(30 days)
The CUSA® Excel+ Ultrasonic 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 tumors 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 tumors 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 or perianal 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 and aspiration, 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), 18 titanium hand piece tips (variety of models), a flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA Excel+ system accommodates most commercially available suction canisters, and specimen traps (optional). A two-pedal footswitch is provided with the console. The CUSA Excel+ System may also be used with an external CUSA Electrosurgical Module (CEM), which provides optional electrosurgical capability.
This document is a 510(k) submission for a change to the labeling of the CUSA Excel+ Ultrasonic Surgical Aspirator System, specifically the removal of a debulking contraindication. It is not a submission for a new device requiring extensive performance testing against acceptance criteria for its primary function. Therefore, the information typically requested for such a device (like sensitivity, specificity, F1 score, etc.) and a full comparative study with human readers or a standalone AI algorithm is not provided.
However, based on the provided text, we can extract details regarding the study that justifies the labeling change, which acts as the 'proof' for meeting the modified 'acceptance criteria' (i.e., that the device remains safe and effective without the contraindication).
Acceptance Criteria and Reported Device Performance for the Labeling Change
The "acceptance criteria" here is implicitly that the device remains safe and effective for its indicated uses (including debulking) without the previously stated contraindication regarding the dissemination of malignant cells, and that the removal of this contraindication does not negatively impact the risk profile of the device.
| Acceptance Criterion (Implicit for Label Change) | Reported Device Performance (from the study presented) |
|---|---|
| Device remains safe and effective for indicated uses (including debulking) without the specific debulking contraindication. | Conclusion: "benefits of using CUSA for the removal of unwanted tissue in surgery outweighs the risks of disseminating malignant cells." |
| Removal of the contraindication does not affect the risk profile. | Conclusion: "It was also concluded that the debulking contraindication does not improve the risk-benefit profile of the device; therefore, the removal of the debulking contraindication would not affect the safety and effectiveness of the device nor alter its performance or function when compared to the predicate." |
| No causal relationship between CUSA use and dissemination of malignant cells. | Conclusion: "The review and analysis of this information did not identify a causal relationship between CUSA use and risks associated with dissemination of malignant cells." |
Study Information (Supporting the Labeling Change)
The study justifying the removal of the debulking contraindication is a risk-benefit analysis.
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Sample size used for the test set and the data provenance:
- Test Set (Data Sources): The risk-benefit analysis included:
- Results from a previous bench study (K150682) assessing "misting."
- Clinical literature review.
- Post-market surveillance information relating to the use of the CUSA Excel+.
- A risk assessment.
- Clinical perspective.
- Data Provenance: The document does not specify the country of origin of the clinical literature or post-market surveillance data. It suggests the data is a retrospective aggregation of existing information (clinical literature, post-market surveillance).
- Test Set (Data Sources): The risk-benefit analysis included:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions a "clinical perspective" as part of the risk-benefit analysis. However, it does not explicitly state the number or specific qualifications (e.g., "radiologist with 10 years of experience") of experts involved in providing this perspective or establishing ground truth for the risk-benefit analysis.
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Adjudication method for the test set:
- Not applicable in the context of a risk-benefit analysis based on literature review and post-market data. There is no mention of an adjudication process for conflicting expert opinions or data points. The "clinical perspective" likely informed the interpretation.
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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 type of study (MRMC) is not relevant to this submission, which concerns a surgical device and a labeling change based on a risk-benefit analysis, not an AI diagnostic algorithm.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not applicable as the device is a surgical tool, not an AI algorithm.
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The type of ground truth used:
- The "ground truth" for the risk-benefit analysis was based on expert consensus (implied through "clinical perspective" and risk assessment), aggregated evidence from clinical literature, and real-world performance data from post-market surveillance. For the bench study, the ground truth was direct measurement of spray/misting.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set. The data used was for analysis, not for training a model.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or required for this type of submission.
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