The Alliger Ultrasonic System is indicated for use in the fragmentation and aspiration of both soft and hard (e.g.: bone) tissue in the following surgical specialties:

Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecology

External genitalia

condyloma -
benign tumors (lipomas, fibromas, and leiomyomas)
malignant primary and metastatic tumors of all types and the following cystic lesions:
Bartholin's cysts -
Vestibular adenitis -
Inclusion cysts -
Sebaceous cysts -

Abdominal area any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus.

Thoracic Surgery

Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.

Wound Care

The Misonix Inc. AUSS-7 Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

Device Description

The Alliger Ultrasonic Surgical System is comprised of a generator, which feeds a 22.5 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. Both irrigation / aspiration can be provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.
The AUSS-7 Ultrasonic Surgical System is indicated for use in the fragmentation and aspiration of both soft and hard (e.g.: bone) tissue in the following surgical specialties:

Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecology External genitalia

condyloma -

benign tumors (lipomas, fibromas, and leiomyomas)
malignant primary and metastatic tumors of all types and the following cystic lesions:
Bartholin's cysts -
-Vestibular adenitis
-Inclusion cysts
-Sebaceous cysts

AI/ML Overview

This device, the Alliger Ultrasonic Surgical System Model AUSS-7, is cleared based on demonstrating substantial equivalence to a predicate device (Misonix Inc. Ultrasonic Surgical Aspirator AUS-6, K050776) rather than meeting predefined acceptance criteria through a full clinical study with specific performance metrics.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" presented as quantitative performance thresholds the device must meet, nor are there reported device performance metrics in comparison to such criteria.

Instead, the submission focuses on demonstrating that the new device (AUSS-7) is as safe and effective as the predicate device (AUSS-6). The "performance" is implicitly deemed acceptable if it's found to be substantially equivalent.

The document lists "Non-Clinical Tests Performed for Determination of Substantial Equivalence," which essentially serve as the basis for comparison and demonstrate that the AUSS-7 operates similarly to the AUSS-6. These include:

Non-Clinical Test	Purpose (Implied Acceptance)
Output Frequency Measurements	Demonstrate consistent operating frequency with predicate.
Output Power Measurements (No Load to Maximum Load)	Show comparable power delivery across various loads.
Tip Displacement Measurements	Ensure similar vibrational amplitude at the tip.
Irrigation Flowrate Measurements (Ultrasound On/Flush)	Verify consistent irrigation capabilities.
Life Tests	Ensure expected device durability and longevity.
Vacuum Flowrate and Pressure Measurements	Confirm effective aspiration performance.
Input Power Measurements	Show consistent power consumption.
EMI Tests	Demonstrate electromagnetic compatibility and safety.
Dielectric Tests on Mains and Patient Circuits	Ensure electrical safety and insulation integrity.
Software Validations	Verify proper functioning of microprocessor controls, displays, and alarms.

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

Sample Size: Not applicable. No "test set" of clinical data was used for this 510(k) submission, as no clinical studies were performed. The evaluation was based on non-clinical engineering tests.
Data Provenance: Not applicable.

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

Not applicable. No clinical test set requiring expert ground truth was utilized.

4. Adjudication Method for the Test Set

Not applicable.

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

No. The document explicitly states: "Discussions of Clinical Tests Performed: N/A".

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

Yes, in a way. The "performance" evaluated was entirely standalone, as it relates to the device's physical and electrical characteristics and not to human-in-the-loop performance with a clinician. The non-clinical tests assess the device's intrinsic operational performance.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would have been engineering specifications, design requirements, and the performance characteristics of the predicate device (AUSS-6). The new device's measurements were compared against these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data.

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

Not applicable.

Summary of the Study (Basis for Substantial Equivalence):

The "study" in this context is a series of non-clinical engineering tests and a comparison to a legally marketed predicate device.

Rationale for Equivalence: Misonix, Inc. concluded that the Alliger Ultrasonic System Model AUSS-7 is substantially equivalent to the AUSS-6 because:
- It is identical in its mode of operation.
- It has identical Indications for Use.
- The main differences are updated controls, displays, alarms (microprocessor-controlled, LCD screen), and a different outer housing for cosmetic purposes.
- A comprehensive set of non-clinical tests (listed above in point 1) were performed to confirm that the new design maintains equivalent performance characteristics (output frequency, power, tip displacement, flow rates, electrical safety, software validation, etc.) to the predicate device.
- No new safety or efficacy concerns were identified through risk analysis and voluntary consensus standard investigations.

A clinical study was explicitly not performed or required for this 510(k) clearance, as the changes to the device were deemed minor enough that non-clinical data was sufficient to demonstrate substantial equivalence to the predicate.

Summary

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Exhibit E

K070313

510K SUMMARY - Alliger Ultrasonic Surgical System Model AUSS-7

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMSA 1990 and 21CFR 807.92.

1. Submitter's Identification

Name:	MISONIX, INC.
Address:	1938 New Highway, Farmingdale, NY 11735
Telephone Number:	(631) 694-9555
Contact Person:	Ronald R. Manna, Vice President Regulatory Affairs
Date Prepared:	January 23, 2007

Name of Device 2.

Proprietary Name:	Alliger Ultrasonic Surgical System Model AUSS-
Common / Usual Name:	Ultrasonic Surgical SystemUltrasonic Surgical Aspirator

3. Predicate Device Information

Classification Name:

Original Device:		Misonix Inc. Ultrasonic Surgical Aspirator AUS-6, K050776
------------------	--	-----------------------------------------------------------

Instrument, Ultrasonic Surgical

1. Device Description The Alliger Ultrasonic Surgical System is comprised of a generator, which feeds a 22.5 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. Both irrigation / aspiration can be provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.
  The AUSS-7 Ultrasonic Surgical System is indicated for use in the 5. Intended Use: fragmentation and aspiration of both soft and hard (e.g.: bone) tissue in the following surgical specialties:

Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecology External genitalia

condyloma -

benign tumors (lipomas, fibromas, and leiomyomas)
malignant primary and metastatic tumors of all types and the following cystic lesions:
Bartholin's cysts -
-Vestibular adenitis
-Inclusion cysts
-Sebaceous cysts

{1}------------------------------------------------

any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus.

Thoracic Surgery

Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.

Wound Care

The Misonix Inc. AUSS-7 Utrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.

1. Comparison to Original Device: The AUSS-7 is identical in its mode of operation and Indications for Use. The main difference is the controls, displays and alarms are microprocessor controlled and displayed on an LCD screen. The outer housing is also different for cosmetic purposes.
1. Discussions of Non-Clinical Tests Performed for Determination of Substantial 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 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. Software Validations

1. Discussions of Clinical Tests Performed
  N/A
1. Conclusions
  Based upon an analysis of the operating characteristic specifications. Output of Engineering Tests, Risk Analysis, and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Alliger Ultrasonic System Model AUSS-7 is substantially equivalent to the AUSS-6 and introduces no new safety or efficacy concerns.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2007

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

Re: K070313

Trade/Device Name: Misonix Inc. AUSS-7 Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: April 16, 2007 Received: April 18, 2007

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 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. Ronald Manna

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,

For

Mark N. Melkerson
Director
Division of General, Restorative

DEP

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

K070313 Indications for Use

Device Name: Misonix Inc. AUSS-7 Ultrasonic Surgical Aspirator System

The Alliger Ultrasonic System is indicated for use in the fragmentation and aspiration of both soft and hard (e.g.: bone) tissue in the following surgical specialties:

Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecology

External genitalia

condyloma -
benign tumors (lipomas, fibromas, and leiomyomas)
malignant primary and metastatic tumors of all types and the following cystic lesions:
Bartholin's cysts -
Vestibular adenitis -
Inclusion cysts -
Sebaceous cysts -

Abdominal area any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus.

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number	L070313
---------------	---------

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14070313

Indications for Use (con't)

Thoracic Surgery

Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.

Wound Care

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

Regulation Number and Section

N/A