Search Results

The intended use of the Dalton Lift Chair, Model LC-106 is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.

The Dalton Lift Chair, Model LC-106 is intended to provide lift assistance for persons who have difficulty rising from a seated position to a standing position. It uses standard AC power from an electrical outlet. The device is mainly made of a welded steel frame, upholstery fabric and foam. The chair is assembled to welded steel lifting frame mechanism having a 24V DC motor/actuator powered by AC power from an electrical outlet. A hand-held control device engages the actuator to position the chair to recline, sitting, or standing position.

This document is a 510(k) Summary for the Dalton Lift Chair, Model LC-106. It details the device's characteristics and its substantial equivalence to a predicate device, rather than presenting a study to prove the device meets acceptance criteria. No information about acceptance criteria or specific study results is provided beyond non-clinical testing.

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

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

The document does not explicitly state "acceptance criteria" for the device's performance. Instead, it lists the device's technical specifications and compares them to a predicate device to establish substantial equivalence.

The non-clinical testing for the Dalton Lift Chair LC-106 included:

• IEC 60601-1:1988/A1:1991/A2:1995 for basic safety: "All tests were completed successfully."
• IEC 60601-1-2 for Electromagnetic Compatibility: "All tests were completed successfully."
• California Technical Bulletin No. 117: Test Procedure and Apparatus for Testing the Flame Retardance of Resilient Filling Materials Used in Upholstered Furniture: Tests were conducted. (Implied successful, as it contributes to the conclusion of substantial equivalence).
• Biocompatibility (Upholstery Fabric): Evaluated for Cytotoxicity per ISO 10993-5 and for Skin Irritation and Dermal Sensitization per ISO 10993-10. (Implied successful).

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

This information is not applicable as no clinical test set or data relevant to a diagnostic performance study was conducted. The evaluation was based on non-clinical testing and comparison to a predicate device.

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)

This information is not applicable as no clinical test set requiring expert-established ground truth was performed.

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

This information is not applicable as no clinical test set requiring adjudication was performed.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a mechanical lift chair, not an AI-assisted diagnostic tool.

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

A standalone performance evaluation in the context of an algorithm or AI was not performed. This is a mechanical device.

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

For the non-clinical testing, the "ground truth" would be the specifications and requirements defined by the relevant standards (e.g., IEC 60601-1, IEC 60601-1-2, California Technical Bulletin No. 117, ISO 10993). The device's performance was compared against these standard requirements.

8. The sample size for the training set

This information is not applicable. There is no mention of a training set as this is a mechanical device, not an AI or algorithm-based system that requires machine learning training.

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

This information is not applicable as there was no training set.

Ask a specific question about this device