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To assist persons who have difficulty rising from a seated position to a standing position.

The Winco Models Power Series Lift Chairs are electro mechanical devices designed for use in the home or a health care setting. Their intended function and use is to raise persons from a seated position to a standing position. They are designed for use by elderly or physically challenged individuals who have difficulty rising to a standing position, when seated.

The Winco Series Lift Chairs consist of two models; the model 696 lift chair and the model 905 lift chair. The model 696 chair is the standard version and is designed to accommodate most users. It is smaller and lighter than the model 905 chair, and has a maximum weight capacity of 300 lbs. The model 905 lift chair is designed for bariatric users. It is wider than the standard 696 chair and has a maximum weight capacity of 600 lbs.

The provided text describes a medical device, the Winco Model Power Series Lift Chair, and its 510(k) premarket notification. However, it does not contain the level of detail typically found in reports for AI/ML-driven diagnostic devices, which would include specific acceptance criteria, performance metrics, and detailed study methodologies.

Based on the provided text, the device is a physical medical device (a lift chair), not a diagnostic AI/ML system. Therefore, many of the requested categories (like number of experts, adjudication method, AI assistance, ground truth for training set, etc.) are not applicable to this type of device and are not present in the document.

Here’s an attempt to answer the questions based only on the provided text, highlighting where information is missing or not applicable:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified in the document. The testing mentioned appears to be for structural and material properties, not a clinical trial with a patient test set.
• Data Provenance: Not applicable in the context of clinical data. The tests refer to compliance with standards (IEC 60601-1, CAL 117).

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

• Not Applicable. This is a physical device, and the "ground truth" relates to engineering and material safety standards, not diagnostic interpretations by medical experts.

4. Adjudication method for the test set

• Not Applicable. As above, this is for a physical device, not an AI/ML diagnostic system. No adjudication of expert opinions is mentioned.

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

• Not Applicable. This is not an AI-assisted diagnostic device. No human reader studies with AI assistance were performed.

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

• Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" refers to established engineering and safety standards (IEC 60601-1 for electrical safety, CAL 117 for flame retardancy) and the physical specifications/capabilities of the chair (e.g., weight capacity).

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/ML system requiring a training set.

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

• Not Applicable. As above, no training set for an AI/ML system is involved.

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