The INDUS™ Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in whom stability is desired following anterior cervical fusion. The levels of treatment range from C2 to C7. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.

Device Description

The INDUS™ Anterior Cervical Plate System consists of a variety of shapes and sizes of plates, screws, locking crowns, and the associated instruments. The plates are available in four levels to accommodate one to four levels of fixation. The screws come as self tapping or self drilling in various lengths and diameters. The INDUS™ Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136.

AI/ML Overview

The provided text describes the 510(k) summary for the SpineFrontier INDUS™ Anterior Cervical Plate System. This is a spinal implant system, not an AI/ML device, and therefore the acceptance criteria and study details are based on physical device performance, not AI/ML performance.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Meets performance standard of ASTM Standard F1717-04, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."	The INDUS™ Anterior Cervical Plate System meets the performance standard of ASTM Standard F1717-04.

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

The document does not explicitly state the sample size (number of constructs tested) used for the performance testing. It mentions "Representative samples of the device underwent testing." Data provenance information (country of origin, retrospective/prospective) is also not provided, as this type of mechanical testing typically doesn't involve human data subjects.

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 question is not applicable to a physical spinal implant device's performance testing. "Ground truth" in this context refers to established engineering standards (ASTM F1717-04), not expert medical interpretation of data.

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

This question is not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation, not for mechanical performance testing against a standard.

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 question is not applicable. The device is a physical spinal implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or AI-related effect size would be relevant.

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

This question is not applicable. The device is a physical spinal implant, not an algorithm.

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

The "ground truth" for the device's performance is established by the ASTM Standard F1717-04, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This is a standardized engineering test method, not a medical ground truth based on expert consensus, pathology, or outcomes data in humans.

8. The sample size for the training set

This question is not applicable. The device is a physical spinal implant, not an AI/ML system that requires a training set.

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

This question is not applicable. The device is a physical spinal implant, not an AI/ML system.

Summary

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16073232

FEB 20 2008

5.0 510(k) Summary

1. Sponsor
  SpineFrontier, Inc. 100 Cummings Center Suite 240C Beverly, MA 01915

Primary Contact:	Thomas A. Carlson
Telephone:	1-978-232-3990

Date Prepared: November 2, 2007

2. Indus Cervical Plate System:

Proprietary Name:	INDUS™ Anterior Cervical Plate System
Common/Usual Name:	Spinal Intervertebral Body Fixation Orthosis
Classification Name:	Spinal Intervertebral Body Fixation Orthosis(21 CFR 888.3060), Class II
Product Code:	KWQ

3. Predicate Devices

K030866 - Synthes Spine - Anterior CSLP System

4. Device Description

The screws come as self tapping or self drilling in various lengths and diameters. The INDUS™ Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136.

5. Intended Use

Page 18

Company Confidential

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K073232

Page 2 of 2

spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.

6. Technological Characteristics and Substantial Equivalent

The SpineFrontier INDUS™ Anterior Cervical Plate System and its predicate device have the same indications for use, operating principles and are made of the same materials.

Representative samples of the device underwent testing to demonstrate comparable function and performance characteristics to the predicate device.

7. Performance Testing

The INDUS™ Anterior Cervical Plate System meets the performance standard of ASTM Standard F1717-04, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."

Company Confidential

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

FEB 20 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SpineFrontier, Incorporated % Mr. Tom Carlson Chief Operating Officer 100 Cummings Center, Suite 240C Beverly, MA 01915

Re: K073232

Trade/Device Name: Indus® Anterior Cervical Plate System, Model IM3xxx Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 22, 2008 Received: January 25, 2008

Dear Mr. Carlson:

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 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.

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Page 2 - Mr. Tom Carlson

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millerson

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

Enclosure

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4.0 Indications for Use Statement

510(k) Number (if Known): _ K07323 Z

Indications For Use:

Prescription Use: X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: (Part 21 CFR 807 Subpart C)

Barbara Buche

Division of General, Restorative, and New blogical Devices

510(k) Number K073232

Company Confidential

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.