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510(k) Data Aggregation
(127 days)
The PassPort® Optical Trocar is an access device that may be used with or without visualization that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Vortex Seal functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Blunt Tip Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Shielded Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Cannula Anchor functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The Candidate Devices are a single patient device to be utilized as an access port.
The provided text is a 510(k) summary for several surgical trocar devices. It does not contain information about acceptance criteria or a study proving the device meets said criteria. The document focuses on establishing substantial equivalence to previously cleared predicate devices through device description and indications for use.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study information
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
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(367 days)
Patton Surgical PolarCoat is a single patient use device which is intended for use on electrodes to reduce sticking.
The Candidate Device is a yellow-brown substance, Lecithin with soy protein removed. The Candidate Device is a single patient device, available on sponge or in bottle, to be used on electrodes to reduce sticking. The Candidate Device is sterilized by the Irradiation method and packaged individually within a shipper container of 20 units per container.
The provided text is a 510(k) summary for the Patton Surgical PolarCoat, a device intended to reduce sticking on electrosurgical electrodes. It is a submission for substantial equivalence to a predicate device, not a study evaluating acceptance criteria for a new AI/Software as a Medical Device (SaMD).
Therefore, the information requested in the prompt, such as acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth definitions, are not present in the provided document.
This document describes a medical device (a coating for electrosurgical electrodes) seeking 510(k) clearance based on substantial equivalence to an existing device (Mectra Labs, Inc.'s Electro-Lube). The 510(k) process for this type of device does not typically involve the kind of performance studies, particularly those related to AI/SaMD, that would generate the information you've requested.
In summary, the provided document does not contain the information necessary to complete the table and answer the questions regarding acceptance criteria and study details for an AI/SaMD.
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