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The Culture Dish is intended to be used when culturing tissues and cells. It may be used for the use with sperm and for the culturing of embryos. The catalog number is GDEC-100. The basic design is that of a traditional culture dish. Approx 60mm round with 1½ inch sidewalls. This dish does have defined areas for the cell to be confined within. These areas are squares of picket-fenced walls, which will allow fluids, nutrients and byproducts to freely flow among the culturing cell, embryos.

AI/ML Overview

This document is a 510(k) Premarket Notification for the genX Culture Dish. It mainly focuses on demonstrating substantial equivalence to existing devices rather than providing detailed performance studies with hard acceptance criteria or specific metrics of accuracy, sensitivity, or specificity commonly found for diagnostic devices.

Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be fully answered with the provided information as the document does not contain data from such studies.

Here's an analysis of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use	"To culture tissues and cells". "May be used to hold sperm and culture embryos." (Matches predicate devices)
Design	Traditional culture dish, approx. 60mm round with 1.5 inch sidewalls, defined square areas ("picket-fenced walls") for cell confinement. (Stated as "Same design" as predicate, implying it meets their design criteria).
Materials	Configured the same for use as predicate devices. (Stated as "Same materials configured the same for use").
Procedures/Method	Performs similar procedures by method as predicate devices. (Stated as "Perform similar procedures, by method").
Performance Criteria	Same performance criteria as predicate devices. (Stated as "Same performance criteria").
Sterility Methods	Gamma Irradiated by contractor; Dosage: 2.5 Mrad; Sterility Assurance Level (SAL): 10^-6. Validation in accordance with ANSI / AAMI / ISO 11137-1994 Standards.
Sterility Release	Contractor issues a "Certificate of Sterilization".
Intended Population	Same as predicate devices. (Stated as "Same intended population").

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document does not describe a performance study with a test set. The submission focuses on demonstrating substantial equivalence based on design, materials, and intended use, rather than presenting clinical or laboratory performance data from a specific test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

Not applicable. No adjudicated test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is not mentioned as the device is not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a culture dish, not a digital algorithm or AI.

7. Type of Ground Truth Used

Not applicable. The submission for this type of device (culture dish) relies on demonstrating equivalency to already marketed devices, not on proving diagnostic accuracy against a specific ground truth. The "ground truth" in this context would be the successful and safe use of existing, predicate culture dishes.

8. Sample Size for the Training Set

Not applicable. As a physical medical device (culture dish), there is no 'training set' in the context of machine learning or algorithms. The design and manufacturing process would involve validation and verification, but not in the same way as an AI system.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

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