(59 days)
The CUSA System 200 with Soft Start, and the CUSA Lap™ Accessory are to be used during laparoscopic and thoracoscopic surgery were the fragmentation, emulsification and aspiration of soft tissue is desirable.
The CUSA System 200 is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. The CUSA Lap™ Accessory can be used only with CUSA 200 Systems equipped with Soft Start circuitry and currently available CUSA handpieces. The Accessory consists of a Laparoscopic Extended Life Tip, Laparoscopic Flue, Laparoscopic Sterilizer Case and Tray, Laparoscopic Extended Life Tip Torquing Socket wrench, and Soft Start Circuit Board with External Activation Switch. The CUSA System 200 with soft start and the CUSA Lap™ Accessory may be used with the CUSA Electrosurgical Module (CEM), which will provide electrosurgical capability. This provides the surgeon with the option of delivering cutting or coagulating current through the CUSA tip to the surgical site.
This document describes a medical device, the CUSA System 200 with Soft Start and the CUSA Lap™ Accessory, intended for use in laparoscopic and thoracoscopic surgery for tissue fragmentation, emulsification, and aspiration. However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software.
The document focuses on the mechanical and electrical safety and biocompatibility of the device hardware, not on performance metrics of a diagnostic or predictive algorithm. Therefore, I cannot provide the requested information regarding AI/ML-specific acceptance criteria and studies (points 1-9 of your request).
Here's a breakdown of what the document does provide, and why it doesn't align with your request:
Information Present (relevant to device safety/performance validation, but not AI/ML):
- Intended Use: Fragmentation, emulsification, and aspiration of soft tissue during laparoscopic and thoracoscopic surgery.
- Product Description: An ultrasonically vibrating surgical device with irrigation and aspiration, and a laparoscopic accessory.
- Safety and Performance (Hardware):
- Reliability Testing:
- Dielectric withstand (60 Hz) of the flue
- Trocar insertion/extraction capability
- Biocompatibility Testing: Patient contact materials of the CUSA handpiece and CUSA Lap™ Accessory are biocompatible, similar to legally marketed products.
- Reliability Testing:
Why this doesn't fit your request (AI/ML context):
Your request is specifically geared towards evaluating the performance of an AI/ML algorithm or software (e.g., accuracy, sensitivity, specificity, expert consensus, sample sizes for training/testing sets, MRMC studies). The provided text describes a physical surgical device and its hardware-level safety and reliability tests. There is no mention of any AI component, diagnostic output, or algorithmic performance.
To answer your questions (1-9), I would need a document that describes a study validating an AI/ML component of a medical device, including metrics like accuracy, sensitivity, specificity, and details about the data and ground truth used.
N/A