(276 days)
The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue in the following surgical specialties: Neurosurgery, Orthopedic Surgery, Plastic and Reconstructive Surgery and the following specific uses: Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant turnors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery - including removal of benign or malignant turnors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy Gynecological Surgery - including removal of dysplastic genital epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis.
The CUSA® Excel+ Ultrasonic Surgical Aspirator System (CUSA) is an ultrasonically vibrating surgical device which, in combination with irrigation, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Excel+ System consists of a console which provides control and power functions, two surgical hand pieces which provide ultrasonic mechanical energy (23kHz and 36kHz), titanium hand piece tips (variety of models), flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA Excel+ system accommodates most commercially available suction canisters. A two-pedal footswitch is provided with the console.
The provided text describes the CUSA® Excel+ Ultrasonic Surgical Aspirator System and its indications for use. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance. The document is a 510(k) summary for a medical device, primarily focused on establishing substantial equivalence to a predicate device and expanding indications for use based on existing literature.
Here's a breakdown of what is and is not in the document, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided. The document does not specify quantitative acceptance criteria (e.g., minimum fragmentation rate, maximum aspiration volume, specific tissue selectivity percentages with thresholds) or present a table comparing these criteria to observed device performance in a formal study for the expanded indications.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size:
- For the bench study on spray patterns: Not explicitly stated, described as "A series of randomized experiments covering different settings."
- For the clinical evidence (literature review): "over 500 patients in 34 articles published between 1988 and 2014."
- Specifically: 230 patients with dysplasia, 101 patients with condyloma, 164 patients requiring debulking procedures, and 15 patients with endometriosis.
- Data Provenance:
- Bench study: Performed by Integra (manufacturer).
- Clinical evidence: Derived from "peer-reviewed clinical literature" (retrospective analysis of published studies). The country of origin of this literature is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not provided directly. For the bench study, there's no mention of experts establishing ground truth for spray pattern evaluation.
- For the clinical literature review, the "ground truth" is implied to be the published surgical outcomes and observations reported by the authors of the peer-reviewed articles. The qualifications of these original authors (surgeons, pathologists, etc.) are not detailed in this 510(k) summary.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided. No specific test set with an adjudication method (like 2+1, 3+1 for expert review) is described for the expanded indications. The clinical evidence relies on previously peer-reviewed and published clinical literature.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, not performed. The document does not mention any MRMC study or any comparison of human readers with vs. without AI assistance. The device is a surgical aspirator, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. The CUSA Excel+ is a physical surgical device, not an AI algorithm.
7. Type of Ground Truth Used:
- Bench Study (Spray Patterns): Direct observation and measurement of physical "spray" phenomena under controlled settings.
- Clinical Literature Review: "Clinical evidence" and "successful treatment outcomes" and "minimal complications" as reported in peer-reviewed medical publications. This implicitly refers to surgical observations, pathology reports (for tumor removal), and patient outcomes (healing, recurrence rates, cosmetic results).
8. Sample Size for the Training Set:
- Not applicable. The device is a physical surgical tool, not an AI algorithm that requires a training set. The "development" and "testing" are primarily engineering and bench testing, followed by clinical validation against existing practices and literature.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8).
**In summary, the provided document is a regulatory submission for a medical device that highlights: **
- Its intended use as an ultrasonic surgical aspirator for fragmentation, emulsification, and aspiration of soft and hard tissue across various surgical specialties.
- Its technological characteristics as being the same as the predicate device.
- Support for expanded indications in gynecological surgery based on a review of existing peer-reviewed clinical literature (over 500 patients across 34 articles). This literature review discusses outcomes such as reduced scarring, effective reduction of recurrence rates, successful treatment outcomes for condyloma, dissection of unresectable tumor masses with minimal complications, and effective tissue removal while preserving vessels and nerves.
- A bench study on spray patterns that showed spray could be controlled to near-zero levels.
It does not provide the specific quantitative acceptance criteria or a formal study design that would fit the typical "acceptance criteria vs. reported performance" table format, which is often seen for diagnostic or AI-driven devices. The evidence provided is more descriptive and based on the aggregation of existing clinical outcomes from published studies.
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