The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Device Description

The Dymaxeon Spine System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of polyaxial pedicle screws, reduction screws, and rods. The Dymaxeon Spine System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters.

AI/ML Overview

The provided text describes the Dymaxeon Spine System, a posterior pedicle screw system, and its substantial equivalence to predicate devices based on preclinical testing. It does not describe a study involving humans or AI for diagnostic or predictive purposes. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and comparative effectiveness with AI assistance is not applicable to this document.

Here's the information that can be extracted or deduced from the provided text:

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

The document does not explicitly state numerical acceptance criteria in a table format. However, the reported device performance is that it met the requirements of the ASTM F1717 standard. The acceptance criterion is implied to be "substantially equivalent" to predicate devices, as demonstrated by meeting this standard.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to legally marketed predicate devices, demonstrated by meeting biomechanical standards.	The Dymaxeon Spine System met the requirements of ASTM F1717 for static compression bending, static torsion, and dynamic compression bending. The results demonstrated substantial equivalence.

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

This information is not applicable as the described study is preclinical biomechanical testing, not a human reader study or a study using clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable. Ground truth, in the context of this preclinical testing, would relate to the physical properties and performance of the device against established engineering standards, not expert medical opinions on diagnostic accuracy.

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

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for preclinical mechanical testing.

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 information is not applicable. The provided text describes a medical device (spinal implant) and its preclinical testing, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable. This document does not describe an algorithm or AI.

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

The "ground truth" for this preclinical testing was established by standardized biomechanical testing protocols, specifically ASTM F1717. This standard defines methods for testing spinal implant constructs, and meeting its requirements (as compared to predicate devices) serves as the basis for demonstrating substantial equivalence.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of preclinical mechanical testing of a spinal implant. This term is relevant for machine learning algorithms.

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

This information is not applicable for the reason stated above.

Summary

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510(k) Summary

Device Trade Name:	Dymaxeon Spine System NOV. 5 2012
Manufacturer:	B2B Spine PTY LTDUnit 10, 7 Meridian PlBaulkham Hills NSW 2153 AUSTRALIA
Contact:	Steve BanksB2B Spine PTY LTDUnit 10, 7 Meridian PlBaulkham Hills NSW 2153 AUSTRALIAOffice: +61 2 8887 0100Fax: +61 2 8887 0199Email: steve@globalortho.com.au
Prepared by:	Justin EggletonDirector, Spine Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Office: 202.552.5800Fax: 202.552.5798jeggleton@mcra.com
Date Prepared:	June 15, 2012
Classifications:	21 CFR 888.3070: Pedicle screw spinal system
Class:	III
Product Codes:	NKB, MNI, MNH

Indications for Use:

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Device Description:

Predicate Devices:

Comparative information presented in the 510(k) supports the substantial equivalence of the Dymaxeon Spine System to the following predicate devices: Corelink, LLC Tiger™ Spine System (K110321, K113058), DePuy Moss Miami (K103490, etc), Synthes Universal Reduction Screw (K120571, etc), and Scient'x ISOBAR (K990118, K013444).

Substantial Equivalence:

The components of the Dymaxeon Spine System are substantially equivalent to the identified predicates with respect to its indications for use, geometry, available sizes, materials, methods of fixation and performance.

Preclinical Testing:

The non-clinical tests performed by the company include static compression bending, static torsion, and dynamic compression bending testing per ASTM F1717 of the Dymaxeon Spine System. The results of the performed tests demonstrate that the Dymaxeon Spine System is substantially equivalent to legally marketed predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of two main elements: the HHS symbol and the department's name. The HHS symbol is a stylized representation of a human figure embracing another, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

November 5, 2012

B2B Spine Pty, Limited % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton Director, Spine Regulatory Affairs 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K121786

Trade/Device Name: Dymaxeon Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: September 26, 2012 Received: September 27, 2012

Dear Mr. Eggleton:

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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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Page 2 - Mr. Justin Eggleton

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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. Erin I. Keith

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 4.

510(k) Number (if known): _K121786

Device Name: Dymaxeon Spine System

The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 -S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

ﯿﮯ Prescription Use (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (29 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

EX Keith
(Division Sign-Off)
Surgical, Orthopedic

(Civision of Surgical, C thopedis.
Division of Surgical, C thopedis. Division of Surgical, Division and Restorative Devices
Biostorative Devices

510(k) Number K12

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.