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The ZEOS AQUA VISION Pump is an arthroscopy pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during arthroscopy procedures.

The ZEOS AQUA VISION pump is a micro-processor controlled pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump connects via cable to various interfaces. The pump can be connected to various shaver systems.

The provided text describes the 510(k) premarket notification for the ZEOS AQUA VISION PUMP and tube, which is an arthroscopy pump system. The document focuses on demonstrating substantial equivalence to a predicate device (FMS VUE Fluid Management & Tissue Debridement System) through various non-clinical performance tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a typical performance study. Instead, it states compliance with recognized standards and guidelines as the acceptance criteria for each test category. The reported device performance is that the device meets these standards and demonstrated substantial equivalence to the predicate device.

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

The document does not specify the exact sample sizes for the test sets in any of the mentioned tests (Electrical Safety, EMC, Biocompatibility, Software, Sterilization, Bench Tests). It refers to "evaluation and testing were performed on the subject device" or "on equivalent device" and "the tubing sets."

The data provenance is from non-clinical performance tests conducted by the manufacturer (Hemodia SAS) in support of the 510(k) submission. No country of origin for the data is explicitly stated, other than the manufacturer being based in France and the correspondent in Germany, implying these are likely the origins of the testing. The studies are by nature retrospective for the purpose of this submission, as they were conducted to support a premarket notification.

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

This information is not provided in the document. The studies performed are non-clinical, primarily engineering and laboratory-based tests comparing the device to standards and a predicate. Expert consensus for ground truth is typically relevant for clinical studies, which were not required or performed for this device.

4. Adjudication method for the test set

This information is not applicable as the studies are non-clinical performance tests against established standards and predicate device characteristics, not clinical studies requiring human adjudication of outcomes.

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

This information is not provided and is not applicable. This device is an arthroscopy pump system, which assists in surgery by providing fluid management, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

This information is not applicable. The ZEOS AQUA VISION PUMP is a medical device, not an algorithm, and is intended for human-in-the-loop use during arthroscopic procedures.

7. The type of ground truth used

For the non-clinical tests:

• Electrical Safety and EMC: Ground truth is defined by the requirements of IEC 60601-1 and IEC 60601-1-2 standards.
• Biocompatibility: Ground truth is defined by the requirements of ISO 10993 series standards.
• Software Verification and Validation: Ground truth is defined by the software requirements, FDA guidance "General Principles of Software Validation," and IEC 62304 standard.
• Sterilization Validation: Ground truth is defined by the requirements of ISO 11135, ISO 14937, ISO 10993-7, ISO11607-1, and ASTM-F-1980:2002 standards.
• Bench Tests (Functional and Usability): Ground truth is defined by the functional specifications of the device, usability principles (IEC 62366-1), and the performance characteristics of the predicate device.

8. The sample size for the training set

This information is not applicable. The ZEOS AQUA VISION PUMP is a hardware medical device; it does not involve machine learning or AI models that require training sets. The software mentioned (IEC 62304) focuses on software life cycle processes and validation, not on training data for an algorithm.

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

This information is not applicable as there is no training set for a machine learning model.

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