The XPS Drill System is primarily intended for the controlled incision or removal of bonc in the ear, nose, throat and other areas of the head and neck.

Device Description

The XPS Drill System is made up of a console, electric motor, exchangable handpieces, foot pedal and accessories as described below. It has the ability to operate one handpiece and incorporates irrigation capability. The handpiece speed range is 0 - 90,000 RPM and the stall torque is 3.5 oz-in.

AI/ML Overview

This document describes a medical device submission (K983224) for the XOMED XPS Drill System. It is a 510(k) summary, which means the manufacturer is asserting substantial equivalence to a predicate device rather than conducting new clinical studies to prove effectiveness or safety. Therefore, the device does not have acceptance criteria or a study proving it meets them in the traditional sense of a clinical trial.

However, I can extract information related to the device's intended use, performance characteristics (as described for substantial equivalence), and the regulatory process which implicitly serves as the "acceptance criteria" for marketing the device as substantially equivalent.

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

Since this is a 510(k) for substantial equivalence, formal acceptance criteria and reported performance from specific studies are not detailed. Instead, the "acceptance criteria" here are defined by the predicate devices and the changes made.

Acceptance Criteria (Implied by Predicate & Device Description)	Reported Device Performance (as described for Substantial Equivalence)
Intended Use: Controlled incision or removal of bone in the ear, nose, throat, and other areas of the head and neck.	The XPS Drill System is primarily intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. (Same as intended use)
Operating Speed Range: Similar to existing ENT drills.	Handpiece speed range is 0 - 90,000 RPM.
Stall Torque: Sufficient for intended bone removal.	Stall torque is 3.5 oz-in.
Irrigation Capability: Present in comparable ENT drills.	Incorporates irrigation capability.
Configuration: Console, electric motor, interchangeable handpieces, foot pedal, and accessories.	Made up of a console, electric motor, exchangable handpieces, foot pedal and accessories. Ability to operate one handpiece.
Software: No software involved in operation.	NOTE: There is no software involved with the operation of this device.
Safety and Effectiveness: Demonstrated by substantial equivalence to K904850 and K960853.	"The new XPS Drill System is the same drill system that was previously cleared by K904850 Xomed now intends to market this system for ENT and Head and Neck surgery... As an ENT drill, the XPS Drill System is also substantially equivalent to the MPS Powerforma currently marketed by Xomed (K960853)." Minor changes to labeling (instruction manual and console) are not considered significant.

The "study" proving it meets these "acceptance criteria" is the 510(k) Substantial Equivalence submission itself, which argues that the device is as safe and effective as legally marketed predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable (N/A). This is a 510(k) submission based on substantial equivalence to predicate devices, not a clinical study with a test set of data.
Data provenance: N/A.

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)

Number of experts: N/A. No a specific "ground truth" was established by experts for a test set in the context of this 510(k). The regulatory body (FDA) reviews the submitted information and makes a determination of substantial equivalence.
Qualifications of experts: N/A.

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

Adjudication method: N/A.

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

MRMC study: No. This device is a surgical drill and does not involve AI or human readers for diagnostic interpretation.

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

Standalone performance: No. This device is a physical surgical drill and does not involve algorithms or AI.

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

Type of ground truth: N/A. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices (K904850 and K960853), determined through their original clearance process.

8. The sample size for the training set

Sample size for training set: N/A. This is not an AI/ML device that requires a training set.

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

Ground truth establishment: N/A.

Summary

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OCT 21 1998

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K983224

510k Summary XPS Drill System

1.0 Date Prepared

September 10, 1998

2.0 Submitter (Contact)

David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532

3.0 Device Name

Proprietary Name: XPS Drill System Electric Surgical Drill System Common Name: ENT electric or pneumatic surgical drill Classification Name:

4.0 Device Classification

Currently marketed products of this type have been classified by the Ear, Nose and Throat Panel as follows:

ENT electric or pneumatic surgical drill	77ERL	Class II	874.4250
Surgical Instrument Motors and accessories	79GEY	Class I*	878.4820
* exempted from premarket notification.

રુ:0 Device Description

NOTE: There is no software involved with the operation of this device.

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Revised 10/13/98

Intended Use 6.0

The XPS Drill System is primarily intended for the controlled incision or removal of bonc in the ear, nose, throat and other areas of the head and neck.

7.0 Substantial Equivalence

The new XPS Drill System is the same drill system that was previously cleared by K904850 Xomed now intends to market this system for ENT and Head and Neck surgery. In so doing, we have made some minor changes to the labeling, i.e. the instruction manual and the console None of these changes are significant and are typical of any ENT drill. As an ENT drill, the XPS Drill System is also substantially equivalent to the MPS Powerforma currently marketed by Xomed (K960853). Information from the MPS Powerforma manual was used in modifying the Micro Motors manual for the proposed XPS Drill.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

David M. Timlin Manager, Regulatory Affairs Xomed Surgical Products, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216

Re:

K983224 Xomed XPS Drill System Dated: September 10, 1998 Received: September 14, 1998 Regulatory class: II 21 CFR 874.4250/Procode: 77 ERL

Dear Mr. Timlin:

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 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 vitn diagnostic devices), please contact the Office of Compliance at (301) 5944613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Complianced (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/cdr/dsmaldsmamain.html".

Sincerely yours,

William Yin

Lillian Yin, Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Revised 10/13/98

510(k) Number (if known): __ K983224 Device Name: XPS Drill System__ Indications for Usc:

The XPS Drill System is intended for the controlled incision or renoval of bone in the ear, nose, throat and other areas of the head and neck.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use A (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Formal 1-2-96)

Samil A. Sezern

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.