(90 days)
The CUSA EXcel Ultrasonic Surgical Aspirator System is intended for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery The system may also be combined with electrosurgery using the optional CUSA Electrosurgical Module (CEM).
The CUSA EXcel Ultrasonic Surgical Aspirator System 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 tissues while preserving vessels, ducts and other delicate structures. The CUSA EXcel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy to the surgical site, a titanium handpiece tip and 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 be used with an external CUSA Electrosurgical Module (CEM), which will provide optional electrosurgical capability. The CEM module is a Force FX-8 Generator (FDA clearance was received for the Force FX Generator under K#944602). This provides the surgeon with the option of delivering cutting or coagulating current through the CUSA handpiece tip to the surgical site. The CEM function is controlled either with the Force FX-8 footswitch or by hand, using the CEM nosecone control button(s).
The provided text is a summary of safety and effectiveness information for the CUSA EXcel Ultrasonic Surgical Aspirator System, a medical device. It does not describe a study involving patient data, expert readers, or AI.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as they pertain to clinical or AI-based performance studies which are not detailed here.
The document focuses on:
- Product Description: Explaining what the device is and its features.
- Intended Use: Listing the surgical procedures for which the device is intended.
- Safety and Performance Data: Stating compliance with various electrical and biocompatibility standards. It mentions "Validation and verification... will be accomplished through a combination of analysis and testing," including a "Risk Analysis and an electro/mechanical performance test on prototype units." It also states, "Testing has verified the safe performance and proper function of the product."
- Substantial Equivalence: Comparing the device to previously marketed predicate devices.
- FDA Clearance Letter: Confirming the device's substantial equivalence and clearance for marketing.
Here is what can be extracted based on the provided text:
Acceptance Criteria and Reported Device Performance
The document describes compliance with recognized standards rather than specific quantitative performance metrics against clinical acceptance criteria.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | - IEC 601-1 (1988), Medical Electrical Equipment Part 1: General Requirements for Safety |
- IEC 601-2-2 (1991), Medical Electrical Equipment Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment
- EN 60601-1-2 (1993) Medical Electrical Equipment, Part 1 General Requirements for Safety, 2 Collateral Standard: Electromagnetic Compatibility-requirements and Tests
- IEC 801-3 (1984), Radiated Electromagnetic Field Requirements
- CISPR11, Electromagnetic Compatibility for Industrial-process Measurement and Control Equipment: Emissions Requirements | The CUSA EXcel System has been designed to conform with these applicable standards. "Testing has verified the safe performance and proper function of the product." |
| Biocompatibility | - ISO Standard 10993-1, Biological Evaluation of Medical Devices, Part 1 - Guidance on Selection of Tests, Device Category "External Communicating Device, Blood Path Indirect, contact duration A" | Materials unique to the CUSA EXcel System are "currently undergoing testing in accordance with ISO Standard 10993-1." (Note: The claim of meeting the standard is based on selected materials and ongoing testing for new materials, rather than a final comprehensive report for this specific submission). |
| Functional Performance | - Electro-mechanical performance. | "Validation and verification... will be accomplished through a combination of analysis and testing. This process will include a Risk Analysis and an electro/mechanical performance test on prototype units. The safe performance and proper function of the hardware and external controls of the CUSA EXcel Console will be tested... The CUSA EXcel Handpiece and accessories will also be tested, both alone and in conjunction with the Console." "Testing has verified the safe performance and proper function of the product." |
Study Details (Based on available information)
- Sample size used for the test set and the data provenance: Not applicable. The document discusses device testing against standards and substantial equivalence, not a clinical study involving a "test set" of patient data. Testing was performed on "prototype units" and the "CUSA EXcel Handpiece and accessories."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical "test set" with ground truth established by experts is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is an ultrasonic surgical aspirator, not an AI or imaging diagnostic device, and no MRMC study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm or AI component is described. The "standalone" performance here refers to the device's functional and safety performance, which was verified through engineering tests.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. The "ground truth" for the device's safety and performance was compliance with established engineering and biocompatibility standards, and functional testing on prototype units.
- The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance of a medical device based on compliance with established safety standards and substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic or prognostic performance with a patient cohort.
N/A