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For the delivery of forced humidified air or fluid during ophthalmic surgery.

The Peregrine Wet Set is an 8' tubing set designed to deliver humidified air or fluid into the eye during ophthalmic surgery. It consists of the following: An 8' PVC tube running from an air supply unit to a three channel IV spike for insertion into a bottle of Balanced Salt Solution. The three way spike is designed to inject the air from the air supply unit through the solution, while at the same time deliver humidified air and saline through a dual PVC tube. The dual PVC tube is designed to transport the humidified air in one side and the saline in the other. The dual PVC tube attaches at the other end to a three way stopcock.

The provided text is a 510(k) Premarket Notification Summary for the Peregrine Wet Set, an air/fluid tubing set for ophthalmic surgery. This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, performance studies, or clinical trial data as would typically be found for a device requiring such evidence for approval.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and reader performance cannot be extracted from this document.

However, based on the provided text, here is what can be inferred or stated:

1. A table of acceptance criteria and the reported device performance:
   The document does not explicitly list acceptance criteria as quantitative thresholds for performance. Instead, it relies on a "Substantial Equivalence Comparison" table to show that the Peregrine Wet Set has similar features to two predicate devices (GRIESHABER GLOBAL CONTROL and ALCON VGFI TUBING SET). The "reported device performance" is implicitly that the device functions comparably to these predicate devices based on its design features.

   FEATURES	GRIESHABER GLOBAL CONTROL (Predicate)	ALCON VGFI TUBING SET (Predicate)	PEREGRINE WET SET (Device)
   Number of channels in drip chamber spike	2	2	3
   Pressurized air enters bottle	/INTO FLUID	/INTO AIR SPACE	/INTO FLUID
   Pressurized air to stopcock delivered from	AIR SYSTEM	AIR SYSTEM	BOTTLE
   Fluid Source	BOTTLE	BOTTLE	BOTTLE
   Air system required	YES	YES	YES
   Bottle hung at eye level	YES	YES	YES
   Bottle pressurized by air system	YES	YES	YES
   Delivery line for fluid to stopcock	YES	YES	YES
   Delivery line for air to stopcock	YES	YES	YES
   3-way stopcock for air/fluid selection	YES	YES	YES
   Filter at air line attachment to system	YES	YES	YES
   Extension tube into bottle air space	NO	YES	YES

   The key "acceptance criteria" here appear to be demonstrating that the Peregrine Wet Set possesses the functional characteristics necessary for its intended use, a fact supported by its design being largely analogous to legally marketed predicate devices, with some minor differences noted (e.g., 3 channels vs. 2, and the source of pressurized air to the stopcock). For sterility, the acceptance criterion is that it is ETO sterilized, with validation using the AAMI Overkill Method.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   The document does not describe a clinical performance study with a test set. This device is a tubing set, and its approval appears to be based on substantial equivalence to existing devices and verification of sterility, rather than performance in a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
   Not applicable, as no clinical performance test set or ground truth establishment by experts is described for this type of device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as no clinical performance test set or adjudication process is described.

5. 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 a simple tubing set used for delivering air or fluid, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as no clinical performance study requiring ground truth is described. The relevant "truths" for this submission are the device's physical features, materials, and sterilization efficacy, which are evaluated against established standards and predicate devices.

8. The sample size for the training set:
   Not applicable. There is no training set mentioned for this device, as it is not an AI/machine learning device.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set.

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