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The Kaneka Trimotion™ Injector is indicated for insertion and placement of donor corneal tissue (diameter: ≤ 8.5 mm; thickness: 0.115-0.200 mm) into the anterior chamber of the recipient eye through a minimum 5.5 mm incision during a Descemet's Stripping with Automated Endothelial Keratoplasty (DSAEK) procedure.

The Kaneka Trimotion™ Injector is a single-use pen-shaped injector made of stainless steel and biocompatible plastics. It is used to fold, insert, and place donor corneal tissue by means of a major surgical procedure into a human eye during the Descemet's Stripping with Automated Endothelial Keratoplasty (DSAEK) procedure. Two color-coded sliding controls, called "pushers", are used to control the delivery of the donor tissue. Irrigation with intraocular irrigating solution and an air injection are applied through the device to aid in tissue delivery and placement. The system provides a tubular pathway through an incision posterior to the cornea limbus, allowing delivery of the donor tissue into the human eye.

The provided text is for a medical device (Kaneka Trimotion™ Injector) which is a physical instrument, not an AI/ML powered device. As such, it does not involve the typical AI/ML study design components such as ground truth establishment with experts, training/test sets, or comparative effectiveness studies with human readers.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to this summary.

Here's the information that can be extracted relevant to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable. This summary refers to "simulated use testing", but does not specify a sample size or data provenance in the context of an AI/ML test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth in the context of AI/ML is not relevant for this physical device.

4. Adjudication method for the test set:

• Not applicable.

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 physical injector; it does not involve human readers or AI assistance in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable.

7. The type of ground truth used:

• Not applicable. The "ground truth" for this device's performance would be successful physical operation (e.g., proper tissue insertion without damage) during simulated use.

8. The sample size for the training set:

• Not applicable.

9. How the ground truth for the training set was established:

• Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The Kaneka Trimotion™ Injector's conformance to acceptance criteria was demonstrated through two primary types of testing:

1. Biocompatibility Testing: All materials that directly or indirectly contact tissue were subjected to biocompatibility tests. The results confirmed that the device is biocompatible.
2. Simulated Use Testing: The device underwent testing in a simulated use environment to demonstrate its effectiveness for its intended purpose – the insertion and placement of donor corneal tissue in a DSAEK procedure. The results showed the device to be effective.

Additionally, the device's substantial equivalence to the predicate device (Ocular System Inc. EndoSerter™ corneal endothelium delivery instrument - K090626) served as a key component of its acceptance criteria. This was established through an analysis comparing their indications for use, operating principles, materials, fluid paths, sterility status, and single-use nature. The FDA determined the device to be substantially equivalent.

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