The Power Control 2303 in connection with Power Stick M4 (8564.121) or alternatively Power Stick M3 (8563.111/311) serves to drive Wolf rotary blades/ abraders and morcellators (tissue punches) for removal of tissue in endoscopic operations. At the same time aspiration allows continuous removal of ablated tissue.

Indication and Field of Use:

For use with endoscopic accessories:

· In arthroscopy, e.g. for meniscus resection, removal of soft tissue as well as intraarticular severing or abrasion of osseous tissue (e.g. in ACL or shoulder operations)
· In thorax surgery, e.g. for removing hematomas
In sinus surgery, e.g. for removing of polyps
In spinal surgery (arthroscopic microdiskectomy (AMD)), e.g. for the removal of degenerated tissue

Device Description

The POWER CONTROL 2303 controls the motor in the POWER STICKS M3 and M4 that drives rotary blades and abraders, operated by a footswitch.

The POWER CONTROL 2303 is controlled by software.

The modes clockwise, counter-clockwise or oscillation can be selected in four speed ranges from 100 rpm up to 6000 rpm. The stop position of the rotary blade can be set and stored, so that the blade will always stop in this position until it is removed.

Values, functions and components are monitored at the graphically LCD display in various languages, accompanied by optical and acoustic signals.

Via the integrated CAN-BUS interface, the POWER CONTROL 2303 can be integrated into the R.Wolf RIWO NET SYSTEM with remote control, speech control and touchscreen monitor.

AI/ML Overview

Due to the nature of the provided document, which is a 510(k) summary for a medical device submitted to the FDA, it primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing detailed performance studies with acceptance criteria in the way a clinical trial or algorithm validation study would.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is not present:

Device: Power Control 2303 with Power Stick M4

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

The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical or diagnostic outcome, nor does it report device performance in those terms. Instead, the "performance data" section states adherence to electrical safety standards.

Acceptance Criteria (Implied)	Reported Device Performance
Conformity to electrical safety standards IEC601-1	Designed to meet IEC601-1
Conformity to electrical safety standards IEC601-1-2	Designed to meet IEC601-1-2
Conformity to electrical safety standards UL2601-1	Designed to meet UL2601-1
Safety and effectiveness when used according to instructions	Designed and tested to guarantee safety and effectiveness

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

No clinical or performance test set (as would be understood for an AI or diagnostic device) is described. The document explicitly states: "No clinical tests performed."

The "test set" in this context refers to the device itself being tested for compliance with electrical safety standards, not a set of patient data.

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

Not applicable. No ground truth establishment by experts for a test set of clinical data is mentioned as "No clinical tests performed."

The device operates under direct human control, and its safety/effectiveness is assumed based on compliance with manufacturing and electrical standards and equivalence to predicate devices, not on a ground truth derived from expert consensus on patient cases.

4. Adjudication method for the test set

Not applicable, as no test set requiring adjudication (e.g., of diagnoses or outcomes) is 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

Not applicable. This device is an electromechanical surgical tool (motor control, motor handle), not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance is relevant.

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

Not applicable. This device is not an algorithm; it's a piece of hardware that requires human operation. Performance is intrinsically human-in-the-loop.

7. The type of ground truth used

For this type of device, the "ground truth" for its safety and effectiveness is primarily established through:

Compliance with recognized electrical and medical device safety standards (e.g., IEC601-1, IEC601-1-2, UL2601-1).
Engineering design and testing to ensure the device functions as intended (e.g., speed ranges, control modes, monitoring features).
Substantial equivalence to previously cleared devices which have an established record of safety and effectiveness.

There is no "clinical ground truth" in the sense of pathology, outcomes data, or expert consensus on patient cases, as no clinical studies were performed.

8. The sample size for the training set

Not applicable. This document is for a traditional hardware medical device, not an AI or machine learning system. Therefore, there is no "training set."

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

Not applicable, as there is no training set for an AI or machine learning model.

Summary of Approach in the Document:

The provided document is a 510(k) submission, whose primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove de novo safety and effectiveness through extensive clinical trials or performance metrics against a defined ground truth. For certain Class II devices, particularly electromechanical ones like this, demonstrating conformity to recognized standards (like electrical safety standards) and showing similar technological characteristics and intended use to existing devices is often sufficient for clearance without requiring new clinical performance data. The explicit statement "No clinical tests performed" underscores this approach.

Summary

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Page ①

OCT 3 0 2003

Instruments Corporation

353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: 847-913-1113 Customer Service: 800-323-WOLF www.richard-wolf.com

K 0300 82

13.0 510(k) Summary of Safety and Effectiveness

Submitter:		Date of Preparation:	January 8, 2003
Company / Institution name:	RICHARD WOLF MEDICAL INSTRUMENTS CORP.	FDA establishment registration number:	14 184 79
Division name (if applicable):	N.A.	Phone number (include area code):	( 847 ) 913 1113
Street address:	353 Corporate Woods Parkway	FAX number (include area code):	( 847 ) 913 0924
City:	Vernon Hills	State/Province:	Illinois
Country:	USA	ZIP / Postal Code:	IL 60061
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager
Product Information:
Trade name:	Power Control 2303 with Power Stick M4	Model number:	2303.011/.901/.911, 8564.121/.851
Common name:	Motor control, motor handle	Classification name:	Electric surgical rotary blade/ abrader
Information on devices to which substantial equivalence is claimed:
510(k) Number	Trade or proprietary or model name	Manufacturer
1 K871250	1 Intra-articulated arthro power system 2161	1 Richard Wolf
2 K970088	2 RIWO DRIVE 2302 Generator and accessories	2 Richard Wolf
3 K984521	3 RIWO DRIVE small handle	3 Richard Wolf
4 K002328	4 SIOS-Interface for various devices	4 Richard Wolf

1.0 Description

The POWER CONTROL 2303 controls the motor in the POWER STICKS M3 and M4 that drives rotary blades and abraders, operated by a footswitch.

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Page (9)

2.0 Intended Use

For use with endoscopic accessories:

· In arthroscopy, e.q. for meniscus resection, removal of soft tissue as well as intraarticular severing or abrasion of osseous tissue (e.g. in ACL or shoulder operations)
In thorax surgery, e.g. for removing hematomas .
In sinus surgery, e.g. for removing of polyps .
· In spinal surgery (arthroscopic microdiskectomy (AMD)), e.g. for the removal of degenerated tissue

3.0 Technological Characteristics

The POWER CONTROL 2303 is controlled by software.

Values, functions and components are monitored at the graphically LCD display in various languages, accompanied by optical and acoustic signals.

Via the integrated CAN-BUS interface, the POWER CONTROL 2303 can be integrated into the R.Wolf RIWO NET SYSTEM with remote control, speech control and touchscreen monitor.

4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k)-devices sold by Richard Wolf.

5.0 Performance Data

The POWER CONTROL System 2303 was designed to meet the standards IEC601-1, IEC601-1-2 and UL2601-1.

6.0 Clinical Tests

No clinical tests performed.

7.0 Conclusions Drawn

These devices are designed and tested to quarantee the safety and effectiveness, when used according to the instructions manual.

By:

Robert Casasus

Date:

Robert L. Casarsa Quality Assurance Manager

13-2 revised 8/20/03

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Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three curved lines representing its wings or body. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2003

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

Re: K030082

Trade/Device Name: Power Control 2303 with Power Stick M4 Regulation Number: 21 CFR 888.1100, 878.4820 Regulation Name: Arthroscope, Surgical instrument motors Regulatory Class: II Product Code: HRX, HWE, GEY Dated: August 21, 2003 Received: August 22, 2003

Dear Mr. Casarsa:

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 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. Robert L. Casarsa

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) 594-4659. 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5.0 INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Intended use:

_k030082

Power Control 2303 with Power Stick M4

Indication and Field of Use:

For use with endoscopic accessories:

· In arthroscopy, e.g. for meniscus resection, removal of soft tissue as well as intraarticular severing or abrasion of osseous tissue (e.g. in ACL or shoulder operations)
· In thorax surgery, e.g. for removing hematomas
In sinus surgery, e.g. for removing of polyps
In spinal surgery (arthroscopic microdiskectomy (AMD)), e.g. for the removal of degenerated tissue

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030082

(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

Over-The Counter

(Optional Format 1'2-96)

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.