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The Infiniti® Vision System with OZil® IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectomy, and bipolar coagulation.

The Infinitie Vision System with OZit® IP is an enhanced version of the Infinitie Vision System (K021566) that is modular in design and incorporates both the QZile IP feature and the Infiniti® UltraVit" Vitrectomy Probe and its associated software.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Infiniti® Vision System with OZil® IP.

Unfortunately, the provided text does not contain a study that proves the device meets specific performance acceptance criteria in terms of clinical effectiveness or comparison to human performance (AI vs. human).

The document is a 510(k) summary for a medical device seeking substantial equivalence to already marketed devices. The focus is primarily on safety, compliance with standards, and technological similarities to predicates, rather than a clinical performance study with defined acceptance criteria and statistical analysis.

However, I can extract information related to the device's safety and compliance acceptance criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a clinical performance study with a "test set" in the context of AI or diagnostic performance. The "tests" mentioned are primarily non-clinical engineering and biocompatibility evaluations, following established standards. Therefore, concepts like sample size for a test set or data provenance (country of origin, retrospective/prospective) are not applicable to the information provided.

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

This information is not provided because, as noted above, there's no mention of a human-centric performance test set requiring expert ground truth establishment for diagnostic or treatment outcomes.

4. Adjudication Method for the Test Set

Not applicable, as no such test set or expert ground truth is described.

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

No, an MRMC comparative effectiveness study is not mentioned in the provided document. The device submission focuses on safety, standard compliance, and substantial equivalence to predicate devices, without presenting data on human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an AI algorithm but a surgical system. Therefore, a "standalone algorithm performance" study is not applicable. The device's performance is inherently tied to its operation by a human surgeon. The "functional requirements" are met by the system itself and its components.

7. The Type of Ground Truth Used

For the safety, biocompatibility, and functional evaluations, the "ground truth" used is adherence to established national and international standards (IEC, ISO, AAMI, ANSI, 21 CFR) and successful execution of engineering tests. This is not "expert consensus, pathology, or outcomes data" in a typical clinical study sense, but rather compliance with engineering and manufacturing best practices.

8. The Sample Size for the Training Set

Not applicable. The device is a surgical system, not an AI algorithm that undergoes "training."

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

Not applicable, as no training set for an AI algorithm is involved.

Summary of the document's content regarding acceptance criteria and studies:

The provided 510(k) summary for the Infiniti® Vision System with OZil® IP outlines the device's compliance with a comprehensive set of safety standards (electrical, electromagnetic compatibility, software safety, high-frequency surgical equipment safety), biocompatibility standards for materials in contact with the patient, sterilization validation standards, and adherence to quality system regulations (21 CFR 820) and risk management standards (ISO 14971:2003). The acceptance criteria for these aspects are the successful demonstration of compliance with each listed standard. The study demonstrating this is described as "Non-clinical testing" which "has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate device." This documentation is part of a submission for substantial equivalence to existing legally marketed devices, establishing that the new device is as safe and effective as its predecessors based on technological characteristics and adherence to established regulatory and engineering norms. It does not include clinical performance studies, AI-specific evaluations, or human-in-the-loop performance metrics.

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