(118 days)
It is indicated for use in laparoscopic surgical procedures where fragmentation, emulsification, and aspiration of soft is desirable.
The Sharplan Ultra Model 4300 Ultrasonic Aspirator System is a surgical tool which achieves fragmentation and excision of unwanted tissue by high frequency vibration of the titanium tip housed in the handpiece. The application of the vibration tip to the unwanted tissue results in the rupture of the tissue. Irrigation and aspiration of the debris is also accomplished by the system. There accessories to the system are various handpieces, one of which can be used in laparoscopy.
This 510(k) summary does not contain the information required to populate the table and answer the questions regarding acceptance criteria and study details. The document primarily focuses on establishing substantial equivalence to predicate devices based on technological and functional similarities, particularly the modification of the probe length for laparoscopic use.
It explicitly states: "Based upon a comparison of the performance characteristics of the devices, no significant differences exist. In regards to safety or effectiveness of the Sharplan Ultra Model 4300 Ultrasonic Aspirator System for Laparoscopic Use, Sharplan Lasers, Inc. believes that this modification and expanded indication does not change the performance characteristics of the device and raises no concerns."
This indicates that an effectiveness study with specific acceptance criteria and performance metrics, as would be conducted for a novel device or a device with new performance claims, was not performed or at least not described in this summary. The substantial equivalence argument relies on the predicate devices' established safety and effectiveness.
Therefore, I cannot provide a table of acceptance criteria and reported performance, nor can I answer questions related to sample size, ground truth, expert involvement, or specific study methodologies from the provided text.
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