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This wheelchair provides mobility to non-ambulatory persons. The device is used primarily for transferring individuals into a swimming pool via a ramp.

The MAC-Mobile Aquatic Chair features a rigid frame design and is suitable to provide mobility both indoors and in wet conditions. Primarily designed to assist non-ambulatory users to gain entry to a swimming pool via a ramp, the Aquatic Wheelchair features anti-tip wheels that are built into the design. The MAC-Mobile Aquatic Chair is fabricated from stainless steel that is coated with a tough powder coated finish. The wheels and casters are made from a water friendly plastic material. The rigid plastic seat is specifically designed for use in an aquatic environment. The entire product can be submersed into pool water with no harmful effects. The User's Manual provides information on warnings, maintenance, and operating instructions.

The provided text describes a 510(k) premarket notification for a mechanical wheelchair, the "MAC-Mobile Aquatic Chair," and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically expected for performance-based medical devices (e.g., AI algorithms, diagnostic tools).

Instead, this document focuses on establishing substantial equivalence for a Class I mechanical wheelchair, which is a different type of regulatory pathway. For such devices, acceptance criteria often relate to design specifications, material properties, and functional safety, rather than performance metrics like sensitivity or specificity.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document asserts substantial equivalence to the predicate device (Stainless Steel Aquatic Wheelchair, K031910). This means the device is considered to meet the same safety and effectiveness standards as the predicate, rather than presenting novel performance data against specific, quantitative acceptance criteria.

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

Not applicable in this context. The 510(k) summary does not describe a clinical performance study with a test set of patients or data. The "test" for this type of device is typically a comparison to a legally marketed predicate device, focusing on design, materials, and intended use, rather than a statistical evaluation of patient outcomes.

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

Not applicable. There is no "test set" in the sense of patient data requiring expert ground truth establishment.

4. Adjudication Method:

Not applicable. There is no adjudication method described as no expert review of patient data is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is not relevant for a mechanical wheelchair.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This concept is not applicable to a mechanical wheelchair.

7. Type of Ground Truth Used:

Not applicable. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate device (K031910), against which the new device demonstrates substantial equivalence based on design and intended use.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" as it's a mechanical device, not an AI or diagnostic algorithm.

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

Not applicable.

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