(8 days)
The Pinnacle Stair Way Lift is intended to assist transfers of patients or mobility impaired persons up and down flights of stairs.
The Harmar Summit, LLC Pinnacle Stair Way Lift is a battery powered patient transport. It's intended function and use is to assist transfers of patients or mobility impaired persons up and down flights of stairs. It is intended for indoor use only. The system is designed to carry a single patient, up a single flight of stairs while seated, at angle of between 27-45 degrees. Maximum travel distance is 75' at the maximum patient weight is 350 lbs. Maximum travel speed at full rated load is 20' per minute.
The provided document describes the Harmar Summit Pinnacle Stair Way Lift, a battery-powered patient transport device. However, it does not contain information on the acceptance criteria and study design elements that would typically be found in a medical device clinical validation or performance study.
Here's a breakdown of what is available and what is missing based on your request:
Acceptance Criteria and Reported Device Performance (Missing/Not Applicable)
The document primarily focuses on regulatory approval (510(k)) and substantial equivalence to a predicate device, rather than detailed performance comparisons against quantitative acceptance criteria from a specific study.
- A table of acceptance criteria and the reported device performance: This information is not provided. The document states the device is "CSA and CUS listed under 226703" and "certified by CSA to the following standards; ASME A18.1 Safety Standards for Platform Lifts and Stairway Lifts, ASME A17.1 Safety Code for Elevators and Escalators." This implies the device meets the safety standards, but specific performance metrics and their corresponding acceptance criteria from a separate study are not detailed.
Study Details (Missing/Not Applicable for a medical device clinical validation)
The "Performance Data" section solely refers to certifications to standards, not a dedicated study to assess clinical performance or diagnostic accuracy. Therefore, most of the following information is not present:
- Sample size used for the test set and the data provenance: Not applicable. The document discusses regulatory certification to standards, not a test set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Available Information Related to Performance:
The document mentions some physical specifications and operational limits, which could be interpreted as inherent performance characteristics, but not as part of a formal study with acceptance criteria:
- Maximum patient weight: 350 lbs.
- Maximum travel speed at full rated load: 20' per minute.
- Angle of stairs: between 27-45 degrees.
- Maximum travel distance: 75'.
- Intended for indoor use only.
Conclusion:
The provided 510(k) Premarket Notification focuses on demonstrating substantial equivalence to a predicate device and compliance with established safety standards (ASME A18.1 and A17.1) through CSA certification. It does not present a detailed study with acceptance criteria for device performance in the way one would expect for a diagnostic or AI-powered medical device. The "Performance Data" section simply states that the device is certified to existing safety standards, implying it meets the requirements of those standards rather than detailing a specific experimental validation study.
§ 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.