The Operativ Navigation Pin is indicated for use as temporary fixation pin to attach an orthopedic stereotaxic tracker holder to bone which allows the tracker to be referenced by the computer during a total knee arthroplasty.

Device Description

The Navigation Pin is a partially threaded stainless steel (ASTM F138-08) pin with lengths of 100mm and 150mm. It has a diameter of 3mm. The Navigation Pins are driven into bone using a drill and collet driver. The pins hold the Stryker Navigation OrthoLock stereotaxic accessory device (6007-003-000) in place during a computer navigated total knee replacement. The Navigation Pins are placed in the distal femur and proximal tibia. Two pins are used for each Stryker Navigation OrthoLock stereotaxic accessory device (6007-003-000), one device for the femur and one for the tibia. The Navigation Pins are removed once the total knee replacement is completed. They are not meant for implanting.

AI/ML Overview

This document describes the Navigation Pin by Operativ. The 510(k) summary focuses primarily on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance results for the Navigation Pin itself. The device is a sterile, single-use, partially threaded stainless steel pin designed for temporary fixation of an orthopedic stereotaxic tracker holder to bone during computer-navigated total knee replacement surgery.

Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in the provided text.

Here's an analysis based on the given information:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with reported device performance metrics in the way one would expect for a diagnostic or AI device study. The entire submission is built around demonstrating substantial equivalence to a predicate device, Zimmer CAS Fixation Pins (K100599), based on material, design, and intended use.

The "performance" is implicitly deemed acceptable if it matches the predicate device. The key characteristics compared are:

Feature	Navigation Pin (Operativ)	Predicate Device (Zimmer CAS Fixation Pins, K100599)
Material	Partially threaded stainless steel (ASTM F138-08)	Partially threaded stainless steel (ASTM F138-08)
Diameter	3mm	3.2mm
Lengths	100mm, 150mm	80mm, 150mm
Insertion Method	Driven into bone using a drill and collet driver	Same technique
Location	Distal femur and proximal tibia	Distal femur and medial proximal tibia
Function/Intended Use	Hold Stryker Navigation OrthoLock stereotaxic accessory device during total knee replacement	Hold proprietary stereotaxic device during total knee replacement
Fixation Mechanism	Threads act like a screw, driven into both sides of cortical bone	Threads act like a screw, driven into both sides of cortical bone
Removal	Removed once total knee replacement is completed	Removed once total knee replacement is completed

The "acceptance criteria" here are essentially the demonstration that the Operativ Navigation Pin is acceptably similar to the predicate device in terms of material, design, and intended use, and that any differences (such as slight variations in diameter and length) do not raise new questions of safety or effectiveness. No specific quantitative performance metrics (e.g., pull-out strength, bending stiffness) or thresholds are mentioned as "acceptance criteria" with corresponding "reported performance."

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 and not provided in the document. This is a medical device 510(k) submission, not a study involving a test set of data points or images for a diagnostic algorithm. The "test" for this device involved comparing its physical and functional characteristics to a legally marketed predicate device.

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 and not provided. "Ground truth" in the context of this 510(k) submission refers to the established safety and efficacy of the predicate device, which is assumed to be true based on its prior market clearance. There were no human experts evaluating a "test set" in the context of ground truth for performance.

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

This information is not applicable and not provided. No adjudication method was used as there was no test set of data requiring expert consensus or review.

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 and not provided. An MRMC study is relevant for diagnostic imaging devices often involving AI. The Navigation Pin is a mechanical fixation pin, not a diagnostic or AI-assisted device.

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

This information is not applicable and not provided. The device is a physical pin, not an algorithm.

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

For this type of device, the "ground truth" is typically the established safety and effectiveness of the legally marketed predicate device. The manufacturer demonstrated that their device is substantially equivalent to this predicate based on material, design, and intended use. There is no external "ground truth" established through clinical data, pathology, or outcomes specifically for the Navigation Pin outside of its comparison to the predicate.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for a physical medical device like this pin. This concept is relevant for AI/ML algorithms.

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

This information is not applicable and not provided. As there is no training set, there is no ground truth established for it.

Summary

{0}------------------------------------------------

K131130 Page 1 of 2

5. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	Evergreen Orthopedics Research Lab d/b/a Operativ 11321 NE 120 th St. Kirkland, WA 98034
510(k) CONTACT:	Jeff Stepanian, COO Jeff.stepanian@opertiv.com (425) 284-7262
DATE PREPARED:	May 31, 2013
TRADE NAME:	Navigation Pin
COMMMON NAME:	Threaded Pin
DEVICE CLASSIFICATION NAME:	Stereotaxic Instrument 21 CFR 882.4560
DEVICE PRODUCT CODE:	OLO
PRODUCT CLASS:	II
SUBSTANTIALLY EQUIVALENT DEVICES:	Zimmer CAS Fixation Pins (K100599)

DEVICE DESCRIPTION:

{1}------------------------------------------------

TECHNOLOGICAL COMPARISON to the PREDICATE DEVICE:

The Operativ Navigation Pin is a partially threaded stainless steel pin (ASTM F 138-08). The predicate device is the same material and partially threaded as well. The Navigation Pins are driven into bone using a drill and collet driver. The same technique is used for the predicate device. There are two pins that are inserted into the distal femur and two pins inserted into the medial proximal tibia. The predicate device uses the same location for their pin insertion (distal femur and medial proximal tibia). The Navigation Pins as well as the predicate device are driven into both sides of cortical bone on the femur and tibia. The threads of both the Navigation Pin and the predicate device act like a screw in the bone, holding the stereotaxic accessory device more securely. The Navigation pin has the same function/intended use that the predicate device has which is to hold stereotaxic accessory devices during total knee replacements. They are both removed from bone once the total knee replacement is complete. The differences between the Navigation Pin and the predicate device are the diameter of the pin and the length. The Navigation Pin diameter is 3mm and the predicate device is 3.2mm. The lengths of the Navigation Pin are 100mm and 150mm and the predicate device is 80mm and 150mm. Another difference is that the Navigation Pins hold the Stryker Navigation OrthoLock stereotaxic accessory device (6007-003-000) in place during a computer navigated total knee replacement. The predicate device holds their proprietary stereotaxic device in place during a total knee replacement.

INTENDED USE:

The Operativ Navigation Pin has the indication for use as a temporary fixation pin to attach an orthopedic stereotaxic tracker holder to bone. This allows the tracker to be held without movement while being referenced by the computer during a total knee arthroplasty.

CONCLUSION:

Based upon the similarities in materials (stainless steel ASTM F138-08) and design (partially threaded, trocar tip, length and diameter) as well as function/intended use (temporary fixation pin for stereotaxic device) to the predicate devices, the technological characteristics are sufficient to support a determination of substantial equivalence.

{2}------------------------------------------------

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or supporting another, with flowing lines suggesting movement or care.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Evergreen Orthopedics Research Lab d/b/a Operativ % Jeff Stepanian, COO 11321 NE 120th Street Kirkland, Washington 98034

Re: K131130

Trade/Device Name: Navigation Pin Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: June 04, 2013 Received: June 04, 2013

Dear Mr. Stepanian:

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 Part 801); medical device reporting (reporting of medical

July 19, 2013

{3}------------------------------------------------

Page 2 - Mr. Jeff Stepanian

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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,

Mark N. Melkerson -S

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

Enclosure

{4}------------------------------------------------

4. INDICATIONS FOR USE:

Operativ Navigation Pin Device Name:

Indications for Use:

Operativ Navigation Pin indication for use

Prescription Use _ X (Part 21 CFR 801 subpart D) Over the counter use (Part 21 CFR 801 subpart C)

Joshua C. Nipper -S

(Division Sign-off) . Division of Surgical Devices 510(k) Number K131130

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).