(194 days)
The Mobile Stairlift is a manual transport device which transports the ride in a seated upright position up or down a flight of stairs. The Stairlift is capable of moving adult, adolescent occupants (12 years and up) who are able to remain seated while secured by the safety belt. The Mobile Stairlift is for residential use with proper training. This device can also be used routinely in a hospital environment or as a tool for all types of medical personnel. The target patient population are disabled seated persons i.e. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.
The Mobile Stairlift is a manual transport device which transports the ride in a seated upright position up or down a flight of stairs.
I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that a device meets the acceptance criteria. The text provided is an FDA 510(k) clearance letter for a "Powered Patient Transport" device named "Genesis (MS-P02-GEN)".
It discusses:
- The FDA's review and determination of substantial equivalence.
- General controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
- Additional controls for Class II or III devices.
- FDA guidance documents for changes requiring new premarket notifications.
- Quality System (QS) regulation requirements.
- Compliance with other Act requirements (registration and listing, labeling, medical device reporting, good manufacturing practices, electronic product radiation control provisions, Unique Device Identification System rule).
- Misbranding by reference to premarket notification.
- Contact information for questions.
- Indications for Use for the "Mobile Stairlift" (which is actually the device name, not "Genesis (MS-P02-GEN)", despite being listed under "Device Name" as "Genesis (MS-P02-GEN)").
There is no mention of specific acceptance criteria (like accuracy, sensitivity, specificity, etc.) nor any details about a study conducted to prove the device meets such criteria, the sample size used, expert qualifications, ground truth establishment, or any comparative effectiveness studies with human readers.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study and effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 890.5150 Powered patient transport.
(a)
Powered patient stairway chair lifts —(1)Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.(2)
Classification. Class II. The stairway chair lift 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:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of American Society of Mechanical Engineers (ASME) A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b)
All other powered patient transport —(1)Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.(2)
Classification. Class II.