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General surgical fluids, exudate, soft tissue, and general tissue removal from surgical sites.

General aspirator(s), which use an electrically (AC) driven vacuum pump generating a negative pressure for evacuating surgical waste. The Psi-Tec Aspirator 2 also has the capability to capture the waste air "exhaust" (that creates the negative pressure) in an enclosed container. This now, contained and pressurized air, can then be utilized for driving other devices requiring the use of pressurized air.

This document is a 510(k) summary for a medical device called the "Psi-Tec Aspirator," submitted by Byron Medical, Inc. The purpose of a 510(k) summary is to demonstrate substantial equivalence to legally marketed predicate devices, not to provide detailed performance study results against specific acceptance criteria.

Therefore, the provided text does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or direct performance results.

The document primarily focuses on:

• Identification of the device: Psi-Tec Aspirator
• Manufacturer information: Byron Medical, Inc.
• Classification: Aspirator, Apparatus, Suction, Ward Use and Aspirator, Apparatus, Suction, Operating Room, Wall Vacuum Powered (Class II)
• Intended Use/Indications for Use: General surgical fluids, exudate, soft tissue, and general tissue removal from surgical sites.
• Device Description: Electrically (AC) driven vacuum pump generating negative pressure for evacuating surgical waste, with the Psi-Tec Aspirator 2 also capturing and pressurizing exhaust air for other devices.
• Substantial Equivalence Claim: Lists several predicate devices (General Aspirator by Kolster Methods, Grams Aspirator by Grams Medical, Aspirator and Aspirator II by Wells Johnson Company, General Aspirator by Mentor Corporation) to which the Psi-Tec Aspirator is claimed to be substantially equivalent.
• Approval Letter: A letter from the FDA indicating that the device is substantially equivalent and can be marketed.

In summary, none of the requested information regarding acceptance criteria or the specific study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance) is present in the provided text. The 510(k) process for this type of device typically relies on demonstrating equivalence to predicate devices, often through performance testing that shows similar functional characteristics, rather than establishing de novo acceptance criteria and conducting extensive clinical efficacy trials with detailed statistical reporting as would be expected for a novel device or a device requiring de novo authorization.

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