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The FLOSIMPLE Arthroscopy Pump A120 is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.

The FLOSIMPLE Arthroscopy Pump A120 (the “A120”) is a microprocessor controlled single roller pump, which functions according to the peristaltic system. The device incorporates the following major components and features: a casing, a world power supply, a rechargeable battery pack, a touch screen display. The A120 is to be mounted on a roller-wheel stand and is to be used with a specially designed cartridge tube set and with an optional remote control. The A120 performs a continuous pressure measurement to ensure that the actual pressure in the joint cavity complies with the pre-set nominal pressure. In addition, a software controlled active pressure reduction mechanism is activated if the actual pressure measured in the joint cavity exceeds the preset nominal pressure value. The device is also designed with several alarms to inform the operator in case of an overpressure.

The provided text is a 510(k) summary for a medical device called the FLOSIMPLE Arthroscopy Pump A120. It details the device's function, intended use, and argues for its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI or machine learning performance metrics.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the document.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no mention of a ground truth or expert review for performance testing in the context of AI.
• Adjudication method: Not applicable.
• 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, as this is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety profiles, rather than presenting a performance study against specific acceptance criteria in the way one would for a new diagnostic algorithm.

The key points of the submission are:

• Device Name: FLOSIMPLE Arthroscopy Pump A120
• Intended Use: To provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle, and wrist joint cavities during diagnostic and operative arthroscopic procedures.
• Predicate Devices: Arthroscopy Pump A107 (K030402), Arthro-Surgimat-A103 (K000153), Arthro-Surgimat-1500 (K983910), Lap-Wave 3000 (K990732).
• Argument for Substantial Equivalence: The A120 shares the same intended use and fundamental function (peristaltic system) with its predicates. Technological differences are described as minor (e.g., casing modification, new cartridge, preselectable pressure/flow levels, rechargeable battery, touch screen, single roller pump, single pressure sensor vs. redundant) and are argued not to raise new questions of safety and effectiveness.

In summary, this document is a regulatory submission for a physical medical device (an arthroscopy pump), not an AI/ML-driven diagnostic or assistive device. Therefore, the questions related to AI performance metrics, sample sizes for training/test sets, ground truth establishment, and multi-reader studies are not applicable to the content provided.

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