The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:
Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery
The system may also be combined with electrosurgery using optional RF Surgery interface components.

Device Description

The FS 1000 RF Ultrasonic Surgical Aspirator System is comprised of a generator, which feeds a 23 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation unit is provided to introduce irrigation solution to the operative site. An aspirator system removes fragmented material and waste liquids from the area. Accessories include various probe tips. wrenches, tube sets and cleaning brushes.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of design, materials, and operating parameters. It does not present a study with acceptance criteria and device performance in the way that would be expected for a diagnostic AI or machine learning device.

Therefore, I cannot provide the requested information for an "AI or machine learning device" as the document describes a traditional surgical aspirator system. The questions about AI, reader studies, ground truth establishment, training sets, and sample sizes for diagnostic performance are not applicable to the content provided.

However, I can extract the information related to the device's performance based on the provided document, interpreting "acceptance criteria" as the voluntary standards it was tested against and "reported device performance" as the assertion of substantial equivalence based on meeting those standards and direct comparison to predicate devices.

Non-AI/ML Device Acceptance Criteria and Performance (Based on K062471)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Voluntary Standards)	Reported Device Performance
UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety	Designed and tested to pass this standard.
EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety	Designed and tested to pass this standard.
EN 60601-2-2 Medical Electrical Equipment, Part 2: Particular Requirements for Safety of High Frequency Surgical Equipment	Designed and tested to pass this standard.
EN 60601-1-2:2001 Electromagnetic Compatibility	Designed and tested to pass this standard.
FCC Part 18 EMC Requirement (Electromagnetic Compatibility)	Designed and tested to pass this standard.
Other Non-Clinical Tests (to demonstrate Substantial Equivalence)	Performed and deemed acceptable to support substantial equivalence.
Output Frequency Measurements	Performed.
Output Power Measurements (No Load to Maximum Load)	Performed.
Tip Displacement Measurements	Performed.
Irrigation Flowrate Measurements (Ultrasound On and Flush Mode)	Performed.
Life Tests	Performed.
Acoustic Output Test	Performed.
Vacuum Flowrate and Pressure Measurements	Performed.
Input Power Measurements	Performed.
EMI Tests	Performed.
Dielectric Tests on Mains Circuits	Performed.
Patient Current Leakage and Patient Sink Current Measurements	Performed.
Power Line Ground Leakage Measurements	Performed.
Dielectric Tests on Patient Circuits	Performed.
RF Cautery Life Tests	Performed.
Dielectric Tests with RF Cautery Unit Attached	Performed.
RF Cautery Unit Output Power Tests	Performed.
Software Validation	Software validations reviewed and cleared under 510(k) K032690; not affected by change of indication for use.
Sterilization Validations	Validation statements contained in Exhibit J.

Since this is a filing for a traditional surgical device and not an AI/ML diagnostic, the following questions are not directly applicable to the content provided in the 510(k) summary. I will state why for each:

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

Not applicable to this document. This document describes non-clinical engineering and performance testing against standards, and a comparison of physical device characteristics to predicate devices. There is no "test set" of patient data in the context of diagnostic performance.

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)

Not applicable to this document. There is no "test set" requiring expert ground truth in the context of diagnostic assessment. The "ground truth" for non-clinical engineering tests would be the established scientific and engineering principles and the specifications of the device/standards.

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

Not applicable to this document. No diagnostic test set requiring adjudication 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 to this document. This is a surgical device, not a diagnostic imaging AI. No MRMC study or AI assistance is mentioned.

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

Not applicable to this document. This is not an algorithm-only device. It is a manually operated surgical tool.

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

Not applicable to this document in the diagnostic sense. For the engineering tests, the ground truth would be the validated measurements, specifications, and performance against established engineering standards. For substantial equivalence, the "ground truth" is the performance and safety profile of the predicate devices.

8. The sample size for the training set

Not applicable to this document. There is no "training set" as this is not an AI/ML device.

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

Not applicable to this document. There is no "training set" as this is not an AI/ML device.

Summary

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K 062471

510(k) SUMMARY - Misonix Inc. AUSS-6 Ultrasonic Surgical Exhibit E Aspirator System and Accessories

OCT 2 6 2006

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

Submitter's Identification 】.

Submitter's Name:	MISONIX INCORPORATED
Address:	1938 New Highway, Farmingdale, NY 11735
Telephone Number:	516-694-9555
Contact Person:	Ronald R. Manna
Date Prepared:	August 18, 2006

Name of Device 2.

Proprietary Name:	Misonix Inc. FS 1000 RF Ultrasonic SurgicalAspirator System and Accessories
Common/Usual Name:	Ultrasonic Surgical SystemUltrasonic Surgical Aspirator
Classification Name:	Instrument, Ultrasonic Surgical

3. Predicate Device Information

Misonix Inc. AUSS-6 Ultrasonic Surgical Aspirator, K050776 Misonix Inc. AUSS-5 Ultrasonic Surgical Aspirator, K012028 Radionics CUSA EXCEL Ultrasonic Surgical Aspirator System with Bone Tip, K051947

Device Description: 4.

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system removes fragmented material and waste liquids from the area. Accessories include various probe tips. wrenches, tube sets and cleaning brushes.

1. The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System Intended Use: is indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:
  Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery

The system may also be combined with electrosurgery using optional RF Surgery interface components.

Comparison to Predicate Device 6. The FS 1000 RF System and Accessories are similar in design, material and operating parameters to the Misonix Inc. AUSS-5 Ultrasonic Surgical Aspirator, the CUSA EXCEL Ultrasonic Surgical Aspirator and the Misonix AUSS-6 Ultrasonic Surgical Aspirator Systems.

Safety and Performance Data

The Misonix Inc. FS-1000 RF Ultrasonic Surgical Aspirator System and Accessories have been designed and tested to pass the following Voluntary Standards:

UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety

EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety

EN 60601-2-2 Medical Electrical Equipment, Part 2: Particular Requirements for Safety of High Frequency Surgical Equipment

EN 60601-1-2:2001 Electromagnetic Compatibility

FCC Part 18 EMC Requirement

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1. The software included with this device is not Software Validation: affected by the change of indication for use. All software validations were reviewed and cleared under 510(k) K032690.
1. Sterilization Validations: Validation statements are contained in Exhibit J.
Non-Clinical Tests Performed for Determination of Substantial 9. Equivalence are as follows:

Output Frequency Measurements Output Power Measurements (No Load to Maximum Load) Tip Displacement Measurements Irrigation Flowrate Measurements (Ultrasound On and Flush Mode) Life Tests Acoustic Output Test Vacuum Flowrate and Pressure Measurements Input Power Measurements EMI Tests Dielectric Tests on Mains Circuits Patient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits RF Cautery Life Tests Dielectric Tests with RF Cautery Unit Attached RF Cautery Unit Output Power Tests

ರ. Discussions of Clinical Tests Performed: Since the FDA has cleared the use of ultrasonic energy to ablate hard tissue in numerous 510(k) grants, no clinical tests were conducted in anticipation of this submission.
Conclusions: Based upon a review of the published literature Misonix 10. Inc. can state that the use of an Ultrasonic Surgical Aspirator for Wound Debridement is safe and efficacious. We can also state that the AUSS-6 is substantially equivalent in this regard to the CUSA NS-100, the Misonix Inc. AUSS-5 in soft and hard tissue ablation. The AUSS-6 is also substantially equivalent to sharps debridment of wounds caused by various mechanisms such as burns, radiation and diabetes. Based upon the clinical experiences outlined herein, the Misonix Inc. AUSS-6 Ultrasonic Surgical System and Accessories pose no new issues of safety or efficacy when used for wound debridement.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2006

Misonix, Inc. % Mr. Ronald R Manna Vice President Regulatory Affairs 1938 New Highway Farmingdale, NY 11735

Re: K062471

Trade/Device Name: Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: August 18, 2006 Received: August 24, 2006

Trade/Device Name: Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 18, 2006 Received: August 24, 2006

Dear Mr. Manna:

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

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Page 2 - Mr. Ronald R Manna

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.

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 vour

Rafa Nadal

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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Exhibit C

Indications for Use

K ob2471

Device Name: Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System

Indications for Use: The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the fotlowing surgical specialties:

Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery

The system may also be combined with electrosurgery using optional RF Surgery interface components.

Prescription Use(Part 21 CFR 801 Subpart D)	X
AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-C Division of General, Restor ative, and Neurological Devices

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510(k) Number L062471

Regulation Number and Section

N/A