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My product is constructed of the same materials, as that of all the lift chair manufacturers I have provided. The chairs consist of oak wood, foam and fabric. The steel frame is constructed of 1"x 1", 16 gauge steel and also 1"x 2" 14 gauge steel.
This document, K961663, is a 510(k) premarket notification for a lift chair. It is a submission for a medical device and describes its equivalence to existing predicate devices. However, it does not contain the type of structured data and study information typically found in submissions for AI/ML-driven medical devices that involve performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot extract the information requested in the prompt, such as acceptance criteria tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance.
The document primarily focuses on establishing substantial equivalence by stating:
- The use of UL listed and CSA approved motors and switches (same as predators).
- The lift chair market's long existence, implying established safety profiles.
- The use of similar materials (oak wood, foam, fabric, steel frame) as predicate devices.
- The same weight capacity (300 lbs) as predicate devices.
- Similar frame base width for stability as predicate devices.
In summary, this document is a comparison to predicate devices based on design and materials, not a performance study for a novel AI/ML algorithm or system.
If you have a document related to an AI/ML medical device submission, please provide that, and I will do my best to extract the requested information.
§ 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.