The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion 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. The 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 six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.

Device Description

The subject Cascadia Interbody System is comprised of additively manufactured implants made of titanium allov (ASTM standards F3001 and F136). These devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to add cervical implants to the system and to expand the indications for use of the CASCADIA lumbar implants to include use as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical segments of the spine.

AI/ML Overview

This document describes the Cascadia Interbody System, specifically focusing on its regulatory approval via a 510(k) submission (K160125). A 510(k) submission demonstrates substantial equivalence to legally marketed predicate devices, rather than proving that a device meets specific, pre-defined acceptance criteria through a study designed explicitly for that purpose with detailed performance metrics.

Therefore, the information requested about acceptance criteria and a study proving those criteria are met for an AI/ML device is not directly applicable to this submission for a medical implant. This document does not describe an AI/ML device or a study with performance metrics in terms of sensitivity, specificity, or reader improvement.

However, I can extract information related to the performance evaluation and comparative analysis that was performed for this device to gain FDA clearance.

Here's a breakdown of the relevant information from the provided text, structured as closely as possible to your request for clarity, but with the understanding that it's for a medical implant, not an AI/ML diagnostic system:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a medical implant, there aren't "acceptance criteria" in the sense of specific clinical performance metrics like sensitivity/specificity for an AI/ML algorithm. Instead, the "performance evaluation" described is non-clinical and aims to demonstrate the mechanical and structural equivalence to predicate devices. The "acceptance criteria" can be inferred as successfully passing these non-clinical tests, showing substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Withstand Static Torsion (Worst Case Components)	Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices.
Withstand Static Compression (Worst Case Components)	Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices.
Withstand Dynamic Compression (Worst Case Components)	Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices.
Withstand Dynamic Torsion (Worst Case Components)	Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices.
Withstand Static Compression Shear (ASTM F2077) (Worst Case Components)	Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices.
Withstand Dynamic Compression Shear (ASTM F2077) (Worst Case Components)	Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices.
Resist Subsidence (ASTM F2267) (Worst Case Components)	Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices.
Resist Expulsion (Worst Case Components)	Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices.
Overall Conclusion	"There are no significant differences between the Cascadia Interbody System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." (This is the ultimate "acceptance" for a 510(k) submission).

2. Sample Size for the Test Set and Data Provenance

This information is not applicable. The "test set" in this context refers to the samples used for non-clinical performance evaluations (mechanical testing), not a clinical trial with human data. The document does not specify the exact number of components or test specimens used for the evaluations, nor does it refer to data provenance in terms of country of origin or retrospective/prospective acquisition, as would be relevant for clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. Ground truth, in the context of AI/ML, refers to clinically verified labels or outcomes. For this medical implant, "ground truth" is established by engineering standards and mechanical test results, not by expert clinical review. The document does not mention the involvement of experts for establishing "ground truth" in the AI/ML sense.

4. Adjudication Method for the Test Set

This information is not applicable for a medical implant's non-clinical performance evaluation. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies among human readers or experts establishing ground truth for clinical data, which is not the type of evaluation described.

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. An MRMC study is relevant for evaluating the clinical utility of diagnostic devices, particularly AI/ML algorithms, by comparing human reader performance with and without AI assistance. The Cascadia Interbody System is an implant, not a diagnostic tool or an AI/ML system.

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

This information is not applicable. This refers to the performance of an AI/ML algorithm in isolation. The Cascadia Interbody System is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

For this medical implant, the "ground truth" for the non-clinical performance evaluations is engineering standards and mechanical test results (e.g., ASTM F2077, ASTM F2267). This demonstrates that the device meets intended mechanical properties and behaves similarly to predicate devices. It is not expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train an AI/ML algorithm. The Cascadia Interbody System is a physical implant and does not involve an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reasons as #8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 22, 2016

K2M, Incorporated Ms. Nancv Giezen Manager, Regulatory Affairs 751 Miller Drive Southeast Leesburg, Virginia 20175

Re: K160125

Trade/Device Name: Cascadia Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: March 23, 2016 Received: March 24, 2016

Dear Ms. Giezen:

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 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

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

510(k) Number (if known) K160125

Device Name Cascadia Interbody System

Indications for Use (Describe)

The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion 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. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be sketally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Type of Use (Select one or both, as applicable)

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

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510(k) SUMMARY Cascadia Interbody System K2M, Inc.

Submitter

K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: 571 919-2000 Date Prepared: 04/20/2016

Classification

Trade Name:	Cascadia Interbody System
Common Name:	Intervertebral Fusion Device with Bone Graft
Regulatory Class:	Class II

Classification Name(s):

Intervertebral Fusion Device with Bone Graft, cervical (21 CFR 888.3080, Product Code: ODP) Intervertebral Fusion Device with Bone Graft, lumbar (21 CFR 888.3080, Product Code: MAX)

Predicate Device(s)

Primary Predicate:

K2M Cascadia Interbody System (K150481) ●
Additional Predicates:
K2M Aleutian IBF Spinal System (K082698, K103169, K133614)
K2M Chesapeake Stabilization System (K133494) ●
Globus Patriot (K072991)
NuVasive CoRoent (K150362) ●
Stryker Tritanium (K152304)

Device Description

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical segments of the spine.

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Indications For Use

Technological Comparison to Predicate(s)

The Cascadia Interbody System implants were compared to predicate systems and the design features, materials and sizes were found to be substantially the same as these systems.

Non-clinical Performance Evaluation

Performance evaluations were conducted on constructs representing the worst case components (including static torsion, static compression, dynamic compression, dynamic torsion, static compression shear, dynamic compression shear (ASTM F2077), subsidence (ASTM F2267) and expulsion) and the proposed implants were found to be substantially the same as predicate devices.

Conclusion

There are no significant differences between the Cascadia Interbody System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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.