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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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
You will find enclosed literature on Five (5) Lift chair companies already marketing very similar products.
As you will see the motors and switches are all UL listed and CSA approved on each of the five different chairs. I will be using the same motor and switch made by Hubbell Corp.
The lift chair market has been in existence for 25 years, so the product has been fully tested through many cycles.
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.
The weight capacity of all their units is 300 lbs. which will be the same on mine.
The frame bases on all the units are basically the same width for stability. My frame will be the same.
As you can see my products are actually the same as the products of the five manufacturers enclosed.
As a summary of safety, my products do not raise any safety requirements.
Thank you very much and if you have any questions, my telephone number is (717)-822-8629. My address is as follows:
788 Keating Street Wilkes Barre Twp, PA. 18702
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