The XPS Curved Bur is intended for use in an ear, nose, and throat electric or pneumatic surgical drill for incising or removing bone in the ear, nose, or throat area, and is an accessory to the XPS 3000 System.

Device Description

The XPS Curved Bur consists of a cutting tip connected to a flexible bur shank which is surrounded by a stationary outer cannula. The flexible shank and cutting tip are rotated by a surgical drill motor.

AI/ML Overview

This document is a 510(k) summary for the Medtronic Xomed XPS Curved Bur. It establishes substantial equivalence to a predicate device, focusing on functional characteristics rather than specific performance metrics that would require a study with acceptance criteria. As such, the provided text does not contain the information requested regarding acceptance criteria and a study to prove the device meets them.

Here's a breakdown of why the requested information cannot be extracted from the given text:

No Acceptance Criteria or Performance Metrics: The document's purpose is to demonstrate "substantial equivalence" based on similar intended use, technology, and materials, not to define specific performance benchmarks (like accuracy, precision, speed, etc.) that the device must meet through testing.
No Study Described: There is no description of any study (clinical, laboratory, or otherwise) that was conducted to evaluate the performance of the XPS Curved Bur against predefined acceptance criteria. The "study" mentioned is the 510(k) review itself, which compares the new device to a predicate.
No Data Provenance, Expert Information, or Ground Truth: Since no performance study is described, there's no mention of sample sizes, data origin, experts involved in establishing ground truth, or adjudication methods.
No MRMC or Standalone Performance: These terms are relevant to diagnostic or AI-assisted devices, neither of which the XPS Curved Bur is.
No Training Set Information: This is also not applicable to a purely mechanical surgical instrument.

The document primarily relies on a table comparing the new device's characteristics to the predicate device's characteristics to demonstrate substantial equivalence, rather than providing a performance study.

Therefore, the table below will be largely empty as the information is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria	Reported Device Performance
No specific performance metrics or acceptance criteria are provided in the document.	N/A	N/A
Intended Use / Indications for use	Incising or removing bone in the ear, nose, or throat area	Incising or removing bone in the ear, nose, or throat area
For use with a surgical drill per 21 CRF § 874.4140	Yes	Yes
Maximum rotational speed	80,000 RPM	80,000 RPM
Bur guard integrated into design or available as an accessory	Yes	Yes
Direct patient contacting materials	Stainless Steel and medical polymer	Stainless Steel, 6/6 nylon thread, and medical polymer
Blades / burs biocompatible	Yes	Yes

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable, as no performance test set is described. The 510(k) submission process did not involve a test set for performance evaluation in the context of this document.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no performance test set with ground truth established by experts is described.

4. Adjudication method for the test set:

Not applicable, as no performance test set and corresponding ground truth adjudication are described.

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:

No MRMC study was done. This device is a surgical bur, not an AI-powered diagnostic or assistance tool, so such a study would not be relevant.

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

Not applicable. This device is a mechanical surgical instrument, not an algorithm.

7. The type of ground truth used:

Not applicable, as no performance study requiring ground truth is described. The "ground truth" in the context of this 510(k) summary is the established safety and effectiveness of the legally marketed predicate device to which the XPS Curved Bur is compared.

8. The sample size for the training set:

Not applicable, as no algorithm or training set is involved.

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

Not applicable, as no algorithm or training set is involved.

Summary

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AUG 1 2 2004

510(k) Summary

Date Prepared 1.0

June 25, 2004

Submitter (Contact) 2.0

Martin D. Sargent Regulatory Affairs Manager Medtronic Xomed Jacksonville, FL (904) 279-7586

Device Name 3.0

Proprietary Name:	XPS Curved Bur (the tradename has not been finalized at this time)
Common Name(s):	ENT bur
Classification Name(s):	Ear, nose, and throat bur

Device Classification 4.0

Classification Name:	Ear, nose, and throat bur
Procode:	77EQJ
Class I	21 CFR § 874.4140

Device Description 5.0

Indications for Use 6.0

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510(k) Summary (continued)

Substantial Equivalence 7.0

The proposed XPS Curved Bur is substantially equivalent in operating principle, technology, overall I ne proportion, and cuting surface materials to ENT Burs as described in 21 CFR § 874.4140. acolEh, railetter, and new safety or efficacy issues associated with the proposed device.

Characteristic	ENT Bur(21 CFR § 874.4140)	XPS Curved Bur(This submission)
Intended Use /Indications for use	Incising or removing bone inthe ear, nose, or throat area	Incising or removing bone inthe ear, nose, or throat area
For use with a surgical drillper 21 CRF § 874.4140	Yes	Yes
Maximum rotational speed	80,000 RPM	80,000 RPM
Bur guard integrated into designor available as an accessory	Yes	Yes
Direct patient contactingmaterials (Burs / Blades)	Stainless Steel andmedical polymer	Stainless Steel, 6/6 nylonthread, and medical polymer
Blades / burs biocompatible	Yes	Yes

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration Rockville MD 20857

AUG 1 2 2004

Medtronic Xomed, Inc. c/o Mr. Jefffrey D. Rongero Underwriters Laboratories, Inc. 12 Laboratory Dr. Research Triangle Park, NC 27709

Re: K041985

Trade/Device Name: XPS Curved Bur Regulation Number: 21 CFR 874.4140 Regulation Name: ENT Bur Regulatory Class: Class I Product Codc: 77 EQJ Dated: July 21, 2004 Received: July 23, 2004

Dear Ms. Rongero:

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 for doo ourselve in 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 r va may a 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 (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 does not mean I hat 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 or any I ederal 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. Jeffrey Rongero

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 proceed 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) 594-4613. 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,

A képi korentthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): XPS Curved Bur Device Name: Indications for Use:

The XPS Curved Bur is intended for use in an ear, nose, and throat electric or pneumatic surgical dirill for The XPS Curved Bur is meetided for use mail cal, nose, and is an accessory to the XPS 3000 System.
incising or removing bone in the ear, nose, or throat area, and is an acces

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K041985

Prescription Use
(Per 21 CFR 801.109)

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Regulation Number and Section

§ 874.4140 Ear, nose, and throat bur.

(a)
Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.