The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.

When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

Device Description

The K2M Fenestrated Tap System consists of surgical instruments designed to access vertebral bodies via a posterior surgical approach.

Function: The K2M Fenestrated Tap System can be used to access the vertebral body for obtaining bone biopsies. This system can also be used for the injection of bone cement into the vertebral body using vertebroplasty or kyphoplasty procedures.

AI/ML Overview

The provided text is a 510(k) summary for the K2M Fenestrated Tap System, a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing extensive clinical trials with acceptance criteria, ground truth establishment, or multi-reader studies as one might find for AI/ML-based devices.

Therefore, much of the requested information regarding acceptance criteria, study details, expert qualifications, and ground truth origin is not available in this document.

However, based on the provided text, here is what can be inferred:

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

The document does not explicitly state quantitative acceptance criteria or performance metrics in a table. The "performance" is implicitly evaluated against its intended use and comparison to predicate devices.

Acceptance Criteria (Inferred)	Reported Device Performance
Achieves intended use	"K2M Fenestrated Tap System was determined achieve its intended use." (in cadaver testing)
Substantially equivalent to predicate devices in design features (materials, number of fenestrations, diameters, thread lengths)	"The K2M Fenestrated Tap System was compared to predicate systems and design features such as the materials, number of fenestrations, diameters and thread lengths were found to be substantially the same as these systems."
No significant differences that would adversely affect use compared to marketed systems	"There are no significant differences between the K2M Fenestrated Tap System and other systems currently being marketed which would adversely affect the use of the product."

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 mentions "cadaver testing" but does not specify the sample size (i.e., number of cadavers or tests performed). It also does not specify the provenance (country of origin, retrospective/prospective).

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 provided in the document. Given it's a physical device and not an AI/ML algorithm, the "ground truth" would likely relate to the observed functional performance during cadaver testing, and any expert assessment involved is not detailed.

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

This information is not provided.

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

A multi-reader multi-case study is typically relevant for interpretative devices, especially AI/ML. This is a physical device (biopsy tool/cement dispenser), and therefore, an MRMC study is not applicable and was not performed.

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

"Standalone algorithm performance" is relevant for AI/ML devices. This is a physical device, so this concept is not applicable. The device itself is used by a human surgeon.

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

The document states "The functional characteristics were evaluated in cadaver testing." The "ground truth" for a physical device in cadaver testing would likely involve the observable physical outcomes and performance characteristics, such as successful biopsy sample removal or successful cement dispensing, assessed by those performing the tests. However, the specific method of determining this "ground truth" (e.g., whether success was confirmed by imaging, physical inspection, or expert assessment) is not detailed.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning. Thus, this information is not applicable.

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

As there is no "training set" for this physical device, this information is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The logo is simple, using only black and white.

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

January 5, 2016

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

Re: K152872

Trade/Device Name: K2M Fenestrated Tap System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW, OAR Dated: November 24, 2015 Received: November 25, 2015

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/Resourcesfor You/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,

Lori A. Wiggins -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510{k} Number (if known) K152872

Device Name K2M Fenestrated Tap 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY K2M Fenestrated Tap System

Submitter

K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: 703-777-3155 Date Prepared: 12/02/2015

Classification

Trade Name: Common Name: Regulatory Class:

K2M Fenestrated Tap System Spinal Fixation System Class II

Classification Name(s): Gastroenterology-Urology Biopsy Instrument (21 CFR 876.1075, Product Code KNW) Cement Dispenser (21 CFR 888.4200, Product Code OAR)

Predicate Device(s)

Primary Predicate: Abbott Spinnaker (K052638)

Device Description

The K2M Fenestrated Tap System consists of surgical instruments designed to access vertebral bodies via a posterior surgical approach.

Intended Use

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Technological Comparison to Predicate(s)

The K2M Fenestrated Tap System was compared to predicate systems and design features such as the materials, number of fenestrations, diameters and thread lengths were found to be substantially the same as these systems.

Non-clinical Performance Evaluation

The functional characteristics were evaluated in cadaver testing and the K2M Fenestrated Tap System was determined achieve its intended use.

Conclusion

There are no significant differences between the K2M Fenestrated Tap System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices when comparing materials, number of fenestrations, diameters and thread lengths. In addition the K2M Fenestrated Tap System is being offered for the same intended use as the predicates and was validated via cadaver testing.

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.