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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.

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

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:

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.

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