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The Alliger 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; 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 segmetectomies, nonanatomical subsegmentectomies, and metastatectomies).

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. An irrigation / aspiration unit is provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.

The provided document is a 510(k) summary for the Alliger Ultrasonic Surgical System Model AUSS-5. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials with pre-defined acceptance criteria for device performance. Therefore, many of the requested categories of information related to clinical studies and acceptance criteria are not applicable or not detailed in this document.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The 510(k) summary does not include an explicit table of acceptance criteria or reported device performance in the way a clinical study report would. Instead, it demonstrates substantial equivalence by comparing the design, materials, and operating parameters of the AUSS-5 to its predicate devices (AUSS-4 and CUSA Model NS-100). The "acceptance criteria" in this context are implicitly that the AUSS-5 performs comparably or better than the predicate devices and meets relevant engineering and safety standards.

The document lists "Non-Clinical Tests Performed" which include:

• 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.

The conclusion states that based on an analysis of operating characteristics, output of engineering tests, hazard analysis, and voluntary consensus standard investigations, the device is substantially equivalent. However, specific values or ranges for these tests are not provided in this summary.

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

Not Applicable. This submission is based on non-clinical testing and comparison to predicate devices, not a clinical study with a "test set" of patient data. The non-clinical tests involved physical device measurements and performance evaluations.

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

Not Applicable. No clinical study with a "test set" and associated ground truth established by experts is described in this 510(k) summary.

4. Adjudication Method for the Test Set

Not Applicable. No clinical study with a "test set" requiring adjudication is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states "Discussions of Clinical Tests Performed: N/A". Therefore, no MRMC study was conducted or reported in this summary.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. The Alliger Ultrasonic Surgical System is a physical surgical device, not an algorithm, and the submission clarifies that no clinical tests were performed.

7. Type of Ground Truth Used

Not Applicable. No clinical study requiring "ground truth" (e.g., pathology, outcomes data) is described. The basis for the submission is non-clinical engineering and performance testing, and comparison to legally marketed predicate devices.

8. Sample Size for the Training Set

Not Applicable. As no clinical study was performed, there is no "training set" of data as described in the context of an algorithm or AI.

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

Not Applicable. Since there was no training set, there was no ground truth to establish for it.

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