The MicroPower Hand Piece: High Speed Drill, functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.

Device Description

The MicroPower Hand Piece High Speed Drill device description is identical to the MicroChoice product line cleared in the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised.

The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A chord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.

AI/ML Overview

The provided document describes a Special 510(k) submission for the Linvatec MicroPower Hand Piece High Speed Drill. This type of submission is for modifications to a manufacturer's own legally marketed device, asserting that the modifications do not affect the device's intended use, fundamental scientific technology, or performance specifications such that any new issues regarding safety and effectiveness are raised.

Therefore, the document does not present a traditional "study that proves the device meets the acceptance criteria" in the sense of a standalone clinical trial or a performance study with quantitative metrics against pre-defined acceptance criteria for a novel device. Instead, the "study" alluded to is the testing performed to ensure the modifications do not raise new safety and effectiveness issues and the assertion of substantial equivalence to the predicate device.

Here's an attempt to answer your request based on the provided text, acknowledging the nature of a Special 510(k) submission for a modified device:

Acceptance Criteria and Study for Linvatec MicroPower Hand Piece High Speed Drill

The MicroPower Hand Piece High Speed Drill is a modification of an existing device (MicroChoice product line, cleared under K971059). The acceptance criteria and "study" are framed within the context of demonstrating that these modifications do not introduce new safety or effectiveness concerns, and that the modified device remains substantially equivalent to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from 510(k) nature)	Reported Device Performance
Safety & Effectiveness	No new issues regarding safety and effectiveness are raised by the modifications.	"The changes made to the Universal Drive System have been tested to assure that the proposed modifications do not raise any new issues regarding safety and effectiveness."
Intended Use	The device's intended use is not affected by the modifications.	"These modifications do not affect the device's intended use..." (The fields of application were slightly changed but still align with the functionality of a surgical drill system.)
Fundamental Scientific Technology	The fundamental scientific technology remains unchanged.	"...do not affect the device's ... fundamental scientific technology..." (Based on existing MicroChoice hand piece platform, electric, pencil grip, uses same burs and blades.)
Performance Specifications	The performance specifications are not affected by the modifications.	"...do not affect the device's ... performance specifications..." (Implied to be consistent with the predicate device.)
Substantial Equivalence	The modified device is substantially equivalent to the legally marketed predicate device (K971059).	"The MicroPower Hand Piece High Speed Drill is substantially equivalent in scientific technology, design and in indication for use to the MicroChoice Universal Drive System."

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

Sample Size: Not explicitly stated as a separate "test set" with a numerical size. The "testing" refers to verification and validation activities conducted on the modified device itself.
Data Provenance: Not applicable in the context of clinical data. The data provenance would be from internal engineering and design verification reports for the modified hand piece.
Retrospective/Prospective: Not applicable to this type of submission. The evaluation is focused on the device's design and performance rather than clinical outcomes.

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

This information is not provided in the document, as the submission does not involve clinical data with "ground truth" derived from expert consensus. The "ground truth" here is the established safety and effectiveness of the predicate device, and the demonstration that the modified device maintains those attributes.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a formal adjudication method for a test set, as no clinical study or expert review of data is described. The "adjudication" is internal to the manufacturer's testing and review process, leading to the regulatory submission for substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or those involving human interpretation, to assess improvement with AI assistance. The MicroPower Hand Piece is a surgical tool.

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

No. This question is also not applicable as the device is a physical surgical hand piece, not an algorithm or a decision-support system.

7. The Type of Ground Truth Used

The "ground truth" is implicitly the performance, safety, and effectiveness of the legally marketed predicate device (MicroChoice Universal Drive System, K971059). The Special 510(k) argues that the modified device maintains these established characteristics due to the nature of the modifications not raising new issues.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for AI/machine learning models. The MicroPower Hand Piece is a mechanical/electrical surgical instrument, not an AI-driven device.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as #8.

Summary

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APR 1 0 2006

April 6, 2006

SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the Special 510(k) Summary of Safety and Effectiveness for the MicroPower Hand Piece High Speed Drill.

Submitter A.

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

B. Company Contact

Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX

C. Device Name

Trade Name:	MicroPower Hand Piece High Speed Dril
Common Name:	Surgical Drill System
Classification Names:	882.4360 -Electric Cranial Drill Motor
Proposed Class/Device:	Class II
Product Code:	HBC

D. Predicate/Legally Marketed Devices

K971059 - Universal Drive System

MicroPower Hand Piece High Speed Drill Special 510(k) # _K060260 April 6, 2006,

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E. Device Description

Intended Use

The MicroPower Hand Piece High Speed Drill functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application have changed slightly from the predicate device, including only: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, trauma and spinal procedures.

F. Substantial Equivalence

The MicroPower Hand Piece High Speed Drill is substantially equivalent in scientific technology, design and in indication for use to the MicroChoice Universal Drive System. The Universal Drive System was cleared by FDA under 510(k) K971059. The changes made to the Universal Drive System have been tested to assure that the proposed modifications do not raise any new issues regarding safety and effectiveness.

Ig 2 of 2

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human figures in profile, arranged in a row. The figures are connected and appear to be moving forward. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2006

ConMed Linvatec Corporation c/o Ms. Elizabeth M. Paul Manager, Regulatory Affairs 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K060260

Trade/Device Name: MicroPower Hand Piece: High Speed Drill Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: II Product Code: HBC Dated: March 15, 2006 Received: March 16, 2006

Dear Ms. Paul:

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.

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 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

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Page 2 - Ms. Elizabeth M. Paul

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. 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 (240) 276-0115. 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,

Mark N. Melkerson

Mark N. Melkerson 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

510(k) Number (if known): K060260

Device Name: MicroPower Hand Piece: High Speed Drill

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)

el.gmall.

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number_k060260

Regulation Number and Section

§ 882.4360 Electric cranial drill motor.

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