The Indus™ Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. 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, and 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 nonsterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.

AI/ML Overview

This document describes a 510(k) premarket notification for the Indus 100 Anterior Cervical Plate System.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate devices in terms of indications for use, function, operating principles, and materials.	The Indus™ Anterior Cervical Plate System was shown to be substantially equivalent to predicate devices in these aspects.
Performance equivalence to predicate devices (specifically mechanical testing).	The Indus™ Anterior Cervical Plate System has been shown to be substantially equivalent to predicate devices in terms of performance (mechanical testing). Actual test results or specific metrics for mechanical testing (e.g., tensile strength, fatigue life) are not detailed in the provided summary.

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

This information is not applicable as the document explicitly states, "Clinical data was not required for this device." The evaluation of this device for substantial equivalence was based on mechanical testing and comparison of technical characteristics to predicate devices, not on clinical or human study data.

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 information is not applicable for the same reason as point 2. No ground truth based on expert review of clinical data was established for evaluating this device.

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

This information is not applicable for the same reason as point 2 and 3.

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 information is not applicable. This is a physical spinal implant device, not an AI or imaging-related medical device. Therefore, an MRMC study related to human readers or AI assistance is irrelevant.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device, in the context of substantial equivalence, appears to be the performance and characteristics of the legally marketed predicate devices. The new device's mechanical performance and design characteristics are compared against these established predicates to demonstrate equivalence. No traditional "ground truth" as derived from clinical outcomes or expert labels was used.

8. The sample size for the training set

This information is not applicable as there was no training set in the context of clinical data or AI model development. The device's evaluation was based on mechanical testing.

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

This information is not applicable for the same reason as point 8.

Summary of the Study Proving Acceptance Criteria:

The study proving the device's acceptance criteria was primarily a mechanical testing study and a comparison of technological characteristics against legally marketed predicate devices.

The document explicitly states:

"The Indus™ Anterior Cervical Plate System was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, and materials."
"The Indus™ Anterior Cervical Plate System has been shown to be substantially equivalent to predicate devices in terms of performance (mechanical testing)."
"Clinical data was not required for this device."

This means the "study" involved:

Mechanical Testing: The device underwent mechanical tests to assess its performance characteristics (e.g., strength, fatigue, stability) and these results were compared to the known or expected performance of the predicate devices. The specific tests performed and their quantitative results are not detailed in this summary.
Design and Material Comparison: A detailed comparison was made between the design, materials (Titanium alloy - Ti-6AI-4V ELI conforming to ASTM F 136), and intended use of the Indus 100 Anterior Cervical Plate System and those of the identified predicate devices (K073232, K030866, K052292, K062831). The goal was to demonstrate that any differences did not raise new questions of safety or effectiveness.

Summary

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510(k) Summary 5.0

1. Sponsor

SpineFrontier, Inc. 500 Cummings Center Suite 3500 Beverly, MA 01915

MAR 2 3 2010

Primary Contact:	John Sullivan
Telephone:	1-978-232-3990

December 7, 2009 Date Prepared:

2. Device Name and Classification:

Proprietary Names: Indus 100 Anterior Cervical Plate System Common/Usual Name: Spinal Intervertebral Body Fixation Orthosis Spinal Intervertebral Body Fixation Orthosis Classification Name: (21 CFR 888.3060), Class II Product Code: KWQ

3. Predicate Devices

K073232 - SpineFrontier - Indus Anterior Cervical Plate System K030866 - Synthes Spine - Anterior CSLP System K052292 - X-Spine - Spider Cervical Plate K062831 - Life Spine - NEO

4. Device Description

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This submission is being provided for design changes to the previously cleared Indus ACP System (K073232).

5. Intended Use

6. Technological Characteristics & Substantial Equivalence Determination

The SpineFrontier Indus™ Anterior Cervical Plate System was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, and materials.

The Indus™ Anterior Cervical Plate System has been shown to be substantially equivalent to predicate devices in terms of performance (mechanical testing). Clinical data was not required for this device.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.

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

MAR 2 3 2010

SpineFrontier, Inc. % Mr. John Sullivan Director of QA and Regulatory Compliance 500 Cummings Center - Suite 3500 Beverly, Massachusetts 01915

Re: K093776

Trade/Device Name: Indus™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 16, 2010 Received: March 19, 2010

Dear Mr. Sullivan:

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. John Sullivan

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/CDRHQffices/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.

Harbay Buehr

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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4.0 Indications for Use Statement

510(k) Number (if Known):

Indications For Use:

The Indus™ Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. 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.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K093776 510(k) Number_

SpineFrontier, Inc. Indus™ Anterior Cervical Plate System - 510(k) Premarket Notification December 7, 2009

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.