(136 days)
The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable. The CUSA Excel+ Ultrasonic Surgical Aspirator is indicated for use in:
Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic 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
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), 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 is a 510(k) summary for the CUSA® Excel+ Ultrasonic Surgical Aspirator System. It details the device, its indications for use, and how its substantial equivalence to a predicate device was established.
However, the document states that no non-clinical testing was required as the device itself was not modified. Instead, the justification for expanded indications for use for Gastrointestinal (GI) and Affiliated Organ, Urologic, General, and Laparoscopic surgeries relies entirely on peer-reviewed journal articles summarizing existing clinical evidence.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a specific study designed to prove the device meets pre-defined acceptance criteria in the way typically expected for a new or modified device requiring such testing. The document explicitly states that the device itself was not modified, and the assessment is based on a literature review.
Here's what can be extracted and inferred based on your request categories:
1. A table of acceptance criteria and the reported device performance
This information is not available from the provided text in the traditional sense of a specific study with predefined acceptance criteria. The document relies on a review of existing literature to demonstrate that the CUSA Excel+ (and its predicate) is "safe and effective" and "successful" in various surgical procedures, which serves as the "performance" data.
However, based on the conclusions from the literature review, the implied performance characteristics that were deemed acceptable include:
| Acceptance Criterion (Inferred from Literature Review) | Reported Device Performance (Summary from Literature Review) |
|---|---|
| Safety (General) | No significant issues of safety identified in specific case reports; no adverse events reported in urologic cases. The overall literature demonstrated safe use. |
| Effectiveness (Tissue Fragmentation/Emulsification/Aspiration) | Successfully fragments, emulsifies, and removes unwanted soft and hard tissue. |
| Selectivity (Preservation of surrounding structures) | Allows selective dissection of target tissue while preserving vessels, ducts, and other delicate structures. In renal cases, allows selective aspiration of parenchyma while leaving blood vessels and collecting systems intact. Able to dissect tissues while preserving main structures in laparoscopic procedures. |
| Morbidity Reduction (Laparoscopic procedures) | In laparoscopic liver resection, shown to decrease morbidity, shorten hospital stay, improve cosmesis, and decrease blood loss. ----------- |
| Blood Loss Reduction | Reduced blood loss due to selectivity in renal surgery. Over 150 laparoscopic hepatectomy procedures concluded that use of CUSA led to successful surgical outcomes and reduced blood loss. Advantages in laparoscopic surgery include less blood loss. |
| Increased Visibility | In renal cases, found to result in increased visibility for surgeons. |
| Reduced Operating Time | In renal cases, found to result in reduced operating time. |
| Complications | A single complication observed in laparoscopic cholecystectomies: a thermal pinhole burn leading to bile leakage in one case. Otherwise, generally positive safety reporting. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The "test set" in this case is the cumulative data reviewed across numerous peer-reviewed journal articles.
- Gastrointestinal and Affiliated Organ Surgery: Approximately 2,500 cases reported across 34 articles (focused on open hepatectomy and laparoscopic-assisted liver resection).
- Urologic Surgery: 8 urologic resection cases and 71 cases of nipple valve formation (total 79 cases) reported across 6 articles.
- General Surgery: 10 patients (carcinoma of the tongue) and 5 cases (PCSTP in children).
- Laparoscopic Surgery: 131 laparoscopic cholecystectomies, 9 laparoscopic appendectomies, 3 laparoscopic colon resections, 2 laparoscopic partial gastrectomies, 6 laparoscopic esophagectomies, and over 150 laparoscopic hepatectomy procedures.
- Data Provenance: The data comes from peer-reviewed journal articles. The specific countries of origin are not mentioned in this summary, but such articles typically reflect global clinical practice. The nature of published journal articles means this is overwhelmingly retrospective observational data, summarizing past surgical outcomes.
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 concept of "experts establishing ground truth for a test set" does not directly apply here. The "ground truth" is implied to be the clinical outcomes and observations reported by the surgeon-authors and clinicians in numerous peer-reviewed studies. These clinicians would be the "experts," performing the procedures and reporting on safety and effectiveness. The summary does not quantify the number of individual experts or their specific qualifications beyond being authors of peer-reviewed articles on surgical procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
There was no formal adjudication method as part of a single, controlled test set. The "adjudication" is inherent in the peer-review process of the scientific articles themselves. Each article would have undergone peer review by other experts in the field, and the collective body of evidence across multiple articles provides a form of consensus.
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, an MRMC comparative effectiveness study was not done, and this device is not an AI-assisted diagnostic or interpretative tool. It is a surgical aspirator. The clinical evidence reviewed focuses on the device's performance in surgical procedures, not on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance without human input. Since the CUSA Excel+ is a surgical device operated by a surgeon, this question is not applicable. The device inherently requires a human-in-the-loop for its operation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" is primarily based on clinical outcomes data (e.g., successful tissue removal, reduced blood loss, reduced operating time, decreased morbidity, absence of adverse events, preservation of structures) as reported by expert surgeons in peer-reviewed literature. This relies on the expert judgment and observations of the clinicians performing the surgeries.
8. The sample size for the training set
Not Applicable. As no new non-clinical or clinical testing was conducted for the purpose of this 510(k) (because the device was not modified), there was no "training set" in the context of developing or optimizing a new medical device or algorithm. The review simply aggregated existing clinical data.
9. How the ground truth for the training set was established
Not Applicable for the same reasons as #8.
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