The CASCADIA implants are indicated for use with autgenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use as either one level or two contiguous levels from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intended to be used in patients who have had six months of non-operative treatment.

For all the above indications the CASCADIA implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.

Device Description

The implants consist of hollow tube structures additively manufactured from titanium alloy. The 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 incorporate additional implant sizes into the system.

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cascadia Interbody System, addressing your specific questions.

Important Note: The provided document is an FDA 510(k) summary for a spinal interbody fusion device. These types of devices are primarily mechanical implants. The document does not describe an AI/software device or a study involving human readers or expert consensus for image interpretation. Therefore, many of your questions related to AI studies, ground truth establishment, reader performance, and training/test set sample sizes for AI models are not applicable to this physical medical device submission.

I will answer the questions based on the information available in the document, clarifying when a question is not applicable to this type of device.

Analysis of Cascadia Interbody System 510(k) Summary (K160547)

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

For mechanical implants, acceptance criteria are typically defined by engineering standards and performance benchmarks against predicate devices. The document states:

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Static compression	Performed equally to or better than predicate devices.
Dynamic compression	Performed equally to or better than predicate devices.
Static compression-shear	Performed equally to or better than predicate devices.
Dynamic compression-shear	Performed equally to or better than predicate devices.
Subsidence (ASTM F2267)	Performed equally to or better than predicate devices.
Expulsion	Performed equally to or better than predicate devices.
Biocompatibility:	Assumed to meet standards as the material (titanium alloy) and design are "substantially the same" as predicate.
Material Properties:	Titanium alloy; "substantially the same" as predicate systems. The implants are "additively manufactured."
Design/Function:	"Substantially the same" as predicate systems in design, function.
Indications for Use:	Matched predicate device indications, with additional implant sizes incorporated.

Note: Specific numerical acceptance criteria (e.g., "must withstand X N of compression") are not provided in this summary, but are inherent in the referenced ASTM standards and predicate equivalence.

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

Test Set (for performance evaluation): The document refers to "the worst case implants for the Cascadia Interbody System were previously tested." It does not specify the sample size (N) for these mechanical tests. It implies that only representative "worst-case" configurations were tested, and engineering rationales were used for other sizes.
Data Provenance: The data provenance for mechanical testing is not explicitly mentioned (e.g., "conducted in a lab in USA"). It's internal company testing or testing done by a contracted lab. The data is inherent to the device's design and manufacturing process.
Retrospective/Prospective: Not applicable to mechanical testing of physical device performance.

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

Not applicable. This is a mechanical medical device, not an AI or diagnostic imaging device that requires expert ground truth for interpretation. Performance is assessed through engineering testing and comparison to established standards and predicate devices.

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

Not applicable. This is a mechanical medical device study, not a study involving human reader interpretation or clinical adjudication.

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 mechanical medical device. No human reader studies or AI assistance are involved in this 510(k) submission.

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

Not applicable. This is a mechanical medical device. There is no algorithm for standalone performance.

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

The "ground truth" for this device's performance is established by engineering standards (e.g., ASTM F2077, ASTM F2267) and benchmarking against predicate devices. Its functional safety and effectiveness are supported by demonstrating that it performs "equally to or better than" devices already on the market and that its materials and design are substantially equivalent.

8. The sample size for the training set

Not applicable. This is a mechanical medical device. There is no AI training set.

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

Not applicable. There is no AI training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.

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

March 24, 2016

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

Re: K160547

Trade/Device Name: Cascadia Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 24, 2016 Received: February 26, 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)

K160547

Device Name Cascadia Interbody System

Indications for Use (Describe)

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: 571 919-2168 Date Prepared: 03/23/2016

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, 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, K110843, K130699)

Device Description

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

Indications For Use

The CASCADIA implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intended to be used in patients who have had six months of non-operative treatment.

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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

The worst case implants for the Cascadia Interbody System were previously tested and performed equally to or better than the predicate devices in static compression, dynamic compression, static and dynamic compression shear (ASTM F2077), subsidence (ASTM F2267) and expulsion. Engineering rationales determined that the proposed implants did not represent a new worst case for mechanical testing.

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.