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The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification and aspiration of soft 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.

The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is comprised of a generator that feeds a 23 kHz electrical signal to piezoelectric crystals mounted in a hand-held Handpiece. The crystals then vibrate at the same frequency. The vibration is amplified by a titanium Tip attached to the Handpiece. Fragmentation of unwanted tissue occurs at the end of the Tip. An Irrigation/Aspiration unit is provided to introduce irrigation solution and remove fragmented material and waste liquids. The system incorporates features that allow it to interface with standard electrosurgery generators (modules). By activating the output of the electrosurgery generators, RF voltage is available at the distal end of the ultrasonic cannula. This feature allows the surgeon to cauterize tissue with or without the simultaneous application of ultrasound energy.

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

The device's safety and performance were established by demonstrating substantial equivalence to predicate devices (ValleyLab CUSA® EXCEL Ultrasonic Surgical Aspirator and Misonix Inc. AUSS-5 Ultrasonic Surgical Aspirator) through non-clinical testing performed against recognized voluntary and tested standards.

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criteria (Voluntary and Tested Standards)	Reported Device Performance
   UL 2601-1 Medical Electrical Equipment, Part 1	Device designed to pass and tested against this standard.
   EN 60601-1 Medical Electrical Equipment, Part 1	Device designed to pass and tested against this standard.
   EN 60601-2-2 Medical Electrical Equipment, Part 2	Device designed to pass and tested against this standard.
   EN 60601-1-2:2001 Electromagnetic Compatibility	Device designed to pass and tested against this standard (EMC Requirements).
   FCC Part 18 EMC Requirements	Device designed to pass and tested against this standard (EMI Tests).
   Software Validation	Software has been validated, considering failure and effects analysis.
   Output Frequency Measurements	Performed as part of non-clinical tests.
   Output Power Measurements (No Load to Maximum Load)	Performed as part of non-clinical tests.
   Tip Displacement Measurements	Performed as part of non-clinical tests.
   Irrigation Flowrate Measurements	Performed as part of non-clinical tests.
   Life Tests	Performed as part of non-clinical tests (RF Cautery Life Tests).
   Vacuum Flowrate and Pressure Measurements	Performed as part of non-clinical tests.
   Input Power Measurements	Performed as part of non-clinical tests.
   Dielectric Tests on Mains Circuits	Performed as part of non-clinical tests.
   Difficult Current Leakage and Patient Sink Current Measurements	Performed as part of non-clinical tests.
   Power Line Ground Leakage Measurements	Performed as part of non-clinical tests.
   Dielectric Tests on Patient Circuits	Performed as part of non-clinical tests.
   Dielectric Tests with RF Cautery Unit Attached	Performed as part of non-clinical tests.
   RF Cautery Unit Output Power Tests	Performed as part of non-clinical tests.

2. Sample size used for the test set and the data provenance: Not applicable. The device's substantial equivalence was determined through non-clinical laboratory testing and adherence to standards, not through a clinical test set involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was performed for this 510(k) submission.

4. Adjudication method: Not applicable, as no clinical test set requiring adjudication was performed.

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 ultrasonic surgical aspirator and does not involve AI or human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a surgical instrument, not an algorithm.

7. The type of ground truth used: For the non-clinical tests, the "ground truth" was established by the specifications and requirements of the referenced voluntary and tested standards (e.g., UL 2601-1, EN 60601 series, FCC Part 18) and engineering test protocols for performance metrics (e.g., output frequency, power, tip displacement, flow rates, dielectric strength).

8. The sample size for the training set: Not applicable. This device is a hardware surgical instrument, and its performance was evaluated through non-clinical testing against standards and direct comparison of operating characteristics to predicate devices, not through machine learning model training.

9. How the ground truth for the training set was established: Not applicable. There was no training set for a machine learning model.

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