The ROI is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from TI to L5) and is intended for use with supplemental internal fixation. The ROI may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

Device Description

The ROI vertebral implants consists of a series of flat and wedge shaped implants. The device is used singly or in pairs. The device is offered in nine different configurations to better approximate the anatomical variation observed in different vertebral levels and/or patient anatomy.

The LDR Spine USA, ROI Partial Vertebral Body Replacement System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred.

The LDR Spine ROI Partial Vertebral Body Replacement System is a two piece, hollow chamber, rectangular block. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. Tantalum wire markers (ASTM F-560) are inserted into components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively. The device comes in various sizes and is offered in both straight and tapered styles.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for a medical device, specifically the Radiotransparent Open Implant (ROI) - Partial Vertebral Body Replacement (PVBR). It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria through clinical performance.

Therefore, many of the requested categories for information, such as "reported device performance," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details," are not applicable or available in this type of regulatory document.

The document primarily describes the device, its intended use, materials, and a comparison to predicate devices, focusing on design, material composition, surgical technique, and indications for use to establish substantial equivalence. The "Testing Summary" states that "Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the predicate devices." This refers to biomechanical testing, not clinical studies with human subjects or expert assessments.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Device Performance (as far as available from this document)

Acceptance Criteria (Inferred from Substantial Equivalence to Predicates)	Reported Device Performance (from document)
Indications for Use Equivalence	The ROI's indications for use are identical to the EBI CAS Spine Spacer System and the Signus PEEK Tetris™ Spinal Implant: "To replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The ROI may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system." (Note: The predicate "Signus PEEK Tetris™ Spinal Implant" is listed as "Singularly" for how it's used, while ROI is "Singularly or in pairs", but this difference is deemed substantially equivalent).
Design Equivalence	ROI is a "Modular Cage," which is considered substantially equivalent to the "Cage" design of the CAS Spine Spacer System and the "Same as CAS SSS" for the PEEK Tetris™ Spinal Implant.
Supplied Sterile Equivalence	ROI is supplied "Yes - Gamma radiation," equivalent to predicate devices also supplied sterile (EBI CAS System: "Yes," PEEK Tetris™: "Yes - Gamma radiation").
Material Equivalence	ROI uses "PEEK w/ tantalum markers." This is considered substantially equivalent to the EBI CAS Spine Spacer System ("Titanium") and the PEEK Tetris™ Spinal Implant ("PEEK w/ titanium markers"). Note: While the materials differ (PEEK vs. Titanium, and tantalum vs. titanium markers), the document asserts substantial equivalence, likely based on biocompatibility and mechanical performance for the intended application.
Instrument Equivalence	ROI requires "Specialized reusable instruments," consistent with predicate devices.
Usage Equivalence	ROI can be used "Singularly or in pairs." This is equivalent to the EBI CAS System ("Same") but differs from the PEEK Tetris™ ("Singularly"). Despite this, it is considered substantially equivalent.
Biomechanical Performance	"Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the predicate devices." (No specific numerical performance data or acceptance criteria are reported in this summary beyond this general statement of equivalence.)

Additional Requested Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The "testing summary" refers to biomechanical engineering tests (fatigue and static testing) on "samples," not a clinical test set with patient data. The specific number of samples for these engineering tests is not provided.
- Data Provenance: Not applicable for a clinical test set. For the engineering tests, the data would be generated from lab testing, not patient data from a specific country or retrospective/prospective collection.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" established by experts for a clinical test set is mentioned. The evaluation is based on engineering testing and comparison to predicate devices, which relies on regulatory review of submitted data and literature, not expert consensus on patient cases.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set or expert adjudication is described.
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:
- Not applicable. This document is for a physical implant device, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical ground truth. The "ground truth" for demonstrating device safety and effectiveness in this context is the successful completion of "fatigue and static testing" demonstrating equivalence to predicate devices, and the established safety records of the materials (PEEK, Tantalum) and the predicate devices.
The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable. No training set mentioned.

Summary

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	IDD Car
510(k)Summarv	Spine USA
	JUNE 9, 2005
Premarket Notification, Section 510(k)

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:

Radiotransparent Open Implant (ROI) - Partial Vertebral Body Trade Name: Replacement (PVBR)

Common Vertebral body replacement Name(s):

Classification Name(s): Vertebral body replacement (MQP)

Establishment Name & Registration Number: 2.

Name:	LDR Spine USA
Number:	3004903783

3. Classification(s):

21 CFR § Sec. 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 vertebral bodies. An eve-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.

Device Class: Class II for the requested indications Classification Panel: Orthopaedic and Rehabilitation Devices Panel Product Code(s): MQP

4. Equivalent Predicate Device:

LDR Spine USA proposes that the ROI is substantially equivalent to the following:

-EBI CAS Spine Spacer System- K042268
-Signus PEEK Tetris™ Spinal Implant - K031757
Signus Curved PEEK Tetris™ Spinal Implant K041888 -

Equivalence is demonstrated in the design, material composition, surgical technique and intended use.

ર્ડ Device Description:

ROI.doc

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Materials: all implants are made from implant grade PolyEtherEther-Ketone polymer (PEEK) with tantalum alloy position markers as indicated in the table below:

PEEKOptima LT	USP Class VIASTM F-2026	ISO 10993
Tantalum	ASTM F-560	ISO 5832-3

Indications for Use. The ROI is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from TI to LS) and is intended for use with supplemental internal fixation. The ROI may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

Testing Summary. Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the predicate devices.

Applicant Name & Address: 6.

LDR Spine USA 4030 W. Braker Ln., Ste. 360 Austin, TX. 78759

Office: (512) 344-3333 Fax: (512) 344-3350

7. Company Contact:

Mr. Edward E. Newton Dir. Reg. & Clinical Affairs LDR Spine USA 4030 W. Braker Ln., Ste. 360 Austin, TX. 78759 Office: (512) 344-3316 Fax: (512) 344-3350

8. Submission Correspondent:

Mr. Brian Burkinshaw Dir. Innovation & Technology LDR Spine USA 4030 W. Braker Ln., Ste. 360 Austin, TX. 78759 Office: (512) 344-3304 Fax: (512) 344-3350

9. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTNA LIDR Spine, USA Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 13485 series quality regulations.

LDR Spine USA also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

ROl.doc

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Storage, Packaging & Sterilization Information: 10.

The implantable portions of the ROI are supplied "STERILE". The sterilization process is radiation and the selected protocol has been validated. The minimum Sterility Assurance Level (SAL) of at least 10 .

The instruments are supplied non-sterile and must be cleaned and sterilized prior to first use and each The recommended sterilization process for the instruments is high temperature steam subsequent use. autoclave sterilization. The referenced sterilization cycle produces a Sterility Assurance Level (SAL) of at least 10-6.

The validated cycle is:

Method: Steam Cycle: Gravity Temperature: 270°F (134°C) Exposure Time: 18 minutes

All packages containing implants or instruments should be intact upon receipt. Damaged packaging may indicate the presence of unsafe product. If the package or product is damaged, the product should not be used and should be returned. Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following cleaning, sterilization and accepted surgical sterile technique.

FEATURE	ROI	CAS Spine Spacer System	PEEK and Curved PEEKTetris™ Spinal Implant	SE?
Indications forUse:	The ROI is indicated for use toreplace a vertebral body that hasbeen resected or excised due totumor or trauma/fracture. Thedevice is intended for use as apartial vertebral body replacementin the thoraco-lumbar spine (fromTI to L5) and is intended for usewith supplemental internal fixation.The ROI may be implantedsinularly or in pairs. Supplementalfixation is required to properlyutilize this system	Same as ROI	Indicated for use to replace a vertebralbody that has been resected or exciseddue to tumor or trauma/fracture. Thedevice is intended for use as avertebral body replacement in thethoracolumbar spine (from TI to L5)and is intended for use withsupplemental internal fixation.	YES
Design:	Modular Cage	Cage	Same as CAS SSS	YES
SuppliedSterile:	Yes - Gamma radiation	Yes	Yes - Gamma radiation	YES
Material:	PEEK w/ tantalum markers	Titanium	PEEK w/ titanium markers	YES
Instruments:	Specialized reusable instruments arerequired. Instruments must becleaned and sterilized prior to 1st useand each subsequent use.	Same	Same	YES
How used:	Singularly or in pairs	Same	Singularly	YES
K Number:	K043349 (under review)	K042268	K031757 - K041888	YES
Manufacturer:	LDR Medical	EBI	Signus Medizintechnik, Gmbh	YES
Product Code:	MOP	MOP	MOP	YES

Summary Comparison Table: 11.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is a stylized eagle with three lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian Burkinshaw Director, Innovation and Technology Solutions

LDR Spine USA Incorporated 4030 West Braker Lane, Suite 360

Austin, Texas 78759

Re: K043349 Trade/Device Name: Radiotransparent Open Implant (ROI)- Partial Vertebral Body Replacement (PVBR) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 9, 2005 Received: June 10, 2005

Dear Mr. Burkinshaw:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

JUN 2 9 2005

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Page 2 – Mr. Brian Burkinshaw

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stupt Rhodes

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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643349

Page 1 of 1

K043349 510(k) Number:

Radiotransparent Open Implant (ROI) – Partial Vertebral Body Device Name(s): Replacement (PVBR)

Indications for Use:

The ROI is indicated for use to replace a vertebral body that has been resected or The KOr is included for as to replace is intended for use as a excised due to tunnor of thatha inche thoracolumbar spine (from TV to LS) and partial vertebrar oddy replacemental internal fixation. The ROI may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

Over-The-Counter Use OR × Prescription Use_ PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IN NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Stupt Rhodes

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

KOY3349 510(k) Number_

(Per 21 CFR 801.109)

(Optional format 1-2-96)

P. 1 ot 1

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.