(70 days)
The AUSS-6 Ultrasonic Surgical Aspiration System and Accessories are indicated for the fragmentation and aspiration of soft and hard (i.e. bone) tissues in various General and Specialty surgery applications. It 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 AUSS-6 Ultrasonic Surgical System and Accessories are 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-6 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.
The AUSS-6 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 unit is provided to introduce irrigation solution to the operative site. An aspirator system removes fragmented material and waste liquids from the area. Accessories include probe tips, wrenches, sterile and non sterile tube sets and sterile Surgical Procedure bags.
The Misonix Inc. AUSS-6 Ultrasonic Surgical Aspirator System and Accessories is a medical device for fragmentation and aspiration of soft and hard tissues in various surgical applications, and for wound debridement.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Testing |
|---|---|---|
| Safety Standards | Compliance with medical electrical equipment safety standards. | The device was designed and tested to pass the following Voluntary Standards: |
- UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
- EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety |
| Electromagnetic Compatibility (EMC) | Compliance with EMC requirements. | The device was designed and tested to pass the following Voluntary Standards: - EN 60601-1-2:2001 Electromagnetic Compatibility
- FCC Part 18 EMC Requirements |
| Non-Clinical Performance | The device should demonstrate appropriate functional characteristics for an ultrasonic surgical aspirator. | Non-Clinical Tests Performed for Determination of Substantial Equivalence included: - Output Frequency Measurements
- Output Power Measurements (No Load to Maximum Load)
- Tip Displacement Measurements
- Irrigation Flowrate Measurements
- 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 Validation | If applicable, software validation. | This device does not contain software. |
| Sterilization Validation | Device sterility and appropriate validation. | Validation statements are contained in Exhibit J. |
| Clinical Equivalence (Wound Debridement) | The device should be safe and efficacious for wound debridement, and substantially equivalent to predicate devices for this indication, and to sharps debridement. Other indications (soft and hard tissue ablation) are generally accepted as safe and efficacious based on predicate device history. | For wound debridement, the claim states: "Based upon a review of the published literature Misonix Inc. can state that the use of an Ultrasonic Surgical Aspirator for Wound Debridement is safe and efficacious. We can also state that the AUSS-6 is substantially equivalent in this regard to the CUSA NS-100, the Misonix Inc. AUSS-5 in soft and hard tissue ablation. The AUSS-6 is also substantially equivalent to sharps debridment of wounds caused by various mechanisms such as burns, radiation and diabetes. Based upon the clinical experiences outlined herein, the Misonix Inc. AUSS-6 Ultrasonic Surgical System and Accessories pose no new issues of safety or efficacy when used for wound debridement." The results of clinical tests for Wound Debridement are included in Exhibit L. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as numerical data. The submission refers to "several papers" and "clinical tests for Wound Debridment" outlined in Exhibit L. The nature or size of these clinical tests/studies is not detailed in the provided summary.
- Data Provenance: The document states that Ultrasonic Surgical Aspirators have been employed for 30 years and are "well documented in the public domain." For wound debridement, "published literature" and "clinical tests for Wound Debridment" (Exhibit L) were used. The country of origin is not specified but given the context of FDA submission, it would likely be studies from North America or globally recognized literature. The studies appear to be a mix of retrospective (published literature review) and prospective (the "clinical tests" for AUSS-6).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This information is not provided in the summary. The clinical data relies on "published literature" and "clinical tests," but details about expert involvement in establishing ground truth are absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the summary.
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 MRMC or human-AI comparison study was done. This device is an ultrasonic surgical aspirator, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the general efficacy and safety of ultrasonic surgical aspirators in soft and hard tissue ablation, the "ground truth" is based on long-standing clinical use and published literature.
- For the wound debridement indication, the "ground truth" is derived from published literature discussing the use of ultrasonic surgical systems for debriding wounds, and the results of "clinical tests" on the AUSS-6 device for wound debridement. This implies an assessment of clinical outcomes. Further specifics on how "safe and efficacious" was defined as ground truth (e.g., specific healing rates, reduction in infection, etc.) are not detailed in this summary, but would be expected in Exhibit L.
8. The sample size for the training set:
- This question is not applicable. The device is a physical surgical instrument, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This question is not applicable (as above).
N/A