The FRIOS MicroSaw is a series of instruments used in preparing bone in dental and craniofacial surgical procedures. The MicroSaw components are used in conjunction with the FRIOS Contra-Angle and Straight Handpieces. The MicroSaw consists of the disc for cutting bone, the drill for predrilling techniques and the chisel for elevating and luxating bone. The FRIOS MicroSaw also includes a protector which is attached to the handpiece which is designed to protect the soft tissue and limit the cutting depth.

AI/ML Overview

The provided text is a 510(k) summary for the FRIOS MicroSaw, a device used in dental and craniofacial surgical procedures. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a novel AI or diagnostic device.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Study for FRIOS MicroSaw

This 510(k) submission for the FRIOS MicroSaw focuses on demonstrating substantial equivalence to a previously cleared predicate device (OsteoMed Corporation OsteoPower System and Accessories, K971692). This type of submission does not typically involve a clinical study with specific performance acceptance criteria as would be seen for a new diagnostic or AI-driven device. Instead, the acceptance criterion is generally that the device is as safe and effective as the predicate device, based on similar technological characteristics and intended use.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Primary: Substantial Equivalence to predicate device (OsteoMed OsteoPower System, K971692) in design, function, and intended use.	The FRIOS MicroSaw is stated to be substantially equivalent to the predicate device. "The fundamental technical characteristics of the FRIOS MicroSaw are similar to those of the predicate. The FRIOS MicroSaw is equivalent to the OsteoMed Corporation's OsteoPower System and Accessories in design, function and intended use."
Materials: Stainless steel, standard latch lock	The FRIOS MicroSaw cutting instruments are made of stainless steel and incorporate a standard latch lock for use with FRIOS handpieces.
Intended Use: Preparing bone in dental and craniofacial surgical procedures.	The FRIOS MicroSaw is indicated for use in preparing bone in conjunction with dental and craniofacial surgical procedures.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. This submission is based on a comparison of technological characteristics and intended use to a predicate device, not on a test set or clinical data with a sample size.

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

Not Applicable. Ground truth, in the context of clinical studies with expert consensus, is not relevant for this substantial equivalence submission for a surgical instrument.

4. Adjudication Method for the Test Set:

Not Applicable. No test set or associated adjudication was performed for this submission.

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 device is a surgical instrument, not an AI or diagnostic tool where MRMC studies are typically performed.

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

Not Applicable. This device is a manual surgical instrument and does not involve any algorithm or AI component.

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

Not Applicable. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate device, as determined by the FDA. The comparison relies on documented design, materials, and functional specifications.

8. The Sample Size for the Training Set:

Not Applicable. There is no training set as this is not an AI or data-driven device.

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

Not Applicable. No training set was used.

Summary

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FEB 1 8 2000

SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 14:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

SUBMITTER INFORMATION 14.1

a.	Company Name:	FRIADENT GmbH.
b.	Company Address:	Steinzeugstrasse 50Mannheim D-68229Germany
c.	Company Phone:Company Facsimile:	(011) 49 06 21 4 86 1549(011) 49 06 21 4 86 1866
d.	Contact Person:	Birgit UngerQuality Management and Regulatory Affairs
e.	Date Summary Prepared:	December 17, 1999

14.2. DEVICE IDENTIFICATION

a. Trade/Proprietary Name:	FRIOS MicroSaw
b. Classification Name:	Bone Cutting Instruments and Accessories21 CFR 872.4120

IDENTIFICATION OF PREDICATE DEVICES 14.3

Company	Device	510(k) No.	Date Cleared
OsteoMed Corp.	OsteoPower System andAccessories	K971692	06/27/97

14.4 DEVICE DESCRIPTION

The FRIOS MicroSaw is a series of instruments used in preparing bone in dental and craniofacial surgical procedures. The MicroSaw components are used in

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conjunction with the FRIOS Contra-Angle and Straight Handpieces. The MicroSaw consists of the disc for cutting bone, the drill for predrilling techniques and the chisel for elevating and luxating bone. The FRIOS MicroSaw also includes a protector which is attached to the handpiece which is designed to protect the soft tissue and limit the cutting depth.

14.5 SUBSTANTIAL EQUIVALENCE

The FRIOS MicroSaw is substantially equivalent to the OsteoMed Corporation OsteoPower System and Accessories cleared under premarket notification K971692 on June 27, 1997.

The fundamental technical characteristics of the FRIOS MicroSaw are similar to those of the predicate. The FRIOS MicroSaw is equivalent to the OsteoMed Corporation's OsteoPower System and Accessories in design, function and intended use.

14.6 INDICATIONS FOR USE

The FRIOS MicroSaw is indicated for use in preparing bone in conjunction with dental and craniofacial surgical procedures.

14.7 TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the FRIOS MicroSaw with the predicate device is provided within this submission. Both the FRIOS MicroSaw and the predicate device are similar in design, materials and functionality. The FRIOS MicroSaw cutting instruments are made of stainless steel and incorporate a standard latch lock for use with the FRIOS Straight and Contra-Angle Handpieces.

14.8 510(K) CHECKLIST

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.

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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2000

Friadent GmbH c/o Ms. Carol Patterson Consultant for Friadent GmbH Patterson Consulting Group, Incorporated 21911 Erie Lane Lake Forest, California 92630

Re: K994298 Frios MicroSaw Trade Name: Requlatory Class: II Product Code: KMW Dated: December 20, 1999 Received: December 21, 1999

Dear Ms. Patterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Ms. Patterson

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Direc tor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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FRIADENT GmbH FRIOS MicroSaw Original Premarket 510(k) Notification

INDICATION FOR USE

1994298 To Be Assigned By FDA 510(k) Number:

Device Name:

FRIOS MicroSaw

Indications for Use:

The FRIOS MicroSaw is intended for use in preparing bone in conjunction with dental and craniofacial surgical procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Ove

Over-The-Counter Use _

Susan Runyor

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.