The MRI Safe Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) system rated at 0.5 Tesla or less, for the surgical cutting, shaping and removal of bone, including bones of the skull and spine.

Device Description

The MRI Safe Surgical Drill System is a class II medical device that includes a pneumatic drill motor, foot control, a variety of nosepiece attachments; and bone dissection tools. To make the motor and foot control, a variety of non-looping materials comprising each system component have been replaced with materials known to have significantly lower or no magnetic susceptibility. However, when imaging is being performed the drill system must be moved to at least Zone 4. The MRI Safe Drill System foot control is not intended to be placed within the sterile field nor within MRI magnetic field (Zones 1-3). The MRI Safe motor does not require continuous cooling within MRI magnetic field. The MRI Safe motor operates at a slightly slower speed (60-65k RPM) than non-MRI safe motors (80-85k RPM). Nosepiece and cutters are a direct attachment and support the cutter to minimize run-out, wobble and whipping. They are non-sterile for reusable applications. Cutters are surgically invasive, direct contact (with patient) devices and are provided sterile for single use applications. Cutters carry additional warnings to advise user that "dulling" may occur faster than non-MRI safe cutters if overused or reused.

AI/ML Overview

The provided text describes a medical device, the Anspach MRI Safe Surgical Drill System, and its acceptance for market. However, it does not include detailed acceptance criteria and a study report with performance metrics, sample sizes, ground truth establishment, or multi-reader studies.

The document is a 510(k) summary (K040186) for premarket notification to the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a dedicated clinical study with the rigor described in the request.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes for test/training sets, ground truth establishment expertise, adjudication methods, MRMC studies, or standalone algorithm performance, as this information is not present in the provided text.

The text primarily outlines:

Device Description: A pneumatic surgical drill system designed for use in an MRI environment by replacing magnetic components with non-magnetic ones.
Intended Use/Indications for Use: Intra-operative (non-imaging) surgical cutting, shaping, and removal of bone (skull and spine) within a 0.5 Tesla or less MRI system. It explicitly states the system must be moved to at least Zone 4 when imaging is performed.
Risks/Hazards: Addresses known risks like magnetic field interference, heat generation, noise, image distortion, projectile concerns, and unintended use of non-MRI safe components.
Substantial Equivalence: Claims substantial equivalence to other Anspach Claim Systems (MicroMax and original 65K), noting material changes and a modified locking mechanism.

The FDA's decision letter (K040186) confirms that the device was found substantially equivalent to predicate devices, allowing it to be marketed. This decision is based on the information provided in the 510(k) summary, which argues for substantial equivalence primarily through design modifications and addressing potential risks, not through a performance study against predefined acceptance criteria as might be seen for AI/ML devices or novel therapies.

Summary

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K040186

Exhibit 10

Section 17 510(k) SUMMARY

Anspach MRi Safe Surgical Drill System

The MRI Safe Surgical Drill System is a class II medical device that includes a peumatic arill The MHT Sale Surgical Drill System is a class in mounts; and bone dissection tools. To make motor and fool control, a variety of noooplood comprising each system component have been replaced with materials known to have significantly lower or no magnetic susceptibility. replaced with Thatenals "Rhown" to "have" eighteaning ".
However, when imaging is being performed the drill system must be moved to at least Zone 4.

The MRI Safe Drill System foot control is not intended to be placed within the sterile field nor within MRI magnetic field (Zones 1-3). The MRI Safe motor does not require continuous oling within MHI magned (60-65k RPM) than non-MRI safe motors (80-85k RPM). Nosepiece and fulls at Siower speed (60 ook him) that herinn, wobble and whipping. They are a direct allaciments support the catter to millimize tean, non-sterile for reusable applications. MRI contact (with patient) deviol and are arounders with exception of materials and indications for use. Cutters are surgically invasive, direct contact (with patient) devices and are Indications for use. Oatters are bargloady invaters, arry additional warnings to advise user that "dulling" may occur faster than non-MRI safe cutters if overused or reused.

There are no known unacceptable risks/hazards associated with use of the MRI drill system, There are no nrown andoooplaabo risks identified (over non-MRI cutters) and addressed when used as indicated. Adultional note faction in surgeon control of the motor through design andror laboring melaces of magnetic fields on motor operation (speed/torque, uuring Surgical use, 2) Adverse etc.); 3) Drill, foot control, attachment or cutter becoming heat generation (over noating), notes, se in the MRI environment; 4) MRI image distortion; 5) a projectile dailing acc or while cutters; and 6) Unintended use of non-MRI safe system components with the MRI safe system.

MRI Safe system (including motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a MRI system rated at 0.5 Tesla or less, indicated for intra operative (non removal of bone, including bones of the skull and spine. The for surgical brill System (including drill motor and foot control, nosepiece attachments Mill Care Curgiour Drill System (x presence within zones 1-3 of a MRI system while imaging is and cattle), to occomplished. Presence of the equipment in Zones 1-3 during imaging could cause unacceptable image distortion.

Cleaning, sterilization and storage conditions are specified on product package inserts and Orculing, blenneaton U.S. European Union and in other global market requirements.

The MRI safe drill system is substantially equivalent in form, design to other Anspach The Mill of Claim Systems including MicroMax and the original 65K, their nosepiece attachments pricumedio and by of of a materials, indications for use and a slightly modified locking mechanism, that prevents interchangeability between MRI safe and non-MRI safe system components.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

APR 1 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William G. Conety Director, Regulatory Affairs and Quality Assurance Anspach Companies 4500 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K040186

Trade/Device Name: MRI Safe Surgical Drill System Regulation Number: 21 CFR 883.4370; 21 CFR 882.4310 Regulation Name: Pneumatic drill, Powered simple cranial drills, burrs, trephines and their accessories Regulatory Class: II Product Code: HBB, HBE Dated: January 23, 2004

Received: January 28, 2004

Dear Mr. Conety:

We have reviewed your Section 510(k) promarket 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 Amendnents, 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.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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 docs 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); 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.

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Page 2 - Mr. William G. Conety

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

(celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K040186 510(k) Number (if known):

Device Name:

"MRI Safe Surgical Drill System"

Indications For Use:

The MRI Safe Surgical Drill System (including pneumatic drill motor, foot contributing a Masaction The Mirri Oale Outlers), is indicated for intra-operative (non-imaging) use within a Magnetic allaciments and contens), 15 indicated for the open of the surgical cutting, shaping and removal of bone, including bones of the skull and spine.

Prescription Use:
(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)

Muriam C Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

Regulation Number and Section

§ 882.4370 Pneumatic cranial drill motor.

(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).