The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.

Device Description

The Incite Anchored Cervical Interbody Fusion Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Fusion Device is manufactured from PEEK and Ti6A14V titanium alloy with tantalum radiopaque markers.

AI/ML Overview

The Incite Anchored Cervical Interbody Fusion Device is a medical device designed to act as a spacer in the cervical spine to maintain proper intervertebral and vertebral body spacing and angulation. The provided text describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain details about a clinical study with acceptance criteria and reported device performance in the way a typical AI/software device would.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through bench testing (performance testing) and comparison of design, materials, and function.

Here's a breakdown of the requested information based on the provided text, highlighting what is (and isn't) present:

Most of the requested information (points 2-9) pertains to clinical studies involving human patients or detailed software validation, which are not described in this 510(k) summary for this type of medical implant.

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

Acceptance Criteria (from recognized standards for spinal implants)	Reported Device Performance (from testing)
Axial Compression - Static (per ASTM F2077)	Demonstrated substantial equivalence to predicate devices and suitability for intended use.
Axial Compression - Dynamic (per ASTM F2077)	Demonstrated substantial equivalence to predicate devices and suitability for intended use.
Compression-Shear - Static (per ASTM F2077)	Demonstrated substantial equivalence to predicate devices and suitability for intended use.
Compression-Shear - Dynamic (per ASTM F2077)	Demonstrated substantial equivalence to predicate devices and suitability for intended use.
Torsion - Static (per ASTM F2077)	Demonstrated substantial equivalence to predicate devices and suitability for intended use.
Torsion - Dynamic (per ASTM F2077)	Demonstrated substantial equivalence to predicate devices and suitability for intended use.
Subsidence (per ASTM 2267)	Demonstrated substantial equivalence to predicate devices and suitability for intended use.
Expulsion (per ASTM Draft F04.25.0202)	Demonstrated substantial equivalence to predicate devices and suitability for intended use.
Cadaver Lab (No specific standard mentioned, likely for surgical technique/fit)	Demonstrated substantial equivalence to predicate devices and suitability for intended use. (Details of findings not provided, only that it was performed).
Substantial Equivalence (General)	"The Incite Anchored Cervical Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices when considering indications for use, design, materials, and function."

Note on "Acceptance Criteria" for this device: The acceptance criteria are essentially defined by the recognized ASTM standards listed for each test. The actual numerical thresholds (e.g., minimum load to failure, maximum displacement) are not provided in this summary, but the device is stated to have met the performance requirements implied by these standards and shown substantial equivalence to predicate devices.

Regarding the study that proves the device meets the acceptance criteria:

The "study" in this context refers to the Performance Testing section described. It's a series of bench tests (mechanical and physical tests performed in a lab setting) and a Cadaver Lab, rather than a clinical trial with human subjects for direct outcome measurement.

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

Test Set Sample Size: Not specified for each individual test. For mechanical tests, this typically involves a certain number of devices tested to failure or under specific load conditions. For the Cadaver Lab, the number of cadavers is not mentioned.
Data Provenance: The tests are performed in a lab setting (likely by the manufacturer or a contract testing facility) to comply with recognized ASTM standards. This is laboratory-generated data, not human patient data in the context of a "test set" for performance evaluation in a clinical sense.

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

Not applicable to this type of device and testing. Ground truth for mechanical performance is established by objective physical measurements against engineering specifications and standard requirements, not through expert consensus on interpretation. For the Cadaver Lab, surgical experts might have evaluated surgical technique or fit, but details are not provided.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for clinical trials or image interpretation studies where human experts are making judgments. For mechanical testing, the results are quantitative and directly measured.

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. This is a spinal implant, not an AI or imaging device that would involve human readers or AI assistance.

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

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

7. The type of ground truth used

The ground truth for this device's performance is established by:

Compliance with recognized ASTM standards (e.g., F2077, F2267). These standards define acceptable mechanical properties and performance characteristics for intervertebral body fusion devices.
Substantial equivalence to already legally marketed predicate devices, meaning its performance, design, and materials are comparable and safe for the intended use.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI. Performance is evaluated against engineering standards and comparison to predicates.

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

Not applicable. As there's no "training set," there's no ground truth to establish for it in this context.

Summary

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510(K) SUMMARY

NOV 1 6 2012

Submitter Information

Submitter's Name:Address:	Incite Innovation LLCP.O. Box 153881500 Main Street, Ste 2410Springfield, MA 01115-5707
Telephone:	413-382-0212
Contact Person:	John Kirwan

Date Prepared:	October 22, 2012
Device Trade Name:	Incite Anchored Cervical Interbody Fusion (ACI) Device
Common/Usual Name:	Spinal Intervertebral body fixation orthosis
Classification:	21 CFR §888.3080
Class:	II
Product Code:	OVE

Predicate Devices:

LDR Spine - Cervical Interbody Fusion System, ROI-C, K091088

Zimmer Spine - BAK/Cervical (BAK/C®) Interbody Fusion System, P984008

Intended Use:

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Device Description:

Predicate Device(s):

The Incite Anchored Cervical Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices and had the same indications for use, design, function, and materials used.

Performance Testing:

Testing performed on this device indicates that the Incite Anchored Cervical Interbody Fusion Device is substantially equivalent to predicate devices and suitable for its intended use. Testing performed includes:

. Axial Compression - Static and Dynamic per ASTM F2077
. Compression-Shear - Static and Dynamic per ASTM F2077
Torsion Static and Dynamic per ASTM F2077 .
. Subsidence per ASTM 2267
Expulsion per ASTM Draft F04.25.0202
. Cadaver Lab

Substantial Equivalence:

When considering indications for use, design, materials, and function the Incite Anchored Cervical Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Dated: November 16, 2012

Incite Innovation, LLC % Mr. John Kirwan President 1500 Main Street, Suite 2410 Springfield, Massachusetts 01115

Re: K122008

Trade Name: Incite Anchored Cervical Interbody Fusion Device Regulation Number: 21 CFR 888.3080 · Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: November 7, 2012 Received: November 8, 2012

Dear Mr. Kirwan:

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

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Page 2 - Mr. John Kirwan

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/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/Industrv/default.htm.

Sincerely yours,

Laurence D. Coyne

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K122008

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K122008 510(k) Number_

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.