The MC+ is indicated for use for partial replacement (i.e.: partial vertebrectomy) of a diseased vertebral body that has been resected or excised due to tumor or trauma/fracture in order to achieve anterior decompression of the spinal chord and neural tissues, and to restore the height of a collapsed vertebral body. The components are intended for use in pairs for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and are intended for use with supplemental internal fixation such as the Easyspine System to properly utilize this system.

Device Description

The MC+ vertebral implants consist of a series of square and rectangular D-shaped implants. The device is used in pairs as a partial vertebral body replacement in the thoracolumbar spine (from T1 to LS). The device is offered in seven different configurations to better approximate the anatomical variation observed in different vertebral levels and/or patient anatomy. The LDR Spine USA. MC+ 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 superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. The upper surface of the implant is arched in the anterior/posterior direction for increased stability. 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 with optional anchoring clips made of titanium alloy.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the MC+ Partial VBR device.

Important Note: The provided document is a 510(k) Summary, which is a premarket notification to the FDA. It declares substantial equivalence to previously cleared devices. Unlike a PMA (Premarket Approval) submission, a 510(k) summary often references testing but does not typically include detailed reports of de novo clinical or performance studies with specific statistical acceptance criteria and results in the way you might expect for a novel device. The primary "proof" in a 510(k) is the demonstration of substantial equivalence to predicate devices, which implies that if the predicate devices were safe and effective, and the new device shares similar characteristics and performs similarly, it too can be considered safe and effective for its intended use.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type / Basis of Performance
Material Composition	PEEK compliant with ASTM F-2026; Tantalum with ASTM F-560; Titanium with ASTM F-136,92	All implants made from implant grade PEEK (Optima LT) with tantalum alloy position markers and titanium alloy. Materials meet respective ASTM and ISO standards (e.g., PEEK Optima LT: USP Class VI, ASTM F-2026, ISO 10993; Tantalum: ASTM F-560, ISO 5832-3; Titanium: ASTM F-136,92, ISO 5832-3).	Material testing / Compliance with recognized standards
Mechanical Performance	Expected to perform in a manner equivalent to predicate devices.	"Fatigue and static testing is complete. Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device."	Bench testing (Fatigue and Static testing) against predicate device performance.
Sterility	Minimum Sterility Assurance Level (SAL) of at least 10^-6 for implants.	Implants supplied "STERILE" via radiation sterilization with a validated protocol meeting SAL of at least 10^-6.	Sterilization validation study.
Instrument Sterilization	Instruments supplied non-sterile; recommended steam autoclave cycle to achieve SAL of at least 10^-6.	Recommended sterilization process for instruments: Steam Cycle (Gravity), 270°F (134°C) Temperature, 18 minutes Exposure Time, achieving SAL of at least 10^-6.	Sterilization validation study.
Indications for Use	Partial replacement of diseased vertebral body (tumor/trauma/fracture) in thoracolumbar spine (T1-L5), using pairs, with supplemental internal fixation, to achieve anterior decompression and restore height.	Indications for Use are identical to predicate devices (CAS Spine Spacer System, Pioneer Vertebral Spacer, CPOD / LPOD VBR System, Ellys and Aurys VBR).	Comparison to predicate devices.
Design	Cage design.	Cage design.	Comparison to predicate devices.
Use with Bone Graft	Required.	Required.	Comparison to predicate devices.
Secondary Fixation	Required.	Required.	Comparison to predicate devices.
How Used	In pairs.	In pairs. (Note: Predicate devices vary, but MC+ is specifically for pairs).	Device design and intended use statement.

Study Details (Based on the provided Summary)

Given this is a 510(k) submission, the provided summary does not detail full study protocols or results. The "study" mentioned is primarily focused on demonstrating substantial equivalence.

Sample size used for the test set and the data provenance:
- No specific sample size for a "test set" in the context of clinical performance is provided. The evaluation of mechanical performance (fatigue and static testing) would have used an engineering test sample, but the size is not specified.
- Data Provenance: Not applicable in the sense of patient data. The provenance for material and mechanical testing would be internal lab testing by LDR Spine USA or contracted labs. The basis for "equivalence" is comparison to predicates, meaning the clinical performance of the predicate devices is implicitly referenced.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a medical device for vertebral body replacement, and the "ground truth" for its performance is established through engineering principles and comparison to existing, legally marketed devices, not typically by expert consensus on a test set of images or clinical cases in a 510(k) summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical adjudication of a test set is mentioned or typically required for this type of 510(k) submission.
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 device is a physical implant, not an AI or imaging diagnostic tool. An MRMC study would be irrelevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For material properties: Accepted industry standards (ASTM, ISO, USP).
- For mechanical performance: Engineering specifications and comparative mechanical performance to predicate devices.
- For indications/design: Direct comparison to legally marketed predicate devices, implying their established safety and effectiveness forms the "ground truth" for equivalence.
The sample size for the training set:
- Not applicable. No "training set" in the machine learning sense is relevant for this device.
How the ground truth for the training set was established:
- Not applicable.

Summary

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510(k) Summary	LDR Spine USA
Premarket Notification, Section 510(k)	JUNE 13, 2005

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

1.	Device Name:
	Trade Name:	MC+ Partial VBR	JUN 3 0 2005
	Common Name(s):	Vertebral Body Replacement
	Classification Name(s):	Vertebral Body Replacement (MQP)
2.	Establishment Name & Registration Number:

LDR Spine USA Name: Number: 3004903783

3. Classification(s):

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 a series 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 believes that the MC+ is substantially equivalent to the following:

K042268 - EBI CAS Spine Spacer System K043206 - Pioneer Vertebral Spacer K032064 – CPOD / LPOD VBR System K033109 - Ellys and Aurys VBR

Equivalence can be seen in the design, material composition, surgical technique and intended use.

5. Device Description:

The LDR Spine USA. MC+ 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.

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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. The upper surface of the implant is arched in the anterior/posterior direction for increased stability. 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 with optional anchoring clips made of titanium alloy.

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

PEEKOptima LT	USP Class VIASTM F-2026	ISO 10993
Tantalum	ASTM F-560	ISO 5832-3
Titanium	ASTM F-136,92	ISO 5832-3

Indications for Use. The MC+ is indicated for use for partial replacement (i.e.: partial vertebrectorny) of a diseased vertebral body that has been resected or excised due to tumor or trauma/fracture in order to achieve anterior decompression of the spinal chord and neural tissues, and to restore the height of a collapsed vertebral body. The components are intended for use in pairs for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and are intended for use with supplemental internal fixation such as the Easyspine System to properly utilize this system.

Testing Summary. Fatigue and static testing is comples 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 comparison device.

Applicant Name & Address: 6.

LDR Spine USA

4030 W. Braker Ln., Ste. 360 Austin, TX 78759 Office: (512) 344-3333 (512) 344-3350 Fax:

7. Company Contact:

Mr. Edward E. Newton Dir. Reg. and 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 Solutions LDR Spine USA 4030 W. Braker Ln., Ste. 360 Austin, TX 78759 Office: (512) 344-3304 (512) 344-3350 Fax:

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 ASTM, LDR Spine, USA Standard Operating Procedures, vendor & process certification and

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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.

Storage, Packaging & Sterilization Information: 10.

The implantable portions of the MC+ are supplied "STERILE". The sterilization process is radiation and the selected protocol has been validated. The minimum Sterility Assurance Level (SAL) of at least 10-6.

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

The validated cycle is:

Method: Steam Cycle: Gravity 270°F (134°C) Temperature: 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 instruments must be placed into use following cleaning, sterilization and accepted surgical sterile technique.

Summary Comparison Table: 11.

Feature Comparison Table:

FEATURE	MC+	CAS SpineSpacerSystem	PioneerVertebralSpacer	CPOD /LPOD VBRSystem	Ellys andAurys VBR	SE?
Indications forUse:	The MC+ is indicated for usefor partial replacement (i.e.:partial vertebrectomy) of adiseased vertebral body thathas been resected or exciseddue to tumor ortrauma/fracture in order toachieve anteriordecompression of the spinalchord and neural tissues, andto restore the height of acollapsed vertebral body. Thecomponents are intended foruse in pairs for use as apartial vertebral bodyreplacement in thethoracolumbar spine (fromT1 to L5) and are intendedfor use with supplementalinternal fixation such as theEasyspine System to properlyutilize this system.	Same	Same	Same	Same	YES
Design:	Cage	Cage	Cage	Cage	Cage	YES
Sterile:	Yes	Yes	Yes	Yes	Yes	YES

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Material:	PEEK w/ tantalum markers	Titanium	Peek	Titanium	PEEK w/titaniummarkers	YES
Instruments:	Specialized instrumentsrequired. Reusable. Autoclavebefore use.	Same	Same	Same	Same	YES
Bone Graft:	Required	Same	Same	Same	Same	YES
SecondaryFixation:	Required	Same	Same	Same	Same	YES
How used:	Pairs	Singly	Singly	Pairs	Singly andPairs	YES
K Number:	K043479	K042268	K043206	K032064	K033109	YES
Manufacturer:	LDR Spine USA	EBI	PioneerSurgicalTechnology	Theken Spine	Scient'x	YES
Product Code:	MOP	MOP	MOP	MOP	MOP	YES

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2005

Mr. Brian Burkinshaw Director Technology Solutions LDR Spine USA Incorporated 4030 West Braker Lane,Suite 360 Austin, Texas 78759

Re: K043479

Trade/Device Name: MC+ 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 12, 2005 Received: June 16, 2005

Dear Mr. Burkinshaw:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becaren be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and the Medical Device Amendments, or to commerce prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, do noos mat have over that do not require approval of a premarket approval application (PMA). and Cosmotion Free (110) that the device, subject to the general controls provisions of the Act. The r out may, aterers, inians of the Act include requirements for annual registration, listing 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 If your device 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Drives Interves and regulations administered by other Federal agencies. You must or any I catal statures and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 807), as except (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.

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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) I his letter will anow you to ocgin manxeant your antial equivalence of your everyte your devi premarket notification. THC PDF miding of backand experience 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 If you desire specific advice for your don't and the carres and the regulation entitled, and colliation of Computible at (2 + + ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = " Misoranding by release to promantee no illities under the Act from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or Manufacturers, International and Consanter Prosisions of the markets http://www.fda.html.

Sincerely yours,

Stypt Rurda

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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Kodzu79

Page 1 of 1

510(k) Number: K043479

MC+ Partial Vertebral Body Replacement (PVBR) Device Name(s):

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Stret Ruvdr
Division Sign-Off

Division of General, Restorative and Neurological Devices

(Optional format 1-2-96)

510(k) Number K043479

Page 6 of 16

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.