Intervertebral Body Fusion Device: The Innvotec Surgical SEC IBF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Innvotec Surgical SEC IBF Cage is to be used with supplemental fixation.

Vertebral Body Replacement: When used as a vertebral body replacement, the Innvotec Surgical SEC IBF Cage 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 IBF Cage 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 IBF Cage is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC IBF Cage may be used with bone graft.

Device Description

The SEC IBF Cage acts as a spacer to maintain proper intervertebral and vertebral body spacing and angulation following discectomy or partial corpectomy. The SEC IBF Cage is manufactured from Ti6Al4V and stainless steel.

AI/ML Overview

The provided text describes the 510(k) summary for the Innvotec Surgical SEC IBF Cage and a letter from the FDA regarding its clearance. It does not present a study with acceptance criteria and reported device performance in the format requested, especially not for an AI/software device.

The document is for a physical medical device (an intervertebral body fusion cage made of Ti6Al4V and stainless steel), not a software or AI-based device. Hence, most of the requested information (like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or present in this context.

However, I can extract the relevant information from the provided text regarding the device's performance and its equivalence to established standards, which can be considered its "acceptance criteria" in a regulatory sense for a traditional medical device:

Acceptance Criteria and Device Performance (for SEC IBF Cage - a physical medical device)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Compliance)
ASTM F2077 performance standards	All applicable requirements were met.
Biomechanical integrity of the anterior, middle, and posterior spinal column	Device designed to restore this integrity even in the absence of fusion for a prolonged period.
Substantial equivalence to predicate devices	Shown to be substantially equivalent to previously cleared devices.
Same indications for use as predicate devices	Has the same indications for use as predicate devices.
Same design as predicate devices	Has the same design as predicate devices.
Same function as predicate devices	Has the same function as predicate devices.
Same materials used as predicate devices	Has the same materials used as predicate devices (Ti6Al4V and stainless steel).

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The testing mentioned refers to performance standards for a physical implant, not a clinical study on human subjects with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The "ground truth" here would relate to whether the device meets engineering specifications and is substantially equivalent to predicates, not clinical diagnostic accuracy.

4. Adjudication method for the test set

This information is not applicable and not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This type of study is relevant for evaluating human interpretation with and without AI assistance, which is not applicable to a physical spinal implant device.

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

No, a standalone performance evaluation of an "algorithm" was not done. This device is a physical implant, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this device's acceptance is based on:

Compliance with ASTM F2077 performance standards (engineering and material testing).
Demonstration of substantial equivalence to existing legally marketed predicate devices, implying similar safety and effectiveness based on design, materials, function, and indications for use.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of this physical device.

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

This information is not applicable and not provided. There is no "training set" for this physical device.

In summary, the provided document is for a traditional physical medical device (spinal implant) and its 510(k) clearance process, which relies on adherence to performance standards and substantial equivalence to predicates, rather than clinical efficacy studies or AI performance metrics.

Summary

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510(k) Summary

MAR 1 8 2010

Contact:	Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Device Trade Name:	SEC IBF Cage
Manufacturer:	Innvotec Surgical, Inc.150 North Hill Drive, Suite 1Brisbane, CA 94005
Common Name:	Spinal intervertebral body fixation orthosis
Classification:	21 CFR §888.3080
Class:	II
Product Code:	MAX, MOP

Indications For Use:

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Device Description:

Predicate Device(s):

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

Performance Standards:

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

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.

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

MAR 1 8 2010

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

Re: K093669

Trade/Device Name: SEC IBF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MOP Dated: March 01, 2010 Received: March 02, 2010

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

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Page 2 - Mr. Justin Eggleton

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 (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.

Barbara Buehr

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

Enclosure

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Indications for Use

510(k) Number (if known): K093669

Device Name: SEC IBF Cage

ﮨﮯ Prescription Use (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 CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_ KO93669

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.