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To be used by the aged or partially disabled individuals to help them rise to a standing position from a seated position.

Two Rivers Power Lift/Recline Chair

This document is a 510(k) clearance letter from the FDA for a medical device called the "Two Rivers Power Lift/Recline Chair." It explicitly states that the device is substantially equivalent to a legally marketed predicate device. This type of document, particularly older 510(k) clearances, often does not include the detailed study information, acceptance criteria, or performance metrics that are typical for more recent PMA or de novo applications, or even more rigorous 510(k)s.

Therefore, many of the requested fields cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the document's content:

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

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: Not specified in the document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not specified in the document. This type of detail is typically not included in a 510(k) clearance letter itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. For a device like a power lift/recline chair, "ground truth" and expert adjudication in the context of diagnostic performance are not relevant. Testing would likely involve engineering specifications, safety standards, and user-centric trials for functionality, none of which are detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified.

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 a mechanical device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a mechanical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. Performance would likely be assessed against engineering specifications, safety standards, and functional requirements, rather than diagnostic "ground truth."

8. The sample size for the training set

• Not applicable/Not specified. This is a mechanical device, not a machine learning model.

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

• Not applicable/Not specified.

Summary based on the document:

This document is a regulatory clearance for a physical medical device (a power lift/recline chair), not a diagnostic algorithm or AI system. Therefore, most of the requested information (related to AI performance, ground truth, expert opinions, and reader studies) does not apply or is not present in this type of regulatory correspondence. The approval is based on "substantial equivalence" to a predicate device, meaning it performs similarly and has the same intended use. The detailed testing data supporting this equivalence is typically found in the 510(k) submission itself, not in the clearance letter.

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