The MicroPower® Handpiece System 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.

The MicroPower® OralMax Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial.

The MicroChoice® Handpiece System 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, otolaryngological, oral/maxillofacial, hand, foot, neuro, and plastic/reconstructive surgical procedures.

Device Description

The MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems are electric pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A cord connects the handpiece to the controller that supplies power to the device. The handpieces have a lever or footswitch that is used to actuate the device. The drills use a wide variety of attachments, including bur guards, drill bits and burs. The saws use a wide variety of blades.

AI/ML Overview

This document is a 510(k) summary for the MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems, seeking clearance for these surgical drill systems. A 510(k) summary focuses on demonstrating substantial equivalence to pre-existing devices, rather than establishing acceptance criteria and conducting studies to prove performance against those criteria in the way one might for a novel, higher-risk device.

Therefore, the provided text does not contain the detailed information required to answer all your questions about acceptance criteria and a study proving the device meets them. This type of submission relies on showing that the new device is essentially the same as already cleared predicate devices, and thus "meets the acceptance criteria" by being substantially equivalent, rather than proving performance against new, specific thresholds.

Here's a breakdown based on the information available in the document and what's missing:

The device doesn't have explicit performance acceptance criteria stated but infers "equivalence" to previously cleared devices as the main criteria based on the 510K submission.

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

Acceptance Criteria (Inferred from 510(k))	Reported Device Performance
Substantial equivalence in intended use	Met
Substantial equivalence in design	Met
Substantial equivalence in technological characteristics	Met
No new issues regarding safety and effectiveness	Met (based on testing prior to product release)

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

Sample Size: Not specified. The document states "Testing conducted prior to product release," but does not detail the nature, sample size, or results of this testing.
Data Provenance: Not specified. It's implied to be internal testing by ConMed Linvatec, but country of origin or retrospective/prospective nature is not mentioned.

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

Number of experts: Not applicable. Ground truth, in the context of clinical studies, is not established for this type of 510(k) submission. The evaluation is based on engineering and design comparisons to predicate devices.
Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

Not applicable. There's no mention of a test set requiring adjudication in the clinical or independent expert sense.

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 drill system, not an AI or imaging diagnostic device. MRMC studies are not relevant here.

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

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

7. The type of ground truth used:

Ground Truth: In this context, "ground truth" for a 510(k) submission like this would be the established safety and effectiveness of the identified predicate devices, as recognized by the FDA. The new devices are deemed safe and effective because they are substantially equivalent to devices already cleared for market. There is no external "ground truth" in the sense of pathology or outcome data for this specific submission to prove device performance beyond substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for a physical surgical device like this in the context of an AI/ML algorithm.

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

Not applicable. There is no training set mentioned.

Summary

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OCT 2 4 2007

510(k) SUMMARY

MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number __ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

A. Submitter

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

B. Company Contact

Sue F. Dauterman Regulatory Affairs Specialist (727) 399-5321 Telephone (727) 399-5264 FAX

C. Device Name

Common Name: Surgical Drill System

Proposed Class/Device: Class II

Trade Name	ClassificationPanel	Classification Name	ProductCode
MicroChoice Drillsand Saws	Orthopedic	Arthroscope, 888.1100	HRX
MicroPower Drillsand Saws	Neurology	Electric cranial drill motor,882.4360	HBC
MicroPowerOralMax HighSpeed Drill	Dental	Bone cutting instrument andaccessories, 872.4120	DZI

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510(k) Summarv

MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems

D. Predicate/Legally Marketed Devices

510(k) Name	510(k) #	Owner
Universal Drive System	K971059	LinvatecCorporation
MicroPower Hand Piece: Medium SpeedDrill, Sagittal Saw, Reciprocating Saw, andOscillating Saw	K060198	LinvatecCorporation
MicroPower Hand Piece:High Speed Drill	K060260	LinvatecCorporation
MicroPower Hand Piece:Oral Max HighSpeed Drill	K060270	LinvatecCorporation

E. Device Description

F. Intended Use

Name	Intended Use
MicroPower®HandpieceSystem	The MicroPower® Handpiece System functions as apowered instrument system consisting of drills, sawsand associated handpieces to perform cutting of softtissue and bone. The fields of application include:orthopedic, arthroscopic, neurosurgical,otolaryngological, plastic/reconstructive, andoral/maxillofacial procedures.

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Name	Intended Use
MicroPower®OralMaxHandpieceSystem	The MicroPower® OralMax Handpiece Systemfunctions as a powered instrument system consistingof drills, saws and associated handpieces to performcutting of soft tissue and bone. The field of applicationincludes only oral/maxillofacial.
MicroChoice®HandpieceSystem	The MicroChoice® Handpiece System functions as apowered instrument system consisting of drills, sawsand associated handpieces to perform cutting of softtissue and bone. The fields of application include:orthopedic, arthroscopic, otolaryngological,oral/maxillofacial, hand, foot, neuro, andplastic/reconstructive surgical procedures.

G. Technological Characteristics

The MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems are identical to the predicate devices cleared in the original submissions except for an update to the handpiece identification mechanism as detailed in Section 9 of this submission. These modifications do not affect the device's intended use or performance specifications in a manner that raises any new issues regarding safety and effectiveness.

H. Substantial Equivalence

The MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece · Systems are substantially equivalent in intended use, design and technological characteristics to the below listed systems.

Proposed Name	Predicate 510(k) Name	510(k) #
MicroChoice® HandpieceSystem	Universal Drive System	K971059
MicroPower® HandpieceSystem	MicroPower Hand Piece: MediumSpeed Drill, Sagittal Saw,Reciprocating Saw, andOscillating Saw	K060198
	MicroPower Hand Piece:HighSpeed Drill	K060260
MicroPower® OralMaxHandpiece System	MicroPower Hand Piece:Oral MaxHigh Speed Drill	K060270

Testing conducted prior to product release assures that the new devices do not raise any new issues of safety and efficacy.

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Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, featuring four parallel lines that curve and taper towards the right side of the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2007

ConMed Livatec % Ms. Sue F. Dauterman Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K072706

Trade/Device Name: MicroPower® Handpiece System MicroPower® OralMax Handpiece System MicroChoice® Handpiece System

Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: September 21, 2007 Received: September 24, 2007

Dear Ms. Dauterman:

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. Sue F. Dauterman

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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K072700 510(k) Number (if known):

Device Name: MicroPower® Handpiece System

Indications for Use:

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

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)

of (Division Sign-Off)

(Division Degand Neurological Devices

510(k) Number 16072706

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KO72706 510(k) Number (if known):

Device Name: MicroPower® OralMax Handpiece System

Indications for Use:

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

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)

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510(k) Number (if known): K072706

Device Name: MicroChoice® Handpiece System

Indications for Use:

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

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)

Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.