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The VitreQ CryoTreQ is indicated for use in ophthalmic surgery for retinal detachment, cyclodestructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryodestruction of lash follicles for trichiasis and the treatment of retinopathy of prematurity (ROP).

The VitreQ CryoTreQ is a disposable, handheld instrument intended for use in ophthalmic cryotherapy. The device tip is made of stainless steel. The device utilizes a pressurized cryogen which is circulated to the tip. The cryogenic material remains enclosed within the tip during application, serving to cool the metal tip during therapy. Rapid gas expansion in the tip causes freezing to the Joule-Thompson principle.

The provided text describes the safety and effectiveness of the CryoTreQ device. The device is a disposable, handheld instrument for ophthalmic cryotherapy.

Based on the provided information, the following answers can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Pre-specified criteria were met" for non-clinical freeze and defrost testing. However, specific numerical acceptance criteria and precise performance values are not provided in a table format. The text only indicates the types of tests performed and a general conclusion that the device performed "as well as the identified legally marketed devices."

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

The document mentions "Testing performed on CryoTreQ devices" but does not specify the sample size for any of the non-clinical tests.

The data provenance is non-clinical laboratory testing conducted to evaluate the device's performance, safety, and functionality. There is no information regarding the country of origin of this testing or whether it involved retrospective or prospective data collection from human subjects, as no clinical studies were performed.

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

This information is not provided. As no clinical studies were performed, there was no ground truth based on expert medical opinion needed for the test set. The ground truth for the non-clinical tests would be defined by engineering specifications and standards.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. Since no clinical studies were performed and the testing was non-clinical, there would be no expert adjudication process for image interpretation or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted to compare human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The device described is a physical medical instrument (cryophthalmic unit), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The device's performance was evaluated through non-clinical laboratory tests as a physical medical device.

7. The Type of Ground Truth Used:

The ground truth used was based on engineering specifications, pre-specified criteria, and direct physical measurements for the non-clinical performance tests (e.g., external temperature achieved, ice ball formation, defrost duration, dimensional analyses). It was not based on expert consensus, pathology, or outcomes data, as no clinical studies were conducted.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of AI development.

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

Not applicable. As the device is not an AI/ML model, there is no training set or ground truth establishment method for one.

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