(243 days)
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.
| Characteristic / Feature | Subject Device (Dalton Lift Chair, Model LC-106) | Predicate Device (Lift Chair, Model C5) |
|---|---|---|
| Maximum Duty Cycle | 2 min ON / 18 min OFF | 2 min ON / 18 min OFF |
| Power Requirements | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz |
| Operating Temperature | 10°C (50°F) to 40°C (104°F) | 10°C (50°F) to 40°C (104°F) |
| Weight Capacity | 235 lbs (107 kg) | 325 lbs (147 kg) |
| Weight of Lift Chair | 133 lbs | 133 lbs |
| Maximum Tilt Angle | 45 Degree | Not Specified |
| Seat Height | 19" (483 mm) | 18" (457 mm) |
| Seat Width | 20" (508 mm) | 19" (483 mm) |
| Seat Depth | 20" (508 mm) | 20" (508 mm) |
| Overall Width | 33" (838 mm) | 32.75" (832 mm) |
| Overall Height | 43" (1092 mm) | Not specified |
| Arm Height | 25.6" (650 mm) | Not specified |
| Overall Reclined Depth | 69" (1753 mm) | Not specified |
| Overall Upright Depth | 34.6" (879 mm) | Not specified |
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.
§ 890.3110 Electric positioning chair.
(a)
Identification. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.(b)
Classification. Class II. The electric positioning chair is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable;
(9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and
(10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.