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The Alliger Ultrasonic Surgical System is indicated for use in the fragmentation 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 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 and 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 resection such as segmentectomies, nonanatomical subsegmentectomies, and metastatectomies

The Alliger Ultrasonic Surgical System is comprised of a generator which feeds a 40 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 provided 510(k) summary for the Alliger Ultrasonic Surgical System Model AUSS-4 focuses on establishing substantial equivalence to predicate devices based on non-clinical engineering tests, rather than clinical performance acceptance criteria. Therefore, many of the requested items (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this regulatory submission as it pertains to a pre-market notification for a Class II device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) because it's a device for surgical fragmentation and aspiration, not a diagnostic or imaging device. Instead, the acceptance criteria were based on demonstrating that its operating characteristics are "substantially equivalent" to predicate devices through engineering tests.

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

• Sample size: Not applicable. The study involved non-clinical engineering tests, not a "test set" of patients or data in the traditional sense for evaluating diagnostic or predictive performance.
• Data provenance: Not applicable. These were engineering measurements conducted by the manufacturer, Misonix Inc., likely in their laboratory or a contracted testing facility.

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

• Not applicable. Ground truth for engineering tests is established by physical measurement standards and engineering specifications, not expert consensus as would be used for clinical interpretations.

4. Adjudication method for the test set

• Not applicable. There was no clinical test set requiring adjudication.

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

• No. This device is an ultrasonic surgical system, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

• Not applicable. This is not an algorithmic or AI-driven device. Its performance is inherent to its mechanical and electrical operation.

7. The type of ground truth used

• The "ground truth" for the engineering tests would be measured physical parameters and compliance with established engineering and safety standards (e.g., electrical safety standards, mechanical performance benchmarks, frequency and power specifications). The predicate devices (ValleyLab CUSA® Model 200H and Spembly Selector®) served as benchmarks for demonstrating substantial equivalence of these parameters.

8. The sample size for the training set

• Not applicable. There was no training set, as this is not a machine learning or AI device.

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

• Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the Alliger Ultrasonic Surgical System Model AUSS-4 meets its acceptance criteria (i.e., is substantially equivalent to predicate devices) was a non-clinical engineering study.

• Objective: To determine that the operating characteristics of the Alliger Ultrasonic Surgical System Model AUSS-4 are substantially equivalent to the predicate devices (ValleyLab CUSA® Model 200H and Spembly Selector® Ultrasonic Surgical Aspirator).
• Methodology: A series of engineering tests were performed, including:
  • 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
• Comparison: The results of these tests were compared to the known operating parameters and safety profiles of the predicate devices. The submission also highlights that while the CUSA 200H uses a magnetostrictive transducer, the Spembly Selector, which was previously deemed substantially equivalent to the CUSA 200H, uses a similar piezoelectric transducer as the Alliger system, strengthening the basis for comparison.
• Conclusion: Based on the analysis of these engineering tests, hazard analysis, and voluntary consensus standard investigations, Misonix Inc. concluded that the Alliger Ultrasonic Surgical System Model AUSS-4 is substantially equivalent to its predicate devices. The FDA concurred with this determination, allowing the device to be marketed.

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