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The ESP Tissue Culture Plates are single-use labware intended for use in cell culturing and diagnostic laboratory procedures.

The polystyrene ESP tissue culture plates consist of a square base plate with a square lid key wayed to interlock with the base plate. The key way system keeps the lid securely on the base plate. The bottom of the base plate is recessed to allow stacking of multiple plates without the plates sliding apart. The ability to stack plates reduces space requirements during storage and incubation. The 7 cm x 7 cm square shape allows for handling ease regardless of hand size. ESP plates are sterilized using gamma irradiation.

Five configurations of ESP tissue culture plates are available. All five types of plates are identical except for the different physical configurations described below.

ESP Four Well Tissue Culture Plate: Four equally spaced wells with rounded bottoms. Each well is 3 cm in diameter and has a 5 milliliter capacity. The wells are numbered clockwise, with the numbers molded into each plate.

ESP Six Well Tissue Culture Plate: Six equally spaced wells in a circular configuration. Each well is 2 cm in diameter and has a rounded bottom with a 2.5 milliliter capacity. The wells are numbered counterclockwise, with the numbers molded into each plate.

ESP Micro Six Well Tissue Culture Plate: Six equally spaced wells in a circular configuration. Each well is 2 cm in diameter and has a rounded bottom with a 1milliliter capacity. The wells are numbered counterclockwise, with the numbers molded into each plate.

ESP Well in Well Tissue Culture Plate: A small well (2 cm diameter) within a large well (5.5 cm diameter). The two wells are separated by a vertical wall and a flat ledge.

ESP Square Tissue Culture Plate with Grid: A flat surface marked with a square grid consisting of 25 one-half inch squares. The squares are numbered 1 - 5 across the top, and A - E down the left side. The markings are molded into the bottom side of the base, leaving a smooth working surface on the top side of the base.

The provided text is a 510(k) summary for several ESP tissue culture plates. It describes the devices and compares them to a predicate device (Falcon IVF Four Well Plate). However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/ML medical device.

The document discusses the substantial equivalence of the ESP plates to the predicate device based on:

• Intended Use: Cell culturing, diagnostic lab procedures.
• Indications: Cell culturing, diagnostic lab procedures.
• Materials: Both use Polystyrene.
• Sterilization: Both are sterile (SAL 10-6).
• Pyrogenicity: Both are non-pyrogenic by LAL.
• Embryotoxicity: Both pass the mouse embryo assay (MEA). The difference in MEA (one-cell vs. two-cell) is addressed and deemed not relevant to safety and effectiveness.
• Physical Configuration: Differences in physical configurations are noted (e.g., number of wells, lid design, surface treatment), but these are stated to "not alter the safety and effectiveness of the devices."

Therefore, based on the provided text, I cannot complete the requested table and answer the specific questions about acceptance criteria and study details for an AI/ML device. The document is about physical labware, not an AI/ML algorithm.

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