) K132852

Device Name PEEK Cage for the Vertebral Spine NeoSpace

Indications for Use (Describe)

The PEEK Cage for the Vertebral Spine NeoSpace PLIF, TLIF, and ALIF devices are indicated for spinal fusion procedures at one or two contiguous levels from L2-S1, in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have Grade ! Spondylolisthesis at involved levels. Patients must have undergone a regimen of six months of non-operative treatment in the lumbar spine. The PLIF devices may be used singularly or in pairs. All lumbar devices are to be used with supplemental fixation cleared for use in the lumbar spine.

All lumbar and cervical devices are intended for use with autogenous bone graft.

Type of Use (Select one or both, as applicable)

2 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.

,就在 FOR FDA USE ONLY 1. #4 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 #1 : :

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

Anton E. Dmitriev, Ph

A. Fill in the blanks with appropriate words.

The sun is a star.
The earth is a planet.
The moon is a satellite.
The earth moves around the sun.
The moon moves around the earth.

Division of

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 time to review the collection. 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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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.