The Innvotec Surgical SEC VBR is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.

The Innvotec Surgical SEC VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Innvotec Surgical SEC VBR is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC VBR may be used with bone graft.

Device Description

The SEC VBR acts as a spacer to maintain proper vertebral body spacing and angulation following partial corpectomy. The SEC VBR is manufactured from Ti6Al4V and stainless steel. The SEC VBR is for single level anterior spinal use from T1-L5.

AI/ML Overview

This 510(k) submission for the Innvotec Surgical SEC VBR does not describe a study that uses acceptance criteria based on human or AI performance metrics. Instead, it’s a premarket notification for a medical device (spinal intervertebral body fixation orthosis) seeking substantial equivalence to existing devices.

The "acceptance criteria" and "study" described in the document relate to the physical performance and safety of the device itself, not the performance of an AI or human-AI system in tasks like disease detection or image interpretation.

Here's an analysis based on the provided text, outlining why the requested information cannot be fully provided in the context of this device and what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Biomechanical Integrity	Adherence to ASTM F2077 standards for intervertebral body fusion devices.	"Testing performed on this device indicates that the SEC VBR is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met." This implies the device met the mechanical strength, fatigue, and other biomechanical performance requirements specified in ASTM F2077.
Material Compatibility	Use of standard biocompatible materials for implants.	"The SEC VBR is manufactured from Ti6Al4V and stainless steel." (These are commonly used, biocompatible materials for surgical implants, and their use helps demonstrate substantial equivalence.)
Functional Equivalence	Same intended use, design, and function as predicate devices.	"The SEC VBR was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used." This is the overarching "performance" claim for substantial equivalence.
Safety and Effectiveness	No new safety or effectiveness questions raised compared to predicate devices.	Implicit in the FDA's determination of substantial equivalence (K091743).

Explanation for Missing Information Regarding AI/Human Performance Studies:

The Innvotec Surgical SEC VBR is a physical medical implant, a spinal vertebral body replacement device. The 510(k) submission process for such devices focuses on demonstrating substantial equivalence to already legally marketed predicate devices in terms of:

Intended Use
Design and Materials
Performance (e.g., mechanical strength, fatigue resistance, biocompatibility)
Safety and Effectiveness

The provided text does not contain any information about:

AI algorithms or software.
Interpretation of medical images by humans or AI.
Diagnostic performance (e.g., sensitivity, specificity).
Human readers, experts, or their interpretations.
Training or test sets for AI models.
Ground truth derived from expert consensus or pathology for diagnostic purposes.
Multi-reader multi-case (MRMC) comparative effectiveness studies.

Therefore, the following sections cannot be answered based on the provided document as they are not relevant to the type of device and submission described.

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

Not applicable. This information pertains to studies evaluating the diagnostic/interpretive performance of an algorithm or human-AI system. The provided document describes the physical testing of a medical implant and its demonstration of substantial equivalence to predicate devices, primarily through adherence to ASTM standards.

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)

Not applicable. There is no "ground truth" in the diagnostic sense or expert review process described for the performance of this physical implant. The "ground truth" for the device's performance would be the scientific and engineering principles and the requirements defined by standards like ASTM F2077.

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

Not applicable. This refers to a method used to resolve discrepancies in expert interpretation, which is not part of this device's regulatory submission.

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

Not applicable. No MRMC study was performed or is relevant for this type of medical implant.

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

Not applicable. No algorithm is described for this physical device.

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

The "ground truth" for this device's regulatory review is based on adherence to recognized performance standards (ASTM F2077), material specifications (Ti6Al4V and stainless steel), and established principles of biomechanical engineering and biocompatibility for spinal implants. There is no expert consensus or pathology data mentioned in the context of performance testing within this document.

8. The sample size for the training set

Not applicable. No training set for an AI algorithm is mentioned or relevant to this device.

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

Not applicable. No training set for an AI algorithm is mentioned or relevant to this device.

In summary: The provided 510(k) summary focuses on demonstrating that the Innvotec Surgical SEC VBR is substantially equivalent to predicate devices by meeting established standards for physical device performance (e.g., biomechanical testing per ASTM F2077). It does not involve AI, human interpretation of data, or studies related to diagnostic accuracy.

Summary

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Innvotec Surgical SEC VBR 510(k)

K091743

510(k) Summary 5.

NOV - 2 2009

ﺗﺮ

Contact:	Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Device Trade Name:	SEC VBR
Manufacturer:	Innvotec Surgical, Inc.150 North Hill Drive, Suite 1Brisbane, CA 94005
Common Name:	Spinal intervertebral body fixation orthosis
Classification:	21 CFR §888.3060
Class:	II
Product Code:	MQP

Indications For Use:

The Innvotec Surgical SEC VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a The Innvotec Surgical SEC VBR is always to be used with prolonged period. supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC VBR may be used with bone graft.

Device Description:

Predicate Device(s):

The SEC VBR was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used.

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长091743

Innvotec Surgical SEC VBR 510(k)

Performance Standards:

Testing performed on this device indicates that the SEC VBR is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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. Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Innvotec Surgical, Inc. % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton Director, Spine Regulatory Affairs 1331 H Street, NW - 12th Floor Washington, District of Columbia 20005

NOV - 2 2009

Re: K091743

Trade/Device Name: SEC VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 27, 2009 Received: October 28, 2009

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.

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

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Page 2 - Mr. Justin Eggleton

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 forth in the quality systems (OS) 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours.

Sincerely, Mark,

Mark McMillan

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Innvotec Surgical SEC VBR 510(k)

4. Indications for Use

510(k) Number (if known): K09|743

Device Name: SEC VBR

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of GDRH, Office of Device Evaluation (ODE)

Mark H. Milliken

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K091743

510(k) Number .

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.